In e ne In e en ions 23 (2021) 100363
A ailable online 7 Janua y 2021
2214-7829/© 2021 The Au ho s. Published by Else ie B.V. This is an open access a icle unde he CC BY-NC-ND license
(h p://c ea i ecommons.o g/licenses/by-nc-nd/4.0/).
Blended ansdiagnos ic g oup CBT o emo ional diso de s: A easibili y
ial p o ocol
Amanda Díaz-Ga cía
a
,
*
, Albe o Gonz´
alez-Robles
a
, Azucena Ga cía-Palacios
b
,
c
,
Isabel Fe n´
andez-Felipe
b
, Cin ia Tu
b
, Diana Cas illa
c
,
d
, C is ina Bo ella
b
,
c
a
Depa men o Psychology and Sociology, Uni e sidad de Za agoza (Campus de Te uel), Te uel, Spain
b
Depa men o Basic and Clinical Psychology, and Psychobiology, Uni e si a Jaume I, Cas ellon, Spain
c
CIBER Fisiopa ología Obesidad y Nu ici´
on (CIBERObn), Ins i u o Salud Ca los III, Mad id, Spain
d
Depa men o Pe sonali y, E alua ion and Psychological T ea men s, Uni e sidad de Valencia, Valencia, Spain
ARTICLE INFO
Keywo ds:
Blended psycho he apy
Blended CB
G oup psycho he apy
T ansdiagnos ic
Emo ional diso de s
Anxie y
Dep ession
ABSTRACT
In oduc ion: Emo ional diso de s (anxie y and dep essi e diso de s) a e a ele an public heal h conce n asso-
cia ed wi h high p e alence, high cos s, and impo an disabili y. The e o e, esea ch p io i ies include designing
and es ing cos -e ec i e in e en ions o each e e yone in need. In e ne -deli e ed in e en ions o emo ional
diso de s a e e ec i e and can help o dissemina e and implemen e idence-based ea men s. Howe e ,
al hough hese ea men s a e gene ally e ec i e, no all pa ien s bene i om his ea men o ma equally.
Blended ea men s a e a new o m o in e en ion ha combines he s eng hs o ace- o- ace and In e ne
app oaches. Ne e heless, esea ch on blended in e en ions has ocused p ima ily on indi idual he apy, and
less a en ion has been paid o he po en ial o using his o ma in g oup psycho he apy. This s udy aims o
analyze he easibili y o blended ansdiagnos ic g oup CBT o emo ional diso de s. The cu en a icle de-
sc ibes he s udy p o ocol o his ial.
Me hod and analysis: A one-a med pilo ial will be conduc ed. Pa icipan s will be 30 adul s su e ing om DSM-
5 anxie y and/o dep essi e diso de s. The ea men consis s o a blended ansdiagnos ic g oup in e en ion
deli e ed du ing a pe iod o 24 weeks. G oups o 6 o 10 pa ien s will a end a o al o eigh 2-hou , ace- o- ace
sessions, al e na ed wi h he use o an online pla o m whe e hey will ind he con en s o he ea men p o-
ocol. The in e en ion has ou co e componen s: p esen - ocused awa eness, cogni i e lexibili y, iden i ica ion
and modi ica ion o beha io al and cogni i e pa e ns o emo ional a oidance, and in e ocep i e and si ua ional
exposu e. These componen s a e deli e ed in 16 modules. Assessmen s will be pe o med a baseline, du ing he
ea men , a pos - ea men , and a 3-mon h ollow-up. Clinical and ea men accep abili y ou comes will be
included. Quan i a i e and quali a i e da a (pa icipan s’ iews abou blended g oup psycho he apy) will be
analyzed.
E hics and dissemina ion: The ial has ecei ed e hical app o al om he E hics Commi ee o Uni e si a Jaume I
(Sep embe 2019) and will be conduc ed in acco dance wi h he s udy p o ocol, he Decla a ion o Helsinki, and
good clinical p ac ice. The esul s o his s udy will be dissemina ed by p esen a ion a con e ences and will be
submi ed o publica ion in a pee - e iewed jou nal.
T ial egis a ion: ClinicalT ials.go Iden i ie : NCT04008576. Regis e ed 05 July 2019, h ps://clinical ials.
go /c 2/show/NCT04008576
1. In oduc ion
Emo ional diso de s (anxie y and dep essi e diso de s) (Bullis e al.,
2019) a e he mos p e alen men al diso de s (Fe a i e al., 2013;
Kessle e al., 2005), and impac he li es o millions o people wo ld-
wide (Kohn e al., 2004; S eel e al., 2014). Mo eo e , emo ional dis-
o de s a e associa ed wi h high cos s (Andlin-Sobocki and Wi chen,
2005; Cuijpe s e al., 2012), disabili y (Bax e e al., 2014), ch onici y
* Co esponding au ho .
E-mail add esses: [email p o ec ed] (A. Díaz-Ga cía), [email p o ec ed] (A. Gonz´
alez-Robles), [email p o ec ed] (A. Ga cía-Palacios), [email p o ec ed]
(I. Fe n´
andez-Felipe), [email p o ec ed] (C. Tu ), [email p o ec ed] (D. Cas illa), [email p o ec ed] (C. Bo ella).
Con en s lis s a ailable a ScienceDi ec
In e ne In e en ions
jou nal homepage: www.else ie .com/loca e/in en
h ps://doi.o g/10.1016/j.in en .2021.100363
Recei ed 25 Oc obe 2020; Recei ed in e ised o m 21 Decembe 2020; Accep ed 29 Decembe 2020
In e ne In e en ions 23 (2021) 100363
2
(Richa ds, 2011), and high como bidi y a es wi h o he emo ional
diso de s (K oenke e al., 2007).
A la ge body o esea ch shows he e icacy o cogni i e-beha io al
ea men s (CBT) o emo ional diso de s (Na han and Go man, 2015).
Howe e , al hough he e is li le doub abou he e icacy and e ec-
i eness o CBT o emo ional diso de s, he dissemina ion and e ec i e
implemen a ion o hese p o ocols is s ill a majo challenge o esea ch
and clinical p ac ice (McHugh and Ba low, 2010). In o he wo ds,
despi e esea ch e o s o p o ide empi ically suppo ed ea men s
du ing he pas h ee decades, he e is s ill an impo an ea men gap in
men al heal hca e, leading o a la ge p opo ion o pa ien s who do no
ecei e ea men in men al heal hca e se ices, especially hose wi h
anxie y and mood diso de s (Kohn e al., 2004; Lilien eld e al., 2013;
Wang e al., 2007).
In he pas wo decades, di e en app oaches ha e eme ged o
imp o e he dissemina ion and implemen a ion o e idence-based
ea men s. In his ega d, one impo an line o esea ch is he ans-
diagnos ic app oach o he ea men o emo ional diso de s. The e i-
cacy o ansdiagnos ic ea men s has been shown in a g owing numbe
o me a-analy ic s udies (Ga cía-Escale a e al., 2016; Newby e al.,
2015, 2016; Reinhol and K ogh, 2014). The main de ining cha ac e -
is ic o ansdiagnos ic ea men s is ha hey “apply he same unde -
lying ea men p inciples ac oss men al diso de s, wi hou ailo ing he
p o ocol o speci ic diagnoses” (McManus e al., 2010, p. 4). B oadly,
ansdiagnos ic ea men s a e based on he p emise ha he common-
ali ies o psychological diso de s ou weigh hei di e ences, and ha he
obse ed di e ences (symp oms) a e speci ic mani es a ions o b oade ,
unde lying common psychopa hological p ocesses. This app oach has
been called he “mechanis ically ansdiagnos ic app oach”, and i has
ueled he de elopmen o ansdiagnos ic ea men s based on “sha ed
mechanisms” (Saue -Za ala e al., 2017). Fo hese easons, he use o
ansdiagnos ic ea men s has impo an implica ions o clinical
p ac ice. Fo example, como bid p esen a ions can be a ge ed mo e
app op ia ely (Mansell e al., 2008), and aining cos s a e lowe
because clinicians only ha e o be ained in one p o ocol ins ead o
di e en p o ocols o each speci ic diagnosis (McE oy e al., 2009).The
goal o hese ea men s has ypically been o ain he indi idual in
emo ion egula ion s a egies o add ess he dimension o neu o icism o
nega i e a ec (Ba low e al., 2004; No on, 2012; Ti o e al., 2010,
2011). Howe e , he in e es in di ec ly a ge ing posi i e a ec in he
con ex o emo ional diso de s has inc eased in mo e ecen esea ch
(Ca l e al., 2018; Taylo e al., 2017). Fo ins ance, Ca l e al. (2018)
p oposed a module o he egula ion o posi i e a ec i i y o be applied
ansdiagnos ically ac oss anxie y and dep essi e diso de s. Acco ding
o he au ho s, he module can be implemen ed lexibly, ei he in e-
g a ed in o a modula ea men p og am (e.g., he Uni ied P o ocol) o
as an adjunc ea men o pa ien s who show de ici s in posi i e a ec
a pos - ea men .
Ano he app oach ha could enhance he dissemina ion and imple-
men a ion o e idence-based CBT and conside ably educe he cos s is
he use o he In e ne o deli e ea men s. A numbe o sys ema ic
e iews ha e shown ha In e ne -deli e ed ea men s o dep ession
and anxie y diso de s a e mo e e ec i e han di e en con ol g oups,
such as wai lis and ea men as usual g oups (And ews e al., 2018;
Richa ds and Richa dson, 2012; Spek e al., 2007), and ha hey wo k as
e ec i ely as ace- o- ace psycho he apy (Ca lb ing e al., 2018). In he
con ex o In e ne -deli e ed ea men s, one possibili y consis s o he
so-called “blended ea men s”, ha is, he combina ion o ace- o- ace
and In e ne -deli e ed he apy (Kleiboe e al., 2016; Koois a e al.,
2014). Some o he ad an ages o hese in e en ions include enhancing
he lea ning p ocess (e.g., e en ion o lea ned in o ma ion o
imp o emen o lea ned asks), ex ending he each o in o ma ion by
using he In e ne , and op imizing de elopmen cos s and ime and cos -
e ec i eness (i.e., o o e lea ning s a egies ha each la ge numbe s
o indi iduals quickly) (Cuccia e e al., 2008). Mo eo e , by pa ici-
pa ing in a blended ea men , pa ien s can wo k on hei own men al
heal h be ween sessions, inc easing hei abili y o adap and sel -
manage, which a e co e aspec s in de ining heal h (Hube e al.,
2011). The e is g owing suppo in he li e a u e o he claim ha
blended he apy may sa e clinician ime, lead o lowe d opou a es,
help main ain he e ec s o inpa ien he apy, and inc ease he e ec s o
psycho he apy, compa ed o s and-alone ace- o- ace he apy (E be
e al., 2017). Thus, ano he ad an age o blended ea men s is hei
lowe cos in compa ison wi h adi ional ace- o- ace psycho he apy,
sugges ing ha his ea men deli e y o ma can help o sa e he apis
ime. Fo ins ance, he usual ea men s include be ween 12 and 14
sessions, whe eas blended ea men s a e sho ened o 6–8 sessions,
ep esen ing a 33–57% sa ings in e ms o cos s and ime (Schus e
e al., 2018). Fu he mo e, blended ea men s migh be a good al e -
na i e o hose pa ien s who a e less likely o bene i om guided o
unguided In e ne -deli e ed ea men s (wi h no ace- o- ace con ac ).
Ano he way o educe he cos s o psycho he apy is h ough he use o
he g oup o ma . The li e a u e has shown ha , o he ea men o
anxie y and dep essi e diso de s, di e en me hods o implemen a ion
(indi idual s. g oup CBT) ha e led o simila d op-ou a es o sa is-
ac ion wi h he ea men (Bas ien e al., 2004; J´
onsson e al., 2011).
Nume ous ad an ages ha e been a ibu ed o g oup he apy, such as
suppo ( he g oup become a aluable sou ce o suppo ), con iden iali y
(one o he g ound ules o g oup he apy), o di e si y (i makes i
possible o disco e a whole ange o s a egies o ace p oblems) (APA,
2013; Sepúl eda e al., 2010). In addi ion, as he Na ional Ins i u e o
Heal h and Ca e Excellence ecommends, g oup CBT should be consid-
e ed o people wi h mild o mode a e dep ession who decline low-
in ensi y psychosocial in e en ions such as In e ne -based ea men s
(NIH, 2009). Fu he mo e, he li e a u e sugges s ha he wo ea men
o ma s (indi idual s. g oup) a e compa able in e ms o a es o
ea men accep ance, d opou , emission, o imp o emen (Ba kowski
e al., 2016). The e o e, g oup he apy is an app op ia e s a egy o
educe he bu den o hese diso de s in a mo e cos -e ec i e manne .
A ea men s a egy ha may boos he cos -e ec i eness ela ion-
ship is he combina ion o he blended and g oup o ma s. In spi e o he
ad an ages o g oup CBT, in he speci ic ield o ansdiagnos ic ea -
men s, esea ch has mainly ocused on indi idual ansdiagnos ic
ea men s (Gonz´
alez-Robles e al., 2018a, 2018b), wi h some excep-
ions (No on, 2012; Reinhol e al., 2017). In Spain, Osma e al. (2019)
a e conduc ing a andomized con olled ial (RCT) ha es s ans-
diagnos ic g oup psycho he apy in specialized men al heal h ca e.
Howe e , o ou knowledge, no s udies ha e been published ha
combine blended (i.e., ace- o- ace plus In e ne -deli e ed psycho he -
apy) and g oup deli e y o ma s o p o ide ansdiagnos ic ea men s
o emo ional diso de s. The exis ing s udies on blended g oup psy-
cho he apy a e qui e sca ce, and hey ocus only on he ea men o
majo dep essi e diso de (Schus e e al., 2018). Combining hese wo
ea men app oaches o deli e a ansdiagnos ic ea men migh be a
highly cos -e ec i e ea men s a egy o hese diso de s, which could
ul ima ely con ibu e o he dissemina ion and implemen a ion o
e idence-based ansdiagnos ic CBT.
1.1. Cu en s udy
The objec i e o his s udy is o analyze he easibili y o blended
ansdiagnos ic g oup CBT o emo ional diso de s. To his end, a
ansdiagnos ic In e ne -deli e ed ea men p o ocol will be deli e ed
in combina ion wi h g oup psycho he apy sessions. The ea men p o-
ocol is a mechanis ically ansdiagnos ic ea men ha adds a speci ic
componen o he egula ion o posi i e a ec i i y. Thus, he ea men
con ains s a egies o he egula ion o bo h nega i e a ec i i y and
posi i e a ec i i y. The manualized e sion o his ea men p o ocol
has al eady been pilo - es ed in an indi idual ace- o- ace o ma
(Gonz´
alez-Robles e al., 2019), and esul s o a andomized con olled
ial o he In e ne -deli e ed e sion ha e al eady been published
(Gonz´
alez-Robles e al., 2020). Speci ically, we aim o s udy he
A. Díaz-Ga cía e al.
In e ne In e en ions 23 (2021) 100363
3
adequacy o he di e en me hods o ec ui men and da a collec ion (e.
g., how b oad o es ic i e eligibili y c i e ia a e, how willing pa ien s
a e o pa icipa e, ime needed o collec da a), o explo e easons o
non-pa icipa ion and o d opping ou om he ea men , o analyze
and selec op imal ou come measu es, and o explo e pa ien s’ accep -
abili y o he in e en ion (bo h quan i a i ely and quali a i ely).
Fu he mo e, a seconda y aim o he s udy is o p elimina y es ima e he
impac o he in e en ion a pos - ea men and 3-mon h ollow up.
These objec i es will help o op imize he design o a u u e RCT and
hey a e consis en wi h he ecommenda ions ound in he li e a u e
abou easibili y s udies (Eld idge e al., 2013, 2016). The cu en a icle
desc ibes he s udy p o ocol o his ial.
2. Me hod and analysis
2.1. Design
The cu en s udy uses a single-g oup, open- ial design wi h h ee
measu emen poin s: baseline (p e- ea men ), immedia ely a e he
in e en ion (pos - ea men ), and a 3-mon h ollow-up. A mixed-
me hod design will be used (including quan i a i e and quali a i e
me hodology) (C eswell and Cla k, 2017), in line wi h guidelines o
Good Repo ing o a Mixed Me hod S udy (O’ca hain e al., 2008) and
o complex in e en ions (C aig e al., 2008).This design is app op ia e
o e alua e an in e en ion be o e i is in oduced in a clinical se ing
(Bowen e al., 2009). Quan i a i e da a will be collec ed h ough he
online pla o m using alida ed ques ionnai es. Quali a i e da a will be
collec ed using he ocus g oup me hod using in-dep h ques ions.
Quan i a i e da a will be employed o explo e changes in ou comes,
while quali a i e da a will p o ide da a on he pa icipan s’ opinions
abou he ea men , he ace- o- ace sessions, and he online pla o m.
2.2. Pa icipan s, ec ui men and p ocedu e
Pa icipan s will be adul s a ending he Se ice o Psychological
Assis ance a Uni e si a Jaume I o seek psychological help. The main
aim o his se ice is o p o ide e idence-based ea men p o ocols
using In o ma ion and communica ion Technologies ools. A e an
ini ial sc eening session, an addi ional session will be a anged wi h
hose candida es in e es ed in pa icipa ing o con i m ha hey mee
he eligibili y diagnos ic c i e ia, using he MINI In e na ional Neu o-
psychia ic In e iew (MINI) (Fe ando e al., 1997; Sheehan e al.,
1998). This session will be used o collec sociodemog aphic and o he
clinical da a (e.g., medica ion). Mo eo e , pa ien s will be asked abou
medica ion ypes and dose be o e s a ing he in e en ion, and hese
da a will be moni o ed and eco ded du ing he ea men and ollow-up
pe iods. Once he cha ac e is ics o he s udy ha e been explained o
pa icipan s, hey will be asked o sign an in o med, w i en consen
o m. All he assessmen ins umen s will be deli e ed h ough a web
pla o m (h ps://www.psicologiay ecnologia.labpsi ec.es), and assess-
men s will ake place a p e- and pos - ea men and a 3-mon h ollow-
up. One week be o e he in e en ion s a s (i.e., i s g oup session),
pa ien s will be asked o comple e p e- ea men assessmen in-
s umen s. Pos - ea men ques ionnai es will be comple ed 3 weeks
a e he las g oup session.
G oups will be led by wo ained he apis s (AD-G and AG-R), each
o whom will ha e he suppo o a co- he apis (IF-F and CT). Bo h
he apis s and co- he apis s a e quali ied clinicians wi h expe ience in
he ea men o emo ional diso de s and ha e been ained in he use o
he ansdiagnos ic ea men p o ocol as well as he s udy p o ocol.
Mo eo e , he leading he apis s (AD-G and AG-R) de eloped doc o al
disse a ions ocused on he applica ion o ansdiagnos ic CBT (Díaz-
Ga cía e al., 2017; Gonz´
alez-Robles e al., 2020). All he he apis s ha e
expe ience wi h g oup psycho he apy, and hey will be supe ised by
expe clinicians wi h ex ensi e expe ience in he applica ion o
e idence-based CBT and his ansdiagnos ic p o ocol o emo ional
diso de s. All he he apis s in ol ed in pa icipan assessmen s ha e
al eady been ained in he use o he diagnos ic in e iew (i.e., MINI).
The s udy lowcha is shown in Fig. 1.
The s udy has been egis e ed in Clinical ials.go (h ps://clinical
ials.go /) as NCT04008576 (h ps://clinical ials.go /c 2/show/NC
T04008576) and ecei ed e hical app o al om he E hics Commi ee
o Uni e si a Jaume I (Cas ellon, Spain).
Because he s udy is designed o assess he easibili y o conduc ing
an RCT, a o mal powe calcula ion is no conside ed app op ia e. A
minimum o 30 pa icipan s is conside ed enough o co e he aims o
his easibili y s udy and o p o ide da a abou a numbe o pa ame e s
(i.e., adhe ence, a i ion, sa is ac ion wi h he online ea men and
wi h he ace- o- ace g oup sessions, de e io a ion a e, pla o m usage,
and so on) ha will help o op imize he u u e RCT design.
2.3. Eligibili y c i e ia
The selec ion o pa icipan s will be based on he ollowing eligibili y
c i e ia: a) age 18 yea s old o olde ; b) luency in Spanish; c) daily
access o he In e ne a home and an email add ess; d) mee ing DSM-5
diagnos ic c i e ia (DSM-5 Ame ican Psychological Associa ion, 2013)
o a leas one o he ollowing emo ional diso de s (Bullis e al., 2019):
majo dep essi e diso de , dys hymic diso de , o he speci ied/un-
speci ied dep essi e diso de , panic diso de , ago aphobia, social anxi-
e y diso de , gene alized anxie y diso de , o he speci ied/unspeci ied
anxie y diso de , and obsessi e-compulsi e diso de ; e) absence o
schizoph enia, bipola diso de and/o alcohol and/o subs ance
dependence diso de ; ) absence o high suicide isk; g) no ecei ing any
addi ional psychological ea men du ing he s udy pe iod; and h) no
changes and/o inc eases in pha macological ea men du ing he
ea men and ollow-up pe iods (dec eases in medica ion will be
accep ed).
2.4. T ea men
The ea men consis s o a blended ansdiagnos ic g oup in e -
en ion deli e ed du ing a pe iod o 24 weeks. G oups o 6 o 10 pa ien s
will a end a o al o eigh 2-hou , ace- o- ace sessions, al e na ed wi h
he use o an online pla o m whe e hey will ind he con en s o he
ea men p o ocol. The ea men is a 16-module ansdiagnos ic CBT
In e ne -deli e ed p o ocol adap ed om he Uni ied P o ocol (Ba low
e al., 2011a, 2011b) and ea men s a egies de i ed om Dialec ical
Beha io al The apy (Linehan, 1993). The ea men was ini ially
de eloped and s uc u ed in a pa ien and he apis handbook (Bo ella
e al. T ansdiagnos ic T ea men o Emo ion Diso de s: Manualized
T ea men P o ocol, unpublished) and, la e , adap ed o a mul imedia
web pla o m designed by ou esea ch g oup (h ps://www.psicolo
giay ecnologia.labpsi ec.es). The in e en ion has ou co e compo-
nen s ha aim o: a) inc ease p esen - ocused awa eness, b) p omo e
cogni i e lexibili y, c) iden i y and modi y beha io al and cogni i e
pa e ns o emo ional a oidance, and d) p omo e in e ocep i e and
si ua ional g aded exposu e. Addi ionally, i also con ains a ea men
componen aimed a egula ing posi i e a ec (modules 12 o 15). These
componen s a e p eceded by h ee modules con aining psychoeduca ion
abou emo ions and emo ion egula ion, and a module o acili a e pa-
ien s’ eadiness o change (mo i a ion o change) (modules 1 o 3), and
hey a e ollowed by a elapse p e en ion module (module 16). Mo e
de ails abou he online ea men pla o m and he con en s o he
modules ha e been published elsewhe e (Díaz-Ga cía e al., 2017;
Gonz´
alez-Robles e al., 2019).
Each g oup will mee once e e y h ee weeks. Du ing he h ee weeks
be ween g oup sessions, pa icipan s will be asked o access he online
pla o m o e iew he ea men con en s and do he homewo k asks.
A endance o pa icipan s o he ace- o- ace sessions as well as p og am
usage will be moni o ed h oughou he whole s udy pe iod. O e all,
g oup sessions will be di ided in wo pa s: he i s pa will ocus on
A. Díaz-Ga cía e al.
In e ne In e en ions 23 (2021) 100363
4
discussing he con en s o he modules al eady a ge ed, whe eas he
second pa will be de o ed o p esen ing he con en s o he modules o
be add essed in he ollowing h ee weeks. In o de o make he sessions
mo e dynamic and appealing o pa ien s, a p ac ical and pa icipa i e
app oach will be ollowed. The s uc u e o he ace- o- ace g oup ses-
sions and he con en s o he online modules a e desc ibed in g ea e
de ail in Table 1.
In o de o p omo e he use o he online pla o m be ween he g oup
sessions, all he pa icipan s will be sen wo au oma ized emails (e.g.,
“We encou age you o e iew he modules and ca y ou all he asks
desc ibed in he p og am as many imes as necessa y. Remembe , he
mo e you p ac ice, he mo e you will bene i om he ea men ”) and
wo mobile phone ex messages (e.g. “Hi he e! Don’ gi e up on you
module asks! Dedica e some ime and e o o hem. Remembe ,
p ac ice makes pe ec !”) once a week du ing he ea men pe iod. In
gene al, he pu pose o hese messages is o encou age he p ac ice o he
ea men s a egies, inc ease he ime he pa icipan s spend using he
pla o m, and p o ide posi i e ein o cemen .
2.5. Ou come measu es
2.5.1. Clinical ou comes
2.5.1.1. Diagnos ic in e iew. Mini In e na ional Neu opsychia ic
In e iew Ve sion 7.0.2 (MINI). I is a widely used s uc u ed diagnos ic
psychia ic in e iew o de e mine DSM-5 and ICD-10 diagnoses. This
in e iew is a b ie and accu a e s uc u ed in e iew ha can be
adminis e ed by clinicians a e a b ie aining session and in a sho
pe iod o ime. I can also be adminis e ed by nonclinical in e iewe s
a e mo e in ensi e aining. The MINI has excellen es - e es and
in e - a e eliabili y (k =0.88–1.00) and adequa e concu en alidi y
wi h he Composi e In e na ional Diagnos ic In e iew (Lec ubie e al.,
1997). This in e iew has been ansla ed and alida ed in Spanish
(Fe ando e al., 1997).
2.5.1.2. P ima y ou comes measu es. O e all Anxie y Se e i y and
Impai men Scale (OASIS) (Campbell-Sills e al., 2009). The OASIS is a
5-i em ques ionnai e ha assesses he se e i y and unc ional impai -
men caused by anxie y symp oms du ing he p e ious week. I ems a e
a ed on a scale anging om 0 o 4, added oge he o ob ain a sco e
ha anges be ween 0 and 20. P e ious s udies ha e shown good
in e nal consis ency (
α
=0.80), es - e es eliabili y, and con e gen
and disc iminan alidi y. The Spanish e sion has shown good in e nal
consis ency (
α
=0.86) and cons uc alidi y in pa ien s wi h emo ional
diso de s (Gonz´
alez-Robles e al., 2018a, 2018b).
O e all Dep ession Se e i y and Impai men Scale (ODSIS) (Ben ley
e al., 2014). The ODSIS is a b ie scale made up o 5 i ems o he
assessmen o he se e i y and impai men associa ed wi h dep essi e
symp oms du ing he p e ious week. The esponses a e coded on a 5-
poin scale (0 o 4), and sco es can ange be ween 0 and 20 poin s.
The ins umen has demons a ed excellen in e nal consis ency in
di e en samples (
α
=0.91 o 0.94) and good con e gen and disc im-
inan alidi y. The Spanish alida ion has also shown excellen in e nal
consis ency (
α
=0.93) and con e gen and disc iminan alidi y (Mi a
e al., 2019).
2.5.1.3. Seconda y ou comes measu es. Posi i e and Nega i e A ec
Schedule (PANAS) (Wa son e al., 1988). The PANAS is a 20-i em scale
ha assesses he dimensions o posi i e a ec i i y and nega i e a ec-
i i y. The scale con ains 10 desc ip o s o each dimension (e.g.,
“en husias ic”, “inspi ed”, o “p oud” in he posi i e a ec i i y scale;
“sca ed”, “i i able”, o “guil y” in he nega i e a ec scale). Fo each
i em, esponses a e a ed on a 5-poin scale (1–5), and he sco es on each
scale (10 i ems on each) can ange om 10 o 50. The scale has shown
excellen con e gen and disc iminan alidi y. The Spanish e sion has
demons a ed good psychome ic p ope ies (Díaz-Ga cia e al., 2020;
Sandín e al., 1999).
NEO- i e ac o In en o y (NEO-FFI) (Robins e al., 2001). The NEO-
FFI is a sho e e sion o he NEO-PI-R composed o 60 i ems ha
e alua e he pe sonali y dimensions o he i e- ac o pe sonali y model
(Cos a and McC ae, 1992). Because his s udy is ocused on a mecha-
nis ically ansdiagnos ic ea men ha emphasizes he dimensions o
neu o icism and ex a e sion (McManus e al., 2010), only he sco es in
hese dimensions will be used. The NEO-FFI has shown good es - e es
eliabili y. The Spanish e sion o he ques ionnai e also showed good
psychome ic p ope ies (Aluja e al., 2005).
Quali y o Li e Index (QLI) (Mezzich e al., 1986). The QLI is a scale
con aining 10 i ems ha assesses quali y o li e in he ollowing en
a eas: psychological well-being, physical well-being, emo ional and so-
cial suppo , in e pe sonal unc ioning, sel -ca e and independen
unc ioning, communi y and se ice suppo , occupa ional unc ioning,
sel - ealiza ion, spi i ual sa is ac ion, and an o e all assessmen o
Fig. 1. Flowcha o pa icipan s.
A. Díaz-Ga cía e al.
In e ne In e en ions 23 (2021) 100363
5
Table 1
S uc u e o ace- o- ace sessions and mul imedia elemen s.
Sessions G oup session Modules Mul imedia elemen s
S1 Pa 1 (45′):
– The apis s’ in oduc ion
– Discussion o he ad an ages
and ules o g oup he apy
– Pa ien s’ in oduc ion
Pa 2 (75′):
– P esen a ion o M1 o M3
M1. Emo ional diso de s and
emo ion egula ion
M2. Mo i a ion o change
M3. Unde s anding he ole o
emo ions
Videos 1–5. Objec i es o he module; he ansdiagnos ic app oach; emo ion egula ion;
con en s o he p og am; he impo ance o homewo k asks
Videos 6–12. Examples o pa ien s wi h di e en emo ional diso de s
Mul iple-choice check ques ions
PDF1 ques ions o e lec ion
PDF2 summa y o M1
Videos 1–6. Objec i es o he module; ambi alence abou change; iden i ying objec i es and
goals; p os and cons o changing (example); iden i ying objec i es and goals (example); he
impo ance o homewo k asks
Mul iple-choice check ques ions
PDF1 ques ions o e lec ion
PDF2 decisional balance wo kshee
PDF3 ea men goal se ing wo kshee
PDF4 summa y o M2
Videos 1–4. Objec i es o he module; wha a e emo ions?; he adap i e ole o emo ions; he
h ee-componen model o emo ions;
Mul iple-choice check ques ions
PDF1 he unc ion o emo ions
PDF2 h ee componen model o emo ions wo kshee
PDF3 summa y o M2
S2 Pa 1 (30′):
– P esen a ion o he agenda
– Doub s and ques ions abou M1
o M3
– Emphasis on sel -moni o ing,
p ac ice and homewo k
Pa 2 (90′):
– P esen a ion o M4 and M5
M4. The accep ance o emo ional
expe iences
M5. P ac icing accep ance
Videos 1–5. Objec i es o he module; p ima y and seconda y emo ional esponse; p esen -
ocused emo ional awa eness; obse e he b ea h; he i e senses exe cise
Mul iple-choice check ques ions
PDF1 “wha ” echniques
PDF2 “how” echniques
PDF3 summa y o M4
Videos 1–4. Objec i es o he module; p esen - ocused awa eness o physical sensa ions;
p esen - ocused awa eness o hough s; p esen - ocused awa eness o emo ions
Mul iple-choice check ques ions
PDF1 p esen - ocused awa eness o physical sensa ions wo kshee
PDF2 p esen - ocused awa eness o hough s wo kshee
PDF3 p esen - ocused awa eness o emo ions wo kshee
PDF4 p esen - ocused awa eness o he daily li e wo kshee
PDF5 web links wi h ideos o p ac ice p esen - ocused awa eness o emo ions
PDF6 summa y o M5
S3 Pa 1 (30′):
– P esen a ion o he agenda
– Doub s and ques ions abou M4
and M5
– Emphasis on sel -moni o ing,
p ac ice and homewo k
Pa 2 (90′):
– P esen a ion o M6 and M7
M6. Lea ning o be lexible
M7. P ac icing cogni i e
lexibili y
Videos 1–8. Objec i es o he module; cogni i e app aisal; how in e p e a ions in luence
emo ions; how he same si ua ion can be in e p e ed in di e en ways; how emo ions
in luence in e p e a ions; nega i e hough s (ca as ophizing); downwa d a ow echnique;
iden i ica ion and eapp aisal o au oma ic hough s (example)
Mul iple-choice check ques ions
PDF1 downwa d a ow echnique wo kshee
PDF2 iden i ica ion and eapp aisal o au oma ic hough s wo kshee
PDF3 summa y o M6
Videos 1–5. Objec i es o he module; cogni i e eapp aisal; echniques o cogni i e
eapp aisal; s a egies o he eapp aisal o au oma ic hough s (example); e alua ing
obsessi e, in usi e, nonsensical hough s
Mul iple-choice check ques ions
PDF1 s a egies o he eapp aisal o au oma ic hough s wo kshee
PDF2 iden i ica ion and eapp aisal o au oma ic hough s wo kshee
PDF3 downwa d a ow echnique wo kshee
PDF4 iden i ica ion and eapp aisal o au oma ic hough s wo kshee
PDF5 summa y o M7
S4 Pa 1 (30′):
– P esen a ion o he agenda
– Doub s and ques ions abou M6
and M7
– Emphasis on sel -moni o ing,
p ac ice and homewo k
Pa 2 (90′):
– P esen a ion o M8 and M9
M8. Emo ional a oidance
M9. Emo ion-d i en beha io s
Videos 1–3. Objec i es o he module; ypes o maladap i e emo ional egula ion s a egies;
consequences o maladap i e emo ional egula ion s a egies
Mul iple-choice check ques ions
PDF1 maladap i e emo ional egula ion s a egies wo kshee
PDF2 consequences o emo ional a oidance wo kshee
PDF3 emo ional a oidance s a egies wo kshee
PDF3 summa y o M8
Videos 1–3. Objec i es o he module; emo ion-d i en beha io s; he opposi e ac ion
Mul iple-choice check ques ions
PDF1 emo ion-d i en beha io s wo kshee
PDF2 he opposi e ac ion
PDF3 Summa y o M9
S5 Pa 1 (30′):
– P esen a ion o he agenda
– Doub s and ques ions abou M8
and M9
M10. Accep ing and acing
physical sensa ions
M11. Facing emo ions in he
con ex s whe e hey occu
Videos 1–3. Objec i es o he module; he ole o physical sensa ions in emo ion; he
a oidance o physical sensa ions
Mul iple-choice check ques ions
PDF1 exe cises o gene a e physical sensa ions
PDF2 symp oms associa ed wi h he di e en exe cises
(con inued on nex page)
A. Díaz-Ga cía e al.
In e ne In e en ions 23 (2021) 100363
6
quali y o li e. The QLI has shown high es - e es eliabili y ( =0.87).
The Spanish e sion o he QLI has shown good in e nal consis ency (
α
=0.87) and es - e es eliabili y in a clinical sample (Mezzich e al.,
2000).
Wo k and Social Adjus men Scale (WSAS) (Mund e al., 2002). The
WSAS is a 5-i em scale ha e alua es he deg ee o in e e ence asso-
cia ed wi h he pa ien s’ symp oms in he ollowing i e domains: wo k,
home managemen , p i a e leisu e, social leisu e, and amily ela ion-
ships. I ems a e coded on a scale om 0 (no a all) o 8 ( e y se e ely),
and highe sco es a e indica i e o g ea e in e e ence in he di e en
a eas. The scale has shown good o excellen in e nal consis ency (
α
=
0.70 o 0.94), es - e es eliabili y, and sensi i i y o change. The
Spanish e sion has demons a ed excellen in e nal consis ency and
good concu en alidi y (Echeza aga e al., 2018).
2.5.2. T ea men accep abili y
2.5.2.1. Expec a ions and opinion o ea men . Expec a ions and opinion
o ea men scales (Bo ko ec and Nau, 1972). Each scale con ains 5
i ems a ed om 0 (“no hing a all”) o 10 (“comple ely”). The expec-
a ion scale is applied a e he ea men a ionale has been explained. I
aims o assess subjec i e pa ien expec a ions abou his ea men . The
opinion scale is adminis e ed a e he pa ien has comple ed he ea -
men , and i s objec i e is o e alua e he pa ien ’s sa is ac ion wi h his
ea men . The i ems co e how logical he ea men is (“How logical do
you hink his ea men is?”), he deg ee o sa is ac ion wi h he
ea men (“How sa is ied a e you wi h he ea men ?”), whe he he
pa ien would ecommend i o a pe son wi h simila p oblems (“To
wha ex en do you eel con iden ecommending his ea men o a
iend who has he same p oblems?”), how use ul he ea men would
be in ea ing o he psychological p oblems (“To wha ex en do you
hink his ea men could be use ul in ea ing o he psychological
p oblems?”), and how use ul he ea men is o he pa ien (“To wha
ex en do you hink his ea men will be/was help ul o you?”).Ou
eam has used his scale in a numbe o esea ch s udies (Bo ella e al.,
2009, 2016; Campos e al., 2018; Mi a e al., 2017).
2.5.2.2. Sa is ac ion wi h he g oup sessions. In o de o e alua e he
pa icipan ’s sa is ac ion wi h each o he di e en ace- o- ace g oup
sessions, an ad hoc ques ionnai e was de eloped wi h se en ques ions
a ed on a Like scale. The ques ions, a ed om 0 (no a all) o 10
(ex emely), include he ollowing: 1) How help ul do you hink he
con en s o his session can be o you p oblems?; 2) How use ul do you
hink he con en s o his session can be o you psychological p oblems
a o he imes in you li e?; 3) How logical do he con en s o his session
seem o you?; 4) How di icul /bo ing do he con en s o his session
seem o you?; 5) How in e es ing/enjoyable do he con en s o his
session seem o you?; 6) How clea /unde s andable we e he con en s o
his session o you?; and 7) Wha o e all sco e would you gi e he
session?
Table 1 (con inued)
Sessions G oup session Modules Mul imedia elemen s
– Emphasis on sel -moni o ing,
p ac ice and homewo k
Pa 2 (90′):
– P esen a ion o M10 and M11
PDF3 symp om induc ion es wo kshee
PDF4 in e ocep i e exposu e sel -moni o ing wo kshee
PDF5 summa y o M10
Videos 1–4. Objec i es o he module; wha is g aded exposu e?; Si ua ional exposu e;
exposu e in he imagina ion
Mul iple-choice check ques ions
PDF1 emo ional exposu e hie a chy wo kshee
PDF2 exposu e sel -moni o ing wo kshee
PDF3 summa y o M11
S6 Pa 1 (30′):
– P esen a ion o he agenda
– Doub s and ques ions abou M10
and M11
– Emphasis on sel -moni o ing,
p ac ice and homewo k
Pa 2 (90′):
– P esen a ion o M12 and M13
M12. Lea ning o mo e on
M13. Lea ning o enjoy
Videos 1–6. Objec i es o he module; he ela ionship be ween inac i i y and emo ional
dis ess; how being ac i e can imp o e emo ional well-being; he impo ance o sho - and
long- e m signi ican li e goals; he ole o social suppo in emo ional well-being; di icul ies
wi h and ecommenda ions o beha io al ac i a ion
Mul iple-choice check ques ions
PDF1 ecommenda ions o se ing sho - and long- e m signi ican li e goals
PDF2 ac i i y planning and social suppo o m
PDF3 dia y o daily ac i i ies o m
PDF4 summa y o M12
Videos 1–5. Objec i es o he module; he ole o posi i e emo ions in li e; he induc ion o
posi i e emo ions; he impo ance o smiling; exe cise: smile o o he s
Mul iple-choice check ques ions
PDF1 summa y o M13
Table 2
S udy a iables and assessmen imes.
Measu e A ea o assessmen Time o
assessmen
Diagnos ic in e iew
MINI Psychia ic diagnosis BL
P ima y ou comes
OASIS Se e i y o anxie y BL, pos -M, pos -T
and FU
ODSIS Se e i y o dep ession BL, pos -M, pos -T
and FU
Seconda y ou comes
PANAS Posi i e and nega i e a ec BL, pos -M, pos -
T, FU,
NEO-FFI Neu o icism and ex a e sion BL, pos -T and FU
QLI Quali y o li e BL, pos -T and FU
WSAS Wo k and social adjus men BL, pos -T and FU
Expec a ions
scale
Expec a ions o ea men BL
Opinion scale Opinion o ea men Pos -T
Sa is ac ion scale Sa is ac ion wi h g oup sessions Pos -F2F g oup
sessions
SUS Usabili y o he p og am Pos -T
Pla o m usage
indica o s
Numbe o modules comple ed, numbe
o logins, numbe o imes each module
has been accessed/ e iewed
Th oughou he
s udy pe iod
No e. MINI: MINI Neu opsychia ic In e iew; BL: Baseline; OASIS: O e all
Anxie y Se e i y and Impai men Scale; Pos -M: Pos -module; Pos -T: Pos -
ea men ; FU: Follow-up; ODSIS: O e all Dep ession Se e i y and Impai men
Scale; PANAS: Posi i e and Nega i e A ec Schedule; NEO-FFI: NEO Fi e Fac o
In en o y; QLI: Quali y o Li e In en o y; WSAS: Wo k and Social Adjus men
Scale; F2F: Face- o- ace; SUS: Sys em Usabili y Scale.
A. Díaz-Ga cía e al.
In e ne In e en ions 23 (2021) 100363
7
2.5.2.3. Usabili y o he p og am. The Sys em Usabili y Scale (SUS)
(Bango e al., 2008; B ooke, 1996) is applied in o de o assess he
usabili y o a se ice o p oduc and he accep ance o echnology by he
people who use i . The SUS is a simple, en-i em scale ha indica es he
deg ee o ag eemen o disag eemen wi h he s a emen s on a 5-poin
scale (1 =s ongly disag ee; 5 =s ongly ag ee). The inal sco e is ob-
ained by adding he sco es on each i em and mul iplying he esul by
2.5. Sco es ange om 0 o 100, whe e highe sco es indica e be e
usabili y.
2.5.3. O he ou come measu es
2.5.3.1. Assessmen o ba ie s and acili a o s. A ocus g oup me hod
will be used in o de o ob ain a wide ange o answe s and g ea e
de ail abou he pa icipan s’ opinions o he ea men , he ace- o- ace
sessions, and he online pla o m. This me hodology in ol es he use o
in-dep h ques ions abou a gi en opic in a dynamic g oup wi h he aim
o p o iding abundan in o ma ion abou he pe spec i es, pe cep ions,
opinions, eelings, and hough s indi iduals ha e abou a ce ain issue,
in his case, a blended g oup ansdiagnos ic ea men (K uege and
Casey, 2000). Fo his pu pose, wi h he pa icipan s’ consen , we will
eco d he ocus g oup in e iews on audio apes, and we will conduc
quali a i e da a analyses. Speci ically, we will use he Consensual
Quali a i e Resea ch (CQR) me hodology o ga he in o ma ion wi hin
ce ain hema ic a eas and subsequen domains (Hill e al., 2005). CQR
was de eloped by psycho he apy esea che s, and he e is a da a anal-
ysis p o ocol wi h a clea explana ion abou how o analyze he aw da a
(McLeod, 2013).
2.5.3.2. Online pla o m usage measu es. Pa icipan s’ engagemen and
use o he online ea men pla o m will be assessed using se e al
measu es collec ed by he online sys em. These da a will include in o -
ma ion such as he o al numbe o modules comple ed, he numbe o
days spen in each module, he numbe o imes each module was
accessed (i.e., e e y ime he use logs on o he pla o m), and he
numbe o imes each module was e iewed.
The s udy a iables and assessmen imes a e summa ized in Table 2.
3. E hics and dissemina ion
The ial has ecei ed e hical app o al om he E hics Commi ee o
Uni e si a Jaume I (Sep embe 2019) and will be conduc ed in acco -
dance wi h he s udy p o ocol, he Decla a ion o Helsinki, and good
clinical p ac ice. All pa icipan s will be olun ee s, and hey will sign a
w i en, in o med consen be o e hei pa icipa ion in he s udy. The
secu i y and con iden iali y o he da a will be gua an eed, i.e., all
ans e ed da a will be secu ed ia AES-256 enc yp ion (Ad anced
Enc yp ion S anda d). The web pla o m will be accessed h ough a
unique use name-passwo d combina ion ha will be a ailable on a 24/7
basis. Only pa icipan s will ha e access o hei passwo d. In o de o
p o ec pa ien s’ p i acy, sensi i e in o ma ion, i.e., pe sonal da a, will
be eplaced by codes and s o ed sepa a ely om clinical da a (e.g.
clinical ou comes). Only esea che s di ec ly in ol ed in he cu en
s udy will ha e access o hese da a. The esul s o his s udy will be
dissemina ed by p esen a ion a con e ences and will be submi ed o
publica ion in a pee - e iewed jou nal.
4. Da a analysis plan
Because he goal o his s udy is o analyze he easibili y o a blended
ansdiagnos ic g oup in e en ion o ED, he analysis will be pe -
o med h ough desc ip i e s a is ics a he han o mal hypo hesis
es ing. To p elimina y es ima e he impac o he in e en ion, means,
s anda d de ia ions, e ec sizes and hei co esponding con idence
in e als will be calcula ed o bo h p incipal and seconda y measu es.
The so wa e SPSS e sion 26.0 will be used o conduc hese analyses.
Finally, quali a i e da a analyses will be conduc ed ollowing he
COnsolida ed c i e ia o REpo ing Quali a i e esea ch (COREQ)
(Tong e al., 2007).
5. Discussion
This s udy in es iga es he easibili y o a no el, blended ( ace- o-
ace and In e ne -deli e ed he apy), g oup in e en ion o he egu-
la ion o emo ional diso de s. Fi s , we aim o s udy he adequacy o he
ec ui men and da a collec ion p ocesses (e.g. whe he inclusion and
exclusion c i e ia should be adjus ed; pa ien s’ willingness o pa icipa e
in he ial). Second, ano he goal is o explo e he easons o pa ien s
ha e use o pa icipa e (e.g., he pa ien p e e s an indi idual o ma ).
Rela edly, compliance wi h bo h he ea men and assessmen p o-
ocols, e en ion and a i ion a es, as well as easons o d op ou will
be s udied. The e o e, he psychome ic da a ob ained in his ial will be
help ul o de ine he assessmen p o ocol in an icipa ion o a u u e RCT.
Finally, bo h quan i a i e (i.e., expec a ions and opinion o ea men ,
usabili y o he ea men pla o m) and quali a i e da a (i.e., in e iews
abou pa icipan s’ opinions) will be collec ed and analyzed. In ou own
expe ience as clinical esea che s, quali a i e analysis p ocedu es can
p o ide c i ical da a o imp o e he design and de elopmen o clinical
ials (Fe n´
andez-´
Al a ez e al., 2017). On he o he hand, his s udy
seeks o p elimina y es ima e he impac o he in e en ion in a numbe
o clinical measu es a pos - ea men and 3-mon h ollow up. Taken
oge he , hese objec i es will help o op imize he design o a u u e
RCT. The p esen s udy seeks o con ibu e o sol ing some o he
challenges in he men al heal h ield, speci ically o ans o m he
heal hca e sys em and policy esponses in o de o dissemina e and
implemen e idence-based ea men s (EBTs) a ound he wo ld (Collins
e al., 2011) and p o ide psychological suppo o all hose in need
(Kazdin, 2015). In line wi h his, he in e en ion desc ibed in his s udy
combines he ad an ages o ansdiagnos ic ea men s o emo ional
diso de s (be e managemen o como bid p esen a ions, highe cos -
e ec i eness, and dissemina ion) (Mansell e al., 2009; McE oy e al.,
2009; Saue -Za ala e al., 2017) and In e ne -deli e ed ea men s
(accessibili y, e sa ili y, and anonymi y) (And ews e al., 2010;
Richa ds and Richa dson, 2012; Spek e al., 2007).
Al hough In e ne -deli e ed ea men s a e gene ally e ec i e o
dep ession and anxie y diso de s, no all pa ien s bene i om his
ea men deli e y o ma equally (e.g., pa ien s who need mo e pe -
sonal con ac o hose less likely o bene i om In e ne -deli e ed
ea men s) (Fe n´
andez-´
Al a ez e al., 2017). Consequen ly, ace- o-
ace he apy emains an impo an aspec o men al heal hca e.
Blended in e en ions ha e been de eloped o co e he esea ch p i-
o i y o deli e ing cos -e ec i e in e en ions. I is no su p ising,
he e o e, ha combining hese wo app oaches (i.e., ace- o- ace and
In e ne -deli e ed ea men s) in o one in eg a ed ea men may be a
way o ake ad an age o he bes aspec s o hese wo ea men mo-
dali ies (Koois a e al., 2014; Van de Vaa e al., 2014; Wen zel e al.,
2016). Ne e heless, esea ch on blended in e en ions has ocused
p ima ily on indi idual he apy, and less a en ion has been paid o he
po en ial o using his o ma in g oup psycho he apy and, mo e spe-
ci ically, in g oup ansdiagnos ic ea men s, which ha e al eady
shown hei e icacy in se e al RCTs (No on, 2012; Reinhol e al.,
2017). Adding he g oup o ma in e en ion o a ansdiagnos ic
ea men o emo ional diso de s and deli e ing i in a blended he apy
o ma could con ibu e o some o he esea ch p io i ies, such as he
implemen a ion o EBTs and he dissemina ion and sus ainabili y o
men al heal h p omo ion (Fo sman e al., 2015; Wykes e al., 2015).
Despi e he exis ence o e ec i e e idence-based ea men s, hei
ans e o ou ine p ac ice is o en qui e sca ce (Cunningham e al.,
2010; G imshaw e al., 2012). Speci ically, he implemen a ion o
blended he apy combining ace- o- ace and In e ne -deli e ed in-
e en ions is s ill limi ed. The use o blended he apy may depend on i s
A. Díaz-Ga cía e al.
In e ne In e en ions 23 (2021) 100363
8
clinical e ec i eness, bu also on i s accep ance by pa ien s unde going
he ea men . In his ega d, knowledge abou ba ie s and acili a o s
in he implemen a ion o a blended he apy om he pa ien s’
pe spec i e seems o be essen ial. A quali a i e app oach ( ocus g oup)
will be ollowed o explo e his aspec .
In summa y, his easibili y s udy p esen s a use -cen e ed blended
g oup in e en ion o he ea men o emo ional diso de s. To he bes
o ou knowledge, his is he i s s udy o in es iga e he easibili y o a
blended g oup ansdiagnos ic ea men in pa ien s wi h emo ional
diso de s.
We a e awa e ha his s udy has limi a ions. On he one hand, he
ial has no con ol g oup, and so no conclusions can be d awn abou he
clinical e icacy o he in e en ion. The selec ion o an adequa e con ol
g oup (e.g., ad an ages and disad an ages o di e en ypes o con ol
g oup) will be ca e ully conside ed when planning he u u e RCT.
Howe e , he aim o his s udy is o gain insigh in o he implemen a ion
alue o a ansdiagnos ic g oup blended ea men , a he han i s
clinical e ec i eness. On he o he hand, because ace- o- ace sessions
ake place once e e y 3 weeks, some pa ien s’ use o he online pla o m
migh be lowe han expec ed. To mi iga e his, we de eloped a suppo
p o ocol ha includes au oma ized emails and ex messages (e.g., wi h
eminde s abou he impo ance o doing he homewo k asks, p ac-
icing he di e en s a egies, and so on).
The esul s o his s udy will p o ide da a on he accep abili y and
easibili y o a ansdiagnos ic blended ea men o pa ien s wi h
emo ional diso de s. Fu he mo e, i will acili a e knowledge acquisi-
ion and open up new o ms o pa ien - o-pa ien o pa ien - o- he apis
communica ion. This will p o ide aluable da a abou he way pa ien s
use he p og am modules, he equency and du a ion wi h which hey
en e hem, he opinion abou each o hem, and he adhe ence o he
p og am. This s udy may help o conside he u ili y o easibili y s udies
in p ac ice, wi h he aim o be e unde s anding he way an in e en-
ion wo ks and acili a ing ongoing adap a ion o he ea men and
assessmen design in p epa a ion o a andomized con olled ial o a
blended ansdiagnos ic g oup ea men o emo ional diso de s.
E hics app o al and consen o pa icipa e
The s udy ollows he guidelines o he Decla a ion Helsinki and
exis ing guidelines in Spain and he Eu opean Union o he p o ec ion
o pa ien s in clinical ials. All pa icipan s in e es ed in pa icipa ing
signed an in o med consen o m. The s udy has been app o ed by he
E hics Commi ee o Uni e si a Jaume I (Cas ell´
on, Spain).
Consen o publica ion
“No applicable” in his sec ion.
A ailabili y o da a and ma e ial
I is no possible o sha e he da a because he s udy is in p og ess. We
a e now a he s age o da a ec ui men .
Funding
Funding o he s udy was p o ided by g an : CIBER de Fisiopa o-
logía de la Obesidad y Nu ici´
on-ISCIII CB06/03/0052. The unde had
no ole in s udy design, da a collec ion and analysis, decision o publish,
o p epa a ion o he manusc ip .
CRediT au ho ship con ibu ion s a emen
AD-G d a ed he manusc ip . AD-G, in collabo a ion wi h AG-R, AG-
P, and CB designed he s udy. IF-F, CT, and DC pa icipa ed in each o i s
phases. AG-P and CB pa icipa ed in he e iew and e ision o he
manusc ip . All he au ho s ha e app o ed he inal manusc ip o be
published.
Au ho s’ in o ma ion
AD-G holds a PhD in Clinical Psychology a Uni e si a Jaume I in he
Depa men o Basic and Clinical Psychology, and Psychobiology,
g an ed by Minis y o Economy and Compe i i eness. AD-G is also PhD
Assis an P o esso a he Depa men o Psychology and Sociology
(Uni e sidad de Za agoza) and membe o LabPsiTec (Labo a o y o
Psychology and Technology) (www.labpsi ec.com) a Uni e si a Jaume
I. AG-R is PhD Assis an P o esso a he Depa men o Psychology and
Sociology (Uni e sidad de Za agoza) and IF-F and CT a e PhD s uden in
Clinical Psychology a LabPsiTec. DC holds a PhD in Clinical Psychology
and she is PhD Assis an P o esso a Uni e sidad de Valencia, Spain, in
he Depa men o Pe sonali y, E alua ion and Psychological T ea -
men s, and she is membe o LabPsiTec. AG-P is Full P o esso o Clinical
Psychology in he Depa men o Basic and Clinical Psychology, and
Psychobiology. AG-P is also di ec o o LabPsiTec. CB is p o esso
eme i us a Uni e si a Jaume I in he Depa men o Basic and Clinical
Psychology, and Psychobiology.
Decla a ion o compe ing in e es
The au ho s decla e ha hey ha e no compe ing in e es s.
Acknowledgemen s
This s udy was unded by he Ins i u e o Heal h Ca los III (ISCiii)
CIBERobn is an ini ia i e o ISCIII (ISCIII CB06 03/0052), and Ho izon
2020 ECoWeB p ojec (754657-2. H2020-SC1-2016-2017).
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