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Negative and positive affect regulation in a transdiagnostic internet-based protocol for emotional disorders: Randomized controlled trial

Abstract

Background: Emotional disorders (EDs) are among the most prevalent mental disorders. Existing evidence-based psychological treatments are not sufficient to reduce the disease burden of mental disorders. It is therefore essential to implement innovative solutions to achieve a successful dissemination of psychological treatment protocols, and in this regard, the use of information and communication technologies such as the internet can be very useful. Furthermore, the literature suggests that not everyone with an ED receives the appropriate treatment. This situation has led to the development of new intervention proposals based on the transdiagnostic perspective, which attempts to address the underlying processes common to EDs. Most of these transdiagnostic interventions focus primarily on downregulating negative affectivity (NA), and less attention has been paid to strengths and the upregulation of positive affectivity, despite its importance for well-being and mental health. Objective: This study aims to evaluate the efficacy of a transdiagnostic internet-based treatment for EDs in a community sample. Methods: A 3-armed randomized controlled trial was conducted. A total of 216 participants were randomly assigned to a transdiagnostic internet-based protocol (TIBP), a TIBP+ positive affect (PA) component, or a waiting list (WL) control group. The treatment protocol contained core components mainly addressed to downregulate NA (ie, present-focused emotional awareness and acceptance, cognitive flexibility, behavioral and emotional avoidance patterns, and interoceptive and situational exposure) as well as a PA regulation component to promote psychological strengths and enhance well-being. Data on depression, anxiety, quality of life, neuroticism and extraversion, and PA/NA before and after treatment were analyzed. Expectations and opinions of treatment were also analyzed. Results: Within-group comparisons indicated significant pre-post reductions in the two experimental conditions. In the TIBP+PA condition, the effect sizes were large for all primary outcomes (d=1.42, Beck Depression Inventory [BDI-II]; d=0.91, Beck Anxiety Inventory [BAI]; d=1.27, Positive and Negative Affect Schedule-Positive [PANAS-P]; d=1.26, Positive and Negative Affect Schedule-Negative [PANAS-N]), whereas the TIBP condition yielded large effect sizes for BDI-II (d=1.19) and PANAS-N (d=1.28) and medium effect sizes for BAI (d=0.63) and PANAS-P (d=0.69). Between-group comparisons revealed that participants who received one of the two active treatments scored better at posttreatment than WL participants. Although there were no statistically significant differences between the two intervention groups on the PA measure, effect sizes were consistently larger in the TIBP+PA condition than in the standard transdiagnostic protocol. Conclusions: Overall, the findings indicate that EDs can be effectively treated with a transdiagnostic intervention via the internet, as significant improvements in depression, anxiety, and quality of life measures were observed. Regarding PA measures, promising effects were found, but more research is needed to study the role of PA as a therapeutic component. Díaz-García, A.; González-Robles, A.; García-Palacios, A.; Fernández-Álvarez, J.; Castilla, D.; Bretón, J.M.; Baños, R.M.; Quero, S.; Botella, C.

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Negative and positive affect regulation in a transdiagnostic internet-based protocol for emotional disorders: Randomized controlled trial

Author: Díaz-García, A.; González-Robles, A.; Baños, R.M.; García-Palacios, A.; Fernández-Álvarez, J.; Quero, S.; Castilla, D.; Botella, C.; Bretón, J.M.
Year: 2021
DOI: 10.2196/21335
Source: https://zaguan.unizar.es/record/99737/files/texto_completo.pdf
O iginal Pape
Nega i e and Posi i e A ec Regula ion in a T ansdiagnos ic
In e ne -Based P o ocol o Emo ional Diso de s: Randomized
Con olled T ial
Amanda Díaz-Ga cía1, PhD; Albe o González-Robles1, PhD; Azucena Ga cía-Palacios2,3, PhD; Ja ie
Fe nández-Ál a ez4, MSc; Diana Cas illa3,5, PhD; Juana Ma ía B e ón2, PhD; Rosa Ma ía Baños3,5, PhD; Soledad
Que o2, PhD; C is ina Bo ella2,3, PhD
1Depa men o Psychology and Sociology, Uni e sidad de Za agoza, Te uel, Spain
2Uni e si a Jaume I, Cas ellón de la Plana, Spain
3CIBER Fisiopa ología Obesidad y Nu ición (CIBERObn), Ins i u o Ca los III, Mad id, Spain
4Depa men o Psychology, Uni e si à Ca olica del Sac o Cuo e, Milan, I aly
5Depa men o Pe sonali y, E alua ion and Psychological T ea men s, Uni e sidad de Valencia, Valencia, Spain
Co esponding Au ho :
Amanda Díaz-Ga cía, PhD
Depa men o Psychology and Sociology
Uni e sidad de Za agoza
Calle Cdad. Escola , S/N, 44003 Te uel
Te uel, 44003
Spain
Phone: 34 878618154
Email: amandadiaz@uniza .es
Abs ac
Backg ound: Emo ional diso de s (EDs) a e among he mos p e alen men al diso de s. Exis ing e idence-based psychological
ea men s a e no su icien o educe he disease bu den o men al diso de s. I is he e o e essen ial o implemen inno a i e
solu ions o achie e a success ul dissemina ion o psychological ea men p o ocols, and in his ega d, he use o in o ma ion
and communica ion echnologies such as he in e ne can be e y use ul. Fu he mo e, he li e a u e sugges s ha no e e yone
wi h an ED ecei es he app op ia e ea men . This si ua ion has led o he de elopmen o new in e en ion p oposals based on
he ansdiagnos ic pe spec i e, which a emp s o add ess he unde lying p ocesses common o EDs. Mos o hese ansdiagnos ic
in e en ions ocus p ima ily on down egula ing nega i e a ec i i y (NA), and less a en ion has been paid o s eng hs and he
up egula ion o posi i e a ec i i y, despi e i s impo ance o well-being and men al heal h.
Objec i e: This s udy aims o e alua e he e icacy o a ansdiagnos ic in e ne -based ea men o EDs in a communi y sample.
Me hods: A 3-a med andomized con olled ial was conduc ed. A o al o 216 pa icipan s we e andomly assigned o a
ansdiagnos ic in e ne -based p o ocol (TIBP), a TIBP+ posi i e a ec (PA) componen , o a wai ing lis (WL) con ol g oup.
The ea men p o ocol con ained co e componen s mainly add essed o down egula e NA (ie, p esen - ocused emo ional awa eness
and accep ance, cogni i e lexibili y, beha io al and emo ional a oidance pa e ns, and in e ocep i e and si ua ional exposu e)
as well as a PA egula ion componen o p omo e psychological s eng hs and enhance well-being. Da a on dep ession, anxie y,
quali y o li e, neu o icism and ex a e sion, and PA/NA be o e and a e ea men we e analyzed. Expec a ions and opinions
o ea men we e also analyzed.
Resul s: Wi hin-g oup compa isons indica ed signi ican p e-pos educ ions in he wo expe imen al condi ions. In he TIBP+PA
condi ion, he e ec sizes we e la ge o all p ima y ou comes (d=1.42, Beck Dep ession In en o y [BDI-II]; d=0.91, Beck
Anxie y In en o y [BAI]; d=1.27, Posi i e and Nega i e A ec Schedule-Posi i e [PANAS-P]; d=1.26, Posi i e and Nega i e
A ec Schedule-Nega i e [PANAS-N]), whe eas he TIBP condi ion yielded la ge e ec sizes o BDI-II (d=1.19) and PANAS-N
(d=1.28) and medium e ec sizes o BAI (d=0.63) and PANAS-P (d=0.69). Be ween-g oup compa isons e ealed ha pa icipan s
who ecei ed one o he wo ac i e ea men s sco ed be e a pos ea men han WL pa icipan s. Al hough he e we e no
s a is ically signi ican di e ences be ween he wo in e en ion g oups on he PA measu e, e ec sizes we e consis en ly la ge
in he TIBP+PA condi ion han in he s anda d ansdiagnos ic p o ocol.
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Conclusions: O e all, he indings indica e ha EDs can be e ec i ely ea ed wi h a ansdiagnos ic in e en ion ia he in e ne ,
as signi ican imp o emen s in dep ession, anxie y, and quali y o li e measu es we e obse ed. Rega ding PA measu es, p omising
e ec s we e ound, bu mo e esea ch is needed o s udy he ole o PA as a he apeu ic componen .
T ial Regis a ion: ClinicalT ials.go NCT02578758; h ps://clinical ials.go /c 2/show/NCT02578758
In e na ional Regis e ed Repo Iden i ie (IRRID): RR2-10.1186/s12888-017-1297-z
(J Med In e ne Res 2021;23(2):e21335) doi: 10.2196/21335
KEYWORDS
ansdiagnos ic; posi i e a ec i i y; nega i e a ec i i y; emo ion egula ion; emo ional diso de s; in e ne
In oduc ion
T ansdiagnos ic T ea men s o he Common
Psychopa hological P ocesses Unde lying Emo ional
Diso de s
Emo ional diso de s (EDs) a e de ined as anxie y and unipola
mood diso de s. These diso de s ha e been g ouped based on
hei common biological and psychological ulne abili ies [1].
The es ima ed li e ime p e alence a es o EDs a e high (28.8%
o anxie y diso de s and 20.8% o mood diso de s). In addi ion,
he co-occu ence o mul iple EDs has also been ound o be
ele a ed, wi h s udies showing ha mo e han 40% o people
wi h one diagnosis also me he diagnos ic c i e ia o a second
diso de o e a 12-mon h pe iod [2].
In ecen yea s, esea ch has demons a ed ha e idence-based
psychological ea men s (EBTs) a e e ec i e in he ea men
o EDs [3]. Howe e , he e has been li le success in dec easing
he p e alence and incidence o men al illness, and only a small
p opo ion o people in need ac ually ecei e adequa e
psychological ea men [4]. In addi ion, dissemina ing EBTs
has become a eal challenge because o hei cos , he du a ion
o he ea men s, and he lack o well-quali ied p o essionals
[5], which can explain why EBTs a e unde u ilized in clinical
p ac ice se ings [6].
Recen ly, ansdiagnos ic app oaches ha e eme ged ha add ess
he common cha ac e is ics ound in cogni i e, beha io al,
emo ional, and o he dys egula ion a eas unde lying di e en
EDs, ha is, he biological and psychological ulne abili ies
sha ed by di e en men al diso de s [7,8]. Wi h ega d o
ansdiagnos ic p ocesses, maladap i e emo ion egula ion
s a egies ha e been sugges ed as po en ial explana o y ac o s
unde lying he como bidi y ac oss EDs [9].
In esponse o ansdiagnos ic app oaches, se e al
ansdiagnos ic ea men s ha e been de eloped o p o ide
pa ien s wi h a se o skills gea ed speci ically owa d common
ulne abili ies [10]. One example o hese ea men s is he
Uni ied P o ocol (UP) [7], which was designed o be applicable
ac oss di e en EDs and ep esen ed a signi ican shi owa d
ansdiagnos ic psychological ea men s o EDs [11,12]. The
UP has been es ed and esul s indica e ha i is e ec i e in
educing nega i e a ec (NA) [13], wi h imp o emen s
main ained a he 18-mon h ollow-up [14]. Fu he mo e, he
e ec o he UP has been shown on he wo empe amen
dimensions o neu o icism (N)/beha io al inhibi ion (BI) and
ex a e sion (E)/beha io al ac i a ion (BA) [15].
Moun ing e idence demons a es he e icacy o ansdiagnos ic
ea men s in pa ien s wi h EDs compa ed wi h con ol g oups
[16-19], showing ha ansdiagnos ic ea men s a e jus as
e ec i e as diso de -speci ic cogni i e beha io al he apy (CBT)
[12,20]. The da a sugges ha a ansdiagnos ic ea men o
EDs migh be mo e widely e ec i e ac oss a di e se ange o
men al diso de s, add essing di e en diso de s wi h a single
p o ocol [21]. Mo e speci ically, a ecen me a-analysis showed
ha he UP is mo e e ec i e compa ed wi h di e en con ol
g oups, such as ea men as usual, wai lis , and medica ion
con ol g oups, in ea ing anxie y and dep essi e symp oms
[22].
The Role o Posi i e A ec in EDs
Rega ding he empe amen al ulne abili ies, some au ho s ha e
iden i ied wo essen ial dimensions o empe amen in he
e iology and cou se o EDs: N/NA and E/posi i e a ec (PA)
[8]. Hence, neu o icism has been iden i ied as a co e ac o
in ol ed in he de elopmen o EDs [23]. In addi ion, N/NA
and E/PA ha e been closely ela ed o G ay’s (1987) cons uc s
o BI and BA, espec i ely [24-26], and hese e ms a e o en
used in e changeably as he mos s able measu es o
empe amen [8,15,26,27]. Thus, people wi h EDs ha e highe
le els o N/NA/BI [8], and hey expe ience nega i e emo ions
mo e in ensely and equen ly [28] han people who do no ha e
any ED. In con as , he dimension o posi i e emo ionali y,
E/PA/BA, has also been obse ed in many diso de s, sugges ing
ha people wi h an ED show low le els o E/BA [29], which
can p edic he onse o dep ession [30] and inc ease he se e i y
o he p oblem [31]. Despi e he impo ance o PA in heal h and
well-being, he e is limi ed esea ch on i s p omo ion; he e o e,
mo e esea ch is needed in his a ea. Fu he mo e,
no wi hs anding he ecen upsu ge in ansdiagnos ic ea men s
o EDs, mos o hese p o ocols ha e ocused on educing NA.
They ha e add essed co e psychopa hological de ici s in he
way pa ien s expe ience and espond o nega i e emo ions [32].
Howe e , less a en ion has been paid o posi i e emo ions o
p omo ing PA [33]. In addi ion o being in ol ed in he
symp oma ology o EDs, posi i e emo ionali y is conside ed a
co e elemen o men al heal h, showing bene icial, gene alized
e ec s on heal h and unc ioning [34-37]. Thus, he ela ionship
be ween emo ion egula ion (eg, cogni i e eapp aisal) and
well-being has also been demons a ed [38]. On he basis o he
li e a u e ha highligh s he po en ial impo ance o posi i e
emo ionali y as a ea men componen [39-43], i is necessa y
o de elop and es ea men componen s ocused on
up egula ing PA.
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In e ne -Based T ea men s
The e a e many models o deli e ing in e en ions in no el
ways ha can be scaled up o each la ge numbe s o people in
need [4]. In his ega d, in o ma ion and communica ion
echnologies (ICTs) play an impo an ole and can acili a e
he a ailabili y o EBTs [44]. Speci ically, he in e ne is used
o he assessmen and ea men o clinical condi ions, and i
has been es ablished as a use ul and e ec i e ool o deli e ing
psychological ea men s o ea se e al psychological diso de s
[45], pa icula ly dep ession and anxie y diso de s [46].
Mo eo e , some me a-analyses ha e e ealed ha hese
in e en ions a e as e icacious as ace- o- ace adi ional
ea men s [47,48].
This S udy
The pu pose o his s udy is o es he e icacy o a web-based
psychological ea men p o ocol o indi iduals om a
communi y sample wi h one o mo e diagnoses o EDs: majo
dep essi e diso de (MDD), dys hymic diso de (DD),
obsessi e-compulsi e diso de , and ou anxie y diso de s: panic
diso de (PD), ago aphobia (AG), gene alized anxie y diso de
(GAD), social anxie y diso de (SAD), anxie y diso de no
o he wise speci ied, and (unipola ) mood diso de no o he wise
speci ied [49]. Ra he han ocusing solely on NA, he ea men
p o ocol includes 2 ypes o componen s: one based on classical
pe spec i es o down egula ing NA and he o he aimed a
up egula ing PA. The p o ocol can be applied ei he in i s
adi ional o ma ( ansdiagnos ic in e ne -based p o ocol,
TIBP) o by including bo h o hese componen s (TIBP+PA).
Some s udies ha e es ed he e icacy o ansdiagnos ic
in e en ions in imp o ing PA measu es. Howe e , hese s udies
do no include a speci ic componen o add ess PA egula ion
[13], o hey a e uncon olled ials [50-52]. Only one s udy ha
e alua ed he e icacy o a new ansdiagnos ic ea men ocuses
on PA, bu i is a pilo s udy a he han a andomized con olled
ial (RCT) [53]. To he bes o ou knowledge, no published
RCT has es ed he e icacy o a ansdiagnos ic in e ne -based
ea men o EDs wi h a speci ic componen o add ess PA
egula ion. The e o e, he aim o his s udy is o in es iga e he
e ec i eness o his ansdiagnos ic p o ocol o EDs, wi h and
wi hou he speci ic componen o up egula e PA, e sus a
wai -lis con ol g oup. A seconda y aim is o es he di e en ial
e ec o he speci ic ea men componen designed o
up egula e PA. Finally, we s udy pa ien s’ accep ance o he
p og am de eloped o apply he ea men p o ocol o e he
in e ne wi h minimal suppo by he clinician. We hypo hesized
ha (1) bo h sel -applied p o ocol modali ies (TIBP and
TIBP+PA) would be mo e e ec i e han he wai -lis con ol
condi ion in he ea men o EDs; (2) bo h in e en ions would
esul in signi ican imp o emen s in dep essi e and anxious
symp oma ology a pos ea men ; (3) he TIBP+PA would
signi ican ly ou pe o m he TIBP g oup on PA measu es; and
(4) bo h p o ocols a e well accep ed, wi h no s a is ical
di e ences be ween condi ions.
Me hods
S udy Design
This s udy was a h ee-a med supe io i y RCT in which
pa icipan s we e andomly alloca ed o 1 o 3 condi ions: (1)
TIBP, (2) TIBP+PA, and (3) wai ing lis (WL) con ol condi ion.
Fo e hical easons, pa icipan s in he con ol condi ion we e
o e ed he possibili y o ecei ing he ea men p o ocol a e
spending ime on he WL (16 weeks), hus lea ing no con ol
g oup o he ollow-up measu emen s. Block andomiza ion
was pe o med o ensu e ha all p ima y diagnoses we e equally
ep esen ed ac oss condi ions. The ial was egis e ed a
ClinicalT ial.go as NCT02578758 on Oc obe 16, 2015. The
s udy was app o ed by he E hics Commi ee o Uni e si a
Jaume I (Cas ellón, Spain; May 5, 2016) and was conduc ed in
compliance wi h he s udy p o ocol, ollowing he Consolida ed
S anda ds o Repo ing T ials (CONSORT) s a emen [54], he
CONSORT-eHeal h guidelines [55], and he S anda d P o ocol
I ems: Recommenda ions o In e en ional T ials guidelines
[56,57]. De ails o he s udy p o ocol ha e been epo ed
elsewhe e [58]. Di e en e ec sizes ound in he li e a u e
based on he ansdiagnos ic pe spec i e o EDs we e conside ed
o es ima e he s udy powe in his s udy. These calcula ions
we e pe o med wi h he so wa e p og am G*Powe 3.1 [59]
and published in he s udy p o ocol [58]. This s udy epo s on
p e- o pos ea men da a.
S udy Popula ion, Rec ui men , and Eligibili y C i e ia
The clinical ial was conduc ed in a communi y sample o
indi iduals diagnosed wi h one o mo e o he a o emen ioned
diso de s. Pa icipan s we e ec ui ed om adul olun ee s
in e es ed in pa icipa ing in he s udy be ween June 2015 and
July 2018. Po en ial pa icipan s we e a ended by phone by he
clinical eam membe s (who had a leas a uni e si y mas e ’s
deg ee in gene al heal h psychology) o explain he s udy and
cla i y any doub s. People in e es ed in pa icipa ing signed he
web-based in o med consen o m and we e assessed aking
in o accoun all he inclusion c i e ia. The inclusion c i e ia
we e as ollows: (1) being a leas 18 yea s old; (2) mee ing he
Diagnos ic and S a is ical Manual o Men al Diso de s, Fou h
Edi ion (DSM-IV) diagnos ic c i e ia o EDs; (3) ha ing he
abili y o unde s and and ead Spanish; (4) ha ing access o he
in e ne and an email add ess; and (5) p o iding web-based
in o med consen . The exclusion c i e ia we e as ollows: (1)
ha ing schizoph enia, bipola diso de , o alcohol and/o
subs ance dependence diso de ; (2) p esence o a high isk o
suicide (de ined by he Mini-In e na ional Neu opsychia y
In e iew [60] as g ea e han o equal o 10 poin s); (3) p esence
o medical disease/condi ion ha p e en s he pa icipan om
ca ying ou he psychological ea men ; and (4) ecei ing
ano he psychological ea men du ing he s udy. Recei ing
pha macological ea men was no an exclusion c i e ion, bu
any inc ease and/o change in he medica ion (in he case o
ecei ing) du ing he s udy pe iod implied he pa icipan ’s
exclusion om subsequen analyses. Pa icipan s who ul illed
all he s udy c i e ia we e andomized o one o he h ee
expe imen al condi ions by an independen esea che . This
esea che was unawa e o he cha ac e is ics o he s udy and
had no clinical in ol emen in he ial o access o he s udy
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da a. Pa icipan s ag eed o pa icipa e be o e de e mining which
ea men hey we e alloca ed. All pa icipan s we e ee o
wi hd aw om he ea men a any ime. Access and
pa icipa ion in he s udy did no in ol e paymen in any case.
The T ansdiagnos ic In e en ions
The ea men p o ocol is based on he ansdiagnos ic
pe spec i e de i ed om he UP [5,7] and some s a egies om
Ma sha Linehan’s p o ocol [61]. Ini ially, a manualized p o ocol
was de eloped and s uc u ed in a pa ien and he apis
handbook. La e , he p o ocol was adap ed o a mul imedia web
pla o m ( ideos, igne es, audios, images, e c) o be comple ely
sel -applied ia he in e ne [62] h ough a PC o a able . The
ease o use o he p og am has been s eng hened because i
p esen s a linea na iga ion o op imize he ea men s uc u e
and make he ea men easie and mo e a ac i e o he
pa icipan s.
The p og am consis s o an assessmen p o ocol and a ea men
p o ocol ha includes co e componen s, mainly designed o
down egula e NA (p esen - ocused emo ional awa eness and
accep ance, cogni i e lexibili y, beha io al and emo ional
a oidance pa e ns, and in e ocep i e and si ua ional exposu e)
and up egula e PA o p omo e psychological s eng hs and
enhance well-being [63]. The p o ocol con en is adap ed om
he UP [7] and some o he s a egies o emo ion egula ion
om dialec ical beha io he apy [61]. The PA egula ion
componen is based mainly on BA s a egies [64], s a egies o
p omo e pleasan and signi ican ac i i ies linked o alues and
li e goals, and s a egies o enhance pe sonal s eng hs, posi i e
eelings, posi i e cogni ions, and posi i e beha io [63,65].
Fu he mo e, well-being he apy s a egies [66,67] and some
concep s om F edickson’s B oaden-and-Build Theo y [68]
a e also included in he p og am. The PA egula ion componen
akes place a e he NA egula ion componen . The p o ocol
also includes adi ional he apeu ic componen s o
e idence-based ea men o ED (psychoeduca ion, mo i a ion
o change, and elapse p e en ion). All he ea men
componen s we e de eloped h ough wo sel -applied p o ocol
modali ies (TIBP and TIBP+PA) wi h 12 and 16 modules,
espec i ely, wi h he only di e ence being he inclusion o
absence o he modules ha con ain he PA- egula ion
componen . A de ailed desc ip ion o modules ha con ain he
PA egula ion componen is p esen ed in Mul imedia Appendix
1[64,66,68-77]. The modules in each in e en ion p o ocol a e
desc ibed b ie ly elsewhe e [58].
The du a ion o he p og am could a y among use s, and
pa icipan s in bo h ea men condi ions had equal access o
he p o ocol o a maximum pe iod o 18 weeks. The p og am
sen weekly messages o he pa ien o emind him/he o
con inue o wo k o bene i om he p og am. A p o essional
pla o m was used o send hese messages [78]. The p og am
also sen au oma ic emails wi h eminde s o access he modules
when pa icipan s had no en e ed he pas 15 days. In addi ion
o his ICT suppo , human suppo was also p o ided h ough
weekly phone calls (maximum o 5 min) du ing he ea men
pe iod o esol e any di icul ies o doub s, o o emind hem
o he impo ance o e iewing he ea men con en s.
Ou come Measu es
The assessmen p o ocol was included a he beginning and end
o he web-based p og am. A de ailed desc ip ion o he
measu es and hei aims has been published elsewhe e [58].
The measu es included in his s udy a e desc ibed in Table 1.
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Table 1. S udy measu es.
Time o assessmen
ωa
C onbach αAimMeasu e
Diagnos ic in e iew
BLd
N/A
N/Ac
Psychia ic diagnosis
MINIb
P ima y ou comes
BL, Pos -T
0.91.91Se e i y o dep ession
BDI-IIe
BL, Pos -T0.92.92Se e i y o anxie y
BAIg
BL, Pos -TPA=0.91; NA=0.89
PAi=.91; NAj=.89
Posi i e and nega i e a ec
PANASh
Seconda y ou comes
Pe sonali y measu es
BL, Pos -TN=0.82; E=0.84
Nl=.81; Em=.84
Neu o icism and ex a e sion
NEO FFIk
Quali y o li e
BL, Pos -T0.70.67Heal h- ela ed quali y o li e
EQ-5Dn
Expec a ion and opinion
BLN/AN/AExpec a ion o ea men Expec a ion o ea men scale
Pos -TN/AN/AOpinion o ea men Opinion o ea men scale
aω: coe icien omega in his s udy.
bMINI: Mini-In e na ional Neu opsychia ic In e iew, Ve sion 5.0.0.
cN/A: no applicable.
dBL: baseline.
eBDI-II: Beck Dep ession In en o y-II.
Pos -T: pos ea men .
gBAI: Beck Anxie y In en o y.
hPANAS: Posi i e and Nega i e A ec Schedule.
iPA: posi i e a ec .
jNA: nega i e a ec .
kNEO FFI: NEO Fi e Fac o In en o y.
lN: neu o icism.
mE: ex a e sion.
nEQ-5D: Eu oQoL-5D Ques ionnai e.
S a is ical Analysis
G oup di e ences in pa icipan s’sociodemog aphic and clinical
da a a baseline we e examined o con i m ha hey we e
compa able a e andomiza ion. One-way analysis o a iance
o con inuous a iables and Fishe exac es s o independence
o ca ego ical a iables we e used. In en ion- o- ea (ITT)
using mixed models, wi h ull in o ma ion maximum likelihood
es ima ion and wi hou any ad hoc impu a ions we e conduc ed
o handle missing da a due o pa icipan d opou [79]. This
app oach uses all a ailable da a, does no subs i u e missing
alues wi h assumed o es ima ed alues, and does no assume
ha he las measu emen is s able ( he las obse a ion ca ied
o wa d assump ion) [80]. Mixed model analyses a e app op ia e
o RCTs wi h mul iple ime poin s and p e- o pos only designs
wi h subs an ial d opou a es [81]. The pa e n o missingness
was in es iga ed o de e mine i s likelihood o being andom
a he han sys ema ic (missing no a andom, MNAR).
Subsequen ly, associa ions be ween sample cha ac e is ics
missingness in he ou come a iables we e examined ( es s
o con inuous a iables and Fishe exac es s o ca ego ical
a iables). A linea mixed model o each ou come measu e
was implemen ed using he linea mixed-e ec s models
(MIXED) p ocedu e wi h one andom in e cep pe subjec . An
iden i y co a iance s uc u e was speci ied o model he
co a iance s uc u e o he andom in e cep . Signi ican e ec s
we e ollowed up wi h pai wise compa isons using he
Bon e oni co ec ion. E ec sizes we e calcula ed o wi hin-
and be ween-g oup compa isons using he s anda dized obse ed
mean di e ence p oposed by Cohen [82]. To de e mine he
exis ence o a eliable change in a pa ien , he eliable change
index (RCI; Jacobson and T uax’s me hod) [83] was used. The
RCI alues o he p ima y ou comes (Beck Dep ession
In en o y, BDI-II; Beck Anxie y In en o y, BAI; Posi i e and
Nega i e A ec Schedule-Posi i e [PANAS-P]; and Posi i e
and Nega i e A ec Schedule-Nega i e [PANAS-N]) we e
calcula ed o he comple e sample (pa icipan s who p o ided
da a a pos ea men ). Fishe exac es s we e pe o med o
e alua e g oup di e ences in RCI a es o comple e s. All
s a is ical analyses we e conduc ed using IBM SPSS S a is ics
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o Windows, e sion 22, and SAS so wa e, e sion 9.4, o he
SAS Sys em o Windows.
Resul s
Pa icipan Flow and A i ion
Ou o he 573 people who exp essed ini ial in e es in he s udy,
as he low diag am shows (Figu e 1), only 402 pe o med he
ini ial in e iew. A his s age, 186 pa icipan s ailed o mee
he inclusion c i e ia. Finally, 216 pa ien s we e included in he
s udy, and hey we e andomly alloca ed o each expe imen al
condi ion: TIBP, n=71; TIBP+PA, n=73; WL, n=72. Rega ding
p e ea men assessmen s, 71 pa icipan s pe o med i in he
TIBP, 73 in he TIBP+PA, and 72 in he WL. A simila numbe
o pa icipan s pe o med he pos ea men assessmen om
bo h in e en ion condi ions (TIBP, n=45; TIBP+PA, n=46).
No signi ican di e ences be ween he h ee condi ions we e
ound in d opou a es (X22=3.8, P=.14). In he TIBP condi ion,
o hose who s a ed he p og am (n=71), 26 pa icipan s (26/71,
37%) wi hd ew om he ea men . In he TIBP+PA condi ion,
a simila pa e n was ound; o hose who s a ed he p og am
(n=73), 27 pa icipan s (27/73, 37%) wi hd ew om he
ea men . Finally, in he WL con ol g oup, da a om 55
pa icipan s we e ob ained a e hey had spen 16 weeks on he
WL (55/72, 76% e en ion; 17/72, 24% d opou ). O e all, o
he 216 pa icipan s who s a ed he s udy, 86 pa icipan s
wi hd ew om he p og am. As a esul , wo pa e ns o
missingness eme ged. One o hem ep esen ed 32% o he
sample (70/216, 32.4%) and he o he ep esen ed a e y low
pe cen age (16/216, 7.4%). Missingness was no ela ed o he
cha ac e is ics lis ed in Table 2 in any o he h ee a ms o he
RCT (all P>.05 in bo h pa e ns). The e o e, pa e ns o
missingness we e no ound o be MNAR and he decision o
con inue he analysis wi h he a ailable da a was made [84,85].
Figu e 1. Flowcha o pa icipan s. DSM-IV-TR: Diagnos ic and S a is ical Manual o Men al Diso de s, Fou h Edi ion, Tex Re ision; ED: emo ional
diso de ; TIBP: T ansdiagnos ic in e ne -Based P o ocol; PA: posi i e a ec ; WL: Wai ing Lis ; ITT: in en ion- o- ea .
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Table 2. Demog aphic cha ac e is ics o pa icipan s a p e-assessmen (N=216).
P alueS a is icd
To al (N=216)WLc(n=72)TIBP+PAb(n=73)TIBPa(n=71)Va iable
.09F2213=2.38233.57 (11.24);
18-72
31.82 (10.50);
19-58
33.11 (9.74); 19-5235.82 (13.04);
18-72
Age (yea s), mean (SD); ange
.88
X22=0.2
Sex, n (%)
155 (71.8)53 (74)51 (70)51 (72)Female
61 (28.2)19 (26)22 (30)20 (28)Male
.97
N/Ae
Ma i al s a us, n (%)
127 (58.8)42 (58)41 (56)44 (62)Single
75 (34.7)25 (35)27 (37)23 (32)Ma ied o pa ne ed
14 (6.5)5 (7)5 (7)4 (6)Di o ced o widowed
.46N/AEduca ion le el, n (%)
9 (4.2)3 (4)5 (7)1 (1)Basic s udies
44 (20.4)17 (24)12 (16)15 (21)Medium s udies
163 (75.5)52 (72)56 (77)55 (78)Highe s udies
.57N/AP incipal diagnosis, n (%)
36 (16.7)16 (22)9 (12)11 (15)
MDD
3 (1.4)2 (3)0 (0)1 (1)
DDg
71 (32.9)24 (33)21 (29)26 (37)
GADh
16 (7.4)6 (8)6 (8)4 (6)
PDi/AGj
9 (4.2)3 (4)4 (6)2 (3)PD
13 (6.0)1 (1)6 (8)6 (9)AG
54 (25.0)16 (22)23 (32)15 (21)
SADk
6 (2.8)2 (3)1 (1)3 (4)
OCDl
7 (3.2)1 (1)3 (4)3 (4)
Anxie y NOSm
1 (0.5)1 (1)0 (0)0 (0)Dep ession NOS
.17N/ANumbe o como bid diso de s, n (%)
81 (37.5)34 (47)19 (26)32 (45)0
92 (42.6)26 (36)36 (49)28 (39)1
57 (62)15 (57)22 (61)18 (64)MDD
6 (7)3 (12)2 (6)1 (4)DD
11 (12)2 (8)7 (19)2 (7)GAD
0 (0.0)0 (0)0 (0)0 (0)PD/AG
1 (1)1 (4)0 (0)0 (0)PD
7 (8)2 (8)2 (6)3 (11)AG
10 (10)3 (11)3 (8)4 (14)SAD
0 (0)0 (0)0 (0)0 (0)OCD
0 (0)0 (0)0 (0)0 (0)Anxie y NOS
0 (0)0 (0)0 (0)0 (0)Dep ession NOS
27 (12.5)7 (10)12 (16)7 (10)2
7 (26)2 (29)3 (25)2 (29)MDD and GAD
3 (11)1 (14)1 (8)1 (14)MDD and PD/AG
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P alueS a is icd
To al (N=216)WLc(n=72)TIBP+PAb(n=73)TIBPa(n=71)Va iable
4 (15)2 (29)1 (8)1 (14)MDD and PD
3 (11)0 (0)2 (17)0 (0)MDD and AG
1 (4)0 (0)0 (0)1 (14)MDD and OCD
1 (4)0 (0)1 (8)0 (0)DD and SAD
4 (15)1 (14)1 (8)2 (29)GAD and SAD
2 (7)0 (0)2 (17)0 (0)GAD and AG
1 (4)1 (14)0 (0)0 (0)PD/AG and SAD
1 (4)0 (0)1 (8)0 (0)SAD and OCD
16 (7.4)5 (7)6 (8)4 (6)3
4 (25)2 (40)1 (17)1 (25)MDD, GAD, and AG
4 (25)2 (40)2 (33)0 (0)MDD, GAD, and SAD
2 (13)0 (0)1 (17)0 (0)MDD, GAD, and OCD
2 (13)0 (0)2 (33)0 (0)MDD, PD, and SAD
1 (6)1 (20)0 (0)0 (0)MDD, PD, and OCD
1 (6)0 (0)0 (0)1 (25)MDD, AG, and SAD
1 (6)0 (0)0 (0)1 (25)MDD, SAD, and OCD
1 (6)0 (0)0 (0)1 (25)GAD, PD/AG, and SAD
aTIBP: ansdiagnos ic in e ne -based p o ocol.
bTIBP+PA: ansdiagnos ic in e ne -based p o ocol+posi i e a ec componen .
cWL: wai ing lis .
dS a is ic: Pea son chi-squa e o Fishe exac es .
eN/A: no applicable.
MDD: majo dep essi e diso de .
gDD: dys hymic diso de .
hGAD: gene alized anxie y diso de .
iPD: panic diso de .
jAG: ago aphobia.
kSAD: social anxie y diso de .
lOCD: obsessi e-compulsi e diso de .
mNOS: no o he wise speci ied.
Baseline Da a and Pa icipan Cha ac e is ics
De ails abou pa icipan s’ sociodemog aphic cha ac e is ics
o each g oup a p e ea men a e p esen ed in Table 2. The
esul s indica ed ha he e we e no signi ican di e ences
be ween he expe imen al g oups be o e ea men o any o
hese a iables, indica ing ha he andomiza ion was success ul.
O e all, pa icipan s’ mean age was 33.57 yea s (SD 11.24,
ange 18-72), he majo i y we e emales (155/216, 71.8%), and
mos o hem we e single (127/216, 58.8%) and had comple ed
o we e pu suing highe s udies (163/216, 75.5%; eg,
unde g adua e deg ee s udies, g adua e s udies o uni e si y
mas e ’s deg ees, o pos g adua e s udies o doc o al deg ees).
P incipal and como bid diagnoses a e p esen ed in Table 2.
Mos o he pa icipan s had GAD (71/216, 32.9%), ollowed
by SAD (54/216, 25.0%) and MDD (36/216, 16.7%). Rega ding
he pa e ns o como bidi y in he sample, 41.7% (90/216) o
he pa icipan s had a leas one como bid diagnosis, wi h MDD
being he mos common como bid diso de (n=57), ollowed
by GAD (n=11), SAD (n=10), AG (n=7), DD (n=6), and PD
(n=1).
Rega ding he clinical cha ac e is ics o he pa icipan s in each
expe imen al condi ion a p e ea men (Table 3), no s a is ically
signi ican di e ences we e ound be ween he g oups on any
o he p ima y and seconda y ou comes.
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Table 3. Clinical cha ac e is ics o pa icipan s a p e-assessmen .
P alueS a is ic, F(d )To al (N=216),
mean (SD)
WLc(n=72),
mean (SD)
TIBP+PAb(n=73),
mean (SD)
TIBPa(n=71),
mean (SD)
Measu e
P ima y ou comes
.141.966 (2213)26.93 (11.76)26.31 (12.43)29.07 (11.33)25.35 (11.33)
BDI-IId
.490.719 (2,197)22.23 (12.04)21.87 (12.56)23.58 (11.50)21.14 (12.10)
BAIe
.281.277 (2213)19.84 (6.22)19.28 (5.67)19.32 (6.22)20.72 (6.52)
PANAS _Posi i e
.062.807 (2213)30.43 (8.61)28.63 (9.03)31.96 (8.79)30.68 (7.73)PANAS_Nega i e
Seconda y ou comes
Pe sonali y measu es
.062.853 (2213)32.36 (7.78)31.39 (8.20)34.11 (8.18)31.54 (6.65)
NEO FFIg_Neu o icism
.141.991 (2213)20.84 (8.39)21.79 (8.66)19.26 (7.59)21.49 (8.77)NEO FFI_Ex a e sion
Quali y o li e
.600.511 (2197)53.75 (18.44)51.91 (17.81)54.78 (19.75)54.60 (17.76)
EQ-5Dh
aTIBP: ansdiagnos ic in e ne -based p o ocol.
bTIBP+PA: ansdiagnos ic in e ne -based p o ocol+posi i e a ec componen .
cWL: wai ing lis .
dBDI-II: Beck Dep ession In en o y-II.
eBAI: Beck Anxie y In en o y.
PANAS: Posi i e and Nega i e A ec Schedule.
gNEO FFI: NEO Fi e Fac o In en o y.
hEQ-5D: Eu oQoL-5D ques ionnai e.
E ec i eness o he In e en ion on P ima y and
Seconda y Ou comes a P e-Pos
P ima y Ou comes
Table 4 includes desc ip i e s a is ics (ie, means and SD) o
TIBP+PA, TIBP, and WL a p e ea men and pos ea men ;
Table 5 includes wi hin-g oup and be ween-g oup e ec sizes
and CIs o all he p ima y ou come measu es in he h ee
expe imen al g oups, based on he ITT sample.
Fo he h ee p ima y ou comes, wi hin-g oup compa isons
indica ed signi ican p e-pos educ ions in he wo expe imen al
condi ions, wi h la ge e ec sizes o he BDI-II (d=1.19) and
PANAS-N (d=1.28), and mode a e e ec sizes o he BAI
(d=0.63) and PANAS-P (d=0.69) in he TIBP condi ion. In he
TIBP+PA condi ion, he e ec sizes we e la ge o all p ima y
ou comes (d=1.42, BDI-II; d=0.91, BAI; d=1.27, PANAS-P;
d=1.26, PANAS-N). Be ween-g oup compa isons e ealed ha
pa icipan s who ecei ed he ea men sco ed be e a
pos ea men han he WL g oup. G ea e educ ions we e ound
in he BDI-II sco es in he TIBP condi ion han in he WL
condi ion (mean di e ence −13.61; P<.001; d=1.18; 95% CI
−1.61 o −0.76), as well as be ween he TIBP+PA condi ion
and WL (mean di e ence −14.31; P<.001; d=1.05; 95% CI
−1.46 o −0.63), wi h la ge e ec sizes. No di e ences we e
ound be ween he wo expe imen al condi ions (mean di e ence
0.70; P=.76; d=0.10; 95% CI −0.51 o −0.31).The esul s o
BAI sco es we e simila o he pa e n o indings o he BDI:
g ea e educ ions in he TIBP condi ion (mean di e ence −8.19;
P=.001; d=0.63; 95% CI −1.07 o −0.20) and TIBP+PA
condi ion (mean di e ence −9.28; P<.001; d=0.68; 95% CI
−1.10 o −0.26), compa ed wi h WL, wi h medium e ec sizes,
and no di e ences be ween he wo expe imen al condi ions
(mean di e ence 1.09; P=.65; d=0.05; 95% CI −0.39 o 0.49).
Finally, pa ien s in he TIBP condi ion expe ienced a la ge
inc ease in PA (PANAS-P) compa ed wi h WL (mean di e ence
5.42; P<.001; d=0.74; 95% CI 0.33 o 1.15) wi h mode a e e ec
sizes and g ea e educ ions in NA (PANAS-N; mean di e ence
−8.34; P<.001; d=0.99; 95% CI −1.41 o −0.57) compa ed wi h
WL wi h la ge e ec sizes. Pa icipan s in he TIBP+PA
condi ion expe ienced he same pa e n as he pa icipan s in
he TIBP condi ion bu achie ing la ge e ec sizes o bo h
highe PA (mean di e ence 7.86; P<.001; d=0.90; 95% CI 0.49
o 1.31) and lowe NA (mean di e ence −8.32; P<.001; d=0.91;
95% CI −1.32 o −0.50) han pa icipan s in he WL condi ion.
No di e ences we e ound be ween he wo expe imen al
condi ions on PA (mean di e ence −2.44; P=.08; d=0.25; 95%
CI −0.66 o 0.17) o NA (mean di e ence −0.02; P=.99; d=0.01;
95% CI −0.42 o 0.40).
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pa icipan s and adhe ence o he p og am. Indeed, his aspec
has g ea ele ance in he li e a u e on in e ne -based
in e en ions [95,96]. The e o e, i his ype o in e en ion is
ca ied ou on a la ge scale in he communi y, as in his s udy,
a undamen al ac o o conside is he ype and amoun o
suppo o p o ide, which would be consis en wi h he s udy
o he balance be ween he bene i s and esou ces in ol ed in
p o iding human suppo in in e ne -based in e en ions.
Technologies play a cen al ole in his aspec because pa o
he suppo can be p o ided au oma ically h ough echnological
de ices. In an a emp o unde s and his issue, ou esea ch
g oup conduc ed a quali a i e s udy o de e mine why pa ien s
d opped ou o he web-based ansdiagnos ic p og am o EDs
(TIBP) [97], wi h he esul s emphasizing he lack o
indi idualiza ion o he ea men o he lack o suppo (ie, he
lack o a ec i e and pe sonal con ac wi h he he apis ). In his
ega d, u u e s udies should de elop pe sonalized ea men s
o add ess pa ien s’speci ic needs and inc ease adhe ence a es.
The e a e some use ul s a egies o pe sonalizing ea men s,
such as selec ing ce ain ea men componen s o be e i he
pa ien ’s symp oms o lowe ing he numbe o sessions equi ed
o success ully ea an indi idual’s symp oms. One s a egy
implies pe sonalizing he ea men o a speci ic p esen a ion,
ha is, by selec ing he ea men componen s ha bes i he
speci ic se o symp oms o weaknesses shown by each pa ien
[10], he eby lowe ing he numbe o sessions equi ed o
success ully ea an indi idual’s symp oms. Ano he example
is he s udy by Ca l e al [98]. In his s udy, he au ho s p esen ed
a module o he egula ion o PA ha can be added o he
ea men once hey ha e comple ed he UP modules, hus
pe sonalizing he ea men o pa ien s who show de ici s in
posi i e emo ions a pos ea men .
This s udy has se e al s eng hs. Fi s , i p esen s a no el ocus
in he ield o ansdiagnos ic ea men s. To he bes o ou
knowledge, his is he i s s udy o a ansdiagnos ic
in e ne -based ea men o EDs wi h a speci ic componen o
up egula e PA. O e all, he indings indica e ha EDs can be
e ec i ely ea ed wi h a ansdiagnos ic in e en ion ia he
in e ne , in addi ion o imp o ing dep ession, anxie y, and
quali y o li e measu es. Rega ding PA measu es, p omising
e ec s we e ound, bu mo e esea ch is needed o s udy he
ole o posi i e emo ions in he cons uc ion o psychological
s eng hs [99,100] om a ansdiagnos ic pe spec i e [42,101].
Mo eo e , his s udy included a la ge sample o people om a
communi y sample, ep esen ing a he e ogeneous popula ion
wi h EDs ha does no ecei e p ima y o specialized ca e, wi h
o wi hou he p esence o como bidi ies. Thus, he
ansdiagnos ic p o ocol ep esen s a success ul app oach o he
ea men o mul iple diso de s in a pa simonious manne [102].
Pa icipan s in he s udy seemed o be in e es ed in he use o
adap i e emo ion egula ion s a egies, ega dless o whe he
hey we e ela ed o hei own di icul y, which is he basis o
ansdiagnos ic p oposals. These in e en ions emphasize he
essen ial p ocesses unde lying di e en diso de s and he use
o co e highe -o de s a egies ha elimina e he need o
mul iple diagnosis-speci ic manuals [103]. Mo eo e , he
in e ne -based o ma o his ansdiagnos ic p o ocol acili a es
he a ailabili y and adminis a ion o he p og am o p o ide
suppo o anyone in need.
Limi a ions
This s udy also has some limi a ions. The mos impo an is he
di e en numbe o modules in he wo p o ocols (TIBP
condi ion: 12 modules; TIBP+PA condi ion: 16 modules). The
TIBP condi ion had mo e ime be ween he las module and
pos assessmen han he TIBP+PA condi ion. Howe e , he
TIBP+PA condi ion had mo e modules. Pos assessmen ook
place a he end o module 12 o 16. These aspec s may ha e
in luenced he esul s. In an a emp o con ol his, equal ime
(ie, a maximum pe iod o 18 weeks om andomiza ion o
pos ea men e alua ion) was gi en o all pa icipan s o allow
hem o use he p og am as much as hey desi ed h oughou
he whole p ocess. Howe e , u u e s udies should show ha
he di e en ial e ec o he PA componen is no simply because
o he la ge numbe o modules in he p o ocol. This leads o
he impo ance o benchma king based on p e ious
ansdiagnos ic in e ne -based in e en ions wi h ega d o e ec
sizes o he leng h o hese in e en ions. This s udy coincides
wi h p e ious simila ansdiagnos ic in e en ions ha also
ob ained la ge e ec sizes o dep ession (g=0.84) and medium
e ec sizes o anxie y (g=0.78), wi h a ea men leng h anging
om 6 o 10 sessions [18]. Fu he mo e, ocusing on PA
measu es, i is impo an o men ion ha his s udy ob ained
la ge e ec sizes o PA, bo h o wi hin- and be ween-
compa isons (TIBP+PA, d=1.27; TIBP+PA s WL, d=0.90)
han o he ansdiagnos ic in e en ions [13,14,50-53]. Ano he
limi a ion o he s udy, sha ed wi h o he ansdiagnos ic
in e en ions, is ha al hough hey a e called ansdiagnos ic
ea men s, hey a e based on disc e e diagnos ic ca ego ies (ie,
DSM-IV). Fu u e esea ch should s udy he mechanis ically
ansdiagnos ic p inciples, ha is, he unde lying mechanisms
ha accoun o he occu ence o speci ic symp oms o include
hem in bo h assessmen s and ansdiagnos ic in e en ions.
Some examples o ansdiagnos ic mechanisms ha ha e been
ound o play a undamen al ole in EDs a e in ole ance o
unce ain y [104], umina ion [105], pe ec ionism [106], o
hough supp ession [107]. Among hese p ocesses, neu o icism
has been s ongly associa ed wi h bo h anxie y and dep essi e
diso de s [86,108]. In addi ion, a i ion a es we e highe in
bo h ea men condi ions (TIBP: 26/71, 37%; TIBP+PA: 27/73,
37%) han in he WL condi ion (17/72, 24%). Howe e , a i ion
a es o 30% o 35% a e commonly obse ed in in e ne -based
in e en ions [47]. Fu he mo e, al hough we conside ha he
sample o his s udy is qui e ep esen a i e, u u e esea ch
should ocus on imp o ing he men al heal h o less eachable
g oups such as olde people, people wi h low income o lowe
educa ional le el, and/o people esiding ou side u ban a eas
(ie, u al popula ions). Mo eo e , i would also be impo an o
collec da a on ce ain demog aphic a iables such as ace,
e hnici y, and sexual o ien a ion in u u e ials. T ansdiagnos ic
ea men s ha a e sociocul u ally adap ed o such g oups could
be a po en ial solu ion o e ec i ely each a la ge numbe o
people in need o psychological help.
Finally, ollow-up da a we e no included in his s udy because
we a e s ill in he ec ui ing p ocess, and we wan ed o p omp ly
p o ide he esul s because o he impo ance o he issue. The
long- e m e ec s o his in e en ion will be p esen ed in u he
esea ch.
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Conclusions
In summa y, he esul s show he e icacy o a ansdiagnos ic
in e ne -based psychological ea men p o ocol o indi iduals
om a communi y sample wi h EDs. These indings show ha
his web-based ansdiagnos ic ea men imp o ed he clinical
si ua ion o he pa icipan s, p o iding hem wi h ools and
s a egies o ace p oblems and di icul ies mo e e ec i ely.
Fu u e lines o esea ch should ca y ou disman ling designs
o de e mine he ac i e componen s o he p o ocol, especially
he con ibu ion o he PA modules, and analyze he
e ec i eness o web-based ea men in o he popula ions, such
as p ima y ca e cen e s. Fu he mo e, he exis ing echniques
and s a egies o imp o e PA equi e u he s udy o de e mine
which ones a e mo e e ec i e and should be included as speci ic
componen s o up egula e PA in cu en psychological
in e en ions. This s udy includes some speci ic s a egies o
p omo e psychological s eng hs and enhance posi i e mood.
Howe e , i is impo an o u u e s udies o explo e mo e
deeply he e ec o hese and o he s a egies on pa ien s wi h
EDs o di ec ly build posi i e esou ces o coun e ac NA.
Undoub edly, u u e esea ch will ha e o de e mine whe he i
is bene icial o include hese componen s designed o enhance
PA, which componen s a e necessa y o whom, and how hey
should be applied.
Fu he mo e, u u e esea ch should ocus on he possibili y o
de eloping ea men componen s aimed a al e ing, modi ying,
o a ying ulne abili y, a key aspec o ansdiagnos ic
pe spec i es. This migh be possible wi h s a egies o
modi ying PA, bu he e a e o he undamen al ac o s ha
in luence men al heal h and well-being. Fo example, a la ge
body o li e a u e has highligh ed he impo ance o accu a e
pe cep ions o eali y in psychological heal h, such as posi i e
illusions o posi i e sel -e alua ions, pe cep ions o con ol o
mas e y, and un ealis ic op imism [109,110]. In addi ion, he e
is e idence o he ela ionship be ween psychological lexibili y
and well-being, sugges ing ha being psychologically lexible
has bene i s o execu i e unc ioning, de aul men al s a es,
and pe sonali y dimensions such as neu o icism [111].
Psychological lexibili y has been conside ed a p o ec i e ac o
in imp o ing physical heal h, men al heal h, and well-being
[112]. Hence, he e is g owing in e es in cons uc s such as
p agma ic p ospec ion, ha is, hinking abou a u u e wi h
desi ed ou comes and a oiding undesi ed ones [113] o openness
o he u u e cha ac e ized by PA owa d he u u e [114]. This
body o knowledge opens up he possibili y o inding new
s a egies o imp o e he e iciency and e ec i eness o u u e
ansdiagnos ic ea men p o ocols o EDs as a way o mo e
e ec i ely add ess empe amen ulne abili ies, ha is, he co e
aspec s o hese diso de s.
Acknowledgmen s
This s udy was unded by he Minis y o Economy and Compe i i eness (Spain; PSI2014-54172-R), a PhD g an om he
Minis y o Economy and Compe i i eness (FPI-MINECO; BES-2015-072360), and CIBER Fisiopa ología de la Obesidad y
Nu ición-ISCIII CB06/03/0052.
Con lic s o In e es
None decla ed.
Mul imedia Appendix 1
Desc ip ion o he posi i e a ec modules.
[DOC File , 38 KB-Mul imedia Appendix 1]
Mul imedia Appendix 2
CONSORT-eHEALTH checklis (V 1.6.1).
[PDF File (Adobe PDF File), 1638 KB-Mul imedia Appendix 2]
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Abb e ia ions
AG: ago aphobia
BA: beha io al ac i a ion
BAI: Beck Anxie y In en o y
BDI-II: Beck Dep ession In en o y, Second Edi ion
BI: beha io al inhibi ion
CBT: cogni i e beha io al he apy
CONSORT: Consolida ed S anda ds o Repo ing T ials
DD: dys hymic diso de
DSM-IV: Diagnos ic and S a is ical Manual o Men al Diso de s, Fou h Edi ion
E: ex a e sion
EBT: e idence-based psychological ea men
ED: emo ional diso de
GAD: gene alized anxie y diso de
ICT: in o ma ion and communica ion echnology
ITT: in en ion- o- ea
MDD: majo dep essi e diso de
MNAR: missing no a andom
N: neu o icism
NA: nega i e a ec o nega i e a ec i i y
NEO FFI: NEO Fi e Fac o In en o y
PA: posi i e a ec
PANAS: Posi i e and Nega i e A ec Schedule
PD: panic diso de
RCI: eliable change index
RCT: andomized con olled ial
SAD: social anxie y diso de
TIBP: ansdiagnos ic in e ne -based p o ocol
UP: Uni ied P o ocol
WL: wai ing lis
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Edi ed by T Rashid So on; submi ed 11.06.20; pee - e iewed by L Eus is Ph.D, E Kelly, C Păsă elu; commen s o au ho 23.07.20;
e ised e sion ecei ed 10.09.20; accep ed 01.12.20; published 01.02.21
Please ci e as:
Díaz-Ga cía A, González-Robles A, Ga cía-Palacios A, Fe nández-Ál a ez J, Cas illa D, B e ón JM, Baños RM, Que o S, Bo ella C
Nega i e and Posi i e A ec Regula ion in a T ansdiagnos ic In e ne -Based P o ocol o Emo ional Diso de s: Randomized Con olled
T ial
J Med In e ne Res 2021;23(2):e21335
URL: h ps://www.jmi .o g/2021/2/e21335
doi: 10.2196/21335
PMID:
©Amanda Díaz-Ga cía, Albe o González-Robles, Azucena Ga cía-Palacios, Ja ie Fe nández-Ál a ez, Diana Cas illa, Juana
Ma ía B e ón, Rosa Ma ía Baños, Soledad Que o, C is ina Bo ella. O iginally published in he Jou nal o Medical In e ne Resea ch
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