STUDY PROTOCOL Open Access
Cogni i e beha io al in e en ion ia a
sma phone app o non-p o essional
ca egi e s wi h dep essi e symp oms:
s udy p o ocol o a andomized con olled
ial
Fe nando L. Vázquez
1*
, Ángela To es
2
, Olga Díaz
1
, Ma io Pá amo
2
, Pa icia O e o
3
, Vanessa Blanco
4
and La a López
1
Abs ac
Backg ound: Al hough majo dep ession is a equen diso de in non-p o essional ca egi e s and he e a e e ec i e
psychological in e en ions o p e en i , ca egi e s ha e di icul y accessing hem. In e en ions o dep ession applied
h ough an app could imp o e accessibili y; ye , o da e, adhe ence o such in e en ions has been low. The objec i es
o his s udy a e o (1) e alua e he e icacy o a cogni i e beha io al dep ession p e en ion in e en ion adminis e ed
h ough a sma phone app wi h and wi hou elephone con e ence calls, (2) analyze he media o s o he change in
he incidence o dep ession and dep essi e symp oms, and (3) assess adhe ence and sa is ac ion wi h he in e en ions.
Me hods: A andomized con olled clinical ial will be conduc ed. Ca egi e s wi h ele a ed symp oms will be andomly
assigned o a cogni i e beha io al in e en ion adminis e ed by a sma phone app (CBIA) g oup, a CBIA plus elephone
con e ence calls (TCCs) g oup (CBIA + TCC), o an a en ion con ol g oup. Each condi ion will consis o app oxima ely 58
pa icipan s. Bo h in e en ions will be adminis e ed in i e modules h ough a sma phone app and he CBIA + TCC g oup
will ecei e addi ional TCCs in g oup o ma ( ou sessions o 30 min each). T ained blind assesso s will conduc p e-
ea men , pos - ea men and ollow-up assessmen s a 1, 3, 6, and 12 mon hs.
Discussion: This s udy will p o ide e idence o he e icacy o a cogni i e beha io al in e en ion o p e en dep ession
in ca egi e s wi h ele a ed dep essi e symp oms adminis e ed h ough a sma phone app and he impac o eedback
applied h ough con e ence calls o inc ease p og am adhe ence and e icacy. I he esul s we e a o able, i would mean
ha we ha e de eloped a mo e e ec i e, accessible, and clinically use ul p e en i e dep ession in e en ion han he
cu en ly a ailable ones o many p esen and u u e ca egi e s.
T ial egis a ion: ClinicalT ials.go : NCT03110991. Regis e ed 5 Ap il 2017.
Keywo ds: Non-p o essional ca egi e s, App, Sma phone, Dep ession, P e en ion, Adhe ence o he in e en ion,
S udy p o ocol
* Co espondence: [email p o ec ed]
1
Depa men o Clinical Psychology and Psychobiology, Uni e si y o
San iago de Compos ela, San iago de Compos ela, Spain
Full lis o au ho in o ma ion is a ailable a he end o he a icle
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Vázquez e al. T ials (2018) 19:414
h ps://doi.o g/10.1186/s13063-018-2793-2
Backg ound
In Eu opean coun ies, app xima ely 54.5 million people
a e ca egi e s o a lo ed one in a si ua ion o depend-
ency [1]. Howe e , s aying in his si ua ion o a p olon-
gued pe iod can a ec hei physical and men al heal h
[2]. In he con ex o men al heal h, majo dep ession is
he mos equen men al diso de in his popula ion,
wi h a p e alence o 8.9% [3]. These igu es a e highly
ele an because dep ession is associa ed wi h impai ed
unc ion [4] and may in e e e wi h he quali y o ca e o
he dependen [5].
In e en ions o p e en dep ession may p e en o e-
duce he occu ence o hese cases o dep ession. Speci -
ically, p e en ion in e en ions aimed a ca egi e s wi h
high dep essi e symp oms bu who ha e no ye de el-
oped clinical dep ession (i.e., indica ed p e en ion) ha e
he g ea es empi ical e idence o da e [6–9]. One o
hese in e en ions, e alua ed by Vázquez e al. [8,9],
was de eloped based on Lewinsohn e al.’s[10] mul i ac-
o ial in eg a o model o dep ession. This in e en ion
ound a signi ican educ ion in he incidence o dep es-
sion and dep essi e symp oms in he cogni i e beha -
io al in e en ion g oup compa ed o he usual ca e
con ol g oup a pos - ea men [8] and a e 12 mon hs
o ollow-up [9]. Mo eo e , he changes ound in ela ion
o dep essi e symp oms we e clinically signi ican [11].
Al hough hese esul s a e p omising, he in e en ion
was applied ace- o- ace, which may limi i s impac on
public heal h since his o ma p esen s a se ies o ba -
ie s ha make i less accessible o ca egi e s. Many
ca egi e s ind i di icul o a end in e en ions due o
lack o ime, displacemen p oblems, no ha ing a ca e-
gi e subs i u e o hei dependen du ing hei absence,
lack o men al heal h se ices, o s igma iza ion.
These accessibili y issues could be easily mi iga ed
h ough in o ma ion and communica ion echnologies,
among which ha wi h he g ea es po en ial is he
mobile phone. Mobile phones a e owned by mo e
han 80% o he wo ld’spopula ion[12], hey a e
po able and can se e as a pla o m o a a ie y o
apps hanks o i s accessibili y o p og amming and
in e ne access (sma phones). Howe e , he e a e
cu en ly only wo andomized con olled ials ha
ha e e alua ed in e en ions o he ea men o de-
p ession h ough an app, nei he o which was aimed
a p e en ing dep ession in ca egi e s and only show-
ing pa ial imp o emen s in he educ ion o dep es-
si e symp oms. Mo e speci ically, A ean e al. [13]
ound no signi ican di e ence a he pos - ea men
and 1-mon h ollow-up be ween a cogni i e aining
in e en ion, ano he in e en ion based on
p oblem-sol ing he apy, and an a en ion con ol
g oup whe e pa icipan s ecei ed he apeu ically in-
ac i e in o ma ion on heal h (Heal h Tips). A he
3-mon h ollow-up, pa icipan s in bo h in e en ions
showed highe emission a es compa ed o con ols
(50% and 49% s. 32%), bu only hose wi h mode a e
dep essi e symp oma ology in he p oblem-sol ing
he apy g oup showed less dep essi e symp oms han
he con ol g oup (d= 0.76). In addi ion, Ly e al. [14]
did no ind any pos - ea men di e ences be ween a p o-
g am based on beha io al ac i a ion and ano he based on
mind ulness. A he 6-mon h ollow-up, he beha io al
ac i a ion in e en ion was mo e e ec i e o pa ien s
wi h g ea e ini ial se e i y o dep ession (d=0.47),
whe eas he mind ulness in e en ion was mo e e ec i e
o pa ien s wi h less se e i y (d=0.98).
The limi a ions in bo h s udies included p oblems o
adhe ence o he in e en ions. D opou a es we e high,
anging om 14.8% [14] o 31.6% [13]; in he s udy by
A ean e al. [13], 57.9% did no e en download he
assigned in e en ion app and he le el o compliance
wi h homewo k assignmen s was no epo ed. These is-
sues a e undamen al because indi iduals who lea e he
in e en ion show wo se esul s and less sa is ac ion
wi h he he apy, and when e alua ing he e icacy o in-
e en ions, high d opou a es can lead o bias due o
a i ion, limi ing he gene alizabili y o he esul s [15].
In addi ion, homewo k comple ion is a signi ican p e-
dic o o he apy ou comes in a ious popula ions and
in e en ions [16], including dep ession p e en ion in-
e en ions in he ca egi e popula ion [17]. This shows
ha when mo e homewo k is comple ed, he he apy e-
sul s a e be e , leading o a g ea e educ ion o dep es-
si e symp oms [17]. Complemen ing he in e en ions
implemen ed h ough sma phones wi h a elephone
con e ence call (TCC) o gi e eedback could help sol e
hese p oblems. In beha io al skills aining p ocedu es,
eedback is speci ically de ined as deli e y o p aise o
co ec pe o mance o a a ge beha io and u he
ins uc ion ollowing inco ec pe o mance [18].
The objec i es o he p esen s udy a e o (1) assess
he e icacy o a cogni i e beha io al in e en ion o in-
dica ed p e en ion o dep ession in in o mal ca egi e s,
adminis e ed h ough a sma phone app (CBIA) wi h
and wi hou TCCs wi h espec o a ca e con ol g oup,
(2) analyze he media o s o change in dep essi e symp-
oms, and (3) assess adhe ence and sa is ac ion wi h he
in e en ions. As a cen al hypo hesis, bo h in e en-
ions a e expec ed o signi ican ly educe he incidence
o dep essi e episodes and dep essi e symp oms com-
pa ed o he con ol g oup a pos - ea men and a 1-,
3-, 6-, and 12-mon h ollow-up. Seconda y hypo heses
a e (1) ha he change in ein o cemen and in nega i e
au oma ic hough s will media e he e ec s o bo h in-
e en ions and (2) ha he pa icipan s ecei ing CBIA
+ TCC will show g ea e adhe ence and sa is ac ion wi h
he in e en ion han hose who ecei e CBIA alone.
Vázquez e al. T ials (2018) 19:414 Page 2 o 10
Me hods
Design
A andomized con olled clinical ial will be conduc ed
o s udy he e icacy o a cogni i e beha io al in e en-
ion o non-p o essional ca egi e s wi h ele a ed de-
p essi e symp oms adminis e ed h ough a sma phone
app wi h and wi hou TCCs. Speci ically, eligible pa ici-
pan s will be andomly assigned o one o h ee condi-
ions, as ollows: (1) CBIA; (2) CBIA + TCC; and (3) an
a en ion con ol g oup (ACG).
The s udy phases a e shown in Fig. 1. The e will be six
measu emen poin s in he h ee g oups (i.e.,
p e- ea men , pos - ea men , and ollow-up a 1, 3, 6,
and 12 mon hs). A e he baseline assessmen (p e--
ea men ), and once ca egi e s who mee he eligibili y
c i e ia a e selec ed and in e en ions a e adminis e ed,
a pos - ea men e alua ion and ou ollow-ups will be
pe o med (a 1, 3, 6, and 12 mon hs). To minimize he
loss o pa icipan s, we will ollow he s a egies
ecommended by G ady e al. [19], such as selec ing pa ic-
ipan s who a e likely o adhe e o he in e en ion, ob ain-
ing a ious means o con ac he pa icipan s (add ess,
elephone, email), and making he in e en ion easy.
Sample size
Based on a p e ious s udy o indica ed p e en ion o de-
p ession in ca egi e s [9], which in ol ed he same p o-
g am ha will be e alua ed in he p esen s udy (albei
in pe son), we es ima e ha a sample size o 49 pa ici-
pan s pe g oup (98 in o al) would be su icien o de-
ec an 18.6% di e ence in he incidence a es o majo
dep ession episodes be ween he expe imen al g oup
and he con ol, assuming a wo- ailed es αo 0.05 and
a powe (1 –β) o 0.80. Howe e , conside ing an a i-
ion a e o app oxima ely 15% based on s udies ha
ha e e alua ed he use o in e en ions o he ea men
o dep ession applied h ough an app [14], we es ima e
Fig. 1 SPIRIT Figu e. Phases o he andomized con olled ial. No e: * Du ing he in e en ion and a pos - ea men
Vázquez e al. T ials (2018) 19:414 Page 3 o 10
ha he numbe o pa icipan s pe g oup should be 58,
esul ing in a inal sample size o 174.
Pa icipan s, ec ui men , and eligibili y c i e ia
Pa icipan s will be ec ui ed om he popula ion o
non-p o essional ca egi e s o pe sons in a si ua ion o
dependency o icially ecognized by he Regional Go -
e nmen o Galicia. Galicia is a egion in he no hwes
o Spain wi h an a ea o 29,434 km
2
and a popula ion o
2,730,337.
I has been p e iously de e mined ha be ween 39%
and 44% o ca egi e s p esen wi h ele a ed dep essi e
symp oms [7,8] and 8.9% ha e had a majo dep essi e
episode [3]. As a esul , o achie e he es ima ed sample
o abou 174 pa icipan s, we would need o selec ap-
p oxima ely 532 ca egi e s o sc eening p io o e i i-
ca ion o eligibili y c i e ia.
Ca egi e s will be con ac ed h ough a le e in i ing
hem o pa icipa e in he s udy and asking hem o e-
u n a sealed pos ca d i hey do no wish o be con-
ac ed again. Ca egi e s who do no send he ca d will
be con ac ed by phone. A ha ime, a b ie desc ip ion
o he s udy will be gi en, and hose who a e in e es ed
will ecei e a b ie sc eening call o e alua e hei de-
p essi e symp oms, he diagnos ic c i e ia o majo de-
p essi e episodes, and he eligibili y c i e ia. Those who
mee he ini ial selec ion c i e ia will be in i ed o pa -
icipa e in a ull e alua ion h ough he app.
To be included in he s udy, pa icipan s mus mee he
ollowing inclusion c i e ia: (1) be a non-p o essional ca e-
gi e o a dependen amily membe whose dependency is
o icially ecognized by he Regional Go e nmen o Gal-
icia; (2) ha e a sma phone; (3) p esen a clinically signi i-
can symp oma ology de ined as a sco e equal o o
g ea e han 16 in he Spanish e sion o he Cen e o
Epidemiologic S udies Dep ession Scale (CES-D [20]); (4)
no mee he diagnos ic c i e ia o a majo dep essi e epi-
sode acco ding o he Diagnos ic and S a is ical Manual o
Men al Diso de s (DSM-5) [21]; (5) no ha e a his o y o
majo dep ession; (6) commi o pa icipa ing in all e alu-
a ions; and (7) p o ide w i en in o med consen . Pa ici-
pan s who mee he ollowing c i e ia will be excluded: (1)
ecei ing psychological o psychopha macological ea -
men in he las 2 mon hs; (2) ha e o he diso de s ha
may ac as con ounding a iables (e.g., symp oms due o
subs ance use); (3) ha e se e e psychological o medical
diso de s equi ing immedia e in e en ion (e.g., suicidal
idea ion) o ha make he s udy impossible (e.g., signi i-
can cogni i e impai men ); (4) ha he pe son in a si u-
a ion o dependence has a se e e o e minal p ognosis
wi hin he nex 14 mon hs; o (5) ha in he nex
14 mon hs hey plan o mo e o o ins i u ionalize he
dependen hey we e ca ing o .
Randomiza ion
Those pa icipan s who mee he eligibili y c i e ia will be
andomly assigned o one o he h ee condi ions, CBIA,
CBIA + TCC, o ACG, by a s a is ics expe no ela ed o
he s udy using a able o andom numbe s gene a ed by a
compu e . The sequence o andomiza ion will be com-
munica ed o he esea che s by means o sealed num-
be ed en elopes, one o each pa icipan , wi h
ins uc ions o use hem in nume ical o de . Due o he
na u e o he in e en ion, i is no possible o blind he
pa icipan s o alloca ion s a us.
In e en ions
We ha e de eloped a p o ocol in e en ion and manua-
lized each in e en ion o inc ease in e nal alidi y. In he
CBIA g oup, all pa icipan s will ecei e he same in e -
en ion con en h ough a sma phone app. In he CBIA
+ TCC g oup, in addi ion o he a o emen ioned in e en-
ion, he in e en ion will be applied by psychologis s
(mas e s o doc o al-le el deg ee) who will be ained o
he adminis a ion o he in e en ion by wo p o es-
sionals wi h mo e han 20 yea s o expe ience in cogni i e
beha io al he apy. They will ecei e app oxima ely 35 h
o aining consis ing o heo e ical and p ac ical semina s
and ole-playing exe cises. In his g oup, TCC sessions will
be eco ded. The p o essionals who will pa icipa e in
he apis s’ aining will assess he deg ee o adhe ence o
he manuals and he abili y o apply he in e en ions, and
will moni o he he apis s weekly.
Cogni i e-beha io al in e en ion adminis e ed h ough a
sma phone app (CBIA)
We ha e adap ed an indica ed p e en ion in e en ion
o dep ession based on he mul i ac o ial model o
Lewinsohn e al. [10] ha has p o ed i s e icacy in p e-
ious ace- o- ace s udies [8,9] and in con e ence ele-
phone o ma [22] o applica ion h ough a sma phone
app. This cogni i e beha io al in e en ion consis s o
i e modules o be pe o med in app oxima ely 5 weeks.
In module 1, we will explain he concep o dep ession,
he need o ac i e coping wi h dep essi e symp oms,
and we will ain pa icipan s in diaph agma ic b ea h-
ing, moni o ing mood and sel - ein o cing echniques.
Module 2 will be ocused on how pleasan ac i i ies
a ec mood and de eloping a plan o in oducing such
ac i i ies in he pa icipan s’daily li es wi h he help o
beha io al con ac s. In module 3, we will add ess how
hough s a ec mood and pa icipan s will be ained on
echniques o manage hough s. In module 4, we will ex-
plain how social con ac s a ec mood, gi e s a egies o
asse i e communica ion, and encou age pa icipan s o
inc ease hei social con ac s. In module 5, pa icipan s
will e iew e e y hing hey ha e lea ned h oughou he
in e en ion and ocus on elapse p e en ion.
Vázquez e al. T ials (2018) 19:414 Page 4 o 10
Cogni i e beha io al in e en ion adminis e ed h ough a
sma phone app + elephone con e ence call (CBIA + TCC)
This g oup will ecei e, in addi ion o CBIA as desc ibed
abo e, a elephone con ac in g oup o ma (in g oups o
i e ca egi e s app oxima ely), using a con e ence sys-
em, o i e weekly 30-min sessions. G oup ules will be
explained in he i s session and posi i e o co ec i e
eedback will be adminis e ed h ough he i e sessions
a e e ising he pe o med homewo k [18]. Posi i e
eedback consis s o p o iding in o ma ion on he co -
ec implemen a ion o he in e sessional asks and
ein o cemen , and co ec i e eedback in ol es iden i y-
ing hose asks ha ha e no been adequa ely ca ied
ou and sugges ing ele an changes o imp o e pe -
o mance. We ollow Mil enbe g’s guidelines [18] o im-
p o e he e ec i eness o eedback, namely ha (1) i
should be gi en immedia ely a e he a ge beha io is
pe o med; (2) i should con ain p aise o o he
ein o cemen o doing he beha io co ec ly and, i
he beha io is inco ec , some ype o p aise should be
gi en o ying; (3) p aise mus be desc ip i e, ocusing
on how he beha io has been pe o med; (4) co ec i e
eedback should no be nega i e and he pe o mance o
he pa icipan should no be desc ibed as w ong o mis-
aken (i is be e o ocus on how o imp o e pe o m-
ance); (5) always p aise some aspec o he beha io
be o e p o iding co ec i e eedback; and (6) p o ide
co ec i e eedback on one aspec o beha io a a ime.
Pa icipan s will also be encou aged o suppo each
o he in he p ocess o change.
A en ion con ol g oup (ACG)
Pa icipan s in he con ol g oup will ecei e in o ma ion
on dep ession equal o he CBIA g oup in du a ion ( i e
modules), ex ension, and mode o adminis a ion ( ia a
sma phone app). Pa icipan s in his g oup will ecei e
he apeu ically inac i e in o ma ion abou dep ession (e.g.,
wha is dep ession, p e alence, causes, symp oms) and
heal hy habi s.
Ou comes
As shown in Table 1, we will collec in o ma ion on he
sociodemog aphic cha ac e is ics o ca egi e s and he
ca e si ua ion, majo dep essi e episodes and o he men-
al diso de s, dep essi e symp oms, media ing a iables
(en i onmen al ein o cemen and nega i e hough s),
d op ou , adhe ence, and sa is ac ion wi h he in e -
en ion. The sel -adminis e ed ins umen s will be
comple ed by he pa icipan s h ough he app.
He e o-adminis e ed ins umen s will be adminis e ed
h ough he elephone by ained in e iewe s who will be
blind o he objec i es o he s udy, he in e en ions ha
will be adminis e ed, and he andomiza ion o he di e -
en g oups. The aining o he e alua o s will be ca ied
ou by wo s udy esea che s wi h mo e han 20 yea s o
expe ience in e alua ion, and will consis o 15 h o heo -
e ical and p ac ical semina s and ole-playing abou he
measu emen ins umen s and he e alua ion s a egies.
Sociodemog aphic cha ac e is ics and ca e si ua ion
These will be e alua ed h ough he Cha ac e is ics and
S a us o Ca egi e Ques ionnai e used in p e ious s ud-
ies [8,9]. I eco ds he sociodemog aphic cha ac e is ics
o he non-p o essional ca egi e s (sex, age, ma i al s a-
us, social class, educa ional le el, main ac i i y) and he
ca e si ua ion ( ela ionship wi h he pe son ca ed o ,
age and sex o he dependen , disease o he dependen ,
ime ca ing o hei ela i e and daily hou s dedica ed
o he ca e).
P ima y ou come measu e: majo dep ession
The p esence o a majo dep essi e episode will be e al-
ua ed wi h he S uc u ed Clinical In e iew o DSM-5
®
–Clinician Ve sion (SCID-5-CV; [23]). This p o ides
diagnoses o DSM-5 and mus be adminis e ed by a clin-
ician. I includes he mos common diso de s in clinical
p ac ice, namely dep essi e diso de , bipola diso de ,
schizoph enia and o he psycho ic diso de s, subs ance
use diso de s, anxie y diso de s, obsessi e-compulsi e
diso de , pos - auma ic s ess diso de , a en ion de ici
hype ac i i y diso de , and adap i e diso de s, and i
allows he sc eening o 17 addi ional diso de s. Fo he
p e- ea men e alua ion, he en i e in e iew will be
used, while in he ollowing e alua ions only he module
co esponding o he majo dep essi e episode will be
used. This in e iew has been applied ace- o- ace and
elephonically [24]. In e obse e eliabili y (Kappa)
anges om 0.70 o 1.00.
Table 1 O e iew o measu es
Ins umen Fo ma
Pa icipan cha ac e is ics
Sociodemog aphic and ca e
si ua ion cha ac e is ics
Sel -adminis e ed
P ima y ou come
Majo dep ession: SCID-5-CV He e o-adminis e ed
Seconda y ou comes
Dep essi e symp oms: CES-D Sel -adminis e ed
Rein o cemen : EROS Sel -adminis e ed
Au oma ic nega i e hough s: ATQ Sel -adminis e ed
D opou and ea men adhe ence He e o-adminis e ed
Sa is ac ion wi h he se ice ecei ed:
CSQ-8
Sel -adminis e ed
SCID-5-CV S uc u ed Clinical In e iew o DSM-5 Diso de s, Clinician
Ve sion, CES-D Cen e o Epidemiologic S udies Dep ession Scale,
EROS En i onmen al Rewa d Obse a ion Scale, ATQ Au oma ic Though s
Ques ionnai e, CSQ-8 Clien Sa is ac ion Ques ionnai e
Vázquez e al. T ials (2018) 19:414 Page 5 o 10
Seconda y ou come measu es
Dep essi e symp oms Dep essi e symp oms will be
e alua ed h ough he CES-D sel - epo scale [25]
(Spanish e sion o Vázquez e al. [20]). I is a 20-i em
scale in which indi iduals epo he equency wi h
which hey ha e expe ienced each symp om du ing he
p e ious week. Each o he i ems is e alua ed on a Like
scale o ou esponse op ions, wi h a ange om 0
( a ely o none o he ime) o 3 (mos o he ime). The
o al sco e ange expands om 0 o 60, whe e a highe
sco e co esponds o a g ea e dep essi e symp oma ol-
ogy. The in e nal consis ency anges om 0.85 o 0.90,
wi h he Spanish e sion ha ing a consis ency o 0.89.
Rein o cemen In o de o e alua e he ein o cemen
o he en i onmen we will use he sel - epo ed En i -
onmen al Rewa d Obse a ion Scale (EROS) [26] (Span-
ish e sion o Ba aca and Pé ez-Ál a ez [27]). I
consis s o 10 i ems in which he pa icipan e alua es
he deg ee o posi i e ein o cemen ecei ed con in-
gen ly om hei en i onmen on a Like scale anging
om 1 (s ongly disag ee) o 4 (s ongly ag ee). The o al
sco e anges om 10 o 40, wi h a highe sco e indica -
ing g ea e posi i e ein o cemen . The in e nal
consis ency o he Spanish e sion is 0.86.
Au oma ic nega i e hough s Nega i e au oma ic
hough s will be e alua ed h ough he Au oma ic
Though s Ques ionnai e (ATQ) [28] (Spanish e sion o
O e o e al. [29]). This is a 30-i em sel - epo ques ion-
nai e in which pa icipan s mus indica e, o each i em,
he equency wi h which hey expe ienced a se ies o
hough s du ing he p io week, in a Like scale anging
om 1 (ne e ) o 5 (always). The o al sco e ange ex-
ends om 30 o 150, whe e a highe sco e indica es
mo e nega i e hough s. I s in e nal consis ency is 0.96.
D opou and ea men adhe ence A eco d will be
kep o he d opou s p oduced in each g oup h oughou
he s udy. In addi ion, in he in e en ions, a eco d o
he numbe o modules comple ed and he ul illmen o
he in e sessional asks by each ca egi e will be made.
Sa is ac ion wi h he se ice ecei ed The sa is ac ion
o he pa icipan s wi h he se ice ecei ed once he in-
e en ions a e comple ed will be e alua ed wi h he Cli-
en Sa is ac ion Ques ionnai e (CSQ-8) [30] (Cas ilian
Spanish e sion o Vázquez e al. [31]). I is a
sel - epo ed scale o eigh i ems and ou possible an-
swe s, wi h a sco e anging om 8 o 32, whe e a highe
sco e implies a g ea e sa is ac ion wi h he se ice e-
cei ed. I s in e nal consis ency anges om 0.80 o 0.93
[32], wi h he Spanish e sion ha ing a consis ency
o 0.80.
Da a managemen
Pe sonal da a (iden i ying in o ma ion) and clinical da a
will be s o ed sepa a ely. The pa icipan iles will be
s o ed in nume ical o de in a sa e place. They will be kep
o 5 yea s a e comple ion o he s udy. All da a will be
en e ed in o a da abase, in which indi iduals canno be
iden i ied. Range checks and consis ency checks agains
da a al eady s o ed in he da abase will be made. All e alu-
a ion ins umen s, audio eco dings, and ha dwa e ela ed
o he s udy da a will be kep in locked cabine s. Access o
s udy da a will be es ic ed, wi h a passwo d sys em ha
only esea che s will know, used o con ol access. A
backup o he o iginal da abase (p ima y da abase) will be
pe o med wice a mon h. All epo s and publica ions de-
i ed om he s udy will be p epa ed in such a way ha
no indi idual can be iden i ied.
S a is ical analyses
We will use he s a is ical package SPSS o Windows
( e sion 21.0) o he analysis o he da a. All analyses will
be pe o med acco ding o he in en - o- ea p inciple. I
pa icipan s d op ou om he s udy, he los alues will
be impu ed using mul iple impu a ion [33].
To analyze he incidence o dep essi e episodes in
each o he measu emen imes (pos - ea men , 1, 3, 6,
and 12 mon hs o ollow-up), a global χ
2
es will be pe -
o med o compa e he h ee g oups. I he di e ences
a e s a is ically signi ican (p< 0.05), pai wise compa i-
sons will be pe o med using logis ic eg ession. The
ela i e isk and he equi ed numbe o pa ien s o be
ea ed will be calcula ed ollowing he o mulas p o-
posed by Guya e al. [34]. In addi ion, he ime i will
ake pa icipan s o unde go a majo dep essi e episode
will be analyzed using a su i al analysis. The analysis o
he e ec o he in e en ions on he ou come a iable
‘dep essi e symp oms’will be pe o med using wo-way
ANOVA wi h epea ed measu es. The analyses ela ed
o he e ec s o mode a ion o media ion will be ca ied
ou as pe he ecommenda ions o Ba on and Kenny
[35]. The model o e alua e mode a ion will include, as
an independen a iable, he ype o ea men , he mod-
e a ing po en ial, and he in e ac ion be ween he wo.
An op imal combined mode a o will also be sough
acco ding o K aeme ’s ecommenda ions [36]. Fo he
analysis o he media ion, we will pe o m adjus men o
h ee eg ession equa ions o assess he e ec (1) o he
p edic o a iable (amoun o ea men ) on he
dependen a iable (change in dep essi e symp oma ol-
ogy a e he in e en ion), (2) o he p edic o a iable
in he media o po en ial o he p edic o a iable
(change in ein o cemen and nega i e hough s), and
Vázquez e al. T ials (2018) 19:414 Page 6 o 10
(3) o he media o po en ial o he dependen a iable,
con olled by he p edic o a iable. D opou s and ad-
he ence o in e en ions will be analyzed using a χ
2
es
o compa e he pe cen age o d opou s and using an in-
dependen es o compa e he numbe o modules
comple ed and he egis e o he in e sessional asks.
Likewise, he le el o sa is ac ion wi h he in e en ions
will be assessed using he CSQ-8 h ough a equency
analysis and desc ip i e s a is ics, and bo h ac i e condi-
ions will be compa ed a pos - ea men using an inde-
penden es .
Moni o ing
A Da a Moni o ing Commi ee (DMC) will be es ab-
lished o moni o and gua an ee he co ec execu ion o
he s udy, which will be independen o he o ganize s o
he s udy and can o de an independen audi ion once a
yea . The s ee ing commi ee, led by he p incipal in es-
iga o , will ollow he p inciples o good clinical p ac-
ice, including quali y con ol o he clinical p o ocol,
da a managemen , and eam mee ing o ganiza ion. A
con iden ial annual epo on he de elopmen o he
ial will be sen o he DMC.
A pilo s udy will be conduc ed o assess he easibili y
o he s udy. Any signi ican p o ocol modi ica ion ha
may a ec he pe o mance o he s udy, he po en ial
bene i o o sa e y o he pa ien , including signi ican
changes in s udy design, popula ion, sample size, o
s udy p ocedu es, will equi e a o mal amendmen o
he p o ocol, which will ha e o be app o ed by he Bio-
e hics Commi ee p io o i s implemen a ion.
In addi ion, an independen s a is ician will conduc a
p elimina y analysis a e he pilo s udy and when 50%
o pa ien s ha e been andomized and ha e comple ed
ollow-up. The s a is ician will in o m he independen
DMC, who will ha e access o all da a and will discuss
he esul s o he analysis wi h he s ee ing commi ee a
a join mee ing. The s ee ing commi ee will hen decide
on he con inua ion o he ial and epo o he Bioe h-
ics Commi ee. Any solici ed o spon aneous epo ed
ad e se e en h ough he s udy will be no i ied o he
s ee ing commi ee, who will ake he necessa y ac ions.
E hics, consen , and pe missions
The human igh s and he digni y o he s udy pa ici-
pan s will be p o ec ed in acco dance wi h he Decla -
a ion o Helsinki. The s udy p ocedu es ha e been
app o ed by he Bioe hics Commi ee o he Uni e si y
o San iago de Compos ela (Spain). The con iden iali y
o all pa icipan s will be gua an eed. Pa icipan s will
ha e o gi e hei in o med consen ( i s e bally by
elephone ollowed by w i en consen by mail). Pa ici-
pa ion will be comple ely olun a y, wi hou any kind o
incen i e (economic o o he ).
Du ing he s udy, i a ca egi e mee s he c i e ia o he
diagnosis o a majo dep essi e episode, he indi idual will
be con ac ed by phone o explain wha is happening o
him o he and e e ed o a cen e whe e he o she can
ecei e pe sonal ea men (e.g., a p ima y ca e cen e , a
men al heal h se ice), discon inuing he s udy. A e
comple ing he s udy, any eques ed ancilla y pos - ial
ca e will be managed by he s ee ing commi ee, who will
make e e als o men al heal h se ices i necessa y.
Discussion
This s udy will e alua e he e icacy o a b ie cogni i e
beha io al in e en ion o indica ed p e en ion o de-
p ession adminis e ed h ough a sma phone app wi h
and wi hou TCCs. The in e en ion will be adap ed
om a p e ious s udy by Vázquez e al. [8,9]. Based on
he esul s o his p e ious s udy, we expec o ind a
signi ican educ ion in he incidence o dep ession and
dep essi e symp oms in bo h in e en ion g oups
compa ed o he con ol g oup.
The de elopmen o his in e en ion ollows he
NICE clinical p ac ice guidelines, which ecommend com-
pu e ized cogni i e beha io al he apy and sel -help e-
sou ces (such as he app) o he ea men o people wi h
mild o mode a e dep ession [37]. In addi ion, using he
app o manage he psychological in e en ion as an al e na-
i e o adi ional ace- o- ace p og ams will inc ease
accessibili y o men al heal h se ices and inc ease he ools
ha p o essionals ha e o each a la ge numbe o people.
This is in acco dance wi h he ecommenda ions o he Na-
ional Ins i u e o Men al Heal h Psychosocial In e en ion
De elopmen Wo kg oup [38] and he New F eedom
Commission on Men al Heal h [39]. The ad an ages o he
in e en ion being adminis e ed h ough an app, and which
inc ease i s accessibili y, include anonymi y, sa ings in cos s
and a el imes, he possibili y o ecei ing he in e en ion
anywhe e and a any ime (being able o ecei e i a home),
wi hou wai ing no he need o make appoin men s, and
being able o e iew ma e ials as o en as necessa y, a one’s
own pace and wi h eal- ime acking [40].
On he o he hand, his s udy p oposes a possible
solu ion o he p oblem o lack o adhe ence ound in
he exis ing es s o psychological in e en ions o he
ea men o dep ession adminis e ed h ough an app
[13,14]. Speci ically, we p opose o complemen he
in e en ion p og am wi h g oup con e ence calls led by
a he apis . In In e ne -adminis e ed in e en ions, i has
been ound ha adding egula elephone con ac in-
c eases adhe ence subs an ially [41]. In addi ion, high
le els o adhe ence o he in e en ion we e ound in a
s udy [22] in which a cogni i e beha io al in e en ion
and a beha io al ac i a ion in e en ion applied by TCC,
such as ha p oposed in his s udy, we e conduc ed. In
ha s udy, a e age a endances we e 4.6 and 4.2 o 5
Vázquez e al. T ials (2018) 19:414 Page 7 o 10
sessions, espec i ely, and a e age comple ed homewo k
assignmen s we e 14.7 o 18 and 9.5 o 12. This s udy
also showed a low pe cen age o d opou s (6.6%) a
pos - ea men , simila o ha ound a he same ime
poin in a ace- o- ace in e en ion [8]. All his sugges s
ha human con ac is i al o achie e high le els o com-
mi men o a non- ace- o- ace psychological in e en ion.
In addi ion, he ac ha elephone con ac s a e
g ouped can sa e cos s and in oduce social suppo , he
la e o which is an impo an s a egy in beha io
change [42]. Finally, he use o eedback as a psycho-
logical echnique adminis e ed in hese elephone con-
ac s, ollowing he guidelines ecommended by
Mil enbe g [18], b ings igo and solidi y o he in e -
en ion p o ocol, acili a es i s eplica ion, and ein o ces
he lea ning o he cogni i e beha io al skills ained
du ing he in e en ion, a o ing he expec ed esul s.
Among he s eng hs o his clinical ial a e he speci i-
ca ion o he le el o p e en ion and he sys ema ic selec-
ion o he pa icipan s acco ding o his, he p io
es ima ion o he sample size, he andomizing by means
o an accep ed me hod, he concealmen o he andom
assignmen , he applica ion o an in e en ion based on a
heo e ical model o dep ession wi h p o en e icacy in
p e ious clinical esea ch, he e alua ion o adhe ence o
he p o ocol, and he blind e alua ion o he esul s by
ained p o essionals, as well as ollow-ups o up o
12 mon hs. Fo he e alua ion o he esul s, we will use
alida ed ins umen s wi h ecognized psychome ic p op-
e ies (see [43]). The incidence o dep ession as a p ima y
ou come will be assessed wi h he SCID-5-CV, which has
been used as he gold s anda d o DSM-5 diagnoses [44].
Dep essi e symp oms as a seconda y ou come will be
e alua ed wi h CES-D, which is he mos widely used in-
s umen o assessing dep essi e symp oms in he ca e-
gi e popula ion [45]. In addi ion, he s udy will be
pe o med in he communi y o ca egi e s and hus i s e-
sul s ha e a high le el o gene alizabili y.
Al hough he e is cu en ly a apid p oli e a ion o
men al heal h apps in he comme cial ield, he e a e
e y ew ha ha e been shown o be e ec i e [46]. This
s udy can educe he dange s associa ed wi h he lack o
quali y con ol o cu en ly a ailable apps, p o iding an
e idence-based in e en ion o p e en dep ession.
In conclusion, his s udy will p o ide in o ma ion on
he e icacy o he in e en ion o p e en dep ession in
non-p o essional ca egi e s, explo ing he use o al e na-
i e o ma s o inc ease he accessibili y o he apies and
assessing a echnique o imp o e he adhe ence and e i-
cacy o he in e en ion. The esul s o his s udy will
bene i a la ge numbe o p esen and u u e ca egi e s.
In addi ion, i has signi ican implica ions o public
heal h in he con ex o he high social and economic
cos s o dep ession [47].
T ial s a us
Rec ui men s a : Sep embe 28, 2018.
S udy comple ion: Decembe 29, 2019.
Addi ional ile
Addi ional ile 1: SPIRIT 2013 Checklis : Recommended i ems o add ess
in a clinical ial p o ocol and ela ed documen s*. (DOC 121 kb)
Abb e ia ions
ACG: A en ion con ol g oup; ATQ: Au oma ic Though s Ques ionnai e;
CBIA: Cogni i e beha io al in e en ion adminis e ed h ough a sma phone
app; CBIA + TCC: Cogni i e beha io al in e en ion adminis e ed h ough a
Sma phone App + elephone con e ence call; CES-D: Cen e o
Epidemiologic S udies Dep ession Scale; CSQ-8: Clien Sa is ac ion
Ques ionnai e; DMC: Da a Moni o ing Commi ee; DSM-5: Diagnos ic and
S a is icalManualo Men alDiso de s;SCID-5-CV: S uc u ed Clinical In e iew o
DSM-5 Diso de s, Clinician Ve sion; TCC: Telephone con e ence call
Funding
This s udy is unded by g an PSI2016–79041-P om he Minis y o
Economy, Indus y and Compe i i eness o Spain. This unding sou ce had
no ole in he design o his s udy and will no ha e any ole du ing i s
execu ion, da a collec ion, analyses, in e p e a ion o he da a, decision o
submi esul s, o p epa a ion o he manusc ip .
A ailabili y o da a and ma e ials
Resea che s will epo s udy esul s h ough publica ions. The da a suppo ing
hese indings will be p esen ed in he main publica ions, and he da ase s
used du ing he s udy can be ob ained om he co esponding au ho on
easonable eques .
Au ho s’con ibu ions
FV is he p incipal in es iga o , designed he s udy and w o e he manusc ip .
AT is co-p incipal in es iga o and e iewed he manusc ip . OD and MP a e
membe s o he p ojec g oup and e iewed he manusc ip . PO and VB will
coo dina e he s udy and helped in designing he s udy and w i ing he
manusc ip . LL helped in w i ing he manusc ip . All au ho s ead and
app o ed he inal manusc ip .
E hics app o al and consen o pa icipa e
The human igh s and he digni y o he s udy pa icipan s will be p o ec ed
in acco dance wi h he Decla a ion o Helsinki. The s udy p ocedu es ha e
been app o ed by he Bioe hics Commi ee o he Uni e si y o San iago de
Compos ela (Spain). The con iden iali y o all pa icipan s will be gua an eed.
Pa icipan s will ha e o gi e hei in o med consen , and he in o med consen
o m has been app o ed by he Bioe hics Commi ee o he Uni e si y o
San iago de Compos ela (Spain). Any signi ican p o ocol modi ica ion will
equi e a o mal amendmen o he p o ocol, which will ha e o be app o ed
by he Bioe hics Commi ee p io o i s implemen a ion. The s udy p o ocol is
in acco dance wi h he S anda d P o ocol I ems: Recommenda ions o
In e en ional T ials (SPIRIT) guidelines (see SPIRIT checklis as Addi ional ile 1).
Consen o publica ion
No applicable.
Compe ing in e es s
The au ho s decla e ha hey ha e no compe ing in e es s.
Publishe ’sNo e
Sp inge Na u e emains neu al wi h ega d o ju isdic ional claims in
published maps and ins i u ional a ilia ions.
Au ho de ails
1
Depa men o Clinical Psychology and Psychobiology, Uni e si y o
San iago de Compos ela, San iago de Compos ela, Spain.
2
Depa men o
Psychia y, Radiology, Public Heal h, Nu sing and Medicine, Uni e si y o
San iago de Compos ela, San iago de Compos ela, Spain.
3
Depa men o
Vázquez e al. T ials (2018) 19:414 Page 8 o 10
Psychology, Uni e si y o A Co uña, A Co uña, Spain.
4
Depa men o
E olu i e and Educa ional Psychology, Uni e si y o San iago de Compos ela,
San iago de Compos ela, Spain.
Recei ed: 4 Ap il 2018 Accep ed: 6 July 2018
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