1
Aguila - La o eA, e al. BMJ Open 2020;10:e038457. doi:10.1136/bmjopen-2020-038457
Open access
E ec i eness and cos - e ec i eness o a
li es yle modi ica ion p og amme in he
p e en ion and ea men o subclinical,
mild and mode a e dep ession in
p ima y ca e: a andomised clinical
ial p o ocol
Alejand a Aguila - La o e ,1 Capilla Na a o,2 Bá ba a Oli án- Blázquez,1,3
Elena Ge illa,2,4 Rosa Magallón Bo aya,1,5 Ca alina Cala a - Villalonga,2
Mau o Ga cía- To o,6,7 San iago Boi a,3 Ma ía Jesús Se ano- Ripoll2,8
To ci e: Aguila - La o eA,
Na a oC, Oli án- BlázquezB,
e al. E ec i eness and cos -
e ec i eness o a li es yle
modi ica ion p og amme in
he p e en ion and ea men
o subclinical, mild and
mode a e dep ession in p ima y
ca e: a andomised clinical
ial p o ocol. BMJ Open
2020;10:e038457. doi:10.1136/
bmjopen-2020-038457
►P epublica ion his o y and
addi ional ma e ials o his
pape a e a ailable online. To
iew hese iles, please isi
he jou nal online (h p:// dx. doi.
o g/ 10. 1136/ bmjopen- 2020-
038457).
Recei ed 11 Ma ch 2020
Re ised 19 Oc obe 2020
Accep ed 19 No embe 2020
Fo numbe ed a ilia ions see
end o a icle.
Co espondence o
D Bá ba a Oli án- Blázquez;
ba ba aoli an@ gmail. com
P o ocol
© Au ho (s) (o hei
employe (s)) 2020. Re- use
pe mi ed unde CC BY- NC. No
comme cial e- use. See igh s
and pe missions. Published by
BMJ.
ABSTRACT
In oduc ion Majo dep ession is a highly p e alen
pa hology ha is cu en ly he second mos common
cause o disease- induced disabili y in ou socie y. The
onse and con inua ion o dep ession may be ela ed o a
wide a ie y o biological and psychosocial ac o s, many
o which a e linked o di e en li es yle aspec s. The e o e,
heal h sys ems mus design and implemen heal h
p omo ion and li es yle modi ica ion p og ammes (LMPs),
aking in o accoun pe sonal ac o s and acili a o s. The
main objec i e o his p o ocol is o analyse he clinical
e ec i eness, cos - e ec i eness and cos u ili y o an
LMP and an LMP wi h in o ma ion and communica ion
echnologies (ICTs) as adjunc i e ea men o dep ession
in p ima y ca e pa ien s. The seconda y objec i es a e
o analyse he clinical e ec i eness in he subg oup
ha p esen s como bidi y and o analyse he co ela ion
be ween pe sonal ac o s on heal h beha iou and li es yle
pa e ns.
Me hods and analysis A andomised, mul icen e
p agma ic clinical ial wi h h ee pa allel g oups
consis ing o p ima y heal hca e pa ien s su e ing om
subclinical, mild o mode a e dep ession. The ollowing
in e en ions will be used: (1) Usual an idep essan
ea men wi h psychological ad ice and/o psycho opic
d ugs p esc ibed by he gene al p ac i ione ( ea men as
usual (TAU)). (2) TAU+LMP. A p og amme o be impa ed in
six weekly 90- minu e g oup sessions, in ended o imp o e
he ollowing aspec s: beha iou al ac i a ion+daily
physical ac i i y+adhe ence o he Medi e anean die
pa e n+sleep hygiene+ca e ul exposu e o sunligh .
(3) TAU+LMP+ICTs: heal hy li es yle ecommenda ions
(TAU+LMP)+moni o ing using ICTs (a wea able
sma wa ch). The p ima y ou come will be he dep essi e
symp oma ology and he seconda y ou comes will be
he quali y o li e, he use o heal h and social esou ces,
pe sonal ac o s on heal h beha iou , social suppo ,
li es yle pa e ns and ch onic como bid pa hology. Da a
will be collec ed be o e and a e he in e en ion, wi h
6- mon h and 12- mon h ollow- ups.
E hics and dissemina ion This s udy has been app o ed
by he Clinical Resea ch E hics Commi ee o A agón
(app o al numbe : C.P.-C.I. PI18/286) and he Resea ch
E hics Commi ee o he Balea ic Islands (IB3950/19
PI). Da a dis ibu ion will be anonymous. Resul s will be
dissemina ed ia con e ences and pape s published in
pee - e iewed, open- access jou nals.
T ial egis a ion numbe ClinicalT ials. go Regis y
(NCT03951350).
INTRODUCTION
Dep ession is conside ed o be he p inciple
cause o disabili y wo ldwide, and i con ib-
u es o he o e all global bu den o mo bidi y
and mo ali y. By 2030, i is expec ed o
be he main con ibu o o he bu den o
mo bidi y.1–3 App oxima ely 25%–35% o all
p ima y ca e pa ien s su e om psychia ic
diso de s, and o e 80% o hese pa ien s
su e om dep ession o anxie y diso -
de s.4 5 In Spanish p ima y heal hca e cen es
S eng hs and limi a ions o his s udy
►The in e en ion has he po en ial o be highly scal-
able and sus ainable o he Spanish Na ional Heal h
Se ice.
►Inc eased mo i a ion, on in oducing sel - egis e s
o e e yone and a g oup ha will be moni o ed us-
ing wea able sma wa ches.
►Mos heal hca e p o essionals can implemen he
in e en ion g oups.
►Some indi iduals may e use o pa icipa e in g oup
in e en ion o may wi hd aw om he s udy du ing
he 12- mon h ial pe iod.
►Di icul y o en i e g oup’s a endance o a session
held on one speci ic da e and ime.
P o ec ed by copy igh . on Feb ua y 2, 2021 a Uni e sidad de Za agoza. Biblio eca.h p://bmjopen.bmj.com/BMJ Open: i s published as 10.1136/bmjopen-2020-038457 on 28 Decembe 2020. Downloaded om
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(PHCs), he p e alence o dep ession anges om 9.6%
o 20.2%.6 7 Fu he mo e, dep ession gene a es g ea
disabili y and high economic and social cos s.8
The p e alence o dep ession in Spain is 13% o e
one’s li e ime and 4% pe yea .9 Indeed, como bidi y
wi h o he ch onic condi ions is high (64.9%–71.0%)
(diabe es, hype ension, ca dio ascula diseases and
cance , among o he s)10–12 as well as como bidi y wi h
o he psychia ic diseases such as anxie y diso de s is also
high (40%–66%).13
Despi e he nega i e impac o dep ession on people’s
li es and he exis ence o nume ous ea men in e en-
ions,14 hese in e en ions a e o en no app op ia ely
used in PHC se ices,6 mainly due o physician ime o
esou ce limi a ions.7 Thus, pha macological15 ea men
is usually ecommended, e en hough esea ch has shown
ha in subclinical, mild o mode a e dep ession, non-
pha macological in e en ions a e ecommended.15 16
Since op ions and ou comes o he ca e o indi iduals
su e ing om dep ession and hei access o ea men
emains limi ed,17 i is impo an o p omo e cos -
e ec i e ea men op ions. The onse and con inua ion
o dep ession has been linked o nume ous biological
and psychosocial ac o s, many o which a e ela ed o
dis inc li es yle aspec s.18–21 The e o e, many o he s a -
egies p omo ing a heal hie li es yle could ha e an ide-
p essan u ili y.20 22–24 In addi ion o mul imodal s udies,
o he s ha e ocused on one o he ollowing aspec s o
li es yle modi ica ion: daily physical ac i i y,25 adhe ence
o he Medi e anean die ,26 27 sleep hygiene p ac ices28 29
and ca e ul exposu e o sunligh .30 31
The p esen s udy will be amed a ound he heo y
o salu ogenesis,32 which es ablishes ha an indi idual’s
abili y o modi y ou li es yle is in luenced by psychoso-
cial gene alised esis ance esou ces, which consis o
pe sonal, in e pe sonal o con ex ual esou ces (money,
knowledge, expe ience, sel - es eem, heal hy habi s,
commi men , social suppo , cul u al capi al, in elligence,
adi ions and ision o li e) and he sense o cohe ence
(way o making sense o he wo ld, which is a majo ac o
in de e mining how well an indi idual manages s ess and
s ays heal hy).
Mo eo e , p e ious s udies show ha he use o acili a-
o s is qui e impo an (simplici y o guidelines, ailo ing
h ough mo i a ional in e iewing, p olonged and
in ense moni o ing h oughou he di e en s ages o
he diso de and he p o ision o adequa e eedback and
social suppo )23 o acili a e adhe ence o li es yle modi-
ica ion p og ammes (LMPs). Fo example, enhanced
mo i a ion can be achie ed h ough he use o in o ma-
ion and communica ion echnologies (ICTs) and wi h
he social suppo esul ing om in e en ion g oup
pa icipa ion.33 Pe sonal ac o s and acili a o s mus be
aken in o accoun in li es yle modi ica ion in e en ions,
since hey may de e mine he success o heal h p omo-
ion p og ammes.
The main objec i e o his p o ocol is o analyse he
clinical e ec i eness, cos - e ec i eness and cos u ili y o
an LMP and an LMP wi h ICTs as adjunc i e ea men
o dep ession in p ima y ca e pa ien s. The seconda y
objec i es a e o analyse he clinical e ec i eness in he
subg oup ha p esen s como bidi y and o analyse he
co ela ion be ween pe sonal ac o s on heal h beha iou
and li es yle pa e ns.
METHODS AND ANALYSIS
S udy design
Mul icen e p agma ic andomised con olled ial in
h ee pa allel g oups.
Se ing and s udy sample
We will ec ui pa ien s ha ing subclinical, mild o
mode a e dep ession (sco ing ≥10 and ≤30 poin s on he
Beck II Sel - Applied Dep ession In en o y (BDI- II))34
om PHCs o wo Spanish a eas (Za agoza and Mallo ca).
Inclusion c i e ia: indi iduals o e he age o 18, bo h
sexes, ha ing a du a ion o dep ession symp oms o a leas
2 mon hs, who unde s and w i en and spoken Spanish
and who ha e p o ided hei in o med consen (online
supplemen al ile 1). Exclusion c i e ia will be: su e ing
om ano he disease ha a ec s he b ain (o ganic b ain
pa hology o ha ing su e ed a auma ic b ain inju y o
any se e i y, demen ia); ha ing ano he psychia ic diag-
nosis o se ious psychia ic illness (subs ance dependence
o abuse, a his o y o schizoph enia o o he psycho ic
diso de s, ea ing diso de s) wi h he excep ion o anxious
pa hology o pe sonali y diso de s (collec ed h ough a
medical his o y and om he Mini- In e na ional Neu o-
psychia ic In e iew (MINI))35; p esence o a se ious o
uncon olled medical, in ec ious o degene a i e illness
ha may in e e e wi h he a ec i e symp oms; he p es-
ence o deli ium o hallucina ions, isk o suicide, p eg-
nancy o lac a ion; pa ien s who ha e pa icipa ed in
ano he clinical ial o e he pas 6 mon hs, who a e
cu en ly in psycho he apy o hose who ha e been p ac-
icing mind ulness, yoga, medi a ion o simila p ac ices
o e he pas 6 mon hs, engaging in o mal p ac ice a
leas once a week and he p esence o any medical,
psychological o social p oblem ha could se iously in e -
e e wi h he pa ien ’s pa icipa ion in he s udy.
Sample size
Scien i ic e idence sugges s ha a 17% educ ion in he
BDI- II34 is conside ed clinically ele an .36 In a p e ious
s udy conduc ed by ou eam wi h psychia ic ou pa ien s,
we ound ha he a e age BDI sco e a he beginning
o he s udy was 24.5 poin s (SD 9.8),22 so we conside
ha a educ ion o a leas 4.8 poin s would ha e clinical
signi icance and would bene i he pa ien . Accep ing an
α isk o 0.05 and a β isk o 0.20 in a bila e al con as ,
44 subjec s will be equi ed o each g oup. Wi h an
es ima ed wi hd awal a e o 20%, he sample size will
equi e app oxima ely 53 pa ien s in each g oup. The
o al sample equi ed is 159 subjec s. A o mula based
on he Snedeco ’s F dis ibu ion37 has been used (see
P o ec ed by copy igh . on Feb ua y 2, 2021 a Uni e sidad de Za agoza. Biblio eca.h p://bmjopen.bmj.com/BMJ Open: i s published as 10.1136/bmjopen-2020-038457 on 28 Decembe 2020. Downloaded om
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Aguila - La o eA, e al. BMJ Open 2020;10:e038457. doi:10.1136/bmjopen-2020-038457
Open access
online supplemen al ile 2). I is es ima ed ha app oxi-
ma ely 50% o hese pa ien s will p esen some physical o
men al como bidi y.12
Rec ui men
Gene al p ac i ione s (GPs) om he PHCs o Za a-
goza and Mallo ca will be in i ed o e e pa ien s who
a e suspec ed o su e ing om dep ession. Mos ep e-
sen a i e PHCs in he a ea will be in i ed, based on size,
u ban o u al a ea, and PHCs wi h a di e en sociode-
mog aphic p o ile will be selec ed. GPs will explain he
cha ac e is ics o he s udy o hei pa ien s and i hey
ag ee o pa icipa e, hey will be asked o p o ide a phone
numbe o be con ac ed by a ained esea ch assis an
(RA) du ing he nex week. The RA will call pa ien s and
es ablish an appoin men in hei PHC, in which he will
explain hem he s udy, p o ide hem he pa ien in o -
ma ion shee and ge he in o med consen signed. To
ensu e ha hey ul il he inclusion c i e ia, he RA will
adminis a e he BDI- II34 and he MINI.35 I pa icipan s
mee he c i e ia, he RA will adminis e he baseline
ques ionnai es a he same appoin men . Rec ui men
and baseline assessmen s will be ca ied ou un il he inal
sample size has been achie ed.
Randomisa ion, alloca ion and masking o s udy g oups
Once baseline da a a e collec ed, he pa icipan s will be
andomised. An independen s a is ician will pe o m he
indi idual andomisa ion using a compu e - gene a ed
andom numbe sequence. The andomisa ion will be
ca ied ou using a lis o pa ien s om Za agoza and
Mallo ca ( igu e 1). Gi en he na u e o he in e en-
ions, pa icipan s will no be blinded o hei alloca ion.
An RA will call hem o explain hei assigned in e en-
ion and whe e hey should go and when. The RA will
eques ha pa icipan s no o in o m o he esea che s
o hei alloca ion.
Da a collec ion and moni o ing
One RA will collec he da a and ano he will pe o m
en y and coding o he iden i ied da a. All RA managing
he da a will be blinded o pa icipan alloca ion, as well
as he RA conduc ing he ou come assessmen s and
da a analysis. All in o ma ion collec ed will be ea ed in
acco dance wi h he p o isions o cu en legisla ion on
pe sonal da a p o ec ion.
The s udy will no ha e a o mal da a moni o ing
commi ee since ad e se in e en ion e en s ha e no
been epo ed. Any se ious unexpec ed ad e se e en s
o ou comes will be discussed by he ial managemen
commi ee (iden ical o he au ho s o his p o ocol).
The e a e no plans o discon inue o modi y in e en-
ions, o o imp o e adhe ence o p omo e pa icipan
e en ion. The ial managemen commi ee will moni o
ec ui men , ea men and a i ion a es and any
conce ns ela ed o he s udy. Reasons o d opping ou
will be also egis e ed. Concomi an ca e is pe mi ed and
egis e ed as long as i is no one o he exclusion c i e ia.
G oup- speci ic p ocesses will be aken in o accoun and
will be e alua ed and in o med, in acco dance wi h
ecommenda ions o he ‘mechanisms o ac ion in g oup-
based in e en ions’ (MAGI) amewo k.38
In e en ion de elopmen and e alua ion
Pa ien s alloca ed in he i s a m (con ol g oup) will
ollow he usual ea men p o ided by hei GP ( ea -
men as usual (TAU)).
Pa ien s alloca ed in he second a m ( i s in e en ion
g oup) will ollow he TAU and he LMP. This p og amme
will consis o six weekly g oup sessions (las ing 90 min
each) led by an expe ienced psychologis and comple-
men ed by Powe Poin p esen a ions.
Pa ien s alloca ed in he hi d a m (second in e en ion
g oup) will ollow TAU and LMP and will be moni o ed
using a wea able sma w is wa ch ha will ack hei
daily sleep pa e ns and physical ac i i y (LMP+ICTs).
The g oup sessions will consis o he ollowing con en :
1. P esen a ion o he p ojec and psychoeduca ion on
dep ession: p esen a ion o he p ojec and a e iew
o he s udy objec i es. De ini ion, symp oms, causes,
consequences o dep ession and, also, how li es yles
and social en i onmen changes in luence he symp-
oma ology o dep ession.
2. Beha iou ac i a ion: a psychologis will p o ide in o -
ma ion on he impo ance o es ablishing, main aining
Figu e 1 Flowcha o he s udy: andomisa ion, sampling
and moni o ing o pa ien s. GP, gene al p ac i ione ; ICTs,
in o ma ion and communica ion echnologies; ITT, in en ion
o ea ; LMP, li es yle modi ica ion p og amme; MI, mul iple
impu a ion; TAU, ea men as usual.
P o ec ed by copy igh . on Feb ua y 2, 2021 a Uni e sidad de Za agoza. Biblio eca.h p://bmjopen.bmj.com/BMJ Open: i s published as 10.1136/bmjopen-2020-038457 on 28 Decembe 2020. Downloaded om
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Open access
and moni o ing ac i i ies. Fo he LMP+ICTs g oup,
hey will also lea n how o use he sma w is wa ch,
ensu ing all pa icipan s a e able o use i .
3. Sleep hygiene habi s and ca e ul exposu e o sunligh :
ecommenda ions on heal hy sleep habi s, ac o s in-
luencing sleep quali y and possible solu ions. The
bene i s o ca e ul exposu e o sunligh and ecom-
menda ions o when o do so and o how long. Re-
sponding o ques ions ega ding he p e ious session.
4. Physical ac i i y: he bene i s o engaging in egula
physical ac i i y. Pe sonalised ecommenda ions abou
wha physical exe cise may be p ac iced, how and
when o do so. Responding o ques ions ega ding he
p e ious session.
5. Adhe ence o he Medi e anean die : explana ions
abou he Medi e anean die , ood g oups and hei
cha ac e is ics, as well as he mos bene icial oods o
physical and men al heal h, how o cook i and ood-
ela ed habi s. Responding o ques ions ega ding he
p e ious session.
6. Summa y o p e ious sessions wi h p ac ical inal sug-
ges ions: pe sonalised expe iences and doub s o he
pa icipan s h oughou he cou se. Recommenda ions
o daily heal hy li es yle p ac ices o he u u e and
a ewell.
A he end o each session, he pa icipan s will ecei e
a pape wi h sel - egis a ion ables (online supplemen al
ile 3). They will comple e he ables wi h he in o ma ion
on hei daily ou ines ega ding he modi ica ion o li e-
s yles on which hey ha e been ins uc ed. They will be
asked abou when hey wake up and when hey go o bed,
he du a ion o hei sleep, he ime spen exposed o
sunligh , he die pa e n, he physical ac i i y and spo s
p ac iced, he social suppo and he subjec i e pe cep-
ion o sa is ac ion a e hese ac i i ies. A quali a i e
s udy associa ed wi h his s udy will be included o analyse
he pa icipan s' di icul ies in ollowing he in e en ion.
Ou comes and measu es
We will collec pa ien da a using he ques ionnai es
adminis e ed in baseline, immedia ely a e he in e en-
ion (in a pe iod o 2–7 days a e he las in e en ion
session) and a 6- mon h and 12- mon h ollow- up a e he
las in e en ion session (wi h a ma gin o ±2 weeks) (see
able 1). A blinded RA will call each pa ien o he h ee
a ms and se up an appoin men in hei PHC o ques-
ionnai e adminis a ion. S udy ou comes and measu es
a e summa ised in able 1.
Sociodemog aphic da a
We will collec in o ma ion on gende , age, ma i al s a us,
educa ion, occupa ion and economical le el. These da a
will be collec ed h ough an ad hoc ques ionnai e.
Table 1 S udy a iables
Ins umen Assessmen a ea Measu es
BDI- II34 39 Se e i y o dep ession Baseline and ollow- up sessions*
MINI35 Psychia ic diagnosis Baseline
Gende , age, ma i al s a us, educa ion, occupa ion,
economical le el
Sociodemog aphic Baseline and ollow- up sessions*
Glucose concen a ion (mg/dL), glyca ed haemoglobin
(%), c ea inine, a e ial p essu e (mm Hg) and choles e ol
(mg/dL)
Como bidi y wi h ch onic diseases Baseline and 6- mon h and
12- mon h ollow- up
EQ- 5D40 42 Heal h- ela ed quali y o li e Baseline and ollow- up sessions*
MOS- SS46 47 Social suppo Baseline and ollow- up sessions*
CSRI48 49 Heal h and social se ices use Baseline and ollow- up sessions*
IPAQ- SF50 51 Physical ac i i y Baseline and ollow- up sessions*
MEDAS53 54 Adhe ence o he Medi e anean die Baseline and ollow- up sessions*
PSQI55 56 Quali y and pa e ns o sleep Baseline and ollow- up sessions*
Sel - E icacy Scale57 62 Sel - e icacy Baseline and ollow- up sessions*
PAM58 63 Pa ien ac i a ion in hei own heal h Baseline and ollow- up sessions*
SOC-1359 64 Sense o cohe ence Baseline and ollow- up sessions*
HLS- EUQ1660 65 Heal h li e acy Baseline and ollow- up sessions*
IPS61 66 P oc as ina ion Baseline and ollow- up sessions*
*Follow- up sessions: pos in e en ion (in a pe iod o 2–7 days a e he las session o he in e en ion) and 6- mon h and 12- mon h
ollow- up (6 and 12 mon hs a e he las session o he in e en ion (±2 weeks)).
BDI- II, Beck II Sel - Applied Dep ession In en o y; CSRI, Clien Se ice Receip In en o y; EQ- 5D, Eu opean Quali y o Li e-5 Dimensions
Ques ionnai e; HLS- EUQ16, Heal h Li e acy Eu ope Ques ionnai e; IPAQ- SF, In e na ional Physical Ac i i y Ques ionnai e- Sho Fo m;
IPS, I a ional P oc as ina ion Scale; MEDAS, 14- i em Medi e anean Die Adhe ence Sc eene ; MINI, Mini- In e na ional Neu opsychia ic
In e iew; MOS- SS, Medical Ou comes S udy Social Suppo Su ey; PAM, Pa ien Ac i a ion Measu e Ques ionnai e; PSQI, Pi sbu gh
Sleep Quali y Index; SOC-13, Sense o Cohe ence Ques ionnai e.
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P ima y ou come
Se e i y o dep ession
The p ima y ou come will be measu ed using he BDI- II.34
This is a sel - epo in en o y o measu ing he se e i y
o dep ession, consis ing o 21 mul iple- choice ques ions
wi h each answe being sco ed on a scale anging om 0
o 3. I was ansla ed and alida ed in o Spanish wi h a
eliabili y o 0.89.39 The s anda dised cu o s a e: 0–13:
minimal dep ession; 14–19: mild dep ession; 20–28:
mode a e dep ession and 29–63: se e e dep ession.
Seconda y ou comes
Heal h- ela ed quali y o li e
Heal h- ela ed quali y o li e will be measu ed using he
Eu opean Quali y o Li e-5 Dimensions Ques ionnai e
(EQ- 5D).40 41 EQ- 5D sco es will be used o calcula e
he quali y- adjus ed li e yea (QALY) du ing he moni-
o ing pe iod by adjus ing he leng h o ime a ec ed
by he heal h esul by he u ili y alue. I con ains i e
heal h dimensions (mobili y, sel - ca e, usual ac i i ies,
pain/discom o and anxie y/dep ession) and each o
hese has h ee le els (no p oblems, sligh p oblems o
mode a e and se e e p oblems). The EQ eco ds he
pa ien ’s sel - a ed heal h on a e ical Visual Analogue
Scale (VAS) o 20 cm, whe e he endpoin s a e labelled
‘The bes heal h you can imagine’ and ‘The wo s heal h
you can imagine’. The VAS can be used as a quan i a i e
measu e o heal h ou come ha e lec he pa ien ’s own
judgemen . Pa ien s ma k he poin on he e ical line
ha bes e lec s hei assessmen o hei cu en global
heal h s a us.42 C onbach’s alpha coe icien has been
calcula ed in esea ch wi h disease- speci ic popula ions.
We highligh he s udy o Seoane e al43 in which he
o e all alpha alue was 0.788. Being he only s udy wi h a
gene al popula ion, i p o ides an o e all mean es ima e
o he minimum impo an di e ence o he EQ- 5D,
which is 0.074.44
Como bidi y wi h ch onic diseases
Como bidi y wi h ch onic diseases will be de e mined
acco ding o he In e na ional Classi ica ion o Diseases,
Ten h Re ision45: diabe es (glucose concen a ion
(mg/dL), glyca ed haemoglobin (%), c ea inine, a e-
ial hype ension and diseases o lipid me abolism. In
pa ien s wi h ch onic hea disease, coagula ion a iables
will be added. They will be collec ed om he las blood
es o con ol measu emen s o he clinical his o y, aken
by hei GP o nu se (assuming hey we e aken o e he
pas 3 mon hs). O he wise, hei GP will be asked o a
blood con ol es . I is es ima ed ha app oxima ely 50%
o hese pa ien s will p esen some como bidi y.12 An h o-
pome ic measu es will also be collec ed (weigh , size and
pe ime e o he wais ).
Social suppo
I will be measu ed by he Medical Ou comes S udy Social
Suppo Su ey (MOS- SS).46 I is a sel - epo ins umen
consis ing o ou subscales (emo ional/in o ma ional,
angible, a ec iona e and posi i e social in e ac ion) and
an o e all unc ional social suppo index. I has a good
eliabili y (C onbach’s alpha ≥0.91) and is qui e s able
o e ime. I has 19 i ems, a 5- poin Like Scale. Highe
sco es indica e mo e suppo . We will use he Spanish ali-
da ed e sion.47
Use o heal h and social se ices
I will be measu ed using he Clien Se ice Receip In en-
o y.48 These da a may be used o a wide ange o appli-
ca ions, including es ima es o he cos s o se ice eceip .
To collec in o ma ion on he en i e ange o se ices
and suppo s used by s udy pa icipan s. I e ospec i ely
collec s da a on he use o se ices o e he pas 6 mon hs
(eg, a es o use o indi idual se ices, mean in ensi y o
se ice use, a es o accommoda ion use o e ime). We
will use he alida ed Spanish e sion.49
Assessmen o li es yle
Physical ac i i y
Physical ac i i y will be measu ed using he In e na ional
Physical Ac i i y Ques ionnai e- Sho Fo m (IPAQ- SF).50
I assesses he le els o habi ual physical ac i i y o e he
las 7 days. I has se en i ems and eco ds he ac i i y
o ou in ensi y le els: igo ous- in ensi y ac i i y and
mode a e- in ensi y ac i i y (walking and si ing). We will
use he alida ed Spanish e sion.51 IPAQ- SF has accep -
able alidi y o he measu emen o o al and igo ous
physical ac i i y and poo alidi y o mode a e ac i i y
and good eliabili y.52
Adhe ence o he Medi e anean die
Adhe ence o he Medi e anean die will be measu ed
using he 14- i em Medi e anean Die Adhe ence
Sc eene (MEDAS), de eloped wi hin he p e en ion
wi h Medi e ean die (PREDIMED) s udy g oup.53 I
includes i ems on ood consump ion and in ake habi s:
he use o oli e oil as he main sou ce o cooking a , p e -
e ence o whi e mea o e ed mea , se ings o ege a-
bles, po ions o ui , ed mea o sausages, se ings o
animal a , suga - swee ened be e ages, ed wine, legumes,
ish, comme cial pas ies and d essing ood wi h a adi-
ional sauce made o oma oes, ga lic, onion o leeks
sau éed in oli e oil. The o al sco e anges om 0 o 14,
wi h a highe sco e indica ing a be e acco dance wi h
he Medi e anean die .54
Quali y and pa e ns o sleep
Quali y and pa e ns o sleep will be measu ed using he
Pi sbu gh Sleep Quali y Index (PSQI).55 I di e en i-
a es be ween ‘poo ’ and ‘good’ sleep by measu ing se en
domains: subjec i e sleep quali y, sleep la ency, sleep
du a ion, habi ual sleep e iciency, sleep dis u bances,
use o sleep medica ion and day ime dys unc ion o e he
pas mon h. I consis s o 19 sel - applied ques ions and
i e ques ions ha eques he e alua ion o he pa ien ’s
bedma e o oomma e ( hese a e no sco ed). Answe s
ange om 0 (no di icul y) o 3 (se e e di icul y). The
o e all sco e anges om 0 o 21 poin s. In i s Spanish
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e sion, he C onbach’s alpha coe icien is 0.81, sensi-
i i y is 88.63% and speci ici y is 74.99%. We will use he
alida ed Spanish e sion.56
Pe sonal ac o s on heal h beha io
We will assess: (1) sel - e icacy57; (2) ac i a ion58; (3)
sense o cohe ence59; (4) heal h li e acy60 and (5)
p oc as ina ion.61
Sel -e icacy
Sel - e icacy will be measu ed using he Sel - E icacy
Scale.57 To measu e Gene al Sel - E icacy Subscale (17
i ems including indi iduals' belie s in hei abili y o
pe o m well in a a ie y o si ua ions) and Social Sel -
E icacy Subscale (six i ems). I con ains 23 i ems ha a e
a ed on a 14- poin scale ( anging om s ongly ag ee o
s ongly disag ee). Highe sco es indica e highe le els o
sel - e icacy. I has a C onbach coe icien alpha o 0.86
o Gene al Sel - E icacy Subscale and 0.71 o he Social
Sel - E icacy Subscale. The unpublished Spanish e sion
was ansla ed by Godoy in 1990.62
Pa ien ac i a ion in hei own heal h
Pa ien ac i a ion in hei own heal h will be measu ed
using he Pa ien Ac i a ion Measu e (PAM) Ques ion-
nai e wi h ega d o he managemen o hei heal h.58
I e alua es he pa ien ’s pe cei ed knowledge, skills and
con idence o engage in sel - managemen ac i i ies. I has
13 i ems wi h a Like Scale om 1 (s ongly disag ee)
o 4 (s ongly ag ee). The esul ing sco e (be ween 0
and 100) places he indi idual a one o ou le els o
ac i a ion, each o which e eals insigh in o a ange o
heal h- ela ed cha ac e is ics, including beha iou s and
ou comes. Highe sco es indica e highe le els o ac i a-
ion.58 This scale is only alida ed in Spanish o ch onic
pa ien s. I had an i em sepa a ion index o he pa ame-
e s o 6.64 and a eliabili y o 0.98.63
Sense o cohe ence
Sense o cohe ence will be measu ed using he Sense o
Cohe ence (SOC-13) Ques ionnai e by An ono sky.59 I
alues he pe sonal disposi ion owa ds he assessmen
o i al expe iences. I measu es he sense o cohe ence,
comp ehensibili y, manageabili y and meaning ulness.
I has 13 i ems sco ing be ween 13 and 91 poin s. I has
consis ency a es be ween 0.84 and 0.93. Highe sco es
(a e e e sal o he in e ed i ems) indica e a highe
sense o cohe ence. We will use he alida ed Spanish
e sion.64
Heal h li e acy
Heal h li e acy will be measu ed using he Heal h Li e acy
Eu ope Ques ionnai e (HLS- EUQ16).60 I can indica e
ha he p obabili y o unc ional li e acy in limi ed heal h
is high, a possibili y o unc ional li e acy in limi ed
heal h, and unc ional heal h li e acy in adequa e heal h.
I con ains 16 i ems. Highe sco es indica e be e heal h
li e acy. I p esen s a high consis ency (C onbach’s alpha
o 0.982) in he Spanish alida ion.65
P oc as ina ion
P oc as ina ion will be measu ed using he I a ional
P oc as ina ion Scale (IPS).66 To measu e gene al p oc as-
ina ion (dys unc ional delay). I has nine i ems, a ed on
a 5- poin Like Scale, wi h highe sco es (a e e e sal o
he h ee p oc as ina ion- inconsis en i ems) indica ing
a highe le el o p oc as ina ion. I s C onbach’s alpha
alue is 0.90. We will use he alida ed Spanish e sion.61
Da a analysis plan
Analysis o he ou comes a baseline
Fi s , desc ip i e analyses o all he a iables (p opo -
ions o quali a i e a iables, means and SD o quan-
i a i e a iables) will be pe o med. Then, co ela ion
analysis will be ca ied ou be ween he ques ionnai es
ha e alua e pe sonal ac o s on heal h beha iou (Sel -
E icacy Scale, PAM, SOC-13, HLS- EUQ16 and IPS),
social suppo (MOS- SS) and dep ession (BDI- II). We will
also analyse he co ela ion be ween pe sonal ac o s on
heal h beha iou and he ques ionnai es assessing li e-
s yle pa e ns (IPAQ- SF, MEDAS and PSQI). Finally, we
will analyse he ela ion o li es yle pa e ns and social
suppo wi h dep ession. In e en ial s a is ical analysis
will be ca ied ou using he χ2 es o quali a i e a i-
ables, and S uden ’s - es o one- wayanalysis o a iance
(ANOVA) es o assess he po en ial ela ionship be ween
quali a i e and quan i a i e a iables.
Da a collec ion and s a is ical analysis will be pe o med
using Excel so wa e, SPSS so wa e (V.25.0)67 and he R
s a is ical so wa e en i onmen (V.3.6.2).68
Clinical e ec i eness analysis
The epo o he esul s will ollow a p especi ied plan,
based on he Consolida ed S anda ds o Repo ing T ials
guidelines69 in o de o compa e he h ee g oups using
an in en ion- o- ea analysis and mul iple impu a ion
(MI) echnique o handling missing da a. Ini ially, a
desc ip i e compa ison (p opo ions, means o medians)
will be ca ied ou be ween g oups o p ognos ic a i-
ables in o de o es ablish hei baseline compa abili y
a e andomisa ion. To analyse he clinical e ec i eness,
a epea ed- measu e linea eg ession will be conduc ed,
including all e alua ions o e ime. Fo his pu pose,
he main a iable, BDI- II sco e, will be used as a con in-
uous a iable. The models will include adjus men s o
he baseline alue o he BDI- II and o any o he a i-
able ha would ha e shown di e ences in he baseline
measu emen . Possible g oup pe ime in e ac ions will
be examined using linea eg ession. Simila analyses will
be ca ied ou using he seconda y ou comes (pe sonal
ac o s on heal h beha iou and assessmen o li es yle).
To coun e ac he p oblem o mul iple compa isons, we
will use Bon e oni co ec ion.
Compa isons will also be made be ween he LMP
and LMP+ICTs g oups ega ding adhe ence o li es yle
modi ica ion equi emen s. Adhe ence will be consid-
e ed as a good o bene icial sco e on he ques ionnai es
assessing li es yle pa e ns (IPAQ- SF, MEDAS and PSQI).
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In addi ion, we will compa e he LMP and combined
LMP+ICTs g oups, assuming ha hey a e compa able o
each o he and he wo g oups ha e signi ican esul s.
A bina y a iable ega ding como bidi y will be c ea ed
(como bidi y yes/no). We will de e mine i he e ec-
i eness o he in e en ion di e s in he subg oup
p esen ing como bidi y and i he pa hology imp o es.
S a is ical analyses will be selec ed based on subsample
size (pa ame ic o non- pa ame ic es s).
As o he imepoin in which we adminis a e he
ollow- up ques ionnai es, we will conside he i s
ollow- up assessmen (in a pe iod o 2–7 days a e he las
session o he in e en ion) as mo e ele an . We expec
o ind an immedia e e ec in he LMP and LMP+ICTs
g oups a e a ending g oup in e en ion, due o he
po en ial social suppo ecei ed. In he 6- mon h and
12- mon h ollow- up, we expec a bene icial change in he
ques ionnai es assessing li es yle, e lec ing a long- las ing
e ec .
Cos -e ec i eness and cos -u ili y analysis
The e ec i eness o he in e en ions will be es ima ed
using he di e ence be ween he BDI- II baseline sco e
and he sco e a he 6- mon h and 12- mon h ollow- ups,
and u ili y will be es ima ed using QALYs a he 6- mon h
and 12- mon h ollow- ups. QALYs will be calcula ed based
on hese sco es using he Spanish EQ- 5D a i s.70 Along
wi h he EQ- 5D u ili y sco es, sco es eco ded on he EQ
VAS will also be used as an ou come o he analysis.
Cos - e ec i eness will be explo ed h ough he calcu-
la ion o inc emen al cos - e ec i eness a ios (ICERs)
o he ac i e in e en ion g oups (LMP and LMP+ICTs)
using he TAU g oup as he con ol. ICER is de ined as
he a io be ween inc emen al cos s and inc emen al
e ec i eness. In his way, cos u ili y will be explo ed
by calcula ing inc emen al cos - u ili y a ios, which a e
de ined as he a io be ween inc emen al cos s and inc e-
men al u ili ies measu ed on QALYs. QALYs gained in
each e alua ion a e app oxima ed using he a ea unde
he cu e echnique.71
To al cos s will be calcula ed by adding di ec and indi-
ec cos s. Di ec cos s will be calcula ed by adding he
cos s de i ed om he medica ion and he use o heal h
se ices and clinical es s. The medica ion cos s will be
calcula ed by de e mining he p ice pe millig am du ing
he s udy pe iod acco ding o he ade- mecum o he las
yea o s udy, including alue- added ax. The o al cos o
d ug ea men will be calcula ed by mul iplying he p ice
pe millig am by he daily dose in millig ams and he
numbe o days he ea men is ecei ed. Cos s de i ed
om he use o heal h se ices will be calcula ed consid-
e ing he da a om he Oblikue da abase.72 Indi ec cos s
will be calcula ed based on he sick lea e days and mul i-
plying hem by he Spanish minimum daily wage du ing
he s udy pe iod, 2019–2020.
We assume ha da a will be missing a andom. Only
pa ien s wi h bo h cos and ele an ou come da a a he
6- mon h and 12- mon h ollow- ups will be included in he
cos - e ec i eness and cos - u ili y analyses. No wi hs anding
his, sensi i i y analysis impu ing missing 6- mon h and
12- mon h da a will es he obus ness o cos - e ec i eness
and cos - u ili y esul s. The impu a ions will be pe o med
using he ‘mice’ package,73 eely a ailable in he Comp e-
hensi e R A chi e Ne wo k (CRAN- R).68
DISCUSSION
Dep ession is a signi ican cause o mo bidi y ha ing low
de ec ion and ea men a es in p ima y ca e.74 75 Only 9%
o all dep essed p ima y ca e pa ien s ecei e adequa e ea -
men , and only 6% achie e emission, making dep ession an
impo an managemen issue in p ima y ca e.76 An e ec i e
ea men o dep ession ha can be implemen ed in PHCs
is b ie psycho he apy (six o eigh sessions p og ammes),
which ha e he ad an age o being pe o med by ei he
men al heal h p o essionals o ained non- men al heal h
p o ide s.77 In his case, he p omo ion o heal hy li es yles
will be used o add ess dep essi e symp oms, as i has shown
e icacy in a numbe o s udies.20–31 To ensu e ea men
adhe ence, acili a o s should be used, such as he use o ICTs
and he g oup o ma . They p o ide moni o ing and social
suppo , espec i ely.33 O ganising g oup he apies in PHCs
gene a es a ange o o ganisa ional bene i s, in ela ion o
e icien use o acili ies, high he apis - o- pa ien a ios and
po en ial educ ions o ea men wai imes.78 Mo eo e ,
pa icipan s a e jus as likely o engage in g oup ea men
as indi idual wo k and he bene i s a e also main ained o e
ime.79
The s eng hs o his s udy include he design and he
wide ange o ou come measu es. I will p o ide a weal h o
in o ma ion on he in e play be ween dep ession, pe sonal
ac o s on heal h beha iou and li es yles. S udy limi a ions
include he possible a i ion o pa icipan s due o session
scheduling o pa icipan e usal o pa icipa e in a g oup
in e en ion o do he comple e ollow- ups.80 Howe e , he
possible easons o a i ion and o he issues will be egis-
e ed ega ding MAGI amewo k.38
The e o e, he c ea ion o a six- session g oup p og amme
add essing li es yle modi ica ions (plus es ing he moni-
o ing wi h ICTs by adding a sma wa ch o one o he in e -
en ion g oup) appea s o be a good choice o dep ession
ea men . The long- e m aim o his s udy is o es ablish
in e en ion o pa ien s wi h dep ession, making i acces-
sible in hei PHCs, e ec i e and cos - e ec i e.
Execu ion da es
Ini ial ec ui men o pa ien s: Ap il 2020.
Finalisa ion o pa ien ec ui men : May 2020.
Finalisa ion o pa ien moni o ing pe iod: June 2021.
Publica ion o esul s: July 2021.
Pa ial pa ien and public in ol emen (PPI)
PPI ep esen a i es wo ked wi h us o e ine he esea ch
ques ion; howe e , i was di icul o in ol e pa ien s in o he
a eas o he s udy design due o da a p o ec ion es ic ions
and he e y echnical me hods equi ed o do a da a linkage
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analysis. PPI ep esen a i es will w i e a plain language
summa y and design a lea le o dissemina ion o hei pee s
and dis ibu ing o pa ien g oups.
ETHICS APPROVAL
E hics app o al was g an ed by he Clinical Resea ch E hics
Commi ee o A agón (PI18/286) and he Resea ch E hics
Commi ee o he Balea ic Islands (IB3950/19 PI). The s udy
has been de eloped in acco dance wi h he Decla a ion o
Helsinki. All o he subjec s will sign an in o med consen
o m, hei da a will be anonymised and will only be used
o he pu poses o he s udy. Pa icipan s and heal hca e
p o essionals will be in o med abou he esul s. Pa ien s o
he TAU g oup will be in i ed o pa icipa e in he LMP a he
end o he s udy. The e hics commi ee will be no i ied o any
p o ocol modi ica ions.
Au ho a ilia ions
1P ima y Heal h Ca e Resea ch G oup o A agón (GAIAP), Ins i u e o Heal h
Resea ch A agón (IIS A agón), Za agoza, Spain
2Depa men o Psychology, Uni e si y o he Balea ic Islands, Palma de Mallo ca,
Spain
3Depa men o Psychology and Sociology, Uni e si y o Za agoza, Za agoza, Spain
4S a is ic and psychome ic p ocedu es implemen ed in Heal h Sciences Resea ch
G oup, Balea ic Islands Heal h Resea ch Ins i u e (IdISBa), Palma de Mallo ca, Spain
5Depa men o Medicine, Psychia y and De ma ology, Uni e si y o Za agoza,
Za agoza, Spain
6Men al diso de s o high p e alence Resea ch G oup (TRAMAP), Balea ic Islands
Heal h Resea ch Ins i u e (IdISBa), Palma de Mallo ca, Spain
7Depa men o Medicine, Uni e si y o he Balea ic Islands, Palma de Mallo ca,
Spain
8Resea ch in P e en i e Ac i i ies and P omo ion and in Cance Illes Balea s
(GRAPP- CAIB), Balea ic Islands Heal h Resea ch Ins i u e (IdISBa), Palma de
Mallo ca, Spain
Acknowledgemen s The au ho s would like o hank he P ima y Ca e P e en ion
and Heal h P omo ion Ne wo k (RedIAPP- Heal h Ins i u e Ca los III, Spain), P ima y
Heal h Ca e Resea ch G oup o A agon (GAIAP- B21- 17R) o he Depa men o
Science, Uni e si y and Knowledge Socie y o he A agon (Spain) go e nmen and
FEDER Funds ‘Ano he way o make Eu ope’.
Con ibu o s BO- B, M- JS- R and MG- T designed and de eloped he s udy and had
he o iginal idea. RMB, M- JS- R, CN and BO- B coo dina ed he ieldwo k. AA- L and
CCV unde ook he ieldwo k. AA- L, BO- B, EG and SB w o e he i s d a o he
a icle. The es o he signing au ho s ha e ead he manusc ip c i ically, o e ing
con ibu ions and app o ing he inal e sion. BO- B a es s ha all lis ed au ho s
mee au ho ship c i e ia and ha no o he s mee ing he c i e ia ha e been omi ed.
Funding This wo k was suppo ed by Ca los III Heal h Ins i u e g an numbe
PI18/01336, FEDER Funds ‘Ano he way o make Eu ope’. The unde s ha e no
ole in s udy design, da a collec ion and analysis, decision o publish o manusc ip
p epa a ion. The unding body will conduc audi ial once a yea .
Compe ing in e es s None decla ed.
Pa ien consen o publica ion No equi ed.
Supplemen al ma e ial This con en has been supplied by he au ho (s). I has
no been e ed by BMJ Publishing G oup Limi ed (BMJ) and may no ha e been
pee - e iewed. Any opinions o ecommenda ions discussed a e solely hose
o he au ho (s) and a e no endo sed by BMJ. BMJ disclaims all liabili y and
esponsibili y a ising om any eliance placed on he con en . Whe e he con en
includes any ansla ed ma e ial, BMJ does no wa an he accu acy and eliabili y
o he ansla ions (including bu no limi ed o local egula ions, clinical guidelines,
e minology, d ug names and d ug dosages), and is no esponsible o any e o
and/o omissions a ising om ansla ion and adap a ion o o he wise.
Open access This is an open access a icle dis ibu ed in acco dance wi h he
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