GET.ON Mood Enhancer: efficacy of Internet-based guided self-help compared to psychoeducation for depression: an investigator-blinded randomised controlled trial.
BACKGROUND
Major depressive disorder (MDD) imposes a considerable disease burden on individuals and societies. A large number of randomised controlled trials (RCTs) have shown the efficacy of Internet-based guided self-help interventions in reducing symptoms of depression. However, study quality varies considerably. The aim of this study is to evaluate the efficacy of a new Internet-based guided self-help intervention (GET.ON Mood Enhancer) compared to online-based psychoeducation in an investigator-blinded RCT.


METHODS
A RCT will be conducted to compare the efficacy of GET.ON Mood Enhancer with an active control condition receiving online psychoeducation on depression (OPD). Both treatment groups will have full access to treatment as usual. Adults with MDD (n=128) will be recruited and randomised to one of the two conditions. Primary outcome will be observer-rated depressive symptoms (HRSD-24) by independent assessors blind to treatment conditions. Secondary outcomes include changes in self-reported depressive symptom severity, anxiety and quality of life. Additionally, potential negative effects of the treatments will systematically be evaluated on several dimensions (for example, symptom deteriorations, attitudes toward seeking psychological help, relationships and stigmatisation). Assessments will take place at baseline, 6 and 12 weeks after randomisation.


CONCLUSIONS
This study evaluates a new Internet-based guided self-help intervention for depression using an active control condition (psychoeducation-control) and an independent, blinded outcome evaluation. This study will further enhance the evidence for Internet-based guided self-help interventions for MDD.


BACKGROUND
German Clinical Trial Registration (DRKS): DRKS00005025.
Leuphana University, Innovation Incubator, Division Health Trainings online, Rotenbleicher Weg 67, Lüneburg 21335, Germany. ebert@inkubator.leuphana.de.
David Daniel
DD
Ebert
Dirk
D
Lehr
Harald
H
Baumeister
Leif
L
Boß
Heleen
H
Riper
Pim
P
Cuijpers
Jo Annika
JA
Reins
Claudia
C
Buntrock
Matthias
M
Berking
D000339:Affect; D002985:Clinical Protocols; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D005858:Germany; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D020407:Internet; D010353:Patient Education as Topic; D011569:Psychiatric Status Rating Scales; D011613:Psychotherapy / Q000379:methods*; D011788:Quality of Life; D012107:Research Design; D012720:Severity of Illness Index; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D013813:Therapy, Computer-Assisted; D013997:Time Factors; D016896:Treatment Outcome