Clinical trial NCT03795480: Online Intervention for Depression: MOOD
Official title: A Randomized-controlled Trial (RCT) on the Efficacy of a New Online Intervention for Depression: MOOD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2019-01-07
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to examine the efficacy and acceptance of a self-help internet intervention "MOOD" in a sample of individuals with depressive symptoms. It is tested whether depressive symptomatology decreases in the intervention group compared to a wait-list control group. Further aims are to ascertain changes in self-worth and quality of life, to assess subjective evaluation of the program and to examine whether expectations of the program's helpfulness would predict symptom reduction.

Detailed description: The study aims to examine the efficacy and acceptance of a self-help internet intervention "MOOD" in a sample of individuals with depressive symptoms. It is tested whether depressive symptomatology decreases in the intervention group compared to a wait-list control group. Secondary aims are to ascertain changes in self-worth and quality of life, to assess subjective evaluation of the program and to examine whether expectations of the program's helpfulness would predict symptom reduction. During the intervention period of six weeks, participants of the intervention group have access to the online program MOOD. Prior and following this period both groups complete a pre- and post-assessment. Participants of the wait-list control group receive access to MOOD following the post-assessment.

Eligibility criteria: Inclusion Criteria:

* presence of psychological strain and desire for treatment for depressive symptoms
* internet access
* sufficient command of the German language

Exclusion Criteria:

* acute suicidality (as assessed with one item of the BDI)
* lifetime diagnoses of bipolar disorder and psychosis

Primary outcomes:
measure: Beck Depression Inventory (BDI)
timeFrame: Change in BDI from baseline to post (intervention period is 6 weeks)
Secondary outcomes:
measure: Rosenberg self-esteem scale (RSE)
timeFrame: Change in RSE from baseline to post (intervention period is 6 weeks)
measure: WHOQOL-Bref
timeFrame: Change in WHOQOL-Bref from baseline to post (intervention period is 6 weeks)
measure: University of Rhode Island Change Assessment (URICA)
timeFrame: Only at Baseline (pre intervention)
measure: Subjective appraisal
timeFrame: Only at post-assessment (6 weeks)
measure: Patient Health Questionnaire-9 Depression Module (PHQ-9)
timeFrame: Change in PHQ-9 from baseline to post (intervention period is 6 weeks)
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department for Psychiatry and Psychotherapy of University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Steffen Moritz, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bucker L, Schnakenberg P, Karyotaki E, Moritz S, Westermann S. Diminishing Effects After Recurrent Use of Self-Guided Internet-Based Interventions in Depression: Randomized Controlled Trial. J Med Internet Res. 2019 Oct 2;21(10):e14240. doi: 10.2196/14240.