Online Intervention for Depression: MOOD

NCT03795480 | Completed

• 1 other identifier: MOOD
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

• Beck Depression Inventory (BDI)

  This questionnaire assesses symptoms of depression and their severity (Beck, Steer, \& Brown, 1996). It contains 21 items and the participant is asked to rate how severe he or she experiences each symptom on a 4-point Likert scale ranging from 0 (not at all severe) to 3 (extreme form of each symptom).

  Change in BDI from baseline to post (intervention period is 6 weeks)

Secondary Outcomes (5)

• Rosenberg self-esteem scale (RSE)

  Change in RSE from baseline to post (intervention period is 6 weeks)

• WHOQOL-Bref

  Change in WHOQOL-Bref from baseline to post (intervention period is 6 weeks)

• University of Rhode Island Change Assessment (URICA)

  Only at Baseline (pre intervention)

• Subjective appraisal

  Only at post-assessment (6 weeks)

• Patient Health Questionnaire-9 Depression Module (PHQ-9)

  Change in PHQ-9 from baseline to post (intervention period is 6 weeks)

Study Arms (2)

MOOD

EXPERIMENTAL

The online program "MOOD" is based on methods of cognitive behavior therapy (KVT) and contains elements of mindfulness and metacognition. Participants can contact a moderator (trained psychologists) if they have any questions. However, this function is optional. The program consists of nine interactive modules, one of which is an introductory module. The other modules are called: ABC-Scheme, Positive Activities, Self-Worth, Social Competence, Mindfulness, Modifying Thoughts, Sleep, and Relapse Prevention.

Behavioral: MOOD

Control

NO INTERVENTION

The wait-list control group does not receive additional treatment. However, previously started therapies (psychotherapy/ psychopharmacotherapy) may be continued during the study. Individuals of the wait-list control group receive access to MOOD after completion of the post-assessment.

Interventions

MOOD BEHAVIORAL

MOOD is an online self-help program targeted on depressive symptoms. The program consists of nine modules, one of which is an introductory module. The other modules are called: ABC-Scheme, Positive Activities, Self-Worth, Social Competence, Mindfulness, Modifying Thoughts, Sleep, and Relapse Prevention. All modules are based on principles of cognitive behavioral therapy (CBT) and include elements of mindfulness-based and metacognitive techniques. The modules contain interactive exercises which are aimed at incorporating the participant's experiences into the program and increasing identification of the participant with the presented material. Participants are free to work through the different modules in their own speed and way, however, it is recommended to work on one to two modules per week.

MOOD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Department for Psychiatry and Psychotherapy of University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (1)

• 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.

  PMID: 31579014 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Steffen Moritz, Prof.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: January 7, 2019
• Study Start: May 7, 2018
• Primary Completion: July 22, 2018
• Study Completion: July 22, 2018
• Last Updated: January 7, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)