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Completed

NCT Number: NCT03795480

Online Intervention for Depression: MOOD

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.

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Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Depression

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Beck Depression Inventory (BDI)

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

    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).

Secondary outcomes

  1. Rosenberg self-esteem scale (RSE)

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

    The RSE is a self-report questionnaire assessing an individual's self-esteem (Rosenberg, 1965) The scale consists of 10 items and the participants are asked to rate in how far they agree with each item on a 4-point Likert scale ranging from "strongly disagree" to "strongly agree".

  2. WHOQOL-Bref

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

    The WHOQOL-Bref is a questionnaire assessing Quality of Life (QOL) (Whoqol Group, 1998). It is an abbreviated version of the WHOQOL-100 and contains 26 items. The questionnaire has four types of 5-point Likert scales asking the participant "how much", "how completely", "how often", "how good" or "how satisfied" he felt in the last two weeks. The four different scales are distributed across the four domains sampled in this questionnaire: Physical health, Psychological, Social relations, Environment.

  3. University of Rhode Island Change Assessment (URICA)

    Time frame: Only at Baseline (pre intervention)

    The URICA is a measure of willingness to change (Dozois, Westra, Collins, Fung & Garry, 2004) and was assessed at baseline. It consists of 32 items that depict four stages of change: pre-contemplation, contemplation, action and maintenance. In the present study, in total 9 items are used which were chosen from the subscales of pre-contemplation, contemplation and action. Internal consistency is .83 and test-retest reliability lies between .63-.75.

  4. Subjective appraisal

    Time frame: Only at post-assessment (6 weeks)

    In the post-assessment, individuals of the intervention group also answered questions on subjective evaluation and appraisal of the program. Items were for example "I think this program is useful as a self-help tool" or "I had to bring myself to make use of the program". The items could be answered on a 4-point Likert scale ranging from "Totally disagree" to "Totally agree". Participants also had the possibility to provide feedback on the program.

  5. Patient Health Questionnaire-9 Depression Module (PHQ-9)

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

    The PHQ-9 is used to measure depression and its severity (Kroenke, Spitzer, & Williams, 2001). It consists of 9 items which can be rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day), depending on the severity and frequency of the symptoms.

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

A Randomized-controlled Trial (RCT) on the Efficacy of a New Online Intervention for Depression: MOOD

Acronym: MOOD

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 7, 2019
Registry last updated
Jan 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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