Online Intervention for Depression: MOOD (MOOD)

January 4, 2019 updated by: Universitätsklinikum Hamburg-Eppendorf

A Randomized-controlled Trial (RCT) on the Efficacy of a New 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Department for Psychiatry and Psychotherapy of University Medical Center Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MOOD
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
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.
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Change in BDI from baseline to post (intervention period is 6 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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".
Change in RSE from baseline to post (intervention period is 6 weeks)
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.
Change in WHOQOL-Bref from baseline to post (intervention period is 6 weeks)
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.
Only at Baseline (pre intervention)
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.
Only at post-assessment (6 weeks)
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.
Change in PHQ-9 from baseline to post (intervention period is 6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinikum Hamburg-Eppendorf

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Steffen Moritz, Prof., Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 22, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 22, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MOOD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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