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Depressive SymptomsMOODNCT03795480

Online Intervention for Depression: MOOD

A study testing MOOD in people with Depressive Symptoms, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Depressive Symptoms
What is being tested?
MOOD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteGermany
Study dates
7 May 2018to 22 Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    Hamburg, 20246

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
MOOD
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MOODBehavioural

    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.

Study groups in NCT03795480
Study groupRoleWhat they receive
MOODExperimentalThe 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.
Receives: Behavioral: MOOD
ControlNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (5)

  1. Rosenberg self-esteem scale (RSE)

    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".

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

  2. WHOQOL-Bref

    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.

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

  3. University of Rhode Island Change Assessment (URICA)

    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.

    Measured: Only at Baseline (pre intervention)

  4. Subjective appraisal

    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.

    Measured: Only at post-assessment (6 weeks)

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

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2019
  2. Study start7 May 2018
  3. Primary completion22 Jul 2018
  4. Study completion22 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03795480
Sponsor's protocol ID
MOOD
Acronym
MOOD
Status last verified
Jan 2019
First submitted
16 Aug 2018
Last updated
7 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31579014

Questions about this trial

What is this clinical trial studying?

A study testing MOOD in people with Depressive Symptoms, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Beck Depression Inventory (BDI) (time frame: Change in BDI from baseline to post (intervention period is 6 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03795480, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2019.

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