DepressionNCT02437357
A Trial on Metacognitive Training for Depression (D-MCT)
A study testing Metacognitive Training and Positivity Training in people with Depression, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The purpose of the present randomized-controlled trial is to investigate the efficacy of Metacognitive Training for Depression (D-MCT), a new low-threshold, modular group intervention. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depression
- What is being tested?
- Metacognitive Training and Positivity Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2015to Jun 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Major Depression according to DSM-IV (MINI Interview)
- Diagnosis of Dysthymia according to DSM-IV (MINI Interview)
- DSM-IV = The Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition, Text Revision (American Psychiatric Association, 2000)
Who cannot join
- Lifetime psychotic symptoms (i.e., hallucinations, delusions, or bipolar disorder) according to DSM-IV (MINI Interview)
- Current substance dependency according to DSM-IV (MINI Interview)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized-Controlled Trial on Metacognitive Training for Depression (D-MCT) - an New Group Intervention for Depressed Patients
The purpose of the present randomized-controlled trial is to investigate the efficacy of Metacognitive Training for Depression (D-MCT), a new low-threshold, modular group intervention.
Read the detailed description
Despite the existence of evidence-based treatment methods, a significant treatment gap remains for major depression. While in acute psychiatric treatment of severely depressed patients a pharmacological treatment is usually applied, depression-specific psychotherapeutic (group) concepts are rarely part of the treatment, though recommended in clinical guidelines. A main reason is that present group concepts were designed primarily for outpatient settings and do not meet the structural requirements of inpatient care (i.e., short residence time, continuous admissions and dismissals).
Metacognitive Training for Depression (D-MCT) is a new low-threshold, modular group intervention which was designed to fill this treatment gap by addressing contextual and structural shortcomings of existing concepts for the use in inpatient treatment. The training targets depressive symptoms by changing (meta-) cognitive biases identified in both cognitive models of depression and basic research. D-MCT was positively evaluated with regard to feasibility and acceptance in a non-randomized pilot study.
Aim of the present randomized-controlled trial is to investigate the efficacy of D-MCT as an add-on intervention in inpatient treatment of depressed patients compared with a standard add-on group therapy (Positivity Training, PT). Based on a power analysis, the investigators target a sample size of 60 depressed patients, who will be randomized either to D-MCT or PT. Blind to diagnostic status, symptom level as well as cognitive biases will be assessed pre- and post-treatment (8 group sessions) as well as 3 months later (follow-up). Primary outcome parameter is severity of depressive symptoms measured with the HDRS total score (17-item version). Secondary outcome measures are self-assessed depression (BDI), dysfunctional beliefs (DAS), metacognitions (MCQ), self-esteem (RSE), and quality of life (WHOQOL-BREF).
- Conditions
- Depression
- Being tested
- Metacognitive Training, Positivity Training
- Keywords
- Psychotherapy, Group, Metacognition, Cognitive Bias
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive TrainingOther
8 group sessions á 60 min
Positivity TrainingOther
8 group sessions á 60 min
| Study group | Role | What they receive |
|---|---|---|
| Metacognitive Training | Experimental | D-MCT is conceptualized as a variant of cognitive behavioral therapy (CBT) that uses a metacognitive perspective to focus on the modification of cognitive biases by using creative and engaging strategies (e.g., multimedial presentation). The training seeks to enable group members to recognize and correct the often automatic and unconscious depressive thought patterns, in part by viewing this depressive thought process at a distance (i.e., depersonalizing). Besides dysfunctional assumptions about one's thought processes, more general cognitive biases, which have been identified by basic research are at the core of the D-MCT. Finally, dysfunctional coping-strategies (i.e., thought suppression, rumination as problem-solving) are discussed and modified. Receives: Other: Metacognitive Training |
| Positivity Training | Active comparator | Positivity Training (PT) is a "euthymic therapy" group based on cognitive behavioral therapy (CBT) with a focus on the education and training of sensual enjoyment and pleasure. Aim of the training is to reduce depressive symptomatology by increasing the ability to enjoy and to (re-)install positive sensory experiences. Therefore, group members are informed about the impact of positive experiences on well-being and the awareness of the five senses is trained in different practical exercises (hearing, sight, smell, taste, and touch). Receives: Other: Positivity Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depression Rating Scale (HDRS), total score from pre to post treatment (4 weeks) and follow-up (3months)
Clinician-rated severity of depressive symptoms, 17-item version, most commonly used interview-based measure of depression
Measured: 4 months
Secondary outcomes (7)
Change in Beck Depression Inventory (BDI), total score from pre to post treatment (4 weeks) and follow-up (3months)
Self-assessed severity of depressive symptoms (questionnaire)
Measured: 4 months
Change in Dysfunctional Attitudes Scale (DAS) from pre to post treatment (4 weeks) and follow-up (3months)
questionnaire
Measured: 4 months
Change in Metacognitions Questionnaire (MCQ-30) from pre to post treatment (4 weeks) and follow-up (3months)
questionnaire
Measured: 4 months
Change in Ruminative Responses Scale (RRS) from pre to post treatment (4 weeks) and follow-up (3months)
questionnaire
Measured: 4 months
Change in Rosenberg Self-Esteem-Scale (RSE) from pre to post treatment (4 weeks) and follow-up (3months)
questionnaire
Measured: 4 months
Change in quality of life (WHOQOL-BREF) from pre to post treatment (4 weeks) and follow-up (3months)
questionnaire
Measured: 4 months
Change in coping (Brief-Cope) from pre to post treatment (4 weeks) and follow-up (3months)
questionnaire
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marit Hauschildt, Ph.D., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437357
- Sponsor's protocol ID
- NWF-15/03
- Status last verified
- Sep 2016
- First submitted
- 23 Mar 2015
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Jelinek L, Otte C, Arlt, S, Hauschildt M. Denkverzerrungen erkennen und korrigieren: Eine Machbarkeitsstudie zum Metakognitiven Training bei Depressionen (D-MKT). Zeitschrift für Psychiatrie und Psychotherapie, 61(4): 1-8, 2014.
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized-Controlled Trial on Metacognitive Training for Depression (D-MCT) - an New Group Intervention for Depressed Patients
- ClinicalTrials.gov ID
- NCT02437357
- Acronym / sponsor ID
- NWF-15/03
- Conditions
- Depression
- Keywords
- Psychotherapy, Group, Metacognition, Cognitive Bias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the present randomized-controlled trial is to investigate the efficacy of Metacognitive Training for Depression (D-MCT), a new low-threshold, modular group intervention.
Detailed description
Despite the existence of evidence-based treatment methods, a significant treatment gap remains for major depression. While in acute psychiatric treatment of severely depressed patients a pharmacological treatment is usually applied, depression-specific psychotherapeutic (group) concepts are rarely part of the treatment, though recommended in clinical guidelines. A main reason is that present group concepts were designed primarily for outpatient settings and do not meet the structural requirements of inpatient care (i.e., short residence time, continuous admissions and dismissals).
Metacognitive Training for Depression (D-MCT) is a new low-threshold, modular group intervention which was designed to fill this treatment gap by addressing contextual and structural shortcomings of existing concepts for the use in inpatient treatment. The training targets depressive symptoms by changing (meta-) cognitive biases identified in both cognitive models of depression and basic research. D-MCT was positively evaluated with regard to feasibility and acceptance in a non-randomized pilot study.
Aim of the present randomized-controlled trial is to investigate the efficacy of D-MCT as an add-on intervention in inpatient treatment of depressed patients compared with a standard add-on group therapy (Positivity Training, PT). Based on a power analysis, the investigators target a sample size of 60 depressed patients, who will be randomized either to D-MCT or PT. Blind to diagnostic status, symptom level as well as cognitive biases will be assessed pre- and post-treatment (8 group sessions) as well as 3 months later (follow-up). Primary outcome parameter is severity of depressive symptoms measured with the HDRS total score (17-item version). Secondary outcome measures are self-assessed depression (BDI), dysfunctional beliefs (DAS), metacognitions (MCQ), self-esteem (RSE), and quality of life (WHOQOL-BREF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metacognitive Training | Experimental | Other: Metacognitive TrainingD-MCT is conceptualized as a variant of cognitive behavioral therapy (CBT) that uses a metacognitive perspective to focus on the modification of cognitive biases by using creative and engaging strategies (e.g., multimedial presentation). The training seeks to enable group members to recognize and correct the often automatic and unconscious depressive thought patterns, in part by viewing this depressive thought process at a distance (i.e., depersonalizing). Besides dysfunctional assumptions about one's thought processes, more general cognitive biases, which have been identified by basic research are at the core of the D-MCT. Finally, dysfunctional coping-strategies (i.e., thought suppression, rumination as problem-solving) are discussed and modified. |
| Positivity Training | Active comparator | Other: Positivity TrainingPositivity Training (PT) is a "euthymic therapy" group based on cognitive behavioral therapy (CBT) with a focus on the education and training of sensual enjoyment and pleasure. Aim of the training is to reduce depressive symptomatology by increasing the ability to enjoy and to (re-)install positive sensory experiences. Therefore, group members are informed about the impact of positive experiences on well-being and the awareness of the five senses is trained in different practical exercises (hearing, sight, smell, taste, and touch). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Major Depression according to DSM-IV (MINI Interview)
- Diagnosis of Dysthymia according to DSM-IV (MINI Interview)
Key exclusion criteria (2 listed)
- Lifetime psychotic symptoms (i.e., hallucinations, delusions, or bipolar disorder) according to DSM-IV (MINI Interview)
- Current substance dependency according to DSM-IV (MINI Interview)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive Training8 group sessions á 60 min | Other | Metacognitive Training |
| Positivity Training8 group sessions á 60 min | Other | Positivity Training |
Primary outcome
Change in Hamilton Depression Rating Scale (HDRS), total score from pre to post treatment (4 weeks) and follow-up (3months)
Time frame: 4 months
Clinician-rated severity of depressive symptoms, 17-item version, most commonly used interview-based measure of depression
7 secondary outcomes
Change in Beck Depression Inventory (BDI), total score from pre to post treatment (4 weeks) and follow-up (3months)
Time frame: 4 months
Change in Dysfunctional Attitudes Scale (DAS) from pre to post treatment (4 weeks) and follow-up (3months)
Time frame: 4 months
Change in Metacognitions Questionnaire (MCQ-30) from pre to post treatment (4 weeks) and follow-up (3months)
Time frame: 4 months
Change in Ruminative Responses Scale (RRS) from pre to post treatment (4 weeks) and follow-up (3months)
Time frame: 4 months
Change in Rosenberg Self-Esteem-Scale (RSE) from pre to post treatment (4 weeks) and follow-up (3months)
Time frame: 4 months
Change in quality of life (WHOQOL-BREF) from pre to post treatment (4 weeks) and follow-up (3months)
Time frame: 4 months
Change in coping (Brief-Cope) from pre to post treatment (4 weeks) and follow-up (3months)
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- BackgroundJelinek L, Otte C, Arlt, S, Hauschildt M. Denkverzerrungen erkennen und korrigieren: Eine Machbarkeitsstudie zum Metakognitiven Training bei Depressionen (D-MKT). Zeitschrift für Psychiatrie und Psychotherapie, 61(4): 1-8, 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marit Hauschildt, Ph.D. principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Training and Positivity Training in people with Depression, 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 27 Sep 2016. 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?
Change in Hamilton Depression Rating Scale (HDRS), total score from pre to post treatment (4 weeks) and follow-up (3months) (time frame: 4 months). 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 NCT02437357, 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 27 Sep 2016.