Unipolar DepressionNCT03268434
Evaluation of Metacognitive Training for Depression (D-MCT) in Outpatient Care
A study testing D-MCT and Cognitive remediation in people with Unipolar Depression, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Aim of the current study is to investigate the acceptance and efficacy of Metacognitive Training for Depression (D-MCT) compared to cognitive remediation in outpatients with major depressive disorders in a randomized, controlled, assessor-blind, group trial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Unipolar Depression
- What is being tested?
- D-MCT and Cognitive remediation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteGermany
- Study dates
- 10 Oct 2017to 24 Sep 2019
- 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
- informed consent
- age between 18 and 70 years
- diagnosis of a single Episode or recurrent Major depressive disorder (MDD) or dysthymia (verified by the MINI)
Who cannot join
- lifetime psychotic symptoms (i.e., hallucinations, delusions, or mania), suicidality (Suicidal Behaviors Questionnaire-Revised ≥ 7), intellectual disability (estimated IQ < 70) or dementia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Metacognitive Training for Depression (D-MCT) in Outpatient Psychiatric-psychotherapeutic Care: Randomized Controlled Trial
Aim of the current study is to investigate the acceptance and efficacy of Metacognitive Training for Depression (D-MCT) compared to cognitive remediation in outpatients with major depressive disorders in a randomized, controlled, assessor-blind, group trial.
Read the detailed description
Evidence-based treatments for depression include pharmacological and psychological interventions. Within psychological interventions, cognitive behavioral therapy (CBT) is one of the most extensively researched evidence-based approaches for depression (Cuijpers, 2015). However, even if optimal treatment and access to services were available to all patients, the burden of depression would be reduced by only 30% (Andrews et al., 2004). Moreover, as depression represents the disorder with the highest drop-out rates during CBT treatment (36.4%) (Fernandez et al., 2015), and a relapse rate of 54% for treatment responders within the two years after treatment termination (Vittengl et al., 2007), it is pivotal to improve treatment for depression. It has been argued that this is less a question of developing novel psychological treatments as of determining how existing treatments may be improved (Cuijpers, 2015) and better disseminated to increase retention rates and to use the waiting phase to rise interest in therapy (Fernandez et al., 2015). Due to hopelessness and the discouraging character of the disorder, this poses a particular challenge.
To meet this aim, Metacognitive Training for Depression (D-MCT) has been developed as a low-threshold, highly standardized and yet easy to administer group concept for the treatment of depression. It is conceptualized as a variant of CBT that adopts a metacognitive perspective focusing on the modification of cognitive biases, and is compatible with a general CBT treatment approach. Use of standardized presentations reduces time needed for preparation and administration of the training; moreover, this "packaging" increases the accessibility of D-MCT to a wide range of health care providers, and encourages standardization across therapists. The training seeks to enable group members to recognize and correct the often automatic and unconscious thought patterns that accompany depression. To this end, it attempts to challenge cognitive biases through the use of creative and engaging exercises supported by a multimedia presentation (e.g., insight based on "aha" effects rather than psychoeducation) and to encourage patients to take a metacognitive perspective ("think about one's thinking"). The training is highly flexible with regard to depth and intensity. Patients do not need to (but may) discuss their own problems, and can still experience how cognitive biases work and influence one's mood in a playful atmosphere. The training is conceptualized as an open group: New patients can join the group in every session. Thus, the threshold for administration of and participation in this intervention is low.
The general structure of and exercises in D-MCT were inspired by Metacognitive Training for psychosis (Moritz et al., 2014); however, contents were modified upon to suit the specific problems of individuals with depression. Beside depressive thought patterns already targeted in CBT (e.g., overgeneralization, "mind reading"), a number of general cognitive biases, which have been identified by basic cognitive research, form the core of D-MCT (e.g., mood-congruent memory (Mathews and MacLeod, 2005)). Finally, as in Metacognitive Therapy (MCT) sensu Adrian Wells (Wells, 2011) dysfunctional coping strategies (i.e., thought suppression, rumination as problem-solving) are challenged. D-MCT thus blends established elements from CBT and MCT as well as newly developed and evidence-based exercises in one coherent metacognitive approach.
D-MCT was positively evaluated with regard to feasibility and acceptance in a non-randomized pilot study (Jelinek et al., 2013). Moreover, efficacy of D-MCT was suggested in a randomized controlled trail (RCT) in comparison to an active control intervention (Jelinek et al., 2016). In this trial patients with depressive disorder were completing a psychosomatic outpatient treatment program and were randomly assigned to either D-MCT or general health training. Severity of depression and cognitive biases were assessed at baseline (t0), post treatment (t1) and 6 months (t2) later by raters blind to diagnostic status. Intention-to-treat analyses demonstrated that at the end of treatment, as well as 6 months later, improvement in depression was significantly greater in the D-MCT relative to the health training group at medium effect sizes. A significantly greater number of patients in the D-MCT group were in remission at 6-month follow-up. Moreover, the decrease in cognitive biases and increase in psychological well-being/quality of life was larger in the D-MCT than the health training group over time. Patients' subjective appraisal of D-MCT was also positive (Jelinek et al., 2017).
Aim of the current study is to investigate the acceptance and efficacy of D-MCT in outpatients.The Hamilton Depression Rating Scale (HDRS, 17-item version) total score as well as the Quick Inventory of Depressive Symptomatology (QIDS) serve as primary outcome. Self-assessed depression, dysfunctional beliefs, self-esteem, quality of life, rumination, remission rate as well as neuropsychological functioning serve as secondary outcomes.
- Conditions
- Unipolar Depression
- Being tested
- D-MCT, Cognitive remediation
- Keywords
- Depression, Metacognition, CBT, D-MCT, cognitive bias
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-MCTBehavioural
Also called Metacognitive Training for Depression
Metacognitive Training for Depression (D-MCT), 8 sessions (60min); once a week over a period of 8 weeks. Metacognitive Training for depression (D-MCT) is a low-threshold, easy to administer group intervention. It aims at the reduction of depressive symptoms by changing cognitive biases; not only biases targeted in cognitive behavioral therapy but also those identified by basic research.
Cognitive remediationBehavioural
A computerized cognitive remediation program that covers several cognitive domains, such as attention, visuomotor skills, and Memory. The difficulty level adapts automatically to the performance level of each patient. At the end of each session, the patient receives individual feedback on his or her performance; 8 sessions (60min), once a week over a period of 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| D-MCT Group | Experimental | Metacognitive Training for Depression (D-MCT), 8 sessions (60min); once a week over a period of 8 weeks. Metacognitive Training for depression (D-MCT) is a low-threshold, easy to administer group intervention. It aims at the reduction of depressive symptoms by changing cognitive biases; not only biases targeted in cognitive behavioral therapy but also those identified by basic research. Receives: Behavioral: D-MCT |
| Cognitive remediation | Active comparator | A computerized cognitive remediation program that covers several cognitive domains, such as attention, visuomotor skills, and Memory.The difficulty level adapts automatically to the performance level of each patient. At the end of each session, the patient receives individual feedback on his or her performance.; 8 sessions (60min), once a week over a period of 8 weeks Receives: Behavioral: Cognitive remediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Inventory of Depressive Symptomatology (QIDS)
Primary outcome is change on the Quick Inventory of Depressive Symptomatology (QIDS) from baseline to follow-up (t0 - t2)
Measured: eight months from baseline (t0) to 6-months follow up (t2)
Secondary outcomes (15)
Hamilton Depression Rating Scale
Change on the Hamilton Depression Rating Scale (HDRS, 17-item version) from baseline to follow-up (t0 - t2)
Measured: [Time Frame: eight months from baseline (t0) to 6-months follow up (t2)]
Self-assessed depression
Change in self-assessed depression as measured by the Patient Health Questionnaire (PHQ-9) from baseline to follow-up (t0 to t2)
Measured: [Time Frame: eight months from baseline (t0) to 6-months follow up (t2)]
Quick Inventory of Depressive Symptomatology (QIDS)
Change on the Quick Inventory of Depressive Symptomatology (QIDS) from baseline to post intervention assessment (t0 - t1)
Measured: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]
Hamilton Depression Rating Scale
Change on the Hamilton Depression Rating Scale from baseline to post intervention assessment (t0 - t1)
Measured: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]
Patient Health Questionnaire (PHQ-9)
Change on the Patient Health Questionnaire (PHQ-9) from baseline to post intervention assessment (t0 - t1)
Measured: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]
Dysfunctional beliefs
Change in dysfunctional beliefs as measured by the Dysfunctional Attitude Scale (DAS) from baseline to follow-up (t0 to t2)
Measured: eight months from baseline (t0) to 6-months follow up (t2
Quality of life
Change in quality of life as measured by the World Health Organization Quality of Life Assessment (WHOQOL-BREF) from baseline to follow-up (t0 to t2)
Measured: eight months from baseline (t0) to 6-months follow up (t2)
Dysfunctional metacognitive beliefs
Change in metacognitive beliefs as measured by the Metacognitions Questionnaire (MCQ-30) from baseline to follow-up (t0 to t2)
Measured: eight months from baseline (t0) to 6-months follow up (t2)
Rumination
Rumination measured by the Ruminative Response Scale (RRS) from baseline to follow-up (t0 to t2)
Measured: eight months from baseline (t0) to 6-months follow up (t2)
Self-esteem
Change in self-esteem as measured by the Rosenberg Self-Esteem Scale (RSE) from from baseline to follow-up (t0 to t2)
Measured: eight months from baseline (t0) to 6-months follow up (t2)
Remission rate
Remission rate at T2 as measured by the Hamilton Depression Rating Scale (HDRS score ≤ 8)
Measured: eight months from baseline (t0) to 6-months follow up (t2)
Information processing
Information processing as measured by the Trail-Making Test A (TMT-A) from baseline to post treatment assessment (t0 to t1)
Measured: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]
Subjective appraisal of the training
Subjective appraisal of the training after each session as well as at post treatment and follow up assessment (for questionnaire see Jelinek et al., 2017)
Measured: each week (session data) [time frame: 8 weeks] and six months from post treatment assessment (t1) to 6 months follow up (t1 to t2) [time frame: 6 months]
Executive functioning
Executive functions as measured by the Trail-Making Test B (TMT-B) from baseline to post treatment assessment (t0 to t1)
Measured: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]
Verbal memory
Memory functioning as measured by Rivermead Behavioral Memory Test from baseline to post treatment assessment (t0 to t1)
Measured: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start10 Oct 2017
- Primary completion22 Aug 2019
- Study completion24 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Unipolar DepressionStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Asklepios Kliniken Hamburg GmbH
- Responsible party
- Sponsor
- Investigators
- Marion Hagemann-Goebel, Dr., Principal investigator, Asklepios Klinik Nord-Ochsenzoll
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268434
- Sponsor's protocol ID
- LJ05207
- Status last verified
- Sep 2019
- First submitted
- 3 Aug 2017
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moritz S, Veckenstedt R, Andreou C, Bohn F, Hottenrott B, Leighton L, Kother U, Woodward TS, Treszl A, Menon M, Schneider BC, Pfueller U, Roesch-Ely D. Sustained and "sleeper" effects of group metacognitive training for schizophrenia: a randomized clinical trial. JAMA Psychiatry. 2014 Oct;71(10):1103-11. doi: 10.1001/jamapsychiatry.2014.1038.
PubMed 25103718Jelinek L, Hauschildt M, Wittekind CE, Schneider BC, Kriston L, Moritz S. Efficacy of Metacognitive Training for Depression: A Randomized Controlled Trial. Psychother Psychosom. 2016;85(4):231-4. doi: 10.1159/000443699. Epub 2016 May 27. No abstract available.
PubMed 27230865Jelinek L, Otte C, Arlt S, & Hauschildt M. Denkverzerrungen erkennen und korrigieren: Eine Machbarkeitsstudie zum Metakognitiven Training bei Depressionen (D-MKT). [Identifying and correcting cognitive biases: A Pilot study on the Metacognitive Training for Depression (D-MCT)] Zeitschrift für Psychiatrie, Psychologie und Psychotherapie, 61, 247-254, 2013.
Jelinek L, Moritz S, Hauschildt M. Patients' perspectives on treatment with Metacognitive Training for Depression (D-MCT): Results on acceptability. J Affect Disord. 2017 Oct 15;221:17-24. doi: 10.1016/j.jad.2017.06.003. Epub 2017 Jun 7.
PubMed 28628763Andrews G, Issakidis C, Sanderson K, Corry J, Lapsley H. Utilising survey data to inform public policy: comparison of the cost-effectiveness of treatment of ten mental disorders. Br J Psychiatry. 2004 Jun;184:526-33. doi: 10.1192/bjp.184.6.526.
PubMed 15172947Cuijpers P. Psychotherapies for adult depression: recent developments. Curr Opin Psychiatry. 2015 Jan;28(1):24-9. doi: 10.1097/YCO.0000000000000121.
PubMed 25415495Fernandez E, Salem D, Swift JK, Ramtahal N. Meta-analysis of dropout from cognitive behavioral therapy: Magnitude, timing, and moderators. J Consult Clin Psychol. 2015 Dec;83(6):1108-22. doi: 10.1037/ccp0000044. Epub 2015 Aug 24.
PubMed 26302248Mathews A, MacLeod C. Cognitive vulnerability to emotional disorders. Annu Rev Clin Psychol. 2005;1:167-95. doi: 10.1146/annurev.clinpsy.1.102803.143916.
PubMed 17716086Vittengl JR, Clark LA, Dunn TW, Jarrett RB. Reducing relapse and recurrence in unipolar depression: a comparative meta-analysis of cognitive-behavioral therapy's effects. J Consult Clin Psychol. 2007 Jun;75(3):475-88. doi: 10.1037/0022-006X.75.3.475.
PubMed 17563164Wells, A., 2011. Metacognitive Therapy for anxiety and depression. The Guilford Press, New York.
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Metacognitive Training for Depression (D-MCT) in Outpatient Psychiatric-psychotherapeutic Care: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03268434
- Acronym / sponsor ID
- LJ05207
- Conditions
- Unipolar Depression
- Keywords
- Depression, Metacognition, CBT, D-MCT, cognitive bias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Asklepios Kliniken Hamburg GmbH
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 22 Aug 2019 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 31 Aug 2017 (actual)
- 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.
Aim of the current study is to investigate the acceptance and efficacy of Metacognitive Training for Depression (D-MCT) compared to cognitive remediation in outpatients with major depressive disorders in a randomized, controlled, assessor-blind, group trial.
Detailed description
Evidence-based treatments for depression include pharmacological and psychological interventions. Within psychological interventions, cognitive behavioral therapy (CBT) is one of the most extensively researched evidence-based approaches for depression (Cuijpers, 2015). However, even if optimal treatment and access to services were available to all patients, the burden of depression would be reduced by only 30% (Andrews et al., 2004). Moreover, as depression represents the disorder with the highest drop-out rates during CBT treatment (36.4%) (Fernandez et al., 2015), and a relapse rate of 54% for treatment responders within the two years after treatment termination (Vittengl et al., 2007), it is pivotal to improve treatment for depression. It has been argued that this is less a question of developing novel psychological treatments as of determining how existing treatments may be improved (Cuijpers, 2015) and better disseminated to increase retention rates and to use the waiting phase to rise interest in therapy (Fernandez et al., 2015). Due to hopelessness and the discouraging character of the disorder, this poses a particular challenge.
To meet this aim, Metacognitive Training for Depression (D-MCT) has been developed as a low-threshold, highly standardized and yet easy to administer group concept for the treatment of depression. It is conceptualized as a variant of CBT that adopts a metacognitive perspective focusing on the modification of cognitive biases, and is compatible with a general CBT treatment approach. Use of standardized presentations reduces time needed for preparation and administration of the training; moreover, this "packaging" increases the accessibility of D-MCT to a wide range of health care providers, and encourages standardization across therapists. The training seeks to enable group members to recognize and correct the often automatic and unconscious thought patterns that accompany depression. To this end, it attempts to challenge cognitive biases through the use of creative and engaging exercises supported by a multimedia presentation (e.g., insight based on "aha" effects rather than psychoeducation) and to encourage patients to take a metacognitive perspective ("think about one's thinking"). The training is highly flexible with regard to depth and intensity. Patients do not need to (but may) discuss their own problems, and can still experience how cognitive biases work and influence one's mood in a playful atmosphere. The training is conceptualized as an open group: New patients can join the group in every session. Thus, the threshold for administration of and participation in this intervention is low.
The general structure of and exercises in D-MCT were inspired by Metacognitive Training for psychosis (Moritz et al., 2014); however, contents were modified upon to suit the specific problems of individuals with depression. Beside depressive thought patterns already targeted in CBT (e.g., overgeneralization, "mind reading"), a number of general cognitive biases, which have been identified by basic cognitive research, form the core of D-MCT (e.g., mood-congruent memory (Mathews and MacLeod, 2005)). Finally, as in Metacognitive Therapy (MCT) sensu Adrian Wells (Wells, 2011) dysfunctional coping strategies (i.e., thought suppression, rumination as problem-solving) are challenged. D-MCT thus blends established elements from CBT and MCT as well as newly developed and evidence-based exercises in one coherent metacognitive approach.
D-MCT was positively evaluated with regard to feasibility and acceptance in a non-randomized pilot study (Jelinek et al., 2013). Moreover, efficacy of D-MCT was suggested in a randomized controlled trail (RCT) in comparison to an active control intervention (Jelinek et al., 2016). In this trial patients with depressive disorder were completing a psychosomatic outpatient treatment program and were randomly assigned to either D-MCT or general health training. Severity of depression and cognitive biases were assessed at baseline (t0), post treatment (t1) and 6 months (t2) later by raters blind to diagnostic status. Intention-to-treat analyses demonstrated that at the end of treatment, as well as 6 months later, improvement in depression was significantly greater in the D-MCT relative to the health training group at medium effect sizes. A significantly greater number of patients in the D-MCT group were in remission at 6-month follow-up. Moreover, the decrease in cognitive biases and increase in psychological well-being/quality of life was larger in the D-MCT than the health training group over time. Patients' subjective appraisal of D-MCT was also positive (Jelinek et al., 2017).
Aim of the current study is to investigate the acceptance and efficacy of D-MCT in outpatients.The Hamilton Depression Rating Scale (HDRS, 17-item version) total score as well as the Quick Inventory of Depressive Symptomatology (QIDS) serve as primary outcome. Self-assessed depression, dysfunctional beliefs, self-esteem, quality of life, rumination, remission rate as well as neuropsychological functioning serve as secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-MCT Group | Experimental | Behavioral: D-MCTMetacognitive Training for Depression (D-MCT), 8 sessions (60min); once a week over a period of 8 weeks. Metacognitive Training for depression (D-MCT) is a low-threshold, easy to administer group intervention. It aims at the reduction of depressive symptoms by changing cognitive biases; not only biases targeted in cognitive behavioral therapy but also those identified by basic research. |
| Cognitive remediation | Active comparator | Behavioral: Cognitive remediationA computerized cognitive remediation program that covers several cognitive domains, such as attention, visuomotor skills, and Memory.The difficulty level adapts automatically to the performance level of each patient. At the end of each session, the patient receives individual feedback on his or her performance.; 8 sessions (60min), once a week over a period of 8 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- informed consent
- age between 18 and 70 years
- diagnosis of a single Episode or recurrent Major depressive disorder (MDD) or dysthymia (verified by the MINI)
Key exclusion criteria (1 listed)
- lifetime psychotic symptoms (i.e., hallucinations, delusions, or mania), suicidality (Suicidal Behaviors Questionnaire-Revised ≥ 7), intellectual disability (estimated IQ < 70) or dementia.
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 |
|---|---|---|
| D-MCTAlso: Metacognitive Training for DepressionMetacognitive Training for Depression (D-MCT), 8 sessions (60min); once a week over a period of 8 weeks. Metacognitive Training for depression (D-MCT) is a low-threshold, easy to administer group intervention. It aims at the reduction of depressive symptoms by changing cognitive biases; not only biases targeted in cognitive behavioral therapy but also those identified by basic research. | Behavioural | D-MCT Group |
| Cognitive remediationA computerized cognitive remediation program that covers several cognitive domains, such as attention, visuomotor skills, and Memory. The difficulty level adapts automatically to the performance level of each patient. At the end of each session, the patient receives individual feedback on his or her performance; 8 sessions (60min), once a week over a period of 8 weeks | Behavioural | Cognitive remediation |
Primary outcome
Quick Inventory of Depressive Symptomatology (QIDS)
Time frame: eight months from baseline (t0) to 6-months follow up (t2)
Primary outcome is change on the Quick Inventory of Depressive Symptomatology (QIDS) from baseline to follow-up (t0 - t2)
15 secondary outcomes
Hamilton Depression Rating Scale
Time frame: [Time Frame: eight months from baseline (t0) to 6-months follow up (t2)]
Self-assessed depression
Time frame: [Time Frame: eight months from baseline (t0) to 6-months follow up (t2)]
Quick Inventory of Depressive Symptomatology (QIDS)
Time frame: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]
Hamilton Depression Rating Scale
Time frame: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]
Patient Health Questionnaire (PHQ-9)
Time frame: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]
Dysfunctional beliefs
Time frame: eight months from baseline (t0) to 6-months follow up (t2
Quality of life
Time frame: eight months from baseline (t0) to 6-months follow up (t2)
Dysfunctional metacognitive beliefs
Time frame: eight months from baseline (t0) to 6-months follow up (t2)
Rumination
Time frame: eight months from baseline (t0) to 6-months follow up (t2)
Self-esteem
Time frame: eight months from baseline (t0) to 6-months follow up (t2)
Remission rate
Time frame: eight months from baseline (t0) to 6-months follow up (t2)
Information processing
Time frame: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]
Subjective appraisal of the training
Time frame: each week (session data) [time frame: 8 weeks] and six months from post treatment assessment (t1) to 6 months follow up (t1 to t2) [time frame: 6 months]
Executive functioning
Time frame: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]
Verbal memory
Time frame: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]
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 2019.
- Background: PubMed 25103718Moritz S, Veckenstedt R, Andreou C, Bohn F, Hottenrott B, Leighton L, Kother U, Woodward TS, Treszl A, Menon M, Schneider BC, Pfueller U, Roesch-Ely D. Sustained and "sleeper" effects of group metacognitive training for schizophrenia: a randomized clinical trial. JAMA Psychiatry. 2014 Oct;71(10):1103-11. doi: 10.1001/jamapsychiatry.2014.1038.
- Background: PubMed 27230865Jelinek L, Hauschildt M, Wittekind CE, Schneider BC, Kriston L, Moritz S. Efficacy of Metacognitive Training for Depression: A Randomized Controlled Trial. Psychother Psychosom. 2016;85(4):231-4. doi: 10.1159/000443699. Epub 2016 May 27. No abstract available.
- BackgroundJelinek L, Otte C, Arlt S, & Hauschildt M. Denkverzerrungen erkennen und korrigieren: Eine Machbarkeitsstudie zum Metakognitiven Training bei Depressionen (D-MKT). [Identifying and correcting cognitive biases: A Pilot study on the Metacognitive Training for Depression (D-MCT)] Zeitschrift für Psychiatrie, Psychologie und Psychotherapie, 61, 247-254, 2013.
- Background: PubMed 28628763Jelinek L, Moritz S, Hauschildt M. Patients' perspectives on treatment with Metacognitive Training for Depression (D-MCT): Results on acceptability. J Affect Disord. 2017 Oct 15;221:17-24. doi: 10.1016/j.jad.2017.06.003. Epub 2017 Jun 7.
- Background: PubMed 15172947Andrews G, Issakidis C, Sanderson K, Corry J, Lapsley H. Utilising survey data to inform public policy: comparison of the cost-effectiveness of treatment of ten mental disorders. Br J Psychiatry. 2004 Jun;184:526-33. doi: 10.1192/bjp.184.6.526.
- Background: PubMed 25415495Cuijpers P. Psychotherapies for adult depression: recent developments. Curr Opin Psychiatry. 2015 Jan;28(1):24-9. doi: 10.1097/YCO.0000000000000121.
- Background: PubMed 26302248Fernandez E, Salem D, Swift JK, Ramtahal N. Meta-analysis of dropout from cognitive behavioral therapy: Magnitude, timing, and moderators. J Consult Clin Psychol. 2015 Dec;83(6):1108-22. doi: 10.1037/ccp0000044. Epub 2015 Aug 24.
- Background: PubMed 17716086Mathews A, MacLeod C. Cognitive vulnerability to emotional disorders. Annu Rev Clin Psychol. 2005;1:167-95. doi: 10.1146/annurev.clinpsy.1.102803.143916.
- Background: PubMed 17563164Vittengl JR, Clark LA, Dunn TW, Jarrett RB. Reducing relapse and recurrence in unipolar depression: a comparative meta-analysis of cognitive-behavioral therapy's effects. J Consult Clin Psychol. 2007 Jun;75(3):475-88. doi: 10.1037/0022-006X.75.3.475.
- BackgroundWells, A., 2011. Metacognitive Therapy for anxiety and depression. The Guilford Press, New York.
- Individual participant dataSharing planned: No
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Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
RecruitingPhase 2
Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder
Major Depressive Disorder
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.
Marion Hagemann-Goebel, Dr. principal investigator
Asklepios Klinik Nord-Ochsenzoll
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-MCT and Cognitive remediation in people with Unipolar 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 1 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 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?
Quick Inventory of Depressive Symptomatology (QIDS) (time frame: eight months from baseline (t0) to 6-months follow up (t2)). 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 NCT03268434, which also lists 10 linked publications.
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 2019.