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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.

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

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
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.

Germany1 site
  • Asklepios Klinik Nord-Ochsenzoll

    Hamburg, 22419

Other trials in Germany

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.

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 groups in NCT03268434
Study groupRoleWhat they receive
D-MCT GroupExperimentalMetacognitive 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 remediationActive comparatorA 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.

  1. 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)
  1. 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)]

  2. 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)]

  3. 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]

  4. 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]

  5. 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]

  6. 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

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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]

  13. 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]

  14. 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]

  15. 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.

  1. First posted31 Aug 2017
  2. Study start10 Oct 2017
  3. Primary completion22 Aug 2019
  4. Study completion24 Sep 2019

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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
86 participants (actual)
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 25103718
  • Jelinek 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 27230865
  • Jelinek 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 28628763
  • Andrews 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 15172947
  • Cuijpers P. Psychotherapies for adult depression: recent developments. Curr Opin Psychiatry. 2015 Jan;28(1):24-9. doi: 10.1097/YCO.0000000000000121.

    PubMed 25415495
  • Fernandez 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 26302248
  • Mathews 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 17716086
  • Vittengl 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 17563164
  • Wells, A., 2011. Metacognitive Therapy for anxiety and depression. The Guilford Press, New York.

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.

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