Long-term Efficacy of Metacognitive Training for Depression (D-MCT)
2. august 2017 opdateret af: Universitätsklinikum Hamburg-Eppendorf
Long-term Efficacy of Metacognitive Training for Depression (D-MCT): a 3-year Follow up
Aim of the current study is to investigate the long-term efficacy of Metacognitive Training for Depression (D-MCT) and to explore whether previously observed effects at the 6-month follow-up of a randomized, controlled, assessor-blind, parallel group trial are maintained at the 3-year follow-up.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Dissemination of treatment for depression is still unsatisfying: every second patient does not receive, refuses, or is waiting for treatment.
Moreover, with a drop-out rate of almost 25% in routine clinical practice, and a 54% relapse rate for treatment responders within the two years after treatment termination, improving treatment is necessary.
Metacognitive Training for depression (D-MCT), a low threshold, easy to administer group intervention was designed to fill this gap.
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.
It was positively evaluated with regard to feasibility and acceptance in a non-randomized pilot study.
Moreover, efficacy of D-MCT was suggested in a randomized controlled trail (RCT) in comparison to an active control intervention (Jelinek et al., in press).
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.
Aim of the current study is to investigate the long-term efficacy of D-MCT.
For this purpose, an additional 3 year follow-up assessment (t3) is conducted.
The Hamilton Depression Rating Scale (HDRS, 17-item version) total score serves as the primary outcome.
Self-assessed depression, dysfunctional beliefs, self-esteem, quality of life, and ability to work serve as secondary outcomes.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
84
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Hamburg, Tyskland, 20246
- University Medical Center Hamburg Eppendorf
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria for the current study are:
- informed consent
- intention-to-treat-sample of the study Evaluation of Metacognitive Training for Depression (D-MKT) in psychosomatic rehabilitation, DRKS-ID: DRKS00007907 (see Jelinek et al., in press, Psychotherapy and Psychosomatics)
- age between 18 and 65 years
- diagnosis of a single episode or recurrent major depressive disorder (MDD) or dysthymia (verified by the MINI).
The exclusion criteria were:
- lifetime psychotic symptoms (i.e., hallucinations, delusions, or mania), suicidality (Suicidal Behaviors Questionnaire-Revised ≥ 7), intellectual disability (estimated IQ < 70).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: D-MCT Group
Metacognitive Training for Depression (D-MCT), 8 sessions (60min); twice a week over a period of 4 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.
|
Metacognitive Training for Depression (D-MCT), 8 sessions (60min); twice a week over a period of 4 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.
Andre navne:
|
|
Aktiv komparator: Health Training Group
Health Training Group (Walking/ Psychoeducation on health); 8 sessions (60min), twice a week over a period of 4 weeks
|
Health Training Group (Walking/ Psychoeducation on health); 8 sessions (60min), twice a week over a period of 4 weeks
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Hamilton Depression Rating Scale
Tidsramme: 3 years from baseline (t0) to 3-year follow up (t3)
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Primary outcome is change on the Hamilton Depression Rating Scale (HDRS, 17-item version) from baseline to follow-up (t0 - t3)
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3 years from baseline (t0) to 3-year follow up (t3)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Self-assessed depression
Tidsramme: 3 years from baseline (t0) to 3-year follow up (t3)
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Change in self-assessed depression as measured by the Beck-Depression Inventory (BDI) from baseline to follow-up (t0 to t3)
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3 years from baseline (t0) to 3-year follow up (t3)
|
|
Dysfunctional beliefs
Tidsramme: 3 years from baseline (t0) to 3-year follow up (t3)
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Change in dysfunctional beliefs as measured by the Dysfunctional Attitude Scale (DAS) from baseline to follow-up (t0 to t3)
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3 years from baseline (t0) to 3-year follow up (t3)
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Dysfunctional metacognitive beliefs
Tidsramme: 3 years from baseline (t0) to 3-year follow up (t3)
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Change in metacognitive beliefs as measured by the Metacognitions Questionnaire (MCQ-30) from baseline to follow-up (t0 to t3)
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3 years from baseline (t0) to 3-year follow up (t3)
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Quality of life
Tidsramme: 3 years from baseline (t0) to 3-year follow up (t3)
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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 t3)
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3 years from baseline (t0) to 3-year follow up (t3)
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Work status
Tidsramme: at 3-year follow-up (t3)
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Work status (full or part-time employment, unemployed, house wife/husband, student, on sick leave, retired) at T3 assessment
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at 3-year follow-up (t3)
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Self-esteem
Tidsramme: 3 years from baseline (t0) to 3-year follow up (t3)
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Change in self-esteem as measured by the Rosenberg Self-Esteem Scale (RSE) from from baseline to follow-up (t0 to t3)
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3 years from baseline (t0) to 3-year follow up (t3)
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Remission rate
Tidsramme: at 3-year follow up (t3)
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Remission rate at T3 as measured by the Hamilton Depression Rating Scale (HDRS score ≤ 8)
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at 3-year follow up (t3)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Lena Jelinek, PD Dr., Universitätsklinikum Hamburg-Eppendorf
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- Jelinek L, Otte C, Arlt S, Hauschildt M: Denkverzerrungen erkennen und korrigieren: Eine Machbarkeitsstudie zum Metakognitiven Training bei Depression (D-MKT). [Identifying and correcting cognitive biases: A pilot study on the Metacognitive Training for Depression (D-MCT)]. Zeitschrift Für Psychiatr Psychol Und Psychother 61:1-8, 2013.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2016
Primær færdiggørelse (Faktiske)
1. maj 2017
Studieafslutning (Faktiske)
1. maj 2017
Datoer for studieregistrering
Først indsendt
5. april 2016
Først indsendt, der opfyldte QC-kriterier
12. maj 2016
Først opslået (Skøn)
13. maj 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. august 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. august 2017
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1027/106
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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