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Long-term Efficacy of Metacognitive Training for Depression (D-MCT)

2 augustus 2017 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

84

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Duitsland
      • Hamburg, Duitsland, 20246
        • University Medical Center Hamburg Eppendorf

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: D-MCT
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.
Andere namen:
  • Metacognitieve training voor depressie
Actieve vergelijker: Health Training Group
Health Training Group (Walking/ Psychoeducation on health); 8 sessions (60min), twice a week over a period of 4 weeks
Gedragsmatig: Health Training
Health Training Group (Walking/ Psychoeducation on health); 8 sessions (60min), twice a week over a period of 4 weeks

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Hamilton Depression Rating Scale
Tijdsspanne: 3 years from baseline (t0) to 3-year follow up (t3)
Primary outcome is change on the Hamilton Depression Rating Scale (HDRS, 17-item version) from baseline to follow-up (t0 - t3)
3 years from baseline (t0) to 3-year follow up (t3)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Self-assessed depression
Tijdsspanne: 3 years from baseline (t0) to 3-year follow up (t3)
Change in self-assessed depression as measured by the Beck-Depression Inventory (BDI) from baseline to follow-up (t0 to t3)
3 years from baseline (t0) to 3-year follow up (t3)
Dysfunctional beliefs
Tijdsspanne: 3 years from baseline (t0) to 3-year follow up (t3)
Change in dysfunctional beliefs as measured by the Dysfunctional Attitude Scale (DAS) from baseline to follow-up (t0 to t3)
3 years from baseline (t0) to 3-year follow up (t3)
Dysfunctional metacognitive beliefs
Tijdsspanne: 3 years from baseline (t0) to 3-year follow up (t3)
Change in metacognitive beliefs as measured by the Metacognitions Questionnaire (MCQ-30) from baseline to follow-up (t0 to t3)
3 years from baseline (t0) to 3-year follow up (t3)
Quality of life
Tijdsspanne: 3 years from baseline (t0) to 3-year follow up (t3)
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)
3 years from baseline (t0) to 3-year follow up (t3)
Work status
Tijdsspanne: at 3-year follow-up (t3)
Work status (full or part-time employment, unemployed, house wife/husband, student, on sick leave, retired) at T3 assessment
at 3-year follow-up (t3)
Self-esteem
Tijdsspanne: 3 years from baseline (t0) to 3-year follow up (t3)
Change in self-esteem as measured by the Rosenberg Self-Esteem Scale (RSE) from from baseline to follow-up (t0 to t3)
3 years from baseline (t0) to 3-year follow up (t3)
Remission rate
Tijdsspanne: at 3-year follow up (t3)
Remission rate at T3 as measured by the Hamilton Depression Rating Scale (HDRS score ≤ 8)
at 3-year follow up (t3)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Onderzoekers

  • Hoofdonderzoeker: Lena Jelinek, PD Dr., Universitätsklinikum Hamburg-Eppendorf

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2016

Primaire voltooiing (Werkelijk)

1 mei 2017

Studie voltooiing (Werkelijk)

1 mei 2017

Studieregistratiedata

Eerst ingediend

5 april 2016

Eerst ingediend dat voldeed aan de QC-criteria

12 mei 2016

Eerst geplaatst (Schatting)

13 mei 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 augustus 2017

Laatste update ingediend die voldeed aan QC-criteria

2 augustus 2017

Laatst geverifieerd

1 augustus 2017

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 1027/106

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

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