- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02771535
Long-term Efficacy of Metacognitive Training for Depression (D-MCT)
2. august 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
84
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Hamburg, Tyskland, 20246
- University Medical Center Hamburg Eppendorf
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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 navn:
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Aktiv komparator: Health Training Group
Health Training Group (Walking/ Psychoeducation on health); 8 sessions (60min), twice a week over a period of 4 weeks
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Health Training Group (Walking/ Psychoeducation on health); 8 sessions (60min), twice a week over a period of 4 weeks
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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)
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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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Lena Jelinek, PD Dr., Universitätsklinikum Hamburg-Eppendorf
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2016
Primær fullføring (Faktiske)
1. mai 2017
Studiet fullført (Faktiske)
1. mai 2017
Datoer for studieregistrering
Først innsendt
5. april 2016
Først innsendt som oppfylte QC-kriteriene
12. mai 2016
Først lagt ut (Anslag)
13. mai 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. august 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. august 2017
Sist bekreftet
1. august 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1027/106
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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