- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02771535
Long-term Efficacy of Metacognitive Training for Depression (D-MCT)
2 augusti 2017 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
84
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Hamburg, Tyskland, 20246
- University Medical Center Hamburg Eppendorf
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
Andra namn:
|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Hamilton Depression Rating Scale
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Self-assessed depression
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Lena Jelinek, PD Dr., Universitatsklinikum Hamburg-Eppendorf
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2016
Primärt slutförande (Faktisk)
1 maj 2017
Avslutad studie (Faktisk)
1 maj 2017
Studieregistreringsdatum
Först inskickad
5 april 2016
Först inskickad som uppfyllde QC-kriterierna
12 maj 2016
Första postat (Uppskatta)
13 maj 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 augusti 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 augusti 2017
Senast verifierad
1 augusti 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1027/106
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Unipolär depression
-
ProgenaBiomeRekryteringDepression | Depression, postpartum | Depression, ångest | Depression Måttlig | Depression Svår | Klinisk depression | Depression i remission | Depression, Endogen | Depression KroniskFörenta staterna
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRekryteringDepression | Depression Måttlig | Depression Svår | Depression MildFörenta staterna
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.Rekrytering
-
Washington University School of MedicineAvslutadBehandling Resistent depression | Senlivsdepression | Geriatrisk depression | Refraktär depression | Terapiresistent depressionFörenta staterna, Kanada
-
University of California, San FranciscoRekryteringDepression Måttlig | Depression Mild | Depression, tonåringFörenta staterna
-
Baylor College of MedicineUniversity of TexasRekryteringDepression | Depression Måttlig | Depression Svår | Självmord och självskada | Depression i tonåren | Depression MildFörenta staterna
-
University of Cape TownNational Institute of Mental Health (NIMH)AvslutadPostpartum depression | Klinisk depression | Måttlig depressionSydafrika
-
Gerbera Therapeutics, Inc.Har inte rekryterat ännuPostpartum depression | Depression, postpartum | Postnatal depression | Post-partum depression | Post-Natal depressionFörenta staterna
-
Charite University, Berlin, GermanyAvslutadBehandling Resistent depression | Depression, unipolär | Depression KroniskTyskland
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoAvslutadDepression Måttlig | Depression MildFörenta staterna, Dominikanska republiken
Kliniska prövningar på D-MCT
-
Universitätsklinikum Hamburg-EppendorfAsklepios Kliniken Hamburg GmbHAvslutadUnipolär depressionTyskland
-
Children's Hospital of Fudan UniversityRekryteringSpädbarn | Biliär atresi | Näringsstöd | Medelkedjig triglyceridKina
-
Medical University of WarsawAvslutad
-
Klinik ValensTechnische Universität Dortmund, GermanyRekryteringTräning | Cardiorespiratory Fitness | Primär progressiv multipel sklerosSchweiz
-
University of LiverpoolVitaflo International, Ltd; Walton Centre NHS Foundation TrustAvslutadGlioblastom | Glioblastoma Multiforme | Glioblastom, vuxenStorbritannien
-
McGill University Health Centre/Research Institute...AvslutadFysisk aktivitet | Kolorektal cancerKanada
-
Chang Gung Memorial HospitalAvslutad
-
Henry Ford Health SystemAvslutadHjärtsvikt, diastoliskFörenta staterna
-
University of ManchesterAvslutadGeneraliserat ångestsyndromStorbritannien