- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02771535
Long-term Efficacy of Metacognitive Training for Depression (D-MCT)
2 agosto 2017 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
84
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Hamburg, Germania, 20246
- University Medical Center Hamburg Eppendorf
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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).
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
Altri nomi:
|
Comparatore attivo: 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Hamilton Depression Rating Scale
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Self-assessed depression
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Lena Jelinek, PD Dr., Universitätsklinikum Hamburg-Eppendorf
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 marzo 2016
Completamento primario (Effettivo)
1 maggio 2017
Completamento dello studio (Effettivo)
1 maggio 2017
Date di iscrizione allo studio
Primo inviato
5 aprile 2016
Primo inviato che soddisfa i criteri di controllo qualità
12 maggio 2016
Primo Inserito (Stima)
13 maggio 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
3 agosto 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
2 agosto 2017
Ultimo verificato
1 agosto 2017
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1027/106
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su D-MCT
-
Université de SherbrookeCompletato
-
Universitätsklinikum Hamburg-EppendorfAsklepios Kliniken Hamburg GmbHCompletatoDepressione unipolareGermania
-
Children's Hospital of Fudan UniversityReclutamentoInfante | Atresia biliare | Supporto nutrizionale | Trigliceridi a catena mediaCina
-
Medical University of WarsawCompletatoSchizofreniaPolonia
-
Klinik ValensTechnische Universität Dortmund, GermanyReclutamentoEsercizio | Fitness cardiorespiratorio | Sclerosi Multipla Primaria ProgressivaSvizzera
-
University of LiverpoolVitaflo International, Ltd; Walton Centre NHS Foundation TrustCompletatoGlioblastoma | Glioblastoma multiforme | Glioblastoma, adultoRegno Unito
-
McGill University Health Centre/Research Institute...CompletatoAttività fisica | Cancro colorettaleCanada
-
Henry Ford Health SystemTerminatoInsufficienza cardiaca, diastolicaStati Uniti
-
University of ManchesterCompletatoDisturbo d'ansia generalizzatoRegno Unito