- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01178424
My Depression Wellness Toolkit Study
Major depressive disorder (MDD) continues to have a profound impact on individuals, families, and the health care system. Despite marked success in treating active individual episodes of unipolar depression, our understanding of the neural and cognitive mechanisms involved in the return of symptoms remains extremely limited, and few interventions exist that specifically target factors involved in prophylaxis. The research being proposed is among the first that is designed to examine neurocognitive markers for depressive relapse vulnerability and link them directly to clinical prognosis.
Hypothesis 1: Cortical midline structures (CMS) network recruitment will be associated with behavioural and neural indices of a reflexive attentional bias towards dysphoric stimuli in a divided attention task.
Hypothesis 2: Behavioural and neural indices of dysphoric attentional bias following mood challenge will predict depression relapse in prospective 18-month follow up.
Hypothesis 3: Relative to CBT, Mindfulness Based Cognitive Therapy (MBCT) will normalize CMS and right insular/fronto-opercular cortices (INS-FO) network imbalance.
Hypothesis 4: Relative to CBT, MBCT will normalize to healthy control levels, behavioural and neural indices of dysphoric attentional bias, which will be predictive of reduced relapse risk across a 24 month follow up.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Ontario
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Toronto, Ontario, Canada, M5S 2S1
- Centre for Addiction and Mental Health
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Women or men 18-65 years of age
- Meeting criteria for prior depression, currently in recovery or remission, according to Diagnostic and Statistical Manual of Mental Disorders (4th eg; DSM-IV-TR, (American Psychiatric Association, 2000)
- A baseline score of ≤ 12 on the HRSD (Hamilton, 1960)
- Internet access
- English proficiency at or above a grade 8 level
Exclusion Criteria:
- Schizophrenia or current psychosis
- Organic mental disorder
- Pervasive developmental delay (PDD)
- Current substance dependence
- Imminent suicide or homicide risk
- Axis I or II disorder that necessitates primary treatment not provided in the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Mindfulness Based Cognitive Therapy
Mindfulness Based Cognitive Therapy is a manualized, group skills training program (Segal et al., 2013) that is based on an integration of aspects of cognitive therapy for depression (Beck, 1979) with components of the mindfulness-based stress reduction program (Kabat-Zinn, 1990).
Patients participate in 8 weekly sessions, each of which incorporates didactic and experiential learning, along with home practice of mindfulness skills taught in the program.
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Mindfulness-Based Cognitive Therapy, a manualized, group skills training program (Segal et al., 2013) that is based on an integration of aspects of cognitive therapy for depression (Beck, 1979) with components of the mindfulness-based stress reduction program (Kabat-Zinn, 1990).
Patients participate in 8 weekly sessions, each of which incorporates didactic and experiential learning, along with home practice of skills taught in the program.
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Comparateur actif: Cognitive Behaviour Therapy
CBT is an evidence based depression-specific psychotherapy that examines the relationship between thinking styles and the perpetuation of mood symptoms in major depression.
Patients use thought records and activity scheduling, among other tools, to record and reappraise their thinking during situations where negative affect is present, both in session and for homework.
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CBT is an evidence based depression-specific psychotherapy that examines the relationship between thinking styles and the perpetuation of mood symptoms in major depression.
Patients use thought records and activity scheduling, among other tools, to record and reappraise their thinking during situations where negative affect is present, both in session and for homework.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Rates of relapse/recurrence based on CMS and INS/FO configuration.
Délai: 2 years
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Patients who relapse will show Increased neural activation in CMS compared to INS/FO regions compared to non relapsers
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2 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Changes in CMS and INSFO network imbalance following MBCT compared to CBT
Délai: 2 years
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Patients in MBCT will show greater levels of activation in INS/FO compared to patients in CBT
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2 years
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Changes in attentional processing of dysphoric stimuli between the groups
Délai: 8 weeks
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Relapsers will show greater attention to negative self-descriptive adjectives compared to non-relapsers.
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8 weeks
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Zindel V. Segal, PhD, Centre for Addiction and Mental Health
Publications et liens utiles
Publications générales
- Segal ZV, Bieling P, Young T, MacQueen G, Cooke R, Martin L, Bloch R, Levitan RD. Antidepressant monotherapy vs sequential pharmacotherapy and mindfulness-based cognitive therapy, or placebo, for relapse prophylaxis in recurrent depression. Arch Gen Psychiatry. 2010 Dec;67(12):1256-64. doi: 10.1001/archgenpsychiatry.2010.168.
- Farb NA, Segal ZV, Mayberg H, Bean J, McKeon D, Fatima Z, Anderson AK. Attending to the present: mindfulness meditation reveals distinct neural modes of self-reference. Soc Cogn Affect Neurosci. 2007 Dec;2(4):313-22. doi: 10.1093/scan/nsm030.
- Farb NA, Anderson AK, Mayberg H, Bean J, McKeon D, Segal ZV. Minding one's emotions: mindfulness training alters the neural expression of sadness. Emotion. 2010 Feb;10(1):25-33. doi: 10.1037/a0017151. Erratum In: Emotion. 2010 Apr;10(2):215.
- Segal, Z. V., Williams, J. M., & Teasdale, J. D. (2013). Mindfulness-based cognitive therapy for depression (2nd ed.). New York: Guilford Press.
- Farb NAS, Desormeau P, Anderson AK, Segal ZV. Static and treatment-responsive brain biomarkers of depression relapse vulnerability following prophylactic psychotherapy: Evidence from a randomized control trial. Neuroimage Clin. 2022;34:102969. doi: 10.1016/j.nicl.2022.102969. Epub 2022 Feb 19.
- Segal ZV, Anderson AK, Gulamani T, Dinh Williams LA, Desormeau P, Ferguson A, Walsh K, Farb NAS. Practice of therapy acquired regulatory skills and depressive relapse/recurrence prophylaxis following cognitive therapy or mindfulness based cognitive therapy. J Consult Clin Psychol. 2019 Feb;87(2):161-170. doi: 10.1037/ccp0000351. Epub 2018 Nov 15.
- Farb N, Anderson A, Ravindran A, Hawley L, Irving J, Mancuso E, Gulamani T, Williams G, Ferguson A, Segal ZV. Prevention of relapse/recurrence in major depressive disorder with either mindfulness-based cognitive therapy or cognitive therapy. J Consult Clin Psychol. 2018 Feb;86(2):200-204. doi: 10.1037/ccp0000266. Epub 2017 Dec 21.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 093/2010
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Essais cliniques sur Mindfulness Based Cognitive Therapy
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VA Office of Research and DevelopmentComplétéTroubles de stress, post-traumatiqueÉtats-Unis
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University of WashingtonNational Institute on Drug Abuse (NIDA)ComplétéTroubles liés à l'utilisation de substances | Troubles de stress post-traumatique | Sexe à risqueÉtats-Unis