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My Depression Wellness Toolkit Study

10 mars 2018 mis à jour par: Zindel Segal, Centre for Addiction and Mental Health

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

Description détaillée

Relapse and recurrence following recovery from Major Depressive Disorder (MDD) are common and debilitating outcomes that carry enormous social costs [1-3]. Our CIHR funded program of research has studied the nature of psychological vulnerability in affective disorder. We have recently identified the activation of a depressive cognitive mode triggered by temporary dysphoric states as a reliable risk marker for depressive relapse [4, see attached]. In parallel, functional imaging studies have increased our understanding of the neural mechanisms underlying normative affective responses [5] and have begun to examine their dysregulation in affective disorder [6-8]. Our research has identified potential brain biomarkers that predict episode relapse in unipolar depression. However, it remains unknown how these potential biomarkers are related to dysphoria-triggered information processing modes that also predict relapse, and whether these neurocognitive vulnerabilities are amenable to intervention, resulting in more lasting prophylaxis. The present proposal employs a cognitive neuroscience approach to examine whether our previously identified neural markers of depression relapse and prophylaxis are associated with a dysphoric information processing mode. In particular, we will use functional magnetic resonance imaging (fMRI) and behavioural probes to undertake a finely tuned examination of mood linked biases in attention toward dysphoric stimulus events (i.e., sad faces) to link our previously identified neural markers with a specific information processing mode. Further, our preliminary data presented here demonstrate a correlation between these mood linked neural markers and relapse, but we cannot demonstrate that these markers are causally related to relapse or prophylaxis. To address this, we will examine whether these markers and associated dysphoric attentional biases are 1) modifiable via attentional training designed to overcome reflexive modes of thought and perception and 2) are predictive of relapse status across an 24-month prospective follow up of treated patients. This research will elucidate the neural and information processing correlates that may signal relapse risk in recovered depressed patients. This knowledge will increase our limited understanding of the mechanisms underlying enduring depressive relapse vulnerability as well as assess potentially efficient strategies for relapse prophylaxis.

Type d'étude

Interventionnel

Inscription (Réel)

166

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Ontario
      • Toronto, Ontario, Canada, M5S 2S1
        • Centre for Addiction and Mental Health

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

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

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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.
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.
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.
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
Patients who relapse will show Increased neural activation in CMS compared to INS/FO regions compared to non relapsers
2 years

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
Patients in MBCT will show greater levels of activation in INS/FO compared to patients in CBT
2 years
Changes in attentional processing of dysphoric stimuli between the groups
Délai: 8 weeks
Relapsers will show greater attention to negative self-descriptive adjectives compared to non-relapsers.
8 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Collaborateurs

Les enquêteurs

  • Chercheur principal: Zindel V. Segal, PhD, Centre for Addiction and Mental Health

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 août 2010

Achèvement primaire (Réel)

1 août 2017

Achèvement de l'étude (Réel)

1 décembre 2017

Dates d'inscription aux études

Première soumission

9 août 2010

Première soumission répondant aux critères de contrôle qualité

9 août 2010

Première publication (Estimation)

10 août 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 mars 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 mars 2018

Dernière vérification

1 mars 2018

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Mindfulness Based Cognitive Therapy

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