My Depression Wellness Toolkit Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Toronto
Information provided by (Responsible Party):
Zindel Segal, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01178424
First received: August 9, 2010
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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 3: 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.


Condition Intervention
Major Depression
Behavioral: Mindfulness Based Cognitive Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: My Depression Wellness Toolkit Study

Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Rates of relapse/recurrence based on CMS and INS/FO configuration. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in CMS and INSFO network imbalance following MBCT compared to CBT [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Changes in attentional processing of dysphoric stimuli between the groups [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: August 2010
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psychotherapy
Mindfulness Based Cognitive Therapy and Cognitive Behaviour Therapy
Behavioral: Mindfulness Based Cognitive Therapy
An intervention which uses structured attentional practices that promote metacognitive distancing from negative events as the means for regulating negative affect.

Detailed Description:

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 18-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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01178424

Locations
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1
Sponsors and Collaborators
Centre for Addiction and Mental Health
University of Toronto
Investigators
Principal Investigator: Zindel V. Segal, PhD Centre for Addiction and Mental Health
  More Information

Additional Information:
Publications:
Responsible Party: Zindel Segal, Principal Investigator, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01178424     History of Changes
Other Study ID Numbers: 093/2010
Study First Received: August 9, 2010
Last Updated: August 19, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre for Addiction and Mental Health:
Unipolar depression
Mindfulness based cognitive therapy
Cognitive behavioural Therapy
Functional magnetic resonance imaging
Relapse
Depressive relapse
Dysphoric
Cognitive reactivity
Serotonin transporter gene

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014