My Depression Wellness Toolkit Study

Major Depression Clinical Trial

Official title:

My Depression Wellness Toolkit Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01178424
• Other study ID #: 093/2010
• Status: Completed
• Phase: N/A
• First received: August 9, 2010
• Last updated: March 10, 2018
• Start date: August 2010
• Est. completion date: December 2017

Study information

• Verified date: March 2018
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Behavioral:
• Mindfulness Based Cognitive Therapy
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.
• 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.

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	University of Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Segal, Z. V., Williams, J. M., & Teasdale, J. D. (2013). Mindfulness-based cognitive therapy for depression (2nd ed.). New York: Guilford Press.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of relapse/recurrence based on CMS and INS/FO configuration.	Patients who relapse will show Increased neural activation in CMS compared to INS/FO regions compared to non relapsers	2 years
Secondary	Changes in CMS and INSFO network imbalance following MBCT compared to CBT	Patients in MBCT will show greater levels of activation in INS/FO compared to patients in CBT	2 years
Secondary	Changes in attentional processing of dysphoric stimuli between the groups	Relapsers will show greater attention to negative self-descriptive adjectives compared to non-relapsers.	8 weeks

External Links

•   Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital. It is fully affiliated with the University of Toronto, and is a PAHO/WHO Collaborating Centre