NCT01178424

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2010

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 13, 2018

Status Verified

March 1, 2018

Enrollment Period

7 years

First QC Date

August 9, 2010

Last Update Submit

March 10, 2018

Conditions

Major Depression

Keywords

Unipolar depressionMindfulness based cognitive therapyCognitive behavioural TherapyFunctional magnetic resonance imagingRelapseDepressive relapseDysphoricCognitive reactivitySerotonin transporter gene

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Changes in CMS and INSFO network imbalance following MBCT compared to CBT

    2 years

  • Changes in attentional processing of dysphoric stimuli between the groups

    8 weeks

Study Arms (2)

Mindfulness Based Cognitive Therapy

EXPERIMENTAL

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.

Behavioral: Mindfulness Based Cognitive Therapy

Cognitive Behaviour Therapy

ACTIVE COMPARATOR

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.

Behavioral: Cognitive Behaviour Therapy

Interventions

Mindfulness Based Cognitive TherapyBEHAVIORAL

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.

Mindfulness Based Cognitive Therapy
Cognitive Behaviour TherapyBEHAVIORAL

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.

Cognitive Behaviour Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Publications (8)

  • 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.

    PMID: 18985137BACKGROUND

  • 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.

    PMID: 20141299BACKGROUND

  • 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.

    PMID: 21135325BACKGROUND

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

    BACKGROUND

  • Wu LC, Segal ZV, Farb NAS. Depression vulnerability and gray matter integrity of interoceptive networks in remitted depressed outpatients. J Affect Disord. 2025 Jul 1;380:113-123. doi: 10.1016/j.jad.2025.03.106. Epub 2025 Mar 21.

    PMID: 40122253DERIVED

  • 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.

    PMID: 35367955DERIVED

  • 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.

    PMID: 30431297DERIVED

  • 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.

    PMID: 29265831DERIVED

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorDepressive DisorderRecurrence

Interventions

Mindfulness-Based Cognitive TherapyCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MindfulnessBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Zindel V. Segal, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 9, 2010

First Posted

August 10, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

March 13, 2018

Record last verified: 2018-03

Locations

CA(1)