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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05111665
Other study ID # H07-03046
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 14, 2008
Est. completion date October 31, 2008

Study information

Verified date October 2021
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objective: "Decentering" is defined as the ability to observe one's thoughts and feelings as temporary, objective events in the mind, and is increasingly regarded as a candidate mechanism in mindfulness-based interventions. The current study sought to examine the role of decentering, and other related variables, in the efficacy of Mindfulness-based cognitive therapy (MBCT) as compared to two active comparison conditions. Method: Formerly depressed individuals (N = 227), randomly assigned to MBCT (n = 74), relaxation group therapy (RGT; n = 77) or treatment-as-usual (TAU; n = 76), completed self-report measures of decentering and symptoms of depression at pre-, mid-, and post-treatment, and relapse was assessed at 3, 6, 9, and 12 months, post-treatment.


Recruitment information / eligibility

Status Completed
Enrollment 227
Est. completion date October 31, 2008
Est. primary completion date October 31, 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - a Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM IV-TR; American Psychiatric Association (APA), diagnosis of major depressive disorder (MDD) without psychotic features, in Full Remission; - three or more prior major depressive episodes; - age between 18 and 65 years; - cognitive reactivity (CR) or mood-activated dysfunctional beliefs score greater than or equal to eight (see assessment procedure below); - a score of less than 10 on the Hamilton Rating Scale for Depression (HRSD); - minimum of a 10 week period free of psychotropic medication other than stable dosage of antidepressant medication for a minimum of four weeks; - fluency in English; An increased cognitive reactivity score of eight points or more and, - ability to give informed consent and complete questionnaires unassisted. Exclusion Criteria: - a diagnosis of bipolar disorder (past or present), schizophreniform disorders, substance abuse or dependence (current or within the past six months), borderline or antisocial personality disorder, or neurocognitive disorders; - current psychotherapy or counselling more frequently than twice per month; - current practice of meditation more than once per week or yoga more than twice per week; - electroconvulsive therapy within the past six months; or - self-reported ingestion of alcohol or other psychoactive substances within the past 48 hrs.

Study Design


Intervention

Behavioral:
Mindfulness-based Cognitive Therapy (MBCT)

Relaxation Group Therapy (RGT)

Treatment as usual (TAU)


Locations

Country Name City State
Canada Mark Lau Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Major depressive disorder (MDD) relapse/recurrence - incidence of Number of participants meeting criteria for relapse/recurrence of MDD during follow-up 12- month post-treatment follow-up
Primary Change in major depressive disorder (MDD) relapse/recurrence - time to relapse/recurrence Change in relapse/recurrence of MDD (i.e., survival) across follow-up 3-, 6-, 9-, and 12- month post-treatment follow-up
Secondary Change in Beck Depression Inventory - Second Edition total scores Change in symptoms of depression across MBCT treatment Pre-, mid- (i.e., at week 4 of MBCT), and post-treatment (i.e., after 8 weeks of MBCT)
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