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Decentering and Relapse/Recurrence in MBCT for Depression in Adults

Primary Purpose

Depression, Depressive Disorder, Major, Depression in Remission

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mindfulness-based Cognitive Therapy (MBCT)
Relaxation Group Therapy (RGT)
Treatment as usual (TAU)
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mark Lau

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Mindfulness-based Cognitive Therapy (MBCT)

Relaxation Group Therapy (RGT)

Treatment as usual (TAU)

Arm Description

Remitted depressed participants received eight-weekly, two-hour MBCT sessions (Segal et al., 2013). This program combines MBSR meditation practices (e.g., body scan, mindful stretching, mindfulness of breath/body/sounds/thoughts) with traditional CT techniques (e.g., psychoeducation about depression symptoms and automatic thoughts, exercises designed to demonstrate how the nature of one's thoughts change with one's mood, questioning of automatic thoughts and creating a relapse prevention plan). Finally, participants engaged in a daily meditation practice and homework exercises directed at integrating the application of awareness skills into daily life. Each MBCT group was led by a masters-level clinician who was an active MBCT/Mindfulness-Based Stress Reduction (MBSR) instructor.

The revised edition of the Changeways Relaxation Programme (Paterson, 1997) served as the active control condition to control for non-specific group factors including group participation, expectation of change or therapeutic contact and attention. The rationale was that relaxation can be used to better manage life stressors which precipitate depressive episodes. Participants received eight-weekly, two-hour relaxation training sessions. This group program combines psychoeducation regarding the effects of stress, diaphragmatic breathing, progressive muscle relaxation, passive relaxation and imagery. It also incorporates time for participants to discuss the events of the week to facilitate the supportive aspect of group participation. Finally, participants were asked to engage in daily exercises to practice the various relaxation strategies. Each RGT group was led by a doctoral-level therapist.

Participants randomized to the TAU group were instructed that participants would receive MBCT at the end of the follow-up period and to seek help from their family doctors or other sources as the normally would, should the participants encounter symptomatic deterioration or other difficulties over the course of the study. At the end of the follow-up phase, participants in the TAU and RGT group were offered the opportunity to receive MBCT.

Outcomes

Primary Outcome Measures

Major depressive disorder (MDD) relapse/recurrence - incidence of
Number of participants meeting criteria for relapse/recurrence of MDD during follow-up
Change in major depressive disorder (MDD) relapse/recurrence - time to relapse/recurrence
Change in relapse/recurrence of MDD (i.e., survival) across follow-up

Secondary Outcome Measures

Change in Beck Depression Inventory - Second Edition total scores
Change in symptoms of depression across MBCT treatment

Full Information

First Posted
October 4, 2021
Last Updated
October 28, 2021
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT05111665
Brief Title
Decentering and Relapse/Recurrence in MBCT for Depression in Adults
Official Title
The Association Between Decentering and Reductions in Relapse/Recurrence in Mindfulness-Based Cognitive Therapy for Depression in Adults: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 14, 2008 (Actual)
Primary Completion Date
October 31, 2008 (Actual)
Study Completion Date
October 31, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depressive Disorder, Major, Depression in Remission

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
227 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-based Cognitive Therapy (MBCT)
Arm Type
Experimental
Arm Description
Remitted depressed participants received eight-weekly, two-hour MBCT sessions (Segal et al., 2013). This program combines MBSR meditation practices (e.g., body scan, mindful stretching, mindfulness of breath/body/sounds/thoughts) with traditional CT techniques (e.g., psychoeducation about depression symptoms and automatic thoughts, exercises designed to demonstrate how the nature of one's thoughts change with one's mood, questioning of automatic thoughts and creating a relapse prevention plan). Finally, participants engaged in a daily meditation practice and homework exercises directed at integrating the application of awareness skills into daily life. Each MBCT group was led by a masters-level clinician who was an active MBCT/Mindfulness-Based Stress Reduction (MBSR) instructor.
Arm Title
Relaxation Group Therapy (RGT)
Arm Type
Active Comparator
Arm Description
The revised edition of the Changeways Relaxation Programme (Paterson, 1997) served as the active control condition to control for non-specific group factors including group participation, expectation of change or therapeutic contact and attention. The rationale was that relaxation can be used to better manage life stressors which precipitate depressive episodes. Participants received eight-weekly, two-hour relaxation training sessions. This group program combines psychoeducation regarding the effects of stress, diaphragmatic breathing, progressive muscle relaxation, passive relaxation and imagery. It also incorporates time for participants to discuss the events of the week to facilitate the supportive aspect of group participation. Finally, participants were asked to engage in daily exercises to practice the various relaxation strategies. Each RGT group was led by a doctoral-level therapist.
Arm Title
Treatment as usual (TAU)
Arm Type
Placebo Comparator
Arm Description
Participants randomized to the TAU group were instructed that participants would receive MBCT at the end of the follow-up period and to seek help from their family doctors or other sources as the normally would, should the participants encounter symptomatic deterioration or other difficulties over the course of the study. At the end of the follow-up phase, participants in the TAU and RGT group were offered the opportunity to receive MBCT.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based Cognitive Therapy (MBCT)
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Group Therapy (RGT)
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual (TAU)
Primary Outcome Measure Information:
Title
Major depressive disorder (MDD) relapse/recurrence - incidence of
Description
Number of participants meeting criteria for relapse/recurrence of MDD during follow-up
Time Frame
12- month post-treatment follow-up
Title
Change in major depressive disorder (MDD) relapse/recurrence - time to relapse/recurrence
Description
Change in relapse/recurrence of MDD (i.e., survival) across follow-up
Time Frame
3-, 6-, 9-, and 12- month post-treatment follow-up
Secondary Outcome Measure Information:
Title
Change in Beck Depression Inventory - Second Edition total scores
Description
Change in symptoms of depression across MBCT treatment
Time Frame
Pre-, mid- (i.e., at week 4 of MBCT), and post-treatment (i.e., after 8 weeks of MBCT)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Mark Lau
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6J 5C6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
35343725
Citation
Moore MT, Lau MA, Haigh EAP, Willett BR, Bosma CM, Fresco DM. Association between decentering and reductions in relapse/recurrence in mindfulness-based cognitive therapy for depression in adults: A randomized controlled trial. J Consult Clin Psychol. 2022 Feb;90(2):137-147. doi: 10.1037/ccp0000718.
Results Reference
derived

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Decentering and Relapse/Recurrence in MBCT for Depression in Adults

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