NCT05111665

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
227

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Feb 2008

Shorter than P25 for not_applicable depression

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

February 14, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2008

Completed
12.9 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
Last Updated

November 8, 2021

Status Verified

October 1, 2021

Enrollment Period

9 months

First QC Date

October 4, 2021

Last Update Submit

October 28, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Change in Beck Depression Inventory - Second Edition total scores

    Pre-, mid- (i.e., at week 4 of MBCT), and post-treatment (i.e., after 8 weeks of MBCT)

Study Arms (3)

Mindfulness-based Cognitive Therapy (MBCT)

EXPERIMENTAL

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.

Behavioral: Mindfulness-based Cognitive Therapy (MBCT)

Relaxation Group Therapy (RGT)

ACTIVE COMPARATOR

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.

Behavioral: Relaxation Group Therapy (RGT)

Treatment as usual (TAU)

PLACEBO COMPARATOR

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.

Behavioral: Treatment as usual (TAU)

Interventions

Mindfulness-based Cognitive Therapy (MBCT)
Relaxation Group Therapy (RGT)
Treatment as usual (TAU)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mark Lau

Vancouver, British Columbia, V6J 5C6, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DepressionDepressive Disorder, Major

Interventions

Mindfulness-Based Cognitive TherapyTherapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

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

Study Record Dates

First Submitted

October 4, 2021

First Posted

November 8, 2021

Study Start

February 14, 2008

Primary Completion

October 31, 2008

Study Completion

October 31, 2008

Last Updated

November 8, 2021

Record last verified: 2021-10

Locations