DepressionNCT05111665
Decentering and Relapse/Recurrence in MBCT for Depression in Adults
A study testing Mindfulness-based Cognitive Therapy (MBCT), Relaxation Group Therapy (RGT) and Treatment as usual (TAU) in people with Depression and Depressive Disorder, Major, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Depression, Depressive Disorder, Major, Depression in Remission
- What is being tested?
- Mindfulness-based Cognitive Therapy (MBCT), Relaxation Group Therapy (RGT) and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 227 participants
- Where
- 1 siteCanada
- Study dates
- 14 Feb 2008to 31 Oct 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association Between Decentering and Reductions in Relapse/Recurrence in Mindfulness-Based Cognitive Therapy for Depression in Adults: A Randomized Controlled Trial
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.
- Being tested
- Mindfulness-based Cognitive Therapy (MBCT), Relaxation Group Therapy (RGT), Treatment as usual (TAU)
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Cognitive Therapy (MBCT)Behavioural
Relaxation Group Therapy (RGT)Behavioural
Treatment as usual (TAU)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major depressive disorder (MDD) relapse/recurrence - incidence of
Number of participants meeting criteria for relapse/recurrence of MDD during follow-up
Measured: 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
Measured: 3-, 6-, 9-, and 12- month post-treatment follow-up
Secondary outcomes (1)
Change in Beck Depression Inventory - Second Edition total scores
Change in symptoms of depression across MBCT treatment
Measured: Pre-, mid- (i.e., at week 4 of MBCT), and post-treatment (i.e., after 8 weeks of MBCT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start14 Feb 2008
- Primary completion31 Oct 2008
- Study completion31 Oct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Lau, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111665
- Sponsor's protocol ID
- H07-03046
- Status last verified
- Oct 2021
- First submitted
- 4 Oct 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35343725
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Decentering and Reductions in Relapse/Recurrence in Mindfulness-Based Cognitive Therapy for Depression in Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05111665
- Acronym / sponsor ID
- H07-03046
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 14 Feb 2008 (actual)
- Primary completion
- 31 Oct 2008 (actual)
- Study completion
- 31 Oct 2008 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Cognitive Therapy (MBCT) | Experimental | Behavioral: Mindfulness-based Cognitive Therapy (MBCT)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. |
| Relaxation Group Therapy (RGT) | Active comparator | Behavioral: Relaxation Group Therapy (RGT)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. |
| Treatment as usual (TAU) | Placebo comparator | Behavioral: Treatment as usual (TAU)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based Cognitive Therapy (MBCT) | Behavioural | Mindfulness-based Cognitive Therapy (MBCT) |
| Relaxation Group Therapy (RGT) | Behavioural | Relaxation Group Therapy (RGT) |
| Treatment as usual (TAU) | Behavioural | Treatment as usual (TAU) |
Primary outcome
Major depressive disorder (MDD) relapse/recurrence - incidence of
Time frame: 12- month post-treatment follow-up
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
Time frame: 3-, 6-, 9-, and 12- month post-treatment follow-up
Change in relapse/recurrence of MDD (i.e., survival) across follow-up
1 secondary outcome
Change in Beck Depression Inventory - Second Edition total scores
Time frame: Pre-, mid- (i.e., at week 4 of MBCT), and post-treatment (i.e., after 8 weeks of MBCT)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Derived from this study: PubMed 35343725Moore 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Cognitive Therapy (MBCT), Relaxation Group Therapy (RGT) and Treatment as usual (TAU) in people with Depression and Depressive Disorder, Major, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major depressive disorder (MDD) relapse/recurrence - incidence of (time frame: 12- month post-treatment follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05111665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.