DepressionPhase 4NCT00183560
Preventing Depression Relapse With Mindfulness-Based Cognitive Therapy
A Phase 4 study testing Mindfulness based cognitive therapy (MBCT) and Antidepressants in people with Depression, run by Centre for Addiction and Mental Health at 2 sites in Canada.
Trial summary
This study will determine the effectiveness of mindfulness-based cognitive therapy (MBCT) in preventing depression relapse. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Mindfulness based cognitive therapy (MBCT) and Antidepressants
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2004to Oct 2010
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet DSM criteria for recurrent major depressive disorder, defined as at least one major depressive episode within 3 years prior to study entry AND at least 2 months of normal functioning following the episode
Who cannot join
- Depression secondary to a concurrent medical disorder
- Current use of medication that could cause depressive symptoms
- A rating of level 2 or higher on the Index of Treatment Refractory Depression
- Current diagnosis of any of the following psychiatric disorders: psychotic or organic mental, bipolar, primary obsessive compulsive, borderline personality, antisocial personality, or eating
- Current diagnosis of comorbid chronic depression that is disabling
- Current substance abuse
Show all 10Show fewer
- Score less than 14 on the Hamilton Rating Scale for Depression-17 (HRSD-17)
- At risk for suicide
- Pregnancy or plan to become pregnant during the study
- Practice meditation more than once a week or yoga more than twice a week at study entry
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Joseph's Healthcare
Hamilton, Ontario, L8N 3K7
Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8
About this study
Official title: Prevention of Relapse in Recurrent Depression With MBCT
This study will determine the effectiveness of mindfulness-based cognitive therapy (MBCT) in preventing depression relapse.
Read the detailed description
Depression is a serious condition that can cause significant social and emotional problems and reduce the overall quality of life. Relapses in depressive episodes are common and may result in a patient's reluctance to follow a treatment regimen, thus making the episode more severe. Safe and effective therapies to prevent depression relapse are needed. This study will compare three different approaches to determine which is most effective in preventing relapses in depressive episodes.
This study will comprise 2 parts. In Part 1, all participants will receive antidepressant medication for 6 months. Participants whose depression symptoms do not improve will complete their study participation at the end of Part 1. Participants who respond to their regimen will be enrolled in Part 2. This part will last 18 months. During Part 2, participants will be randomly assigned to one of three groups. Participants in Group 1 will continue the drug regimen they began in Part 1. Participants in Group 2 will discontinue their antidepressants and attend an 8-week relapse prevention program. This MBCT program is designed to help participants learn skills that can increase their awareness and change their reaction to stressful events. Participants in Group 3 will have their antidepressant medication from Phase 1 switched to a placebo without their knowledge. Self-report scales will be used to assess the depressive symptoms of participants at the beginning of the study, at the end of Phase 1, and at the end of the study, after Phase 2.
- Conditions
- Depression
- Being tested
- Mindfulness based cognitive therapy (MBCT), Antidepressants, Placebo plus clinical management
- Keywords
- Depression Recurrence, Drug Therapy, Cognitive Therapy, Relapse, Antidepressants
- Medical subject headings
- Depression, Recurrence
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
Also called MBCT
Following antidepressant discontinuation, participants receive MBCT, an 8-week group program that integrates aspects of cognitive therapy and mindfulness meditation.
AntidepressantsDrug
Also called Antidepressant medication
Participants continue on dosage of the antidepressant that was used to achieve clinical remission.
Placebo plus clinical managementDrug
Also called Placebo and Clinical Management
Following discontinuation of active antidepressant, participants are placed onto the placebo and clinical management regimen.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive mindfulness based cognitive therapy Receives: Behavioral: Mindfulness based cognitive therapy (MBCT) |
| 2 | Active comparator | Participants will receive maintenance antidepressant pharmacotherapy Receives: Drug: Antidepressants |
| 3 | Placebo comparator | Participants will receive placebo plus clinical management Receives: Drug: Placebo plus clinical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse of depression
Measured: Measured at Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Zindel Segal, Centre for Addiction and Mental Health
- Investigators
- Zindel V. Segal, PhD, Principal investigator, Center for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183560
- Sponsor's protocol ID
- R01MH066992
- Other IDs
- R01MH066992, DSIR 83-ATP
- Status last verified
- Jun 2015
- First submitted
- 13 Sep 2005
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Teasdale JD, Segal ZV, Williams JM, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol. 2000 Aug;68(4):615-23. doi: 10.1037//0022-006x.68.4.615.
PubMed 10965637Ma SH, Teasdale JD. Mindfulness-based cognitive therapy for depression: replication and exploration of differential relapse prevention effects. J Consult Clin Psychol. 2004 Feb;72(1):31-40. doi: 10.1037/0022-006X.72.1.31.
PubMed 14756612Teasdale JD, Moore RG, Hayhurst H, Pope M, Williams S, Segal ZV. Metacognitive awareness and prevention of relapse in depression: empirical evidence. J Consult Clin Psychol. 2002 Apr;70(2):275-87. doi: 10.1037//0022-006x.70.2.275.
PubMed 11952186Segal ZV, Pearson JL, Thase ME. Challenges in preventing relapse in major depression. Report of a National Institute of Mental Health Workshop on state of the science of relapse prevention in major depression. J Affect Disord. 2003 Nov;77(2):97-108. doi: 10.1016/s0165-0327(02)00112-x.
PubMed 14607387Segal 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.
PubMed 21135325Bieling PJ, Hawley LL, Bloch RT, Corcoran KM, Levitan RD, Young LT, Macqueen GM, Segal ZV. Treatment-specific changes in decentering following mindfulness-based cognitive therapy versus antidepressant medication or placebo for prevention of depressive relapse. J Consult Clin Psychol. 2012 Jun;80(3):365-72. doi: 10.1037/a0027483. Epub 2012 Mar 12.
PubMed 22409641
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Relapse in Recurrent Depression With MBCT
- ClinicalTrials.gov ID
- NCT00183560
- Acronym / sponsor ID
- R01MH066992
- Conditions
- Depression
- Keywords
- Depression Recurrence, Drug Therapy, Cognitive Therapy, Relapse, Antidepressants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2004
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 16 Sep 2005 (estimated)
- 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.
This study will determine the effectiveness of mindfulness-based cognitive therapy (MBCT) in preventing depression relapse.
Detailed description
Depression is a serious condition that can cause significant social and emotional problems and reduce the overall quality of life. Relapses in depressive episodes are common and may result in a patient's reluctance to follow a treatment regimen, thus making the episode more severe. Safe and effective therapies to prevent depression relapse are needed. This study will compare three different approaches to determine which is most effective in preventing relapses in depressive episodes.
This study will comprise 2 parts. In Part 1, all participants will receive antidepressant medication for 6 months. Participants whose depression symptoms do not improve will complete their study participation at the end of Part 1. Participants who respond to their regimen will be enrolled in Part 2. This part will last 18 months. During Part 2, participants will be randomly assigned to one of three groups. Participants in Group 1 will continue the drug regimen they began in Part 1. Participants in Group 2 will discontinue their antidepressants and attend an 8-week relapse prevention program. This MBCT program is designed to help participants learn skills that can increase their awareness and change their reaction to stressful events. Participants in Group 3 will have their antidepressant medication from Phase 1 switched to a placebo without their knowledge. Self-report scales will be used to assess the depressive symptoms of participants at the beginning of the study, at the end of Phase 1, and at the end of the study, after Phase 2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Mindfulness based cognitive therapy (MBCT)Participants will receive mindfulness based cognitive therapy |
| 2 | Active comparator | Drug: AntidepressantsParticipants will receive maintenance antidepressant pharmacotherapy |
| 3 | Placebo comparator | Drug: Placebo plus clinical managementParticipants will receive placebo plus clinical management |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Meet DSM criteria for recurrent major depressive disorder, defined as at least one major depressive episode within 3 years prior to study entry AND at least 2 months of normal functioning following the episode
Key exclusion criteria (10 listed)
- Depression secondary to a concurrent medical disorder
- Current use of medication that could cause depressive symptoms
- A rating of level 2 or higher on the Index of Treatment Refractory Depression
- Current diagnosis of any of the following psychiatric disorders: psychotic or organic mental, bipolar, primary obsessive compulsive, borderline personality, antisocial personality, or eating
- Current diagnosis of comorbid chronic depression that is disabling
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)Also: MBCTFollowing antidepressant discontinuation, participants receive MBCT, an 8-week group program that integrates aspects of cognitive therapy and mindfulness meditation. | Behavioural | 1 |
| AntidepressantsAlso: Antidepressant medicationParticipants continue on dosage of the antidepressant that was used to achieve clinical remission. | Drug | 2 |
| Placebo plus clinical managementAlso: Placebo and Clinical ManagementFollowing discontinuation of active antidepressant, participants are placed onto the placebo and clinical management regimen. | Drug | 3 |
Primary outcome
Relapse of depression
Time frame: Measured at Month 18
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 1 Jul 2015.
- Background: PubMed 10965637Teasdale JD, Segal ZV, Williams JM, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol. 2000 Aug;68(4):615-23. doi: 10.1037//0022-006x.68.4.615.
- Background: PubMed 14756612Ma SH, Teasdale JD. Mindfulness-based cognitive therapy for depression: replication and exploration of differential relapse prevention effects. J Consult Clin Psychol. 2004 Feb;72(1):31-40. doi: 10.1037/0022-006X.72.1.31.
- Background: PubMed 11952186Teasdale JD, Moore RG, Hayhurst H, Pope M, Williams S, Segal ZV. Metacognitive awareness and prevention of relapse in depression: empirical evidence. J Consult Clin Psychol. 2002 Apr;70(2):275-87. doi: 10.1037//0022-006x.70.2.275.
- Background: PubMed 14607387Segal ZV, Pearson JL, Thase ME. Challenges in preventing relapse in major depression. Report of a National Institute of Mental Health Workshop on state of the science of relapse prevention in major depression. J Affect Disord. 2003 Nov;77(2):97-108. doi: 10.1016/s0165-0327(02)00112-x.
- Background: PubMed 21135325Segal 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.
- Background: PubMed 22409641Bieling PJ, Hawley LL, Bloch RT, Corcoran KM, Levitan RD, Young LT, Macqueen GM, Segal ZV. Treatment-specific changes in decentering following mindfulness-based cognitive therapy versus antidepressant medication or placebo for prevention of depressive relapse. J Consult Clin Psychol. 2012 Jun;80(3):365-72. doi: 10.1037/a0027483. Epub 2012 Mar 12.
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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.
Zindel V. Segal, PhD principal investigator
Center for Addiction and Mental Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mindfulness based cognitive therapy (MBCT) and Antidepressants in people with Depression, run by Centre for Addiction and Mental Health at 2 sites 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 1 inclusion and 10 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 1 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Relapse of depression (time frame: Measured at Month 18). 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 NCT00183560, which also lists 6 linked publications.
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 1 Jul 2015.