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| ID | Type | Description | Link |
|---|---|---|---|
| 2005 6028 | Other Identifier | Fonds Psychische Gezondheid, Netherlands (previously: NFGV) |
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| Name | Class |
|---|---|
| Fonds Psychische Gezondheid | OTHER |
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The purpose of this study is to investigate the effectiveness and possible mediating factors of Mindfulness Based Cognitive Therapy (MBCT) for recurrent depression.
Mindfulness Based Cognitive Therapy (MBCT) is a 8 session group intervention and is well described by several authors.
Previous studies showed Mindfulness Based Cognitive Therapy (MBCT) to be effective to prevent relapse in patients with recurrent depression and 3 or more previous depressive episodes.
Study aims are:
In this study, patients are randomly assigned to a MBCT intervention group or a waiting list control group. Patients allocated to the waiting list control condition will receive the MBCT course three months later. All patients who participated in a MBCT training will be assessed during the year following the completion of the MBCT course. We aim to include about 220 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Based Cognitive Therapy | Experimental | Mindfulness Based Cognitive Therapy |
|
| Waiting list control group | No Intervention | 3-month waiting list group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Cognitive Therapy | Behavioral | 8-weeks group based intervention of mindfulness and cognitive behavioural techniques |
|
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptoms | Hamilton Depression Rating Scale. The HAMD is a standardized 17-item interview to measure number and severity of depressive symptoms on a 0-52 score. Higher values indicate a worse outcome. Specifical, HAMD scores can be interpreted as "no depression" (0-7), "mild depression" (8-16), "moderate depression" (17-23) and "severe depression" (24-52). | Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-report Depressive Symptoms | Beck Depression Inventory (BDI), a 21-item self-report questionnaire to measure depressive symptoms, score range 0-63. Higher scores indicate a worse outcome. Specifically, BDI scores can be interpreted as "minimal depression" (0-13), "mild depression" (14-19), "moderate depression" (20-28) and "severe depression" (29-63). | Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne EM Speckens, Prof. dr. | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Nijmegen Medical Center | Nijmegen | Gelderland | 6525 GC | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10965637 | Background | 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. | |
| 14756612 | Background | Ma 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. |
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Patients were excluded for not having three or more previous depressive episodes (N=19), change in medication within 6 weeks before the start of the study (N=4), previous (hypo)manic episodes (N=2), current substance abuse (N=3), acute need for psychiatric treatment (N=2), unsuitability for groups (N=2), cognitive impairments (N=1).
Patients were referred by their general practitioners or psychiatrists and psychologists in and around Nijmegen, the Netherlands. Alternatively, they were self-referred, informed by local and national advertisements.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness Based Cognitive Therapy | Mindfulness Based Cognitive Therapy Mindfulness Based Cognitive Therapy : 8-weeks group based intervention of mindfulness and cognitive behavioural techniques |
| FG001 | Waiting List Control Group (TAU) | three month waiting list group receiving treatment as usual |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness Based Cognitive Therapy | Mindfulness Based Cognitive Therapy Mindfulness Based Cognitive Therapy : 8-weeks group based intervention of mindfulness and cognitive behavioural techniques |
| BG001 | Waiting List Control Group (TAU) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Depressive Symptoms | Hamilton Depression Rating Scale. The HAMD is a standardized 17-item interview to measure number and severity of depressive symptoms on a 0-52 score. Higher values indicate a worse outcome. Specifical, HAMD scores can be interpreted as "no depression" (0-7), "mild depression" (8-16), "moderate depression" (17-23) and "severe depression" (24-52). | Due to missing values, 9 subjects in the MBCT group and 5 from the waiting list control group could not be analysed. | Posted | Mean | Standard Deviation | units on a scale | Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness Based Cognitive Therapy | Mindfulness Based Cognitive Therapy Mindfulness Based Cognitive Therapy : 8-weeks group based intervention of mindfulness and cognitive behavioural techniques |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne E.M. Speckens | Radboud University Medical Centre | 0031243610449 | a.speckens@psy.umcn.nl |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000099025 | Mindfulness-Based Cognitive Therapy |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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|
| 19249017 | Background | Barnhofer T, Crane C, Hargus E, Amarasinghe M, Winder R, Williams JM. Mindfulness-based cognitive therapy as a treatment for chronic depression: A preliminary study. Behav Res Ther. 2009 May;47(5):366-73. doi: 10.1016/j.brat.2009.01.019. Epub 2009 Feb 5. |
| 16797486 | Background | Kenny MA, Williams JM. Treatment-resistant depressed patients show a good response to Mindfulness-based Cognitive Therapy. Behav Res Ther. 2007 Mar;45(3):617-25. doi: 10.1016/j.brat.2006.04.008. Epub 2006 Jun 23. |
| 17535594 | Background | Kingston T, Dooley B, Bates A, Lawlor E, Malone K. Mindfulness-based cognitive therapy for residual depressive symptoms. Psychol Psychother. 2007 Jun;80(Pt 2):193-203. doi: 10.1348/147608306X116016. |
| 22017808 | Derived | van Aalderen JR, Donders AR, Giommi F, Spinhoven P, Barendregt HP, Speckens AE. The efficacy of mindfulness-based cognitive therapy in recurrent depressed patients with and without a current depressive episode: a randomized controlled trial. Psychol Med. 2012 May;42(5):989-1001. doi: 10.1017/S0033291711002054. Epub 2011 Oct 3. |
Three-month waiting list group receiving treatment as usual (TAU) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Waiting List Control Group | Waiting list control group, from 0 to 3 months. Patients received usual care but not MBCT. |
|
|
| Secondary | Self-report Depressive Symptoms | Beck Depression Inventory (BDI), a 21-item self-report questionnaire to measure depressive symptoms, score range 0-63. Higher scores indicate a worse outcome. Specifically, BDI scores can be interpreted as "minimal depression" (0-13), "mild depression" (14-19), "moderate depression" (20-28) and "severe depression" (29-63). | Posted | Mean | Standard Deviation | units on a scale | Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis |
|
|
|
| 0 |
| 111 |
| 0 |
| 111 |
| EG001 | Waiting List Control Group (TAU) | three month waiting list group receiving treatment as usual | 0 | 108 | 0 | 108 |
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| D004191 |
| Behavioral Disciplines and Activities |