Depressive Disorder, Major
Conditions
Keywords
Recurrent Major Depressive Disorder, Mindfulness Based Cognitive Therapy, Randomized Controlled Trial
Brief summary
The purpose of this study is to investigate the effectiveness and possible mediating factors of Mindfulness Based Cognitive Therapy (MBCT) for recurrent depression.
Detailed description
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: 1. to replicate previous findings in The Netherlands, by a research team which did not develop the intervention 2. to investigate if MBCT is applicable for patients with recurrent depression and current depressive symptoms 3. to examine possible mediators of treatment effect and predictors of relapse in the year following the treatment 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.
Interventions
BEHAVIORALMindfulness Based Cognitive Therapy
8-weeks group based intervention of mindfulness and cognitive behavioural techniques
Sponsors
Fonds Psychische Gezondheid
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 3 or more previous depressive episodes * if treated with medication: constant dose of at least 6 weeks
Exclusion criteria
* Bipolar Disorder * Psychotic disorder * Neurological or somatic illness affecting depression or outcome measures * Current alcohol or drugs dependency * Acute need of psychiatric treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms | Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-report Depressive Symptoms | Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis | 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). |
Countries
Netherlands
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness Based Cognitive Therapy Mindfulness Based Cognitive Therapy
Mindfulness Based Cognitive Therapy : 8-weeks group based intervention of mindfulness and cognitive behavioural techniques | 111 |
| Waiting List Control Group (TAU) Three-month waiting list group receiving treatment as usual (TAU) | 108 |
| Total | 219 |
Baseline characteristics
| Characteristic | Waiting List Control Group (TAU) | Mindfulness Based Cognitive Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 108 Participants | 111 Participants | 219 Participants |
| Age, Continuous | 47.7 years STANDARD_DEVIATION 11.1 | 47.3 years STANDARD_DEVIATION 11.5 | 47.5 years STANDARD_DEVIATION 11.3 |
| Region of Enrollment Netherlands | 108 participants | 111 participants | 219 participants |
| Sex: Female, Male Female | 74 Participants | 71 Participants | 145 Participants |
| Sex: Female, Male Male | 34 Participants | 40 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 111 | 0 / 108 |
| serious Total, serious adverse events | 0 / 111 | 0 / 108 |
Outcome results
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).
Time frame: Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis.
Population: Due to missing values, 9 subjects in the MBCT group and 5 from the waiting list control group could not be analysed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Based Cognitive Therapy | Depressive Symptoms | 7.5 units on a scale | Standard Deviation 5.8 |
| Waiting List Control Group | Depressive Symptoms | 10.5 units on a scale | Standard Deviation 6.8 |
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).
Time frame: Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Based Cognitive Therapy | Self-report Depressive Symptoms | 10.3 units on a scale | Standard Deviation 7.8 |
| Waiting List Control Group | Self-report Depressive Symptoms | 16.2 units on a scale | Standard Deviation 9.8 |