Quality of Research
Documents Reviewed
The documents below were reviewed for Quality of Research. The research point of
contact can provide information regarding the studies reviewed and the availability
of additional materials, including those from more recent studies that may have been conducted.
Study 1Teasdale, J. D., Segal, Z. V., Williams, J. M. G., Ridgeway, V. A., Soulsby, J. M., & Lau, M. A. (2000). Prevention of relapse/recurrence in major depression by Mindfulness-Based Cognitive Therapy. Journal of Consulting and Clinical Psychology, 68(4), 615-623.  Study 2Ma, S. H., & Teasdale, J. D. (2004). Mindfulness-Based Cognitive Therapy for depression: Replication and exploration of differential relapse prevention effects. Journal of Consulting and Clinical Psychology, 72(1), 31-40. Study 3Kuyken, W., Byford, S., Taylor, R. S., Watkins, E., Holden, E., White, K., et al. (2008). Mindfulness-Based Cognitive Therapy to prevent relapse in recurrent depression. Journal of Consulting and Clinical Psychology, 76(6), 966-978.
Supplementary Materials Harper, A., & Power, M. (1998). Development of the World Health Organization WHOQOL-BREF quality of life assessment. Psychological Medicine, 28(3), 551-558.
Mindfulness-Based Cognitive Therapy--Adherence Rating Scale (Version 2002)
Piet, J., & Hougaard, E. (2011). The effect of Mindfulness-Based Cognitive Therapy for prevention of relapse in recurrent major depressive disorder: A systematic review and meta-analysis. Clinical Psychology Review, 31(6), 1032-1040.
Segal, Z. V., Bieling, P., Young, T., MacQueen, G., Cooke, R., Martin, L., et al. (2010). Antidepressant monotherapy vs sequential pharmacotherapy and Mindfulness-Based Cognitive Therapy, or placebo, for relapse prophylaxis in recurrent depression. Archives of General Psychiatry, 67(12), 1256-1264.
Segal, Z. V., Teasdale, J. D., Williams, J. M., & Gemar, M. C. (2002). The Mindfulness-Based Cognitive Therapy Adherence Scale: Inter-rater reliability, adherence to protocol and treatment distinctiveness. Clinical Psychology and Psychotherapy, 9, 131-138.
Spitzer, R. L., Williams, J. B. W., Gibbon, M., & First, M. B. (1992). The Structured Clinical Interview for DSM-III-R (SCID). I: History, rationale, and description. Archives of General Psychiatry, 49(8), 624-629.
Spruance, S. L., Reid, J. E., Grace, M., & Samore, M. (2004). Hazard ratio in clinical trials. Antimicrobial Agents and Chemotherapy, 48(8), 2787-2792.
Outcomes
| Outcome 1: Major depression episode relapse |
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Description of Measures
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Major depression episode relapse was measured by the Structured Clinical Interview for the Axis I DSM Clinical Disorders (SCID-I), a clinician-administered instrument used for making major DSM diagnoses. In one study, the DSM-III-R SCID-I was administered by trained doctoral-level psychologists and an experienced psychiatric social worker who were blind to the study groups. In another study, the DSM-IV SCID-I was administered by a clinical psychologist who was blind to the study groups.
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Key Findings
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In one study, a randomized clinical trial (RCT) was conducted across three treatment sites with patients who had a diagnosis of recurrent major depression, were in recovery or remission, and were not using ADM at study entry. Recurrent major depression was defined as having at least two episodes of major depression according to DSM-III-R criteria in the past 5 years, with one episode in the past 2 years, and a history of ADM treatment. Participants were randomly assigned to the intervention group, which received 2-hour weekly sessions of MBCT over 8 weeks in addition to usual care, or the control group, which received usual care. Usual care was defined as being instructed to seek help from a family doctor or other source for a symptomatic deterioration or other psychological difficulties experienced over the course of the 14-month study period.
Both groups were assessed at baseline; about 8 weeks later, after the intervention group completed the sessions of MBCT (posttreatment); and then bimonthly to 12 months after treatment (12-month posttreatment follow-up period). For each study group, the percentage of participants who had an episode of major depression during the 12-month posttreatment follow-up period was calculated. Results for participants with three or more previous episodes of major depression indicated that the percentage who relapsed into a depressive episode during the 12-month posttreatment follow-up period was smaller for the intervention group than the control group (40% vs. 66%; p < .01). This group difference was associated with a medium effect size (Cohen's h = 0.53).
In a second study, an RCT was conducted at one treatment site with patients who had a diagnosis of recurrent major depression, were in recovery or remission, and were not using ADM at study entry. Recurrent major depression was defined as having at least two episodes of major depression according to DSM-IV criteria in the past 5 years, with one episode in the past 2 years, and a history of ADM treatment. Participants were randomly assigned to the intervention group, which received 2-hour weekly sessions of MBCT over 8 weeks in addition to usual care, or the control group, which received usual care. Usual care was defined as being instructed to seek help from a family doctor or other source for a symptomatic deterioration or other psychological difficulties experienced over the course of the 14-month study period.
Both groups were assessed at baseline; about 8 weeks later, after the intervention group completed the sessions of MBCT (posttreatment); and then at 3-month intervals to 12 months after treatment (12-month posttreatment follow-up period). For each study group, the percentage of participants who had an episode of major depression during the 12-month posttreatment follow-up period was calculated. Results for participants with three or more previous episodes of major depression indicated that the percentage who relapsed into a depressive episode during the 12-month posttreatment follow-up period was smaller for the intervention group than the control group (36% vs. 78%; p = .002). This group difference was associated with a large effect size (Cohen's h = 0.88).
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Studies Measuring Outcome
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Study 1, Study 2
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Study Designs
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Experimental
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Quality of Research Rating
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3.1
(0.0-4.0 scale)
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| Outcome 2: Residual depression symptoms |
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Description of Measures
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Residual depression symptoms were measured by the 17-item Hamilton Rating Scale for Depression (HAM-D). The HAM-D is a semistructured clinician-administered interview that evaluates the presence and severity of depressed mood, vegetative and cognitive symptoms of depression, and comorbid anxiety symptoms, according to DSM-IV criteria. Items are rated with either a 5-point scale ranging from 0 (absent) to 4 (very severe) or a 3-point scale ranging from 0 (absent) to 2 (definite). Higher scores indicate more symptoms of depression with greater severity.
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Key Findings
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An RCT was conducted with patients who had a diagnosis of recurrent major depression (defined as having three or more previous episodes of major depression according to DSM-IV criteria), were either in full or partial remission from depression symptoms, and were receiving a therapeutic ADM regimen (according to the British National Formulary) for at least 6 months prior to study entry. Participants were randomly assigned to the intervention group, which received 2-hour weekly sessions of MBCT over 8 weeks plus tapering or discontinuation of ADM, or the comparison group, which received an ADM maintenance/management program. Participants in the intervention group were supported by their primary care physician in tapering or discontinuation of ADM, beginning in weeks 4-5 of the intervention and ending 6 months after the intervention. Participants in the comparison group were managed by their primary care physician according to standard clinical practice and the British National Formulary to ensure that the ADM dose remained within therapeutic limits throughout the 15-month study period.
Both groups were assessed at baseline and at 3-month intervals to 15 months after randomization (study end). The 3-month follow-up was assessed about 1 month after the intervention group completed the sessions of MBCT (1-month posttreatment assessment), and the 15-month follow-up was assessed about 13 months after the intervention group completed the sessions of MBCT (13-month posttreatment assessment). Results indicated that at the 1- and 13-month posttreatment assessments, participants in the intervention group had fewer and less severe residual depression symptoms than participants in the comparison group (p = .02), after controlling for baseline assessments. This group difference was associated with a medium effect size (eta-squared = .06).
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Studies Measuring Outcome
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Study 3
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Study Designs
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Experimental
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Quality of Research Rating
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3.6
(0.0-4.0 scale)
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| Outcome 3: Psychiatric comorbidity |
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Description of Measures
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Psychiatric comorbidity was measured by the SCID-I, a clinician-administered instrument used for making major DSM diagnoses. Comorbid Axis I psychiatric diagnoses from DSM-IV include the following mental health areas: mood disorders; delirium, dementia, and amnestic disorders; substance-related disorders; schizophrenia; anxiety disorders; social phobias; dissociative disorders; sexual and gender identity disorders; eating disorders; impulse-control disorders; adjustment disorders; and sleep disorders. The DSM-IV SCID-I was administered by a clinical psychologist who was blind to the study groups.
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Key Findings
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An RCT was conducted with patients who had a diagnosis of recurrent major depression (defined as having three or more previous episodes of major depression according to DSM-IV criteria), were either in full or partial remission from depression symptoms, and were receiving a therapeutic ADM regimen (according to the British National Formulary) for at least 6 months prior to study entry. Participants were randomly assigned to the intervention group, which received 2-hour weekly sessions of MBCT over 8 weeks plus tapering or discontinuation of ADM, or the comparison group, which received an ADM maintenance/management program. Participants in the intervention group were supported by their primary care physician in tapering or discontinuation of ADM, beginning in weeks 4-5 of the intervention and ending 6 months after the intervention. Participants in the comparison group were managed by their primary care physician according to standard clinical practice and the British National Formulary to ensure that the ADM dose remained within therapeutic limits throughout the 15-month study period.
Both groups were assessed at study intake and at 15 months after randomization (study end). Results indicated that at study end relative to intake, participants in the intervention group had fewer comorbid psychiatric diagnoses (DSM-IV Axis I) than participants in the comparison group (p < .05). This group difference was associated with a small effect size (Cohen's d = 0.43).
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Studies Measuring Outcome
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Study 3
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Study Designs
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Experimental
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Quality of Research Rating
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3.5
(0.0-4.0 scale)
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| Outcome 4: Antidepressant medication use |
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Description of Measures
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Antidepressant medication use was measured as the number of days that the study participant used ADM during the 15-month study (up to 450 days). This information was obtained from three convergent sources:
- The Morisky Medication Adherence Scale (MMAS), a 4-item self-report adherence measure. Participants responded to each item with "yes" or "no."
- Patient self-report. Participants indicated daily ADM use.
- Medical records from the prescribing physician.
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Key Findings
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An RCT was conducted with patients who had a diagnosis of recurrent major depression (defined as having three or more previous episodes of major depression according to DSM-IV criteria), were either in full or partial remission from depression symptoms, and were receiving a therapeutic ADM regimen (according to the British National Formulary) for at least 6 months prior to study entry. Participants were randomly assigned to the intervention group, which received 2-hour weekly sessions of MBCT over 8 weeks plus tapering or discontinuation of ADM, or the comparison group, which received an ADM maintenance/management program. Participants in the intervention group were supported by their primary care physician in tapering or discontinuation of ADM, beginning in weeks 4-5 of the intervention and ending 6 months after the intervention. Participants in the comparison group were managed by their primary care physician according to standard clinical practice and the British National Formulary to ensure that the ADM dose remained within therapeutic limits throughout the 15-month study period.
Both groups were assessed at baseline and at 3-month intervals to 15 months after randomization (study end). Results indicated the following:
- Across the 15-month study period, ADM use by participants in the intervention group was approximately 65% that of participants in the comparison group (266.46 days vs. 411.40 days; p < .0001). This group difference was associated with a large effect size (Cohen's d = 1.07).
- By the 6-month assessment (i.e., the end of the period for tapering or discontinuation of ADM), 75% of participants in the intervention group had discontinued use of ADM.
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Studies Measuring Outcome
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Study 3
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Study Designs
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Experimental
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Quality of Research Rating
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3.2
(0.0-4.0 scale)
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| Outcome 5: Quality of life |
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Description of Measures
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Quality of life was evaluated by the short version of the World Health Organization Quality of Life instrument (WHOQOL-BREF), a 26-item self-report instrument that assesses the respondent's perceived quality of life. Using a 5-point Likert scale, respondents rate items in four domains: physical health (e.g., "How satisfied are you with your sleep?"), psychological health (e.g., "How much do you enjoy life?"), social relationships (e.g., "How satisfied are you with your personal relationships?"), and environment (e.g., "How satisfied are you with the conditions of your living place?"). Respondents also rate two global items: one regarding the respondent's overall perception of quality of life and another regarding the respondent's overall perception of his or her health. Only three domains--physical health, psychological health, and social relationships--were considered relevant for use in the study.
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Key Findings
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An RCT was conducted with patients who had a diagnosis of recurrent major depression (defined as having three or more previous episodes of major depression according to DSM-IV criteria), were either in full or partial remission from depression symptoms, and were receiving a therapeutic ADM regimen (according to the British National Formulary) for at least 6 months prior to study entry. Participants were randomly assigned to the intervention group, which received 2-hour weekly sessions of MBCT over 8 weeks plus tapering or discontinuation of ADM, or the comparison group, which received an ADM maintenance/management program. Participants in the intervention group were supported by their primary care physician in tapering or discontinuation of ADM, beginning in weeks 4-5 of the intervention and ending 6 months after the intervention. Participants in the comparison group were managed by their primary care physician according to standard clinical practice and the British National Formulary to ensure that the ADM dose remained within therapeutic limits throughout the 15-month study period.
Both groups were assessed at baseline and at 3-month intervals to 15 months after randomization (study end). The 3-month follow-up was assessed about 1 month after the intervention group completed the sessions of MBCT (1-month posttreatment assessment), and the 15-month follow-up was assessed about 13 months after the intervention group completed the sessions of MBCT (13-month posttreatment assessment). Results indicated that relative to participants in the comparison group, those in the intervention group perceived themselves as having a better quality of life in the physical health (p = .04) and psychological health (p = .01) domains of the WHOQOL-BREF at the 1- and 13-month posttreatment assessments, after controlling for baseline assessments. These group differences were associated with small and medium effect sizes (eta-squared = .05 and .06, respectively).
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Studies Measuring Outcome
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Study 3
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Study Designs
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Experimental
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Quality of Research Rating
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3.6
(0.0-4.0 scale)
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Study Populations
The following populations were identified in the studies reviewed for Quality of
Research.
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Study
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Age
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Gender
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Race/Ethnicity
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Study 1
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26-55 (Adult)
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75.9% Female
24.1% Male
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100% Non-U.S. population
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Study 2
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26-55 (Adult)
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76% Female
24% Male
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100% Non-U.S. population
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Study 3
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26-55 (Adult)
55+ (Older adult)
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76.4% Female
23.6% Male
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100% Non-U.S. population
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Quality of Research Ratings by Criteria (0.0-4.0 scale)
External reviewers independently evaluate the Quality of Research for an intervention's
reported results using six criteria:
For more information about these criteria and the meaning of the ratings, see Quality of Research.
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Outcome
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Reliability
of Measures
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Validity
of Measures
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Fidelity
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Missing
Data/Attrition
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Confounding
Variables
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Data
Analysis
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Overall
Rating
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1: Major depression episode relapse
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3.3
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3.3
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2.0
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3.3
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2.8
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4.0
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3.1
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2: Residual depression symptoms
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3.8
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3.8
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3.8
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3.8
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2.8
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4.0
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3.6
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3: Psychiatric comorbidity
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3.3
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3.3
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3.8
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3.8
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2.8
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4.0
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3.5
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4: Antidepressant medication use
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2.0
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2.8
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3.8
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3.8
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2.8
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4.0
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3.2
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5: Quality of life
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3.8
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3.8
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3.8
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3.8
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2.8
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4.0
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3.6
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Study Strengths The clinician-administered SCID-I is a gold standard measure for deriving clinical psychiatric diagnoses in the mental health field. The instrument has strong interrater reliability among clinicians trained in standardized protocols for its administration and strong validity for establishing a psychiatric diagnosis. The clinician-administered HAM-D is also considered a gold standard measure with strong psychometric properties. It is the most widely used and accepted outcome measure for evaluating depression severity in the mental health field and is the usual standard against which other depression rating scales are validated. The WHOQOL-BREF self-report instrument has high internal consistency reliability (Cronbach's alpha values of .82-.95) and high test-retest reliability for a 2-week interval (correlation coefficients of .83-.96), with good content, discriminant, convergent, and construct validity. The intervention was manual driven in all three studies, and in two of the studies, it was delivered by experienced cognitive therapists (i.e., the program developers) who had previously provided MBCT to at least one cohort of patients who had a diagnosis of recurrent major depression and were in recovery or remission. In a third study, the interventionists were a clinical psychologist and an occupational therapist who were trained by one of the program developers and whose competency was established by an experienced MBCT therapist who was independent of the study. In the same study, all program sessions were videotaped and rated by an experienced MBCT therapist with a fidelity instrument that had documented psychometric properties, including strong interrater reliability. All three studies compared study completers with noncompleters for differences and incorporated intent-to-treat approaches in the statistical analyses, even in the case of the two studies with very low attrition rates of 5% and 3%. In one study, missing data were handled by imputing the final scores recorded for all subsequent assessments and conducting sensitivity analyses to confirm that the outcome findings were unaffected by the missing data imputation. All three studies used random assignment to control for potential confounding variables. All three studies used a variety of appropriate analyses, including sophisticated Cox proportional hazard survival modeling of the data, and examined potential moderators of outcome effects.
Study Weaknesses The SCID-I includes skip options that allow a clinician to incorrectly decide not to examine a particular area of psychopathology, thereby decreasing the instrument's reliability and validity in diagnosing psychiatric comorbidity. The reliability of the MMAS is not reported for the sample, and self-report and physician practice databases of ADM adherence may not be reliable. Discrepancies in daily ADM adherence among the MMAS, the patient's self-report, and medical records from the prescribing physician were resolved through discussions among the prescribing physician, the patient, and a research team member who was not blind to the study groups, which may have compromised internal validity. In two of the studies, intervention fidelity was not measured by a fidelity instrument with demonstrated psychometric properties. In two of the studies, results suggested that two subgroups of participants, from different populations, were clustered within each study group and responded differentially to the program. Additionally, the absence of an attention control comparison group in the three studies precludes the elimination of potential confounding influences of expectancy and trust in the instructors.
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