Würtzen, H., Dalton, S.O., Elsass, P., Sumbundu, A.D., Steding-Jensen, M., Karlsen, R.V., . . . Johansen, C. (2013). Mindfulness significantly reduces self-reported levels of anxiety and depression: Results of a randomised controlled trial among 336 Danish women treated for stage I–III breast cancer. European Journal of Cancer 49,1365–1373.

To test, in a randomized controlled study, the effect of a structured eight-week group mindfulness-based stress-reduction program on anxiety and depression among women with breast cancer

The mindfulness-based stress-reduction program consisted of eight weekly two-hour group sessions. The program included guided meditation, yoga and psychoeducational advice on stress and stress reactions, and group dialog about the integration of mindfulness practice into daily life. Three experienced clinical psychologists provided the program. The control group received usual care. Data were collected before randomization and at 6 and 12 months after the intervention.

• The study reported on 336 female patients (168 in the experimental group, 168 in the control group).
• Mean patient age was 54.14 years (SD = 10.30 years).
• Patients had stage I–III breast cancer (97% had stage I or II).
• Recruitment was of patients who had received surgery within 3–18 months. Patients underwent various treatments during the study.

• Multisite
• Outpatient setting
• Hospitals associated with University of Copenhagen, Denmark

• Patients were undergoing active antitumor treatment.
• The study has clinical applicability for elder care and palliative care.

A randomized controlled trial design was used.

• Symptom Checklist-90 Revised (SCL-90-R), Danish version: 13 items relating to the depression subscale and 10 items relating to the anxiety subscale
• Center for Epidemiologic Studies Depression Scale (CESD): 21 items focusing primarily on cognitive and affective, rather than physical, manifestations of depression

• At baseline, researchers noted no difference between groups in regard to clinical or demographic characteristics, depression, or anxiety.
• After intervention, analysis revealed a statistically significant between-group difference regarding CESD scores (p = 0.001). At six months, analysis revealed a significant between-group difference regarding anxiety scores (p = 0.05) and for both depression measures (SCL-90-R, p = 0.01; CESD, p = 0.03). After 12 months, researchers noted a significant difference between groups in regard to SCL-90-R depression and CESD scores. After 12 months, intention-to-treat analyses showed differences between groups in levels of anxiety (p = 0.0002) and depression (SCL-90-R, p < 0.0001; CESD, p = 0.0367).
• The intervention was more effective for those with higher levels of anxiety and depression at baseline.

The mindfulness-based stress-reduction program was effective in reducing anxiety and depression over time in the patients studied. The intervention was most effective for those who had higher levels of anxiety and depression at baseline.

• The study had risk of bias due to lack of appropriate attentional control.
• Key differences between the sample groups could have influenced results.
• The intervention is expensive, impractical to implement, and presents training needs.
• Researchers paid insufficient attention to the control group and provided no blind.
• Patients may have been at different time points in relation to treatment (e.g., chemotherapy, radiation treatment). This may decrease the reliability of study findings.

The intervention appears to be effective. It does, however, require that the facilitator receive special training, which is an extra cost, and the intervention may be difficult to implement in the practice setting. The study does not address whether the effectiveness of the intervention varies with phase of care. As with other types of intervention, the mindfulness-based stress-reduction program appeared to be most effective for patients who had higher levels of anxiety and depression at the beginning of treatment, suggesting that appropriate patient selection for such an intervention can be beneficial. This study was limited by the lack of attentional control; providing attention alone may positively affect the anxiety and depression of patients with cancer.