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The primary aim of this study is to examine the effects of a mindfulness-based stress reduction training program, delivered in individual web-based sessions, among breast cancer patients. The objectives are to study and answer questions regarding effects of the such training in a randomized controlled trial including the following outcome measures: physical and mental health status, perceived stress, post-traumatic stress symptoms, psychological well-being, and sleep quality. In addition to the primary aim, the investigators plan to explore potential mechanisms through which mindfulness training lead to improvement in perceived stress, well-being and sleep-quality. This will be studied by mediational analyses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-based stress reduction | Experimental | Mindfulness-based stress reduction training |
|
| Expressive writing condition | Active Comparator | Expressive writing |
|
| Waiting-list control condition | No Intervention | Waiting list |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-based stress reduction | Behavioral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Perceived Stress | Perceived stress as measured with the Perceived stress scale (PSS) and the Intrusion of event scale revised (IES-R) before and after intervention | Baseline to 8 week follow-up change |
| Change in Psychological Well-Being | Psychological Well-Being as measured with the Psychological Well-Being (PWB) scale by C Ryff; a questionnaire measuring six dimensions of psychological well-being: environmental mastery; self-acceptance; positive relations with others; purpose in life; personal growth; and autonomy. | Baseline to 8 week follow-up change |
| Change in Sleep quality | Sleep quality as measured with the Karolinska Sleep Questionnaire (KSQ) a 13-item questionnaire assessing sleep-time and quality as well as perceived satisfaction with sleep, sleepiness and sleep disturbance. | Baseline to 8 week follow-up change |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Perceived stress | Change in Perceived stress as measured with the Perceived stress scale and the Intrusion of event scale revised (IES-R) | Change from baseline to 12 months follow-up |
| Change in Psychological well-being |
| Measure | Description | Time Frame |
|---|---|---|
| Sickness-absence for work | Gorup differences in sickness-absence from work as measured in national population registries | At 24 months follow-up |
| All cause morbidity | Group differences in all cause morbidity as measured in national registries |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet, Department of clinical neuroscience | Stockholm | 171 77 | Sweden |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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| Expressive writing condition | Behavioral |
|
|
Change in psychological well-being as measured with the Psychological well-being scale.
| Change from baseline to 12-month follow-up |
| Change in Sleep quality | Change in sleep quality as measured with the Karolinska sleep questionnaire. | Change from baseline to 12-month follow-up |
| At 24 months follow-up |
| All cause mortality | Group differences in all cause mortality as measured in national registries. | At 24 months follow-up |
| D017437 |
| Skin and Connective Tissue Diseases |
| D004191 |
| Behavioral Disciplines and Activities |