Effects of Mindfulness Meditation and Stress Management Training on Perceived Stress, Psychological Well-being, and Sleep Quality Among Patients Diagnosed With Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 142
- Locations
- 1
- Primary Endpoint
- Change in Sleep quality
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Breast cancer patient ≥ 18 years of age who has received the cancer diagnosis ≤ 2 years previously
- •Access and regular use of the internet
Exclusion Criteria
- •Non Swedish speaking
- •Previous sever psychiatric illness
Arms & Interventions
Mindfulness-based stress reduction
Mindfulness-based stress reduction training
Intervention: Mindfulness-based stress reduction (Behavioral)
Expressive writing condition
Expressive writing
Intervention: Expressive writing condition (Behavioral)
Waiting-list control condition
Waiting list
Outcomes
Primary Outcomes
Change in Sleep quality
Time Frame: Baseline to 8 week follow-up change
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.
Change in Psychological Well-Being
Time Frame: Baseline to 8 week follow-up change
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.
Change in Perceived Stress
Time Frame: Baseline to 8 week follow-up change
Perceived stress as measured with the Perceived stress scale (PSS) and the Intrusion of event scale revised (IES-R) before and after intervention
Secondary Outcomes
- Change in Perceived stress(Change from baseline to 12 months follow-up)
- Change in Psychological well-being(Change from baseline to 12-month follow-up)
- Change in Sleep quality(Change from baseline to 12-month follow-up)
Investigators
Richard Branstrom
Associate Professor
Karolinska Institutet