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The Long-term Effects of Body-mind-spirit Group Therapy

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clinicaltrials.gov/study/NCT01727635
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT017276350
Health Conditions in Trial
‌
Depression
0
Sleep
Sleep
0
Trial Recruitment Size
600
Trial Sponsor
National Taiwan University Hospital
National Taiwan University Hospital
0
Clinical Trial Start Date
2009
0
Primary Completion Date
2011
0
Study Completion Date
2011
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Supportive Care0
Intervention Type
Other0
Interventional Trial Phase
Phase 20
Phase 30
Official Name
The Long-term Effects of Body-mind-spirit Group Therapy on Close Relationships, Sleeping Quality, Depression, Quality of Life, Meaning of Life, and Saliva Cortisol Responses in Breast Cancer Survivors and Partners0
Last Updated
November 16, 2012
0
Allocation Type
NA0
Intervention Model
Single Group Assignment0
Masking Type
Single0
Masked Party
Investigator0

Other attributes

Intervention Treatment
body-mind-spirit group therapy0
Study summary

Aims and objectives: This study aims to examine the effects of the body-mind-spirit group therapy on marital close relationships, sleeping quality, depression, quality of life, meaning of life, and salivary cortisol levels in metastatic breast cancer survivors and partners. Methods: The design adopts the randomized controlled trial (RCT). The metastatic breast cancer survivors will be recruited from outpatient department of surgical at hospital. The partners will be invited to participate in this study through the survivors. The 120 dyad survivors and spouse will be randomly assigned into an experimental group or a control group. Survivors and spouse partners in an experimental group will receive 2 months time body-mind-spirit group therapy while those in a control will receive usual care in the same period of time. The outcome measures include Experiences in close relationships scale, Moss sleeping scale, Short-form 12 health-related quality of life questionnaires, Meaning of life questionnaire, BDI-II depression scale and salivary cortisol levels. Measurement time-points include pre intervention, post intervention (after 8 weekly group therapy), \& then 3, 6, 12 months after the end of intervention for the maintenance effect. Univariate analyses will be performed to explore the basic characteristics of participants. The hierarchical linear model will be used to test the hypothesis the improvement is higher in intervention group than the control group in the effects of marital close relationships, sleeping quality, depression, meaning of life, quality of life, and salivary cortisol levels in metastatic breast cancer survivors and partners.

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