The Long-term Effects of Body-mind-spirit Group Therapy
Condition: Depression; Sleep
MeSH terms: Depression
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Detailed description: 
      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.
    

Intervention name(s): body-mind-spirit group therapy
Intervention type(s): Other
Intervention description(s): 8-session therapy
Other intervention name(s): group therapy
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Breast cancer, survivors, partners, group therapy