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

Phase 2

Completed

• Conditions: Depression; Sleep
• Interventions: Other: body-mind-spirit group therapy

• Registration Number: NCT01727635
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-21
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-11
• Study First Submitted QC: 2012-11-12
• Last Update Submitted: 2012-11-12
• Study First Posted: 2012-11-16
• Last Update Posted: 2012-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Inclusion criteria of Survivors:

1. breast cancer patients who complete active treatments,
2. those who are willing to participate in the research,
3. those who currently do not receive any individual or group psychotherapy, AND
4. aged between 18 and 65.

Inclusion criteria of Spouse partners:

1. partners of breast cancer patient who complete active treatments,
2. those who are willing to participate in the research,
3. those who currently do not receive any individual or group psychotherapy, AND
4. aged between 18 and 65.

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Exclusion Criteria

Exclusion criteria of Survivors:

1. diagnosed as both breast cancer and other types of cancers,
2. those with adrenal function disorders (for example, Cushing syndrome, Addison's disease, adrenal tumor, pituitary tumor), OR
3. those who currently use antidepressants.

Exclusion criteria of Survivors:

1. diagnosed as adrenal function disorders (for example, Cushing syndrome, Addison's disease, adrenal tumor, pituitary tumor), OR
2. those who currently use antidepressants.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
counseling	body-mind-spirit group therapy	body-mind-spirit group therapy

Primary Outcome Measures

Name	Time	Method
Diurnal Cortisol patterns	pre, post, 3months, 6months and 1year after end of treatment

Secondary Outcome Measures

Name	Time	Method
The Experiences in Close Relationships-Revised questionnaire	pre, post, 3months, 6months and 1year after end of treatment
Beck Depression Inventory	pre, post, 3months, 6months and 1year after end of treatment
Quality of life	pre, post, 3months, 6months and 1year after end of treatment
MOS sleep scale	pre, post, 3months, 6months and 1year after end of treatment
Meaning in Life Questionnaire	pre, post, 3months, 6months and 1year after end of treatment

Trial Locations

Locations (1)

Department of Nursing, College of Medicine, National Taiwan University; 🇨🇳 Taipei, Taiwan