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

Depression Clinical Trial

Official title:

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 Partners

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01727635
• Other study ID #: 200909010R
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 21, 2009
• Last updated: November 12, 2012
• Start date: October 2009
• Est. completion date: November 2011

Study information

• Verified date: November 2012
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Depression
• Sleep

Intervention

Other:
• body-mind-spirit group therapy
8-session therapy

Locations

Country	Name	City	State
Taiwan	Department of Nursing, College of Medicine, National Taiwan University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diurnal Cortisol patterns		pre, post, 3months, 6months and 1year after end of treatment	Yes
Secondary	The Experiences in Close Relationships-Revised questionnaire		pre, post, 3months, 6months and 1year after end of treatment	Yes
Secondary	Beck Depression Inventory		pre, post, 3months, 6months and 1year after end of treatment	Yes
Secondary	Quality of life		pre, post, 3months, 6months and 1year after end of treatment	Yes
Secondary	MOS sleep scale		pre, post, 3months, 6months and 1year after end of treatment	Yes
Secondary	Meaning in Life Questionnaire		pre, post, 3months, 6months and 1year after end of treatment	No