DepressionPhase 2/3NCT01727635
The Long-term Effects of Body-mind-spirit Group Therapy
A Phase 2/3 study testing body-mind-spirit group therapy in people with Depression and Sleep, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Sleep
- What is being tested?
- body-mind-spirit group therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2009to Nov 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- breast cancer patients who complete active treatments,
- those who are willing to participate in the research,
- those who currently do not receive any individual or group psychotherapy, AND
- aged between 18 and 65.
- partners of breast cancer patient who complete active treatments,
- those who are willing to participate in the research,
- those who currently do not receive any individual or group psychotherapy, AND
- aged between 18 and 65.
Who cannot join
- diagnosed as both breast cancer and other types of cancers,
- those with adrenal function disorders (for example, Cushing syndrome, Addison's disease, adrenal tumor, pituitary tumor), OR
- those who currently use antidepressants.
- diagnosed as adrenal function disorders (for example, Cushing syndrome, Addison's disease, adrenal tumor, pituitary tumor), OR
- those who currently use antidepressants.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Nursing, College of Medicine, National Taiwan University
Taipei, 10051
About this study
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
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.
Read the 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.
- Conditions
- Depression, Sleep
- Being tested
- body-mind-spirit group therapy
- Keywords
- Breast cancer, survivors, partners, group therapy
- Medical subject headings
- Depression, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body-mind-spirit group therapyOther
Also called group therapy
8-session therapy
| Study group | Role | What they receive |
|---|---|---|
| counseling | Experimental | body-mind-spirit group therapy Receives: Other: body-mind-spirit group therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diurnal Cortisol patterns
Measured: pre, post, 3months, 6months and 1year after end of treatment
Secondary outcomes (5)
The Experiences in Close Relationships-Revised questionnaire
Measured: pre, post, 3months, 6months and 1year after end of treatment
Beck Depression Inventory
Measured: pre, post, 3months, 6months and 1year after end of treatment
Quality of life
Measured: pre, post, 3months, 6months and 1year after end of treatment
MOS sleep scale
Measured: pre, post, 3months, 6months and 1year after end of treatment
Meaning in Life Questionnaire
Measured: pre, post, 3months, 6months and 1year after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startOct 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fei Hsiao, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727635
- Sponsor's protocol ID
- 200909010R
- Status last verified
- Nov 2012
- First submitted
- 21 Oct 2009
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01727635
- Acronym / sponsor ID
- 200909010R
- Conditions
- Depression, Sleep
- Keywords
- Breast cancer, survivors, partners, group therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 16 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| counseling | Experimental | Other: body-mind-spirit group therapybody-mind-spirit group therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- breast cancer patients who complete active treatments,
- those who are willing to participate in the research,
- those who currently do not receive any individual or group psychotherapy, AND
- aged between 18 and 65.
- partners of breast cancer patient who complete active treatments,
Key exclusion criteria (5 listed)
- diagnosed as both breast cancer and other types of cancers,
- those with adrenal function disorders (for example, Cushing syndrome, Addison's disease, adrenal tumor, pituitary tumor), OR
- those who currently use antidepressants.
- diagnosed as adrenal function disorders (for example, Cushing syndrome, Addison's disease, adrenal tumor, pituitary tumor), OR
- those who currently use antidepressants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| body-mind-spirit group therapyAlso: group therapy8-session therapy | Other | counseling |
Primary outcome
Diurnal Cortisol patterns
Time frame: pre, post, 3months, 6months and 1year after end of treatment
5 secondary outcomes
The Experiences in Close Relationships-Revised questionnaire
Time frame: pre, post, 3months, 6months and 1year after end of treatment
Beck Depression Inventory
Time frame: pre, post, 3months, 6months and 1year after end of treatment
Quality of life
Time frame: pre, post, 3months, 6months and 1year after end of treatment
MOS sleep scale
Time frame: pre, post, 3months, 6months and 1year after end of treatment
Meaning in Life Questionnaire
Time frame: pre, post, 3months, 6months and 1year after end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fei Hsiao, PhD principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing body-mind-spirit group therapy in people with Depression and Sleep, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diurnal Cortisol patterns (time frame: pre, post, 3months, 6months and 1year after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2012.