DepressionPhase 2/3NCT01001884
The Efficacy of the Caregiver Psychoeducational Consultation Program
A Phase 2/3 study testing caregiver psychoeducational consultation program (CPCP) in people with Depression and Sleep, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Aim: To examine the effects of the caregiver psychoeducational consultation program in reducing caregiver burdens, depression, sleep quality, and improving the experience in close relationship, positive meaning of illness and quality of life. This is the 2-year study. 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?
- caregiver psychoeducational consultation program (CPCP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2009to Dec 2010
- 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
- Spouse caregivers of patients with resectable colorectal cancer,
- Those who are willing to participate in the research,
- Aged above 18.
Who cannot join
- Who refuses to participate in this study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Fei-Hsiu Hsiao
Taipei, 10051
Fei Hsiao, PhD, +886-2-23123456 ext. 88432, hsiaofei@ntu.edu.tw
Fei Hsiao, PhD
About this study
Official title: The Efficacy of the Caregiver Psychoeducational Consultation Program in Spouse Caregivers of Resectable Colorectal Cancer
Aim:
To examine the effects of the caregiver psychoeducational consultation program in reducing caregiver burdens, depression, sleep quality, and improving the experience in close relationship, positive meaning of illness and quality of life.
This is the 2-year study. The design adopts the randomized controlled trial (RCT). The caregivers of patients with spouse caregivers of resectable metastatic colorectal cancer will be randomly assigned into two groups: one group receiving usual care, another group receiving the caregiver psychoeducational consultation program (CPCP). The usual care includes providing education materials only. Measurement time-points include pre intervention, post intervention, \& then 1, and 3 months after the end of intervention for the maintenance effect.
Read the detailed description
To examine the effects of the caregiver psychoeducational consultation program in reducing caregiver burdens, depression, sleep quality, and improving the experience in close relationship, positive meaning of illness and quality of life.
This is the 2-year study. The design adopts the randomized controlled trial (RCT). The caregivers of patients with spouse caregivers of resectable metastatic colorectal cancer will be randomly assigned into two groups: one group receiving usual care, another group receiving the caregiver psychoeducational consultation program (CPCP). The usual care includes providing education materials only. Measurement time-points include pre intervention, post intervention, \& then 1, and 3 months after the end of intervention for the maintenance effect.
- Conditions
- Depression, Sleep
- Being tested
- caregiver psychoeducational consultation program (CPCP)
- Keywords
- caregiver, psychoeducational, colon
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caregiver psychoeducational consultation program (CPCP)Other
Also called consultation
6-session caregiver psychoeducational consultation program (CPCP)
| Study group | Role | What they receive |
|---|---|---|
| counseling | Experimental | caregiver psychoeducational consultation program (CPCP) Receives: Other: caregiver psychoeducational consultation program (CPCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-form 12 health-related quality of life questionnaire
Measured: pre intervention, post intervention, 1, and 3,months after the end of the interventions
Secondary outcomes (4)
Caregiver reaction assessment
Measured: pre intervention, post intervention, 1, and 3,months after the end of the interventions
Experiences in close relationships scale
Measured: pre intervention, post intervention, 1, and 3,months after the end of the interventions
Moss sleeping scale
Measured: pre intervention, post intervention, 1, and 3,months after the end of the interventions
BDI-II depression scale
Measured: pre intervention, post intervention, 1, and 3,months after the end of the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Fei Hsiao, PhD, Principal investigator, Department of Nursing, College of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001884
- Sponsor's protocol ID
- 200902029R
- Status last verified
- Jun 2010
- First submitted
- 21 Oct 2009
- Last updated
- 16 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of the Caregiver Psychoeducational Consultation Program in Spouse Caregivers of Resectable Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01001884
- Acronym / sponsor ID
- 200902029R
- Conditions
- Depression, Sleep
- Keywords
- caregiver, psychoeducational, colon
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 27 Oct 2009 (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.
Aim:
To examine the effects of the caregiver psychoeducational consultation program in reducing caregiver burdens, depression, sleep quality, and improving the experience in close relationship, positive meaning of illness and quality of life.
This is the 2-year study. The design adopts the randomized controlled trial (RCT). The caregivers of patients with spouse caregivers of resectable metastatic colorectal cancer will be randomly assigned into two groups: one group receiving usual care, another group receiving the caregiver psychoeducational consultation program (CPCP). The usual care includes providing education materials only. Measurement time-points include pre intervention, post intervention, \& then 1, and 3 months after the end of intervention for the maintenance effect.
Detailed description
To examine the effects of the caregiver psychoeducational consultation program in reducing caregiver burdens, depression, sleep quality, and improving the experience in close relationship, positive meaning of illness and quality of life.
This is the 2-year study. The design adopts the randomized controlled trial (RCT). The caregivers of patients with spouse caregivers of resectable metastatic colorectal cancer will be randomly assigned into two groups: one group receiving usual care, another group receiving the caregiver psychoeducational consultation program (CPCP). The usual care includes providing education materials only. Measurement time-points include pre intervention, post intervention, \& then 1, and 3 months after the end of intervention for the maintenance effect.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| counseling | Experimental | Other: caregiver psychoeducational consultation program (CPCP)caregiver psychoeducational consultation program (CPCP) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Spouse caregivers of patients with resectable colorectal cancer,
- Those who are willing to participate in the research,
- Aged above 18.
Key exclusion criteria (1 listed)
- Who refuses to participate in this study.
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 |
|---|---|---|
| caregiver psychoeducational consultation program (CPCP)Also: consultation6-session caregiver psychoeducational consultation program (CPCP) | Other | counseling |
Primary outcome
Short-form 12 health-related quality of life questionnaire
Time frame: pre intervention, post intervention, 1, and 3,months after the end of the interventions
4 secondary outcomes
Caregiver reaction assessment
Time frame: pre intervention, post intervention, 1, and 3,months after the end of the interventions
Experiences in close relationships scale
Time frame: pre intervention, post intervention, 1, and 3,months after the end of the interventions
Moss sleeping scale
Time frame: pre intervention, post intervention, 1, and 3,months after the end of the interventions
BDI-II depression scale
Time frame: pre intervention, post intervention, 1, and 3,months after the end of the interventions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2010.
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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
Department of Nursing, College of Medicine, 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 caregiver psychoeducational consultation program (CPCP) 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Aug 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fei Hsiao, PhD (+886-2-23123456 ext. 88432, hsiaofei@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-form 12 health-related quality of life questionnaire (time frame: pre intervention, post intervention, 1, and 3,months after the end of the interventions). 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 Aug 2010.