- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00258167
Family Involvement in The Treatment Of a Mentally Ill Relative
June 10, 2008 updated by: Lev-Hasharon Mental Healtlh Center
- Research demonstrates that the families of the seriously mentally ill are burdened by this caregiving role and by their responsibilities
- Research also demonstrates that family interventions are effective and that they have a potential to reduce family burden, as well as to improve the condition of the mentally ill patients.
- We assume that the sibling group intervention would be effective in reducing the family burden of the siblings, and that this reduction would be reflected in their replies to the "Experience of Caregiving Inventory".
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
- The group for siblings is an intervention which is carried out in the outpatient clinic of Lev HaSharon Mental Health Center in cycles which last eight weeks;
- Every group cycle will include between 10-14 participants, all siblings of persons with mental illness. The patients themselves (ill siblings) are either hospitalized in Lev HaSharon Mental Health Center, or are outpatients in the Lev HaSharon Mental Health Outpatient Unit, or in the community at large.
- The group is an ongoing group: short term intensive group intervention in a dynamic orientation. Veteran participants of each cycle are welcome to re-join at following cycles, and at the same time new participants can join at the beginning of each cycle.
- Participants will be asked to fill the "Experience of Caregiving Inventory" twice: first time before the first meeting of a particular cycle of sibling group and second time: after the last (eighth) meeting of this group cycle.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Igor Oyffe, MD
- Phone Number: 972-8981248
- Email: ioyffe@lev-hasharon.co.il
Study Locations
-
-
-
Netanya, Israel, 42100
- Recruiting
- Lev-HasharonMHC
-
Contact:
- Igor Oyffe, MD
- Phone Number: 972-9-8981248
- Email: ioyffe@lev-hasharon.co.il
-
Contact:
- Shuvit Melamed, MSW
- Phone Number: +972-9-8981278
- Email: shuvitm@lev-hasharon.co.il
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Principal Investigator:
- Igor Oyffe, MD
-
Sub-Investigator:
- Shuvit Melamed, MSW
-
Sub-Investigator:
- Michal Ferkel, MSW
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- siblings of persons with mental illness
Exclusion Criteria:
- persons junior then 18 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Score on the "Experience of Caregiving Inventory" following 8 weeks of participation in the group.
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Igor Oyffe, MD, Lev-Hasharon Mental Healtlh Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dixon L, McFarlane WR, Lefley H, Lucksted A, Cohen M, Falloon I, Mueser K, Miklowitz D, Solomon P, Sondheimer D. Evidence-based practices for services to families of people with psychiatric disabilities. Psychiatr Serv. 2001 Jul;52(7):903-10. doi: 10.1176/appi.ps.52.7.903.
- Melamed, S. Permission: A conceptual tool for treating mentally ill patients and their families. Journal of Family Psychotherapy. 12 (2). Pp. 29-42, 2001.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (Anticipated)
November 1, 2008
Study Completion (Anticipated)
November 1, 2008
Study Registration Dates
First Submitted
November 23, 2005
First Submitted That Met QC Criteria
November 23, 2005
First Posted (Estimate)
November 24, 2005
Study Record Updates
Last Update Posted (Estimate)
June 11, 2008
Last Update Submitted That Met QC Criteria
June 10, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- LH12/2005.CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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