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Family Involvement in The Treatment Of a Mentally Ill Relative

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ClinicalTrials.gov Identifier: NCT00258167
Recruitment Status : Unknown
Verified June 2008 by Lev-Hasharon Mental Healtlh Center.
Recruitment status was:  Recruiting
First Posted : November 24, 2005
Last Update Posted : June 11, 2008
Sponsor:
Information provided by:
Lev-Hasharon Mental Healtlh Center

Tracking Information
First Submitted Date  ICMJE November 23, 2005
First Posted Date  ICMJE November 24, 2005
Last Update Posted Date June 11, 2008
Study Start Date  ICMJE November 2005
Estimated Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2008)
Score on the "Experience of Caregiving Inventory" following 8 weeks of participation in the group. [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 23, 2005)
Score on the "Experience of Caregiving Inventory" following 8 weeks of participation in the group.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Family Involvement in The Treatment Of a Mentally Ill Relative
Official Title  ICMJE Family Involvement in The Treatment Of a Mentally Ill Relative
Brief Summary
  • 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".
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Families of Mentally Ill
Intervention  ICMJE Behavioral: filling the "Experience of Caregiving Inventory"
8 weeks of group therapy for family members
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 23, 2005)
50
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2008
Estimated Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • siblings of persons with mental illness

Exclusion Criteria:

  • persons junior then 18 years old
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00258167
Other Study ID Numbers  ICMJE LH12/2005.CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Igor Oyffe, Lev Hasharon Mental Health Center
Study Sponsor  ICMJE Lev-Hasharon Mental Healtlh Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Igor Oyffe, MD Lev-Hasharon Mental Healtlh Center
PRS Account Lev-Hasharon Mental Healtlh Center
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP