Back to resultsEvaluation of a Six-session Psycho-education Group Program
Primary Purpose
Eating Disorders, Personality Disorders
Status
Terminated
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
psycho-education
Sponsored by
About this trial
This is an interventional health services research trial for Eating Disorders focused on measuring Psycho-education, Eating disorders, Personality disorders, Relatives and close friends, Caregiver burden
Eligibility Criteria
Inclusion Criteria:
- Relatives and close friends to persons receiving treatment for their eating disorder and comorbid personality disorder.
- > 18 years,
- Speak and understand norwegian language, and
- Informed consent to participate for both relative and patient.
Sites / Locations
- Østmarka Psychiatric Department, St Olavs Hospital, University Hospital of Trondheim
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
psycho-education
Arm Description
six session psycho-educational group program for family members and close friends of persons with eating disorders and co-morbid personality disorders
Outcomes
Primary Outcome Measures
Scores on perceived caregiver burden (Experience of Caregiving Inventory [ECI])
Secondary Outcome Measures
Scores on general health and relational variables
Full Information
NCT ID
NCT00400933
First Posted
November 16, 2006
Last Updated
February 9, 2012
Sponsor
Norwegian University of Science and Technology
Collaborators
The Royal Norwegian Ministry of Health
1. Study Identification
Unique Protocol Identification Number
NCT00400933
Brief Title
Evaluation of a Six-session Psycho-education Group Program
Official Title
Evaluation of a Six-session Psycho-education Group Program Delivered to Family Members and Close Friends of Patients Suffering From Eating Disorders and Co-morbid Personality Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Terminated
Why Stopped
shortage of experienced health care personnel after reorganisation of units
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
The Royal Norwegian Ministry of Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this project is to analyze the impact of a psycho-educational group program on the family members and close friends of persons with eating disorders and co-morbid personality disorders.
Detailed Description
The aim of this project is to analyze the impact of a six session psycho-educational group program on the family members and close friends of persons with eating disorders and co-morbid personality disorders.
Measurements: General health, perceived caregiver burden, and relation to the patient at the following point of time: pre -, post- and follow up, with waiting list control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders, Personality Disorders
Keywords
Psycho-education, Eating disorders, Personality disorders, Relatives and close friends, Caregiver burden
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
psycho-education
Arm Type
Experimental
Arm Description
six session psycho-educational group program for family members and close friends of persons with eating disorders and co-morbid personality disorders
Intervention Type
Behavioral
Intervention Name(s)
psycho-education
Intervention Description
six session psycho-educational group program for family members and close friends of persons with eating disorders and co-morbid personality disorders
Primary Outcome Measure Information:
Title
Scores on perceived caregiver burden (Experience of Caregiving Inventory [ECI])
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Scores on general health and relational variables
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Relatives and close friends to persons receiving treatment for their eating disorder and comorbid personality disorder.
> 18 years,
Speak and understand norwegian language, and
Informed consent to participate for both relative and patient.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Are Holen, PhD MD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Østmarka Psychiatric Department, St Olavs Hospital, University Hospital of Trondheim
City
Trondheim
ZIP/Postal Code
7044
Country
Norway
12. IPD Sharing Statement
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Evaluation of a Six-session Psycho-education Group Program
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