- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00400933
Evaluation of a Six-session Psycho-education Group Program
February 9, 2012 updated by: Norwegian University of Science and Technology
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Trondheim, Norway, 7044
- Østmarka Psychiatric Department, St Olavs Hospital, University Hospital of Trondheim
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-
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 to 67 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
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
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: psycho-education
six session psycho-educational group program for family members and close friends of persons with eating disorders and co-morbid personality disorders
|
six session psycho-educational group program for family members and close friends of persons with eating disorders and co-morbid personality disorders
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Scores on perceived caregiver burden (Experience of Caregiving Inventory [ECI])
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Scores on general health and relational variables
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Are Holen, PhD MD, Norwegian University of Science and Technology
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, 2006
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
November 16, 2006
First Submitted That Met QC Criteria
November 16, 2006
First Posted (Estimate)
November 17, 2006
Study Record Updates
Last Update Posted (Estimate)
February 13, 2012
Last Update Submitted That Met QC Criteria
February 9, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4,2006.2005
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.