Eating DisordersPhase 1NCT00400933
Evaluation of a Six-session Psycho-education Group Program
A Phase 1 study testing psycho-education in people with Eating Disorders and Personality Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders, Personality Disorders
- What is being tested?
- psycho-education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2006to Dec 2009
- Phase
- Phase 1
- 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 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Østmarka Psychiatric Department, St Olavs Hospital, University Hospital of Trondheim
Trondheim, Trondheim, 7044
About this study
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
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.
Read the 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.
- Conditions
- Eating Disorders, Personality Disorders
- Being tested
- psycho-education
- Keywords
- Psycho-education, Eating disorders, Personality disorders, Relatives and close friends, Caregiver burden
- Medical subject headings
- Feeding and Eating Disorders, Personality Disorders, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psycho-educationBehavioural
six session psycho-educational group program for family members and close friends of persons with eating disorders and co-morbid personality disorders
| Study group | Role | What they receive |
|---|---|---|
| psycho-education | Experimental | six session psycho-educational group program for family members and close friends of persons with eating disorders and co-morbid personality disorders Receives: Behavioral: psycho-education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on perceived caregiver burden (Experience of Caregiving Inventory [ECI])
Measured: 1 year
Secondary outcomes (1)
Scores on general health and relational variables
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionDec 2008
- Study completionDec 2009
Why it stopped: shortage of experienced health care personnel after reorganisation of units
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health
- Responsible party
- Sponsor
- Investigators
- Are Holen, PhD MD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400933
- Sponsor's protocol ID
- 4,2006.2005
- Status last verified
- Feb 2012
- First submitted
- 16 Nov 2006
- Last updated
- 13 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00400933
- Acronym / sponsor ID
- 4,2006.2005
- Conditions
- Eating Disorders, Personality Disorders
- Keywords
- Psycho-education, Eating disorders, Personality disorders, Relatives and close friends, Caregiver burden
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: shortage of experienced health care personnel after reorganisation of units
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health
- Study start
- Nov 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 17 Nov 2006 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| psycho-education | Experimental | Behavioral: psycho-educationsix session psycho-educational group program for family members and close friends of persons with eating disorders and co-morbid personality disorders |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| psycho-educationsix session psycho-educational group program for family members and close friends of persons with eating disorders and co-morbid personality disorders | Behavioural | psycho-education |
Primary outcome
Scores on perceived caregiver burden (Experience of Caregiving Inventory [ECI])
Time frame: 1 year
1 secondary outcome
Scores on general health and relational variables
Time frame: 1 year
Results and safety
The study was stopped early (reason given: shortage of experienced health care personnel after reorganisation of units). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2012.
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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.
Are Holen, PhD MD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing psycho-education in people with Eating Disorders and Personality Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
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 4 inclusion and 0 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: stopped early, as of the sponsor's last update on 13 Feb 2012. 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 Norway. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: shortage of experienced health care personnel after reorganisation of units). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores on perceived caregiver burden (Experience of Caregiving Inventory [ECI]) (time frame: 1 year). 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 13 Feb 2012.