Evaluation of a Six-session Psycho-education Group Program | NCT00400933

Studies
Evaluation of a Six-session Psycho-education Group Program

NCT00400933

Sponsor

Norwegian University of Science and Technology

Status

Terminated

Last Update Posted

Feb 13, 2012Estimated

Enrollment

10Actual

Phase

Phase 1

Conditions

Eating Disorders
Personality Disorders

Interventions

psycho-education

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

shortage of experienced health care personnel after reorganisation of units

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2009Actual

First Submitted Date

Nov 16, 2006

First Submission Date that Met QC Criteria

Nov 16, 2006

First Posted Date

Nov 17, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2012

Last Update Posted Date

Feb 13, 2012Estimated

Name	Class
The Royal Norwegian Ministry of Health	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Behavioral: psycho-education

Interventions

Name	Type	Description	Arm Group Labels	Other Names
psycho-education	Behavioral	six session psycho-educational group program for family members and close friends of persons with eating disorders and co-morbid personality disorders

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Scores on perceived caregiver burden (Experience of Caregiving Inventory [ECI])		1 year

Secondary Outcomes

Measure	Description	Time Frame
Scores on general health and relational variables		1 year

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

67 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Are Holen, PhD MD	Norwegian University of Science and Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Østmarka Psychiatric Department, St Olavs Hospital, University Hospital of Trondheim		Trondheim	Trondheim	7044	Norway

Condition Browse Module

MeSH Terms

ID	Term
D001068	Feeding and Eating Disorders
D010554	Personality Disorders
D000084802	Caregiver Burden

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided