Pre- and Postoperative Cognitive Behavior Therapy for Patients Accepted for Bariatric Surgery - Full Text View

Sponsor:	Helse Fonna
Collaborator:	Helse Vest
Information provided by:	Helse Fonna
ClinicalTrials.gov Identifier:	NCT00635011

Purpose

The purpose of this study is to investigate the relationship between the potential predictive psychological variables and success after bariatric surgery. The investigators will also investigate the purpose of a pre- and postoperative psychological intervention.

Condition	Intervention
Obesity, Morbid	Behavioral: psychotherapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Pre- and Postoperative Cognitive Behavior Therapy for Patients Accepted for Bariatric Surgery

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Loss Surgery

U.S. FDA Resources

Further study details as provided by Helse Fonna:

Primary Outcome Measures:

psychiatric comorbidity [ Time Frame: five years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

weight loss [ Time Frame: five years ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	February 2008
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Cognitive Behavioral therapy

Detailed Description:

Bariatric surgery is the treatment of choice for morbid obesity, but it does not lead to equal results in every patients. Research about personality factors involved in successful outcome after bariatric surgery has led to contrasting results. The existing literature about potential predictors of success after bariatric surgery is far from conclusive. The investigators want to evaluate preoperatively by standardized diagnostic interviews (MINI, SCID-II) and rating scales and questionnaires to assess co-morbid psychopathology. The same evaluation will be done after 1,2 and 5 years. The investigators will look for a relationship between psychological variables and success after bariatric surgery, including amount of weight loss, psychiatric comorbidity, quality of life and employment. The investigators will also investigate the purpose of an pre- and postoperative psychological intervention. Patients on a waiting list for bariatric surgery are randomised to an intervention- and a control group. The intervention is based on cognitive behavior therapy and mindfulness, 6 weeks preoperative and two weeks postoperative programme. Outcome measures are amount of weight loss, psychiatric comorbidity, quality of life and employment.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients on a waiting list for bariatric surgery at Haugesund hospital

Exclusion Criteria:

Patients with psychosis and suicidality
Suicidal attempts the last two years
Or suicidal thoughts or plans.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635011

Locations

Norway
Haugesund Hospital, Helse Fonna HF
Haugesund, Rogaland, Norway, N-5504

Sponsors and Collaborators

Helse Fonna

Helse Vest

Investigators

Principal Investigator:

Haldis Oe Lier, MD

Haugesund Hospital, Helse Fonna HF

More Information

Publications:

H.Ø.Lier, E. Biringer, H. Eriksen, T. Tangen. Subjective health complaints in a sample with morbid obesity and the complaints' relation with work ability. Poster presentation, 17 th European congress of psychiatry, January 24-28, 2009- Lisbon, Portugal

Lier HO, Biringer E, Stubhaug B, Eriksen HR, Tangen T. Psychiatric Disorders and Participation in Pre- and Postoperative Counselling Groups in Bariatric Surgery Patients. Obes Surg. 2010 Apr 16; [Epub ahead of print]

Responsible Party:	Pre- and postoperative Cognitive Behavior Therapy for patients acceptet for Bariatric surgery., Helse Fonna
ClinicalTrials.gov Identifier:	NCT00635011 History of Changes
Other Study ID Numbers:	16280
Study First Received:	March 5, 2008
Last Updated:	June 20, 2011
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Helse Fonna:

comorbidity
Quality of Life
Body Weight Changes

Additional relevant MeSH terms:

Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012