Overview

This trial is active, not recruiting.

Condition obesity, morbid
Treatment psychotherapy
Sponsor Helse Fonna
Collaborator Helse Vest
Start date February 2008
End date December 2011
Trial size 100 participants
Trial identifier NCT00635011, 16280

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
psychiatric comorbidity
time frame: five years

Secondary Outcomes

Measure
weight loss
time frame: five years

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title Pre- and Postoperative Cognitive Behavior Therapy for Patients Accepted for Bariatric Surgery
Principal investigator Haldis Oe Lier, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Helse Fonna.