Clinical trial NCT00635011: Pre- and Postoperative Cognitive Behavior Therapy for Patients Accepted for Bariatric Surgery
Official title: Pre- and Postoperative Cognitive Behavior Therapy for Patients Accepted for Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Keywords: comorbidity
Quality of Life
Body Weight Changes
Lead sponsor: Helse Fonna
Sponsor class: OTHER
Collaborators: name: Helse Vest
First posted: 2008-03-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: psychiatric comorbidity
timeFrame: five years
Secondary outcomes:
measure: weight loss
timeFrame: five years
Other outcomes:
Locations:
city: Haugesund
country: Norway
facility: Haugesund Hospital, Helse Fonna HF
state: Rogaland
Study officials:
affiliation: Haugesund Hospital, Helse Fonna HF
name: Haldis Oe Lier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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. 2011 Jun;21(6):730-7. doi: 10.1007/s11695-010-0146-7.
citation: Lier H, Biringer E, Stubhaug B, Eriksen HR, Tangen T. Patient outcome expectancy from bariatric surgery. European Psychiatry 25 (supplement 1), 2010 819. 18 th European Congress of Psychiatry. February 27, March 2, 2010-Munich, Germany
citation: Lier HO, Biringer E, Hove O, Stubhaug B, Tangen T. Quality of life among patients undergoing bariatric surgery: associations with mental health- A 1 year follow-up study of bariatric surgery patients. Health Qual Life Outcomes. 2011 Sep 26;9:79. doi: 10.1186/1477-7525-9-79.