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| Sponsors and Collaborators: |
Helse Fonna 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: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
| Official Title: | Pre- and Postoperative Cognitive Behavior Therapy for Patients Accepted for Bariatric Surgery |
| 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) |
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. We 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. We 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. We 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Haldis Økland Lier, cand med | 004752732700 | hjol@helse-bergen.no |
| Contact: Tone Tangen, dr med | 004755 95 86 57 | Tone.Tangen@psyk.uib.no |
| Norway, Rogaland | |
| Haugesund Hospital, Helse Fonna HF | Recruiting |
| Haugesund, Rogaland, Norway, N-5504 | |
| Contact: Haldis JO Lier, cand med 0047 52732700 hjol@helse-bergen.no | |
More Information
| Responsible Party: | Helse Fonna ( Pre- and postoperative Cognitive Behavior Therapy for patients acceptet for Bariatric surgery. ) |
| Study ID Numbers: | 16280 |
| Study First Received: | March 5, 2008 |
| Last Updated: | June 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00635011 History of Changes |
| Health Authority: | Norway: Norwegian Social Science Data Services |
|
comorbidity Quality of Life Body Weight Changes |
|
Body Weight Signs and Symptoms Obesity Body Weight Changes Quality of Life |
Nutrition Disorders Overweight Overnutrition Obesity, Morbid |
|
Body Weight Signs and Symptoms Obesity Nutrition Disorders |
Overweight Overnutrition Obesity, Morbid |
