Back to resultsPre- and Postoperative Cognitive Behavior Therapy for Patients Accepted for Bariatric Surgery
Primary Purpose
Obesity, Morbid
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Morbid focused on measuring comorbidity, Quality of Life, Body Weight Changes
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.
Sites / Locations
- Haugesund Hospital, Helse Fonna HF
Outcomes
Primary Outcome Measures
psychiatric comorbidity
Secondary Outcome Measures
weight loss
Full Information
NCT ID
NCT00635011
First Posted
March 5, 2008
Last Updated
February 25, 2018
Sponsor
Helse Fonna
Collaborators
Helse Vest
1. Study Identification
Unique Protocol Identification Number
NCT00635011
Brief Title
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
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helse Fonna
Collaborators
Helse Vest
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
comorbidity, Quality of Life, Body Weight Changes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
psychotherapy
Intervention Description
Cognitive Behavioral therapy
Primary Outcome Measure Information:
Title
psychiatric comorbidity
Time Frame
five years
Secondary Outcome Measure Information:
Title
weight loss
Time Frame
five years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haldis Oe Lier, MD
Organizational Affiliation
Haugesund Hospital, Helse Fonna HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haugesund Hospital, Helse Fonna HF
City
Haugesund
State/Province
Rogaland
ZIP/Postal Code
N-5504
Country
Norway
12. IPD Sharing Statement
Citations:
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
Results Reference
result
PubMed Identifier
20396993
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.
Results Reference
result
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
Results Reference
result
PubMed Identifier
21943381
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.
Results Reference
derived
Learn more about this trial
Pre- and Postoperative Cognitive Behavior Therapy for Patients Accepted for Bariatric Surgery
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