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

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00635011
• Other study ID #: 16280
• Status: Completed
• Phase: N/A
• First received: March 5, 2008
• Last updated: February 25, 2018
• Start date: February 2008
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Helse Fonna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

Behavioral:
• psychotherapy
Cognitive Behavioral therapy

Locations

Country	Name	City	State
Norway	Haugesund Hospital, Helse Fonna HF	Haugesund	Rogaland

Sponsors (2)

Lead Sponsor	Collaborator
Helse Fonna	Helse Vest

Country where clinical trial is conducted

Norway, 

References & Publications (3)

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 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

Lier HØ, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	psychiatric comorbidity		five years
Secondary	weight loss		five years