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

February 25, 2018 updated by: Haldis Økland Lier, Helse Fonna
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Rogaland
      • Haugesund, Rogaland, Norway, N-5504
        • Haugesund Hospital, Helse Fonna HF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
psychiatric comorbidity
Time Frame: five years
five years

Secondary Outcome Measures

Outcome Measure
Time Frame
weight loss
Time Frame: five years
five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Fonna

Collaborators

Helse Vest

Investigators

  • Principal Investigator: Haldis Oe Lier, MD, Haugesund Hospital, Helse Fonna HF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

March 5, 2008

First Submitted That Met QC Criteria

March 12, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Actual)

February 27, 2018

Last Update Submitted That Met QC Criteria

February 25, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16280

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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