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

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ClinicalTrials.gov Identifier: NCT00635011
Recruitment Status : Completed
First Posted : March 13, 2008
Last Update Posted : February 27, 2018
Sponsor:
Collaborator:
Helse Vest
Information provided by (Responsible Party):
Haldis Økland Lier, Helse Fonna

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.

Condition or disease Intervention/treatment Phase
Obesity, Morbid Behavioral: psychotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pre- and Postoperative Cognitive Behavior Therapy for Patients Accepted for Bariatric Surgery
Study Start Date : February 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: psychotherapy
    Cognitive Behavioral therapy


Primary Outcome Measures :
  1. psychiatric comorbidity [ Time Frame: five years ]

Secondary Outcome Measures :
  1. weight loss [ Time Frame: five years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00635011


Locations
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Norway
Haugesund Hospital, Helse Fonna HF
Haugesund, Rogaland, Norway, N-5504
Sponsors and Collaborators
Helse Fonna
Helse Vest
Investigators
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Principal Investigator: Haldis Oe Lier, MD Haugesund Hospital, Helse Fonna HF

Publications of Results:
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Haldis Økland Lier, PhD, medical doctor, Helse Fonna
ClinicalTrials.gov Identifier: NCT00635011     History of Changes
Other Study ID Numbers: 16280
First Posted: March 13, 2008    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Keywords provided by Haldis Økland Lier, Helse Fonna:
comorbidity
Quality of Life
Body Weight Changes
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms