NCT00635011

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 5, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2008

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

3.8 years

First QC Date

March 5, 2008

Last Update Submit

February 25, 2018

Conditions

Keywords

comorbidityQuality of LifeBody Weight Changes

Outcome Measures

Primary Outcomes (1)

  • psychiatric comorbidity

    five years

Secondary Outcomes (1)

  • weight loss

    five years

Interventions

psychotherapyBEHAVIORAL

Cognitive Behavioral therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients on a waiting list for bariatric surgery at Haugesund hospital

You may not qualify if:

  • Patients with psychosis and suicidality
  • Suicidal attempts the last two years
  • Or suicidal thoughts or plans.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haugesund Hospital, Helse Fonna HF

Haugesund, Rogaland, N-5504, Norway

Location

Related Publications (4)

  • 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

    RESULT
  • 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.

  • 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

    RESULT
  • 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.

MeSH Terms

Conditions

Obesity, MorbidBody Weight Changes

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

  • Haldis Oe Lier, MD

    Haugesund Hospital, Helse Fonna HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, medical doctor

Study Record Dates

First Submitted

March 5, 2008

First Posted

March 13, 2008

Study Start

February 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2017

Last Updated

February 27, 2018

Record last verified: 2018-02

Locations