Obesity, MorbidNCT00635011
Pre- and Postoperative Cognitive Behavior Therapy for Patients Accepted for Bariatric Surgery
A study testing psychotherapy in people with Obesity, Morbid, run by Helse Fonna at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2008to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients on a waiting list for bariatric surgery at Haugesund hospital
Who cannot join
- Patients with psychosis and suicidality
- Suicidal attempts the last two years
- Or suicidal thoughts or plans.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obesity, Morbid
- Being tested
- psychotherapy
- Keywords
- comorbidity, Quality of Life, Body Weight Changes
- Medical subject headings
- Obesity, Morbid, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychotherapyBehavioural
Cognitive Behavioral therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
psychiatric comorbidity
Measured: five years
Secondary outcomes (1)
weight loss
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2011
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Fonna
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Vest
- Responsible party
- Principal investigator, Haldis Økland Lier, Helse Fonna
- Investigators
- Haldis Oe Lier, MD, Principal investigator, Haugesund Hospital, Helse Fonna HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635011
- Sponsor's protocol ID
- 16280
- Status last verified
- Feb 2018
- First submitted
- 5 Mar 2008
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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 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.
PubMed 20396993Lier 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 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.
PubMed 21943381
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre- and Postoperative Cognitive Behavior Therapy for Patients Accepted for Bariatric Surgery
- ClinicalTrials.gov ID
- NCT00635011
- Acronym / sponsor ID
- 16280
- Conditions
- Obesity, Morbid
- Keywords
- comorbidity, Quality of Life, Body Weight Changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Helse FonnaUniversity, hospital or other
- Collaborators
- Helse Vest
- Study start
- Feb 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 13 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients on a waiting list for bariatric surgery at Haugesund hospital
Key exclusion criteria (3 listed)
- Patients with psychosis and suicidality
- Suicidal attempts the last two years
- Or suicidal thoughts or plans.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychotherapyCognitive Behavioral therapy | Behavioural | – |
Primary outcome
psychiatric comorbidity
Time frame: five years
1 secondary outcome
weight loss
Time frame: five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Results publicationH.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 publication: PubMed 20396993Lier 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 publicationLier 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
- Derived from this study: PubMed 21943381Lier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haldis Oe Lier, MD principal investigator
Haugesund Hospital, Helse Fonna HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychotherapy in people with Obesity, Morbid, run by Helse Fonna at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
psychiatric comorbidity (time frame: five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00635011, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2018; AzTrials last refreshed its copy on 31 Oct 2026.