Can group therapy improve well-being and mental health of overweight women after gastric bypass surgery?

• Register: ISRCTN
• Last refreshed on: 20 March 2023
• Main ID: ISRCTN16417174
• Date of registration: 23/02/2015
• Prospective Registration: No
• Primary sponsor: Karolinska Institute
• Public title: Can group therapy improve well-being and mental health of overweight women after gastric bypass surgery?
• Scientific title: Can a dissonance-based intervention improve quality of life, social adjustment, eating behaviour and physical activity in women after gastric bypass surgery? A randomised controlled study
• Date of first enrolment: 15/01/2015
• Target sample size: 240
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN16417174
• Study type: Interventional
• Study design: Randomised controlled study (Prevention)
• Phase: Not Applicable

Countries of recruitment

Sweden

Contacts

• Name: Fanny Sellberg

• Name: Daniel Berglind

Key inclusion & exclusion criteria

Inclusion criteria:
1. Eligible for gastric bypass surgery: body-mass index >35 kg/m2, usually between 18–65 (with some exceptions)
2. Aged over 18 years old
3. Able to speak and read Swedish
4. Women

Exclusion criteria: Current diagnosis of depression

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Prevention of unwanted mental and physical outcomes after gastric bypass surgery
Digestive System
Obesity and physical and mental health

Intervention(s)

50% of the recruited patients will be randomly allocated to the intervention group after surgery and 50% to the control group (usual post-operative follow-up). The first intervention session will start about 2 months after surgery. The group sessions will consist of 1 hour discussions, role plays and other activities and will be led by a researcher. We will use a dissonance-based group setting with four 1 hour sessions (one session per week) in the intervention group, covering eating behaviour, physical activity and social and intimate relations. Other versions of this intervention have been successfully used in other settings with the same structure, for example, for the prevention of eating disorders in non-obese individuals. The theory is that the participants will discuss difficult situations that might occur after surgery and propose approaches and solutions in a group setting. It is suggested that individuals will then tend to use these approaches themselves if they face difficulties in the future.

Primary Outcome(s)

1. Quality of life, measured with a validated questionnaire (SF-36)
2. Eating behaviour, measured with the Three-Factor Eating Questionnaire and the Disordered Eating after Bariatric Surgery
3. Body esteem, measured with the Body Esteem Scale
4. Social adjustment, measured with the Social Adjustment Scale
5. Physical activity, measured with an accelerometer at before surgery and at 6 months, 1 year and 2 years after surgery; the accelerometers will be posted to the participants and returned in the post

All questionnaires (except SF-36) will be completed at home and emailed to the research group before surgery and at 6 months, 12 months, 18 months and 24 months after surgery. SF-36 will be measured at the same timepoints with a national register as a part of the usual care.

Secondary Outcome(s)

1. Weight
2. Height
3. Waist circumference

The secondary outcomes will be measured before surgery and at 6 months, 12 months, 18 months and 24 months after surgery by the nurses at the hospital where the surgery is done.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Karolinska Institutet, Centre for epidimeology and social medicine

Ethics review

Status:
Approval date:
Contact:

Stockholm Ethics Review Board, 10/12/2013, Dnr: 2013/1847-31/2

Results

• Results available: Yes
• Date Completed: 01/08/2021