Acceptance and Commitment Therapy in the Treatment of Obesity: Pilot.

NCT ID: NCT03075345

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-31
• Study Completion Date: 2018-01-31

Brief Summary

Obesity is an 'epidemic' within the UK. Individuals living with obseity are at risk of developing cancer, heart problems and dieing. Furthermore, obesity impacts on psychological wellbeing via lowered self-efficacy, self-esteem, body image and overall quality of life (QoL). A pilot randomised controlled trial (RCT) is proposed to investigate the additional benefit of a psychological intervention alongside treatment as usual (TAU) in a weight management service. Patients routinely attending an outpatient clinic will be randomised into TAU with or without additional acceptance and commitment Therapy (ACT) group based-input and their outcomes monitored over time.

Detailed Description

Overweight and obesity is reported as an 'epidemic' problem within the UK as well as the world. Individuals living with this may be at higher risk of developing co-morbidities, such as cancers, heart problems or diabetes, and higher mortality rates are reported in this group. Furthermore, overweight and obesity can also impact on a person's psychological wellbeing, such as their self-efficacy, self-esteem and body image as well as have a negative effect on their overall quality of life (QoL). Therefore, a pilot randomised controlled trial (RCT) is proposed to investigate the additional benefit of a psychological intervention alongside treatment as usual (TAU) in a weight management service. Patients routinely attending an outpatient clinic will be randomised into TAU with or without additional Acceptance and Commitment Therapy (ACT) group based-input.

Conditions

Obesity, Acceptance and Commitment Therapy, Weight Management Service

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment as usual (weight management intervention)

6 session weight management programme (over 12 weeks).

Group Type: ACTIVE_COMPARATOR

Treatment as usual (dietetic intervention)

Intervention Type: BEHAVIORAL

Six sessions of a dietetic intervention will be psychoeducational in nature around weight and nutrition, delivered by professionals working in the service.

Treatment as usual plus acceptance and commitment therapy

6 session weight management programme (over 12 weeks) plus a 4 session acceptance and commitment therapy (ACT) programme. The ACT part will commence straight after the conclusion of the weight management programme.

Group Type: EXPERIMENTAL

Acceptance and commitment therapy

Intervention Type: BEHAVIORAL

Four sessions of the ACT protocol will be psychoeducational in nature, with brief experiential exercises in the class and in-between session practice. It's aim is to allow individuals to be able to sit with difficult experiences (rather than fight against them) and in turn this may allow them to live towards what they value in life.

Treatment as usual (dietetic intervention)

Intervention Type: BEHAVIORAL

Six sessions of a dietetic intervention will be psychoeducational in nature around weight and nutrition, delivered by professionals working in the service.

Interventions

Acceptance and commitment therapy

Four sessions of the ACT protocol will be psychoeducational in nature, with brief experiential exercises in the class and in-between session practice. It's aim is to allow individuals to be able to sit with difficult experiences (rather than fight against them) and in turn this may allow them to live towards what they value in life.

Intervention Type: BEHAVIORAL

Treatment as usual (dietetic intervention)

Six sessions of a dietetic intervention will be psychoeducational in nature around weight and nutrition, delivered by professionals working in the service.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Individuals will be willing and able to give informed consent for participation in the study;
• Male or Female, aged 18 years or above.
• Individuals will have a Body Mass Index (BMI) of over 40 (or over 35 if they are from a black or other minority ethic (BME) group or have a co-existing physical health problem);
• Individuals will be on a waiting list for a weight loss management programme in the UK;
• Individuals will have English as a written language.

Exclusion Criteria

• Individuals who are currently pregnant or breastfeeding;
• Individuals with current drug or alcohol abuse, such that would prevent them from engaging in a weight management programme;
• Individuals who are acutely mentally unwell, such that would prevent them from engaging in a weight management programme;
• Individuals who at time of referral are at significant risk to themselves of others, such that would prevent them from engaging in a weight management programme;
• Individuals who are acutely physically unwell and/or hospitalised, such that would prevent them from engaging in a weight management programme;
• Individuals who have a learning disability or cognitive impairment, such that would prevent them from engaging in a weight management programme.
• Currently in receipt of psychiatric services.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mid Yorkshire Teaching NHS Trust

OTHER

Sponsor Role: collaborator

University of Sheffield

OTHER

Sponsor Role: lead

Responsible Party

Sarah Wakefield

Trainee Clinical Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Sheffield

Sheffield, , United Kingdom

Countries

United Kingdom

Other Identifiers

151261

Identifier Type: -

Identifier Source: org_study_id