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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Testing the Added Benefit of Acceptance and Commitment Therapy (ACT) in the Treatment of Obesity: a Pilot Randomised Controlled Trial.

Conditions
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Obesity, Acceptance and Commitment Therapy, Weight Management Service

Intervention / Treatment
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* Behavioral: Acceptance and commitment therapy
* Behavioral: Treatment as usual (dietetic intervention)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment as usual (weight management intervention)<br>6 session weight management programme (over 12 weeks). | Behavioral: Treatment as usual (dietetic intervention)<br>* Six sessions of a dietetic intervention will be psychoeducational in nature around weight and nutrition, delivered by professionals working in the service.<br>|
| Experimental: Treatment as usual plus acceptance and commitment therapy<br>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. | Behavioral: Acceptance and commitment therapy<br>* 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.<br>Behavioral: Treatment as usual (dietetic intervention)<br>* Six sessions of a dietetic intervention will be psychoeducational in nature around weight and nutrition, delivered by professionals working in the service.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale (HADS) | A measure of psychological distress in relation to anxiety and depression symptoms. There is a total of 14 items (7 items relate to anxiety; 7 items relate to depression) with answers scored on a Likert scale of 0-3 (scores from 0-42; higher scores indicating worse symptoms). | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) | The SF-36 is a generic measure of health related quality of life. There is a total of 36 questions which can be grouped into 3 levels: i) 36 individual items; ii) 8 subscales; iii) 2 summary measures. | 24 hours | 
| Eating Self-Efficacy Scale (ESES) | It measures self-efficacy. It contains 25-items measuring the person's confidence in ability to manage overeating in various situations (Likert scale 1-7 used). | 24 hours | 
| Action and Acceptance Questionnaire - II (AAQ-II) | The AAQ-II is a measure of experiential avoidance (i.e., attempts to alter difficult internal experiences which often leads to increased distress) and psychological inflexibility. Patients are asked to rate their experiences on a 7-point Likert scale (from '1: never true' to '7: always true'). | 24 hours |