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

NCT03075345 | Withdrawn DMC

• 1 other identifier: 151261
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Acceptance and Commitment Therapy, Weight Management Service

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)

  24 hours

• Eating Self-Efficacy Scale (ESES)

  24 hours

• Action and Acceptance Questionnaire - II (AAQ-II)

  24 hours

Study Arms (2)

Treatment as usual (weight management intervention)

ACTIVE COMPARATOR

6 session weight management programme (over 12 weeks).

Behavioral: Treatment as usual (dietetic intervention)

Treatment as usual plus acceptance and commitment therapy

EXPERIMENTAL

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; Behavioral: Treatment as usual (dietetic intervention)

Interventions

Acceptance and commitment therapy 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 plus acceptance and commitment therapy

Treatment as usual (dietetic intervention) 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 (weight management intervention); Treatment as usual plus acceptance and commitment therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sheffield: lead
• Mid Yorkshire Teaching NHS Trust: collaborator

Study Sites (1)

University of Sheffield

Sheffield, S1 1HD, United Kingdom

Location

MeSH Terms

Conditions

Obesity

Interventions

Acceptance and Commitment Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee Clinical Psychologist

Study Record Dates

• First Submitted: March 4, 2017
• First Posted: March 9, 2017
• Study Start: May 1, 2017
• Primary Completion: October 1, 2017
• Study Completion: January 1, 2018
• Last Updated: October 16, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)