Psychological Wellbeing in Clients in Tier 3 Weight Management Service

Body Image, Psychological Distress, Shame and Disordered Eating in Patients in a Tier 3 Weight Management Service Receiving an Online Delivered, Group Based Compassion Focused Therapy (CFT) Informed Psychological Intervention

This study aims to conduct an initial, single case investigation of changes in feelings of shame, overall psychological wellbeing, body image and disordered eating in patients in naturalistic setting, Tier 3 weight management service, following CFT based, online group intervention that runs for 12 weeks.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Psychological Distress; Body Image; Shame; Disordered Eating
• Intervention / Treatment: Other: Psychological therapy

Detailed Description

Tier 3 weight management services are led by multidisciplinary teams (MDTS) what usually include physicians, dieticians, nurses, physiotherapist, psychiatrists, and psychologists. In the service where the study is conducted referrals to psychology are often made by a dietician. The psychologist in the service also accepts self referrals from patients either during initial assessment with dieticians or at any point of their journey in the service. The psychology pathway is "opt-in", in other words, only patient who actively express interest, motivation and wish to make use of the additional psych resource and accepted.

The participants will be offered the intervention by the group facilitating clinician (who is a part of care team). Initially the principal supervisor was meant to facilitate group intervention, but because the principal supervisor is going on maternity leave the group will be facilitated by a qualified substitute clinician. This clinician will offer an assessment of needs to all patients referred for psychological support. The clinician will act as a gatekeeper and will offer CFT based group intervention when clinically and ethically appropriate (see the exclusion and inclusion criteria below). Taking part in the intervention and signing up for the research will not affect the care patients receive from MDT in the service.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ugne Tartilaite, Trainee; Phone Number: 07519913505; Email: u.tartilaite3@canterbury.ac.uk
• Study Contact Backup: Name: Margie Callanan, Prof; Phone Number: 03330117101; Email: margie.callanan@canterbury.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adults with BMI over 30 who have been referred to Tier 3 weight management service.
• Adults with BMI over 25 with Diabetes who have been referred to Tier 3 weight management service.

Exclusion Criteria:

• group intervention not considered clinically appropriate, following specialist assessment of needs
• not being able to commit to 12-week intervention
• severe interpersonal difficulties that would be disruptive to other group's participants
• moderate to severe learning difficulties
• current alcohol or drug abuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CFT based online group intervention; The group will consist of 12 weekly 1.15h long online sessions.	Other: Psychological therapy; The protocol for the group will be developed collaboratively between the chief researcher and the supervisor based in the weight management service. The protocol will contain Compassion Focused Therapy (CFT) based therapeutic approaches, but the group will integrate some Acceptance and Commitment Therapy (ACT) concepts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experiential Shame Scale	25 items questionnaire. Rated on 4 point Likert scale from 1 (not at all) to 4 (very much).Higher scores indicate higher shame. Minimum of total scores-25, Maximum of total scores- 100.	20 weeks
Clinical Outcomes in Routine Evaluation 10	10 items questionnaire. Items on the CORE measures are scored from zero to four, with higher scores indicating greater levels of distress. Scores of the CORE-10 can be divided into categories of distress: Healthy (0-5), low (6-10), mild (11-14), moderate (15-19), moderate-to-severe (20-24), and severe (25 and above). The maximum of total scores-40, the minimum of total score-0.	20 weeks
Disordered Eating Questionnaire	In part A answers are given on a 5-point frequency scale, the alternatives being never, 1-2 per week, 3-4 per week, every day, more than once a day. In part B the answers are given on a 7-point likert scale ranging from 1 (not at all) to 7 (absolutely). Section A consists of 18 items which evaluate the frequency with which the subject adopts a series of disordered eating behaviors. Section B has 6 items dealing with worries and intrusive thoughts regarding weight, food, calories, physical fitness. The unifactorial structure includes all the items from section A, with the exception of the 4 items concerning purging behaviours and all the items from section B. Adding up the scores of all the items included in the factor, a scale score is obtained whose reliability (measured using Cronbach's alpha) is equal to 0.90. The frequency of purging behaviours is calculated separately by adding the frequencies given in the relative 4 items not included in the scale score.	20 weeks
The Three-Factor Eating Questionnaire-Revised	The instrument has 18 items. The responses are given in likert like scale where points range from 1-4, the final question asks to self rate from 1-8. The maximum of total possible (raw) scores is 76, the minimum is 18. The instrument consists of 3 scales: Cognitive Restraint, Uncontrolled Eating and Emotional Eating Scale. Higher scores in the respective scales are indicative of greater cognitive restraint, uncontrolled, or emotional eating. The raw scale scores are standardized to a 0-100 scale using a formula.	20 weeks
The Body Appreciation Scale-2	10-item scale. The items are rated along a 5-point scale (1 = never, 2 = seldom,3= sometimes,4= often,5= always) and are averaged to obtain an overall body appreciation score. Higher scores reflect greater body appreciation. The maximum of total possible scores is 50, the minimum is 10.	20 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experience of the intervention after it has ended	What would you say had the biggest impact on you as the result of the work you did in the group?; How did the work during the group affect your relationship with your body if at all?; How did the work during the group affect your relationship with food if at all?; Has anything else happened in your life in the last 12 weeks that had an impact on your psychological wellbeing, sense of shame, relationship with food or your body?; Is there anything else about your experience of the work you did in the group that is important and that you would like to mention?	20 weeks

Collaborators and Investigators

• Sponsor: Canterbury Christ Church University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: DClinPsych2020UTartilaite

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No