Psychological Wellbeing in Clients in Tier 3 Weight Management Service

Not Applicable

• Conditions: Psychological Distress; Shame; Obesity; Disordered Eating; Body Image
• Interventions: Other: Psychological therapy

• Registration Number: NCT05400096
• Lead Sponsor: Canterbury Christ Church University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-05-27
• Study First Posted: 2022-06-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20
• Study Start: 2022-09
• Primary Completion: 2022-12
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CFT based online group intervention	Psychological therapy	The group will consist of 12 weekly 1.15h long online sessions.

Primary Outcome Measures

Name	Time	Method
The Body Appreciation Scale-2	20 weeks	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.
The Three-Factor Eating Questionnaire-Revised	20 weeks	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.
Experiential Shame Scale	20 weeks	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.
Clinical Outcomes in Routine Evaluation 10	20 weeks	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.
Disordered Eating Questionnaire	20 weeks	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.