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
1 other identifier
interventional
12
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2022
CompletedFirst Posted
Study publicly available on registry
June 1, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedJuly 20, 2022
July 1, 2022
3 months
May 27, 2022
July 19, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (1)
Experience of the intervention after it has ended
20 weeks
Study Arms (1)
CFT based online group intervention
EXPERIMENTALThe group will consist of 12 weekly 1.15h long online sessions.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2022
First Posted
June 1, 2022
Study Start
September 1, 2022
Primary Completion
December 1, 2022
Study Completion
April 1, 2023
Last Updated
July 20, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share