CClinicalTrials.gg
Status unknownNCT05400096Updated Jul 20, 2022

Psychological Wellbeing in Clients in Tier 3 Weight Management Service

An interventional study of Psychological therapy in Psychological Distress, Obesity and Disordered Eating, sponsored by Canterbury Christ Church University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-20.

Sponsored by Canterbury Christ Church University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Psychological Distress
  • Obesity
  • Disordered Eating
  • Shame
  • Body Image
03

In context

Lead sponsor

Canterbury Christ Church University is the lead sponsor of 27 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    CFT based online group intervention

    The group will consist of 12 weekly 1.15h long online sessions.

    Other: Psychological therapy

Interventions

  • OtherPsychological 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 20 weeks

  2. 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.

    Time frame: 20 weeks

  3. 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.

    Time frame: 20 weeks

  4. 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.

    Time frame: 20 weeks

  5. 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.

    Time frame: 20 weeks

Other outcomes

  1. Experience of the intervention after it has ended

    1. What would you say had the biggest impact on you as the result of the work you did in the group? 2. How did the work during the group affect your relationship with your body if at all? 3. How did the work during the group affect your relationship with food if at all? 4. 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? 5. 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?

    Time frame: 20 weeks

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05400096
Lead sponsor
Canterbury Christ Church University
Responsible party
Sponsor
First posted
Jun 1, 2022
Start date
Sep 2022 (estimated)
Primary completion
Dec 2022 (estimated)
Completion
Apr 2023 (estimated)
Last update
Jul 20, 2022

Study contacts

Ugne Tartilaite, Trainee
Contact
u.tartilaite3@canterbury.ac.uk
07519913505
Margie Callanan, Prof
Contact
margie.callanan@canterbury.ac.uk
03330117101

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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