Psychological DistressNCT05400096
Psychological Wellbeing in Clients in Tier 3 Weight Management Service
A study testing Psychological therapy in people with Psychological Distress and Obesity, run by Canterbury Christ Church University.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Distress, Obesity, Disordered Eating
- What is being tested?
- Psychological therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
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.
- Conditions
- Psychological Distress, Obesity, Disordered Eating, Shame, Body Image
- Being tested
- Psychological therapy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CFT based online group intervention | Experimental | The group will consist of 12 weekly 1.15h long online sessions. Receives: Other: Psychological therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study startSep 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canterbury Christ Church University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400096
- Sponsor's protocol ID
- DClinPsych2020UTartilaite
- Status last verified
- Jul 2022
- First submitted
- 27 May 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05400096
- Acronym / sponsor ID
- DClinPsych2020UTartilaite
- Conditions
- Psychological Distress, Obesity, Disordered Eating, Shame, Body Image
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Canterbury Christ Church UniversityUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CFT based online group intervention | Experimental | Other: Psychological therapyThe group will consist of 12 weekly 1.15h long online sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological therapyThe 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. | Other | CFT based online group intervention |
Primary outcome
Experiential Shame Scale
Time frame: 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
Time frame: 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
Time frame: 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.
The Three-Factor Eating Questionnaire-Revised
Time frame: 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.
The Body Appreciation Scale-2
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological therapy in people with Psychological Distress and Obesity, run by Canterbury Christ Church University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ugne Tartilaite, Trainee (07519913505, u.tartilaite3@canterbury.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experiential Shame Scale (time frame: 20 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.