Anorexia NervosaCAREFREENCT06624397
Evaluation of a New Program for Carers of People with Anorexia Nervosa
A study testing CAREFREE Carer's Programme in people with Anorexia Nervosa and Carer Stress Syndrome, run by NHS Forth Valley at 2 sites in United Kingdom.
Trial summary
CAREFREE is a 12-session Carer's Programme for carers of adults with moderate to severe Anorexia Nervosa. This programme was developed to provide carers with an opportunity to develop an understanding of Anorexia from a Biopsychosocial framework, taking into account the complex array of biological, psychological and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anorexia Nervosa, Carer Stress Syndrome
- What is being tested?
- CAREFREE Carer's Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 May 2023to 30 Jun 2025
- 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
- Has a family member, partner or spouse/partner with moderate-severe, treatment resistant and/or co-morbid anorexia nervosa (as diagnosed by a clinician at one these centres)
- Is over the age of 17
- Can speak and read English
- Has access to the internet and is comfortable using an online meeting platform
- Have moderate-severe, treatment resistant and/or co-morbid anorexia nervosa (as diagnosed by a clinician at one these centres)
- Is over 17 years of age
- Can speak and read English
Who cannot join
- Cannot speak/read English
- Is currently suffering from acute psychosis
- Participants with Anorexia
- Is currently suffering from acute psychotic mental health state
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
NHS Glasgow
Glasgow, Scotland, G50YZ
Emma MAwdsley, 44 1412327055, emma.mawdsley@nhs.scot
Charlotte Nevison, 44 1412327055, Charlotte.Nevison@nhs.scot
- Recruiting
NHS Forth Valley
Stirling, Stirlingshire, FK1 5SU
Lesley Symon, 44 1324566316, lesley.symon@nhs.scot
Susan Simpson, 44 1786458549, susan.g.simpson@nhs.scot
About this study
Official title: Evaluation of a Skills-Based Program for Carers & Families of Patients with Anorexia Nervosa
CAREFREE is a 12-session Carer's Programme for carers of adults with moderate to severe Anorexia Nervosa. This programme was developed to provide carers with an opportunity to develop an understanding of Anorexia from a Biopsychosocial framework, taking into account the complex array of biological, psychological and social/environmental factors associated with the development and maintenance of this disorder. The CAREFREE programme is unique in its focus on providing a framework for understanding AN from a Schema -Compassion Focused framework, incorporating psychoeducation in regard to both Anorexia Nervosa and Carer Burnout. The programme has a relational focus, with an emphasis on improving emotional fluency, family communication skills and self-other compassion. The CAREFREE programme is open to carers from across Scotland and runs online. Outcomes (including carer and patient quality of life, family communication, patient motivation to change) will be analysed and published at the end of the 24-month period. One of the key benefits of this programme is that as it is a cross-regional-NHS project.
Read the detailed description
Moderate to Severe Anorexia Nervosa (AN-MS)is characterised by poor treatment outcomes, poor quality of life, low motivation levels and ambivalence about change, with high burden on families and NHS services. This study aims to improve quality of life and relationships amongst those with AN-MS and their families/partners/carers, and enhance motivation to recover amongst adults with AN-MS, ultimately resulting in enhanced care and reduced inpatient admissions. We will evaluate a new online group intervention for families/carers and partners. This is a two-phase study: Phase 1 feasibility trial will evaluate factors such as recruitment and retention of clinicians and participants, collection of assessment measures and acceptability of the intervention. Phase 2 will use this information to inform the development of a second more robust feasibility study which will enable us to determine whether this new untested intervention is effective in its own right, as a precursor for a larger definitive trial.
- Conditions
- Anorexia Nervosa, Carer Stress Syndrome
- Being tested
- CAREFREE Carer's Programme
- Keywords
- Anorexia Nervosa, Burnout, Carer Burnout, CAREFREE
- Medical subject headings
- Anorexia Nervosa, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAREFREE Carer's ProgrammeOther
This programme was developed to provide carers with an opportunity to develop an understanding of Anorexia from a Biopsychosocial framework, taking into account the complex array of biological, psychological and social/environmental factors associated with the development and maintenance of this disorder. CAREFREE programme is unique in its focus on providing a framework for understanding AN from a Schema - Compassion Focused framework, incorporating psychoeducation in regard to both Anorexia Nervosa and Carer Burnout. The programme has a relational focus, with an emphasis on improving emotional fluency, family communication skills and self-other compassion.
| Study group | Role | What they receive |
|---|---|---|
| CAREFREE is a 12-session Carer's Programme | Experimental | This programme was developed to provide carers with an opportunity to develop an understanding of Anorexia from a Biopsychosocial framework, taking into account the complex array of biological, psychological and social/environmental factors associated with the development and maintenance of this disorder. CAREFREE programme is unique in its focus on providing a framework for understanding AN from a Schema Therapy - Compassion Focused framework, incorporating psychoeducation in regard to both Anorexia Nervosa and Carer Burnout. The programme has a relational focus, with an emphasis on improving emotional fluency, family communication skills and self-other compassion. Receives: Other: CAREFREE Carer's Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
(SRS-Version 3) (Johnson, Miller, & Duncan, 2000).
Therapeutic alliance will be evaluated using this 4-item Session Rating Scale after each session
Measured: Weekly after each Carer group Session
Short Rating Scales
- VAS scales will used to assess carers' ratings of: (1) Quality of life (taken from the WHOQOL-BREF) and (2) Quality of relationship with the patient with AN. (taken from SCORE-15)
Measured: Pre (0-6 weeks before group programme begins); Weekly throughout programme; and Post (0-4 weeks after group programme ends)
Experiences in Close Relationships Revised (ECR-R; Fraley et al., 2000; 36 items)
Assesses self reported individual differences regarding attachment-related anxiety and avoidance.
Measured: Pre (0-6 weeks before group programme begins) and Post (0-4 weeks after group programme ends) and at 3-months followup
WHOQOL-BREF (WhoQol Group, 1998)
This is a World Health Organisation Quality of Life Assessment and is a widely used quality of life instrument which contains 26 items over 4 dimensions - physical health, psychological health, social relationships, environment, quality of life and general health.
Measured: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
Depression, anxiety, and stress scale (DASS)
Depression, anxiety, and stress scale (DASS) is a 21-item measure assessing depression, anxiety, and stress over the past seven days using a four-point Likert scale. Scores of these three subscales can be added to obtain a total score for psychological distress.
Measured: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
SCORE-15 Index of Family Functioning and Change (Stratton et al., 2010)
- SCORE is a self report outcome measure designed to be sensitive to the kinds of changes in family relationships that systemic family and couples' therapists see as indications of useful therapeutic change.
Measured: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
Family Questionnaire (Wiedemann et al 2002)
This questionnaire will be used to measure expressed emotion within the family system.
Measured: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
Schema Mode Inventory (Young et al., 2007)
5 items of this scale are included in the outcomes to measure healthy functioning.
Measured: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
Eating disorder symptom impact scale (EDSIS; Sepulveda et al., 2008)
This is a 24-item self-report measure of caregiving burden in eating disorders. The scale comprises of subjective and objective burden across four subscales: managing nutritional situations, dealing with dysregulated behaviors, guilt, and social isolation. Scores are obtained on a five-point Likert scale. Higher scores indicate higher caregiving burden and more negative appraisal of caregiving
Measured: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
Young Parenting Inventory-revised (YPI-R2; Louis, Wood and Lockwood, 2018)
This scale assesses perceived parenting experiences. The YPI-R2 is a 36-item questionnaire measuring parenting styles, namely: Competitiveness and Status seeking; Degradation and Rejection; Emotional Inhibition and Deprivation; Overprotection and Overindulgence; Punitiveness; Controlling. Subscale scores are calculated as mean scores with higher scores indicating stronger perceived negative parenting.
Measured: Pre -group (0-6 weeks before group programme begins)
Secondary outcomes (5)
Eating Disorder Quality of Life questionnaire (EDQoL; Engel et al., 2006).
Measures Quality of Life of the Patient with Anorexia Nervosa
Measured: Pre (0-6 weeks before group programme begins) and Post (0-4 weeks after group programme ends)
SCORE-15 and Young Parenting Inventory (YPI-R))
These measure family functioning in the patient with Anorexia Nervosa
Measured: Pre (0-6 weeks before group programme begins); and Post (0-4 weeks after group programme ends)
Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ; Rieger et al., 2002)
This scale measures motivation to recover in the person with Anorexia Nervosa
Measured: Pre (0-6 weeks before group programme begins); and Post (0-4 weeks after group programme ends)
Demographics Questionnaire
A demographics questionnaire will be filled out by the person with Anorexia Nervosa to ascertain details including: age, age of onset of eating disorder, occupation, relationship with the patient/carer, level of education, postcode, whether or not the person with anorexia is living from home and/or what age they moved out; relationship status, receipt of patient/carer benefits.
Measured: 0-6 weeks before attending group programme
Qualitative Interview with person with Anorexia Nervosa
A Qualitative Interview will be carried out with the person with Anorexia Nervosa whose carers are attending the CAREFREE programme, to ascertain their views on the degree to which the programme has impacted family functioning and relationships, as well as their own perspectives in regard to Anorexia Nervosa.
Measured: 0-4 weeks after group intervention is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start1 May 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- CAREFREE is a 12-session Carer's Programme for carers of adults with moderate to severe Anorexia Nervosa. This programme was developed to provide carers with an opportunity to develop an understanding of Anorexia from a Biopsychosocial framework, taking into account the complex array of biological, psychological and social/environmental factors associated with the development and maintenance of this disorder. CAREFREE is based on a Schema Therapy - Compassion Focused framework, incorporating psychoeducation in regard to both Anorexia Nervosa and Carer Burnout. The programme has a relational focus, with an emphasis on improving emotional fluency, family communication skills and self-other compassion.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Forth Valley
- Sponsor type
- Other government
- Collaborators
- NHS Lothian, University of Stirling, NHS Greater Glasgow and Clyde Board HQ
- Responsible party
- Principal investigator, Dr Susan Simpson, NHS Forth Valley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624397
- Sponsor's protocol ID
- FV1421
- Other IDs
- TCS/22/05
- Acronym
- CAREFREE
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified patient data will only be shared with researchers who are directly involved in the project in some capacity
Publications
Mawdsley E, McNicol S, Rutherford AC, Symon L, Smith D, Elliott H, Simpson S. A case series evaluation of a schema therapy-coaching programme for carers of patients with moderate to severe anorexia nervosa: the CAREFREE programme. J Eat Disord. 2026 Jul 16. doi: 10.1186/s40337-026-01704-9. Online ahead of print.
PubMed 42458655
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Skills-Based Program for Carers & Families of Patients with Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT06624397
- Acronym / sponsor ID
- CAREFREE / FV1421
- Conditions
- Anorexia Nervosa, Carer Stress Syndrome
- Keywords
- Anorexia Nervosa, Burnout, Carer Burnout, CAREFREE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- NHS Forth ValleyOther government
- Collaborators
- NHS Lothian, University of Stirling, NHS Greater Glasgow and Clyde Board HQ
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 3 Oct 2024 (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.
CAREFREE is a 12-session Carer's Programme for carers of adults with moderate to severe Anorexia Nervosa. This programme was developed to provide carers with an opportunity to develop an understanding of Anorexia from a Biopsychosocial framework, taking into account the complex array of biological, psychological and social/environmental factors associated with the development and maintenance of this disorder. The CAREFREE programme is unique in its focus on providing a framework for understanding AN from a Schema -Compassion Focused framework, incorporating psychoeducation in regard to both Anorexia Nervosa and Carer Burnout. The programme has a relational focus, with an emphasis on improving emotional fluency, family communication skills and self-other compassion. The CAREFREE programme is open to carers from across Scotland and runs online. Outcomes (including carer and patient quality of life, family communication, patient motivation to change) will be analysed and published at the end of the 24-month period. One of the key benefits of this programme is that as it is a cross-regional-NHS project.
Detailed description
Moderate to Severe Anorexia Nervosa (AN-MS)is characterised by poor treatment outcomes, poor quality of life, low motivation levels and ambivalence about change, with high burden on families and NHS services. This study aims to improve quality of life and relationships amongst those with AN-MS and their families/partners/carers, and enhance motivation to recover amongst adults with AN-MS, ultimately resulting in enhanced care and reduced inpatient admissions. We will evaluate a new online group intervention for families/carers and partners. This is a two-phase study: Phase 1 feasibility trial will evaluate factors such as recruitment and retention of clinicians and participants, collection of assessment measures and acceptability of the intervention. Phase 2 will use this information to inform the development of a second more robust feasibility study which will enable us to determine whether this new untested intervention is effective in its own right, as a precursor for a larger definitive trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- CAREFREE is a 12-session Carer's Programme for carers of adults with moderate to severe Anorexia Nervosa. This programme was developed to provide carers with an opportunity to develop an understanding of Anorexia from a Biopsychosocial framework, taking into account the complex array of biological, psychological and social/environmental factors associated with the development and maintenance of this disorder. CAREFREE is based on a Schema Therapy - Compassion Focused framework, incorporating psychoeducation in regard to both Anorexia Nervosa and Carer Burnout. The programme has a relational focus, with an emphasis on improving emotional fluency, family communication skills and self-other compassion.
| Arm | Type | Receives |
|---|---|---|
| CAREFREE is a 12-session Carer's Programme | Experimental | Other: CAREFREE Carer's ProgrammeThis programme was developed to provide carers with an opportunity to develop an understanding of Anorexia from a Biopsychosocial framework, taking into account the complex array of biological, psychological and social/environmental factors associated with the development and maintenance of this disorder. CAREFREE programme is unique in its focus on providing a framework for understanding AN from a Schema Therapy - Compassion Focused framework, incorporating psychoeducation in regard to both Anorexia Nervosa and Carer Burnout. The programme has a relational focus, with an emphasis on improving emotional fluency, family communication skills and self-other compassion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has a family member, partner or spouse/partner with moderate-severe, treatment resistant and/or co-morbid anorexia nervosa (as diagnosed by a clinician at one these centres)
- Is over the age of 17
- Can speak and read English
- Has access to the internet and is comfortable using an online meeting platform
- Have moderate-severe, treatment resistant and/or co-morbid anorexia nervosa (as diagnosed by a clinician at one these centres)
Key exclusion criteria (4 listed)
- Cannot speak/read English
- Is currently suffering from acute psychosis
- Participants with Anorexia
- Is currently suffering from acute psychotic mental health state
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 |
|---|---|---|
| CAREFREE Carer's ProgrammeThis programme was developed to provide carers with an opportunity to develop an understanding of Anorexia from a Biopsychosocial framework, taking into account the complex array of biological, psychological and social/environmental factors associated with the development and maintenance of this disorder. CAREFREE programme is unique in its focus on providing a framework for understanding AN from a Schema - Compassion Focused framework, incorporating psychoeducation in regard to both Anorexia Nervosa and Carer Burnout. The programme has a relational focus, with an emphasis on improving emotional fluency, family communication skills and self-other compassion. | Other | CAREFREE is a 12-session Carer's Programme |
Primary outcome
(SRS-Version 3) (Johnson, Miller, & Duncan, 2000).
Time frame: Weekly after each Carer group Session
Therapeutic alliance will be evaluated using this 4-item Session Rating Scale after each session
Short Rating Scales
Time frame: Pre (0-6 weeks before group programme begins); Weekly throughout programme; and Post (0-4 weeks after group programme ends)
- VAS scales will used to assess carers' ratings of: (1) Quality of life (taken from the WHOQOL-BREF) and (2) Quality of relationship with the patient with AN. (taken from SCORE-15)
Experiences in Close Relationships Revised (ECR-R; Fraley et al., 2000; 36 items)
Time frame: Pre (0-6 weeks before group programme begins) and Post (0-4 weeks after group programme ends) and at 3-months followup
Assesses self reported individual differences regarding attachment-related anxiety and avoidance.
WHOQOL-BREF (WhoQol Group, 1998)
Time frame: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
This is a World Health Organisation Quality of Life Assessment and is a widely used quality of life instrument which contains 26 items over 4 dimensions - physical health, psychological health, social relationships, environment, quality of life and general health.
Depression, anxiety, and stress scale (DASS)
Time frame: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
Depression, anxiety, and stress scale (DASS) is a 21-item measure assessing depression, anxiety, and stress over the past seven days using a four-point Likert scale. Scores of these three subscales can be added to obtain a total score for psychological distress.
SCORE-15 Index of Family Functioning and Change (Stratton et al., 2010)
Time frame: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
- SCORE is a self report outcome measure designed to be sensitive to the kinds of changes in family relationships that systemic family and couples' therapists see as indications of useful therapeutic change.
Family Questionnaire (Wiedemann et al 2002)
Time frame: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
This questionnaire will be used to measure expressed emotion within the family system.
Schema Mode Inventory (Young et al., 2007)
Time frame: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
5 items of this scale are included in the outcomes to measure healthy functioning.
Eating disorder symptom impact scale (EDSIS; Sepulveda et al., 2008)
Time frame: Pre (0-6 weeks before group programme begins); Post (0-4 weeks after group programme ends) and at 3-months followup
This is a 24-item self-report measure of caregiving burden in eating disorders. The scale comprises of subjective and objective burden across four subscales: managing nutritional situations, dealing with dysregulated behaviors, guilt, and social isolation. Scores are obtained on a five-point Likert scale. Higher scores indicate higher caregiving burden and more negative appraisal of caregiving
Young Parenting Inventory-revised (YPI-R2; Louis, Wood and Lockwood, 2018)
Time frame: Pre -group (0-6 weeks before group programme begins)
This scale assesses perceived parenting experiences. The YPI-R2 is a 36-item questionnaire measuring parenting styles, namely: Competitiveness and Status seeking; Degradation and Rejection; Emotional Inhibition and Deprivation; Overprotection and Overindulgence; Punitiveness; Controlling. Subscale scores are calculated as mean scores with higher scores indicating stronger perceived negative parenting.
5 secondary outcomes
Eating Disorder Quality of Life questionnaire (EDQoL; Engel et al., 2006).
Time frame: Pre (0-6 weeks before group programme begins) and Post (0-4 weeks after group programme ends)
SCORE-15 and Young Parenting Inventory (YPI-R))
Time frame: Pre (0-6 weeks before group programme begins); and Post (0-4 weeks after group programme ends)
Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ; Rieger et al., 2002)
Time frame: Pre (0-6 weeks before group programme begins); and Post (0-4 weeks after group programme ends)
Demographics Questionnaire
Time frame: 0-6 weeks before attending group programme
Qualitative Interview with person with Anorexia Nervosa
Time frame: 0-4 weeks after group intervention is completed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Derived from this study: PubMed 42458655Mawdsley E, McNicol S, Rutherford AC, Symon L, Smith D, Elliott H, Simpson S. A case series evaluation of a schema therapy-coaching programme for carers of patients with moderate to severe anorexia nervosa: the CAREFREE programme. J Eat Disord. 2026 Jul 16. doi: 10.1186/s40337-026-01704-9. Online ahead of print.
- Individual participant dataSharing planned: Undecided. De-identified patient data will only be shared with researchers who are directly involved in the project in some capacity
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAREFREE Carer's Programme in people with Anorexia Nervosa and Carer Stress Syndrome, run by NHS Forth Valley at 2 sites in United Kingdom.
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 7 inclusion and 4 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 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Susan G Simpson, Doctorate Clinical Psychology (44 + 1786458549, susan.g.simpson@nhs.scot), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(SRS-Version 3) (Johnson, Miller, & Duncan, 2000). (time frame: Weekly after each Carer group Session). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06624397, which also lists 1 linked publication.
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 3 Oct 2024.