AnxietyNCT05980143
Metacognitive Therapy for Common Mental Health Problems in Autistic CYP: A Case Series
A study testing Metacognitive Therapy in people with Anxiety and Depression, run by University of Manchester at 2 sites in United Kingdom.
Trial summary
Anxiety and Depression are common in young people (CYP) and especially in CYP with a diagnosis of Autism. Autistic people often say therapy has not been adapted to meet their needs. Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Metacognitive Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 25 Oct 2023to Apr 2024
- 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 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 11-16 years
- Consent given
- Formal diagnosis of Autism Spectrum Disorder
- Fluent in English
- Seeking treatment for emotional disorder symptoms (i.e., generalised anxiety disorder, panic disorder, agoraphobia, post-traumatic stress disorder, obsessive compulsive disorder, social anxiety; and/or depression)
- Medication for mental health problems permitted but participants must be stabilised for 6 weeks
Who cannot join
- Presence of significant risk or safeguarding concerns
- Head injury/organic impairment
- Attention Deficit Hyperactivity Disorder (formal diagnosis or under assessment)
- Eating Disorder
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Manchester University NHS Foundation Trust
Manchester
Dr Paul Wallis
- Recruiting
Pennine Care NHS Foundation Trust
Manchester
Dr Gordon Milson
About this study
Official title: Can Metacognitive Therapy be Used to Treat Common Mental Health Problems in Autistic Children and Adolescents: A Systematic Case Series
Anxiety and Depression are common in young people (CYP) and especially in CYP with a diagnosis of Autism. Autistic people often say therapy has not been adapted to meet their needs. A recent treatment called metacognitive therapy (MCT) is proving to be helpful, but the investigators do not know how autistic CYP will find MCT, or what changes to the delivery of therapy may be needed to meet their needs. This study hopes to explore whether MCT can help treat anxiety and/or depression in autistic young people.
This study aims to offer five autistic CYP MCT. To take part, they must be between 11-16 years old and have depression and/or anxiety symptoms. The study will involve completing questionnaires at the start, during therapy, at the end and after 6 months. Therapy will be scheduled for at least eight sessions. Therapy involves working on what we think about our worry, rather than on specific worries. What we think about our worry can be positive or negative. For example, 'worrying helps me cope' and 'worrying could make me go mad'. This can affect where our attention goes and how we think. At the end of therapy, participants will be asked to take part in an interview about how they found the therapy.
Read more
The questionnaires will help test how useful the measures are, suggest how helpful the therapy might be and whether benefits continue after the therapy has ended. Information will also be gathered through a post treatment interview about how the young people found the therapy. This will help understand whether any changes to the therapy are needed to meet the needs of autistic people. This information is necessary for planning a large-scale trial for autistic CYP. Such studies may improve treatment options and service provision for mental health problems in this population.
Primary Question:
- Is MCT a feasible and acceptable treatment for treating anxiety and depression in autistic CYP?
Secondary Questions:
- Is MCT associated with clinically significant change in outcome measures following the introduction of treatment for autistic CYP?
- Are improvements associated with MCT maintained at 6 month follow up?
- Are improvements associated with MCT replicable across autistic CYP?
- Do the investigators need to modify how MCT is delivered to autistic CYP?
Read the detailed description
This study is a systematic replication case series utilising an AB design with follow up to deliver MCT to autistic CYP who experience symptoms of anxiety and/or depression. Allocation to baseline lengths will not be randomised, natural baselines will be utilised whereby participants complete the primary outcome measure weekly until they demonstrate stability. Stability will be defined as an absence of decreasing trend of at least three consecutive data points prior to the introduction of treatment.
Recruitment:
Participants will be identified by CAMHS clinicians during routine clinical practice. Potential participants will be provided with information about the study, including the participant information sheet. Those who are identified as eligible and are interested in taking part or finding out more about the study will consent to their details being shared with the researcher. The details will be securely sent to the researcher using the eligibility form. The researcher will then contact potential participants to confirm whether the like to participate and answer any questions they have about the study.
Screening:
Those who wish to participate will then be invited to attend a screening appointment with the researcher. Written consent will be obtained from participants (and parents/guardians where appropriate). Once consent has been obtained, demographic information, baseline measures will be administered.
Baseline:
During the baseline phase, participants will be asked to complete the Personal Rating Scale and the YoCas-1 once a week for a minimum of 3 weeks, until stability is achieved. Only the Personal Rating Scale will be used to measure stability. Stability is defined as the absence of a decreasing trend on three consecutive data points prior to the introduction of treatment. All other outcome measures will be completed at the end of the baseline phase prior to starting treatment.
Intervention:
Participants will be offered a minimum of eight weekly sessions of MCT at their local CAMHS. Each session will last approximately an hour. This will be applied flexibly, and sessions can be extended in response to client progress. This will provide information about whether the investigators need to modify the delivery of MCT to autistic CYP. Participants will be asked to complete sessional measures.
Post Intervention interview:
Participants will be asked to take part in the post intervention interview to gather information about how they found the intervention. This will consider factors such as components of the intervention that were well received, and those which were less well received.
Follow up:
Participants will be asked to complete follow up measures 6 months after the final treatment session.
- Conditions
- Anxiety, Depression
- Being tested
- Metacognitive Therapy
- Keywords
- Anxiety symptoms, Depression symptoms, Metacognitive therapy, Children and young people, Autism
- Medical subject headings
- Anxiety Disorders, Depression, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive TherapyOther
The transdiagnostic Metacognitive model suggests that psychological difficulties arise from the activation of a thinking style called the CAS (Cognitive Attentional Syndrome). Metacognitive Therapy (MCT) aims to bring the CAS under control. The therapist helps the patient to learn new ways of relating to stressful thoughts.
| Study group | Role | What they receive |
|---|---|---|
| Metacognitive Therapy | Experimental | MCT will be delivered in accordance with the MCT-PATHWAY treatment manual. Receives: Other: Metacognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The Revised Children's Anxiety and Depression Scale (RCADS-25) Score
A 25-item screening measure designed to assess anxiety and depressive disorders in CYP aged 8-18.
Anxiety (15 items; maximum score 45) and depression (10 items; maximum score = 30).
In response to each item, participants must select the appropriate response from 'Always' (score = 3), 'Often' (score = 2), 'Sometimes' (score = 1), 'Never' (score = 0).
Total minimum score = 0. Total maximum score = 75. Higher scores indicate worse outcomes.
Measured: Baseline period: baseline time one to end of baseline, 4-6 weeks post baseline; end of treatment:12-16 weeks post-baseline one; and 6 month follow up.
Measure of Credibility and Expectancy
A 3 item measure developed by the researchers measuring expectancy and credibility on a 10 point scale
Measured: Intervention session 1 (3-6 weeks after 1st baseline measure, dependant on length of baseline)
Measure of Adherence and User Friendliness
A 5 item measure developed by the researchers to measure adherence and user friendliness on a 10 point scale
Measured: Final intervention session (12-16 weeks post baseline dependent on whether sessions are extended in response to participant needs)
Post Intervention Interview
A semi structured interview focusing on perceived benefits and challenges of the therapy, as well as specific aspects of the therapy such as the outcome measures or intervention techniques.
Measured: 12-16 weeks post baseline (dependent on whether sessions are extended in response to participant needs)
Change in Personal Rating Scale Score
A personal rating scale developed by the researchers, to be administered weekly measuring how distressing the problem has been and how much the problem has interfered with day to day life
Measured: Weekly during baseline and intervention (across 12-16 weeks dependant on length of baseline and intervention) and at 6 months follow up)
Secondary outcomes (3)
Change in The Youth Cognitive Attentional Syndrome-1 (YoCAS-1) Score
A 7 item self-report measure to assess metacognitive skills and knowledge in youth, including worry/rumination, threat monitoring, coping behaviours and metacognitive beliefs.
Measured: Weekly during baseline and intervention (across 12-16 weeks dependant on length of baseline and intervention) and at 6 months follow up)
Change in Metacognitions Questionnaire - Adolescent version (MCQ-A) Score
A 30-item scale designed to measure metacognitive beliefs in adolescents.
Measured: Baseline period: baseline time one and at end of baseline, 4-6 weeks post baseline; end of treatment: at 12-16 weeks post-baseline one; and 6 month follow up.
Change in Child Health Utility -9D (CHU-9D) Score
A 9 item self-report questionnaire to assess health related quality of life in 7-17-year-olds.
Measured: Baseline period: baseline time one and at end of baseline, 4-6 weeks post baseline; end of treatment: at 12-16 weeks post-baseline one; and 6 month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start25 Oct 2023
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- 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
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust, Pennine Care NHS Foundation Trust
- Responsible party
- Principal investigator, Adrian Wells, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980143
- Sponsor's protocol ID
- 320925
- Status last verified
- Mar 2024
- First submitted
- 9 May 2023
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ebesutani C, Reise SP, Chorpita BF, Ale C, Regan J, Young J, Higa-McMillan C, Weisz JR. The Revised Child Anxiety and Depression Scale-Short Version: scale reduction via exploratory bifactor modeling of the broad anxiety factor. Psychol Assess. 2012 Dec;24(4):833-45. doi: 10.1037/a0027283. Epub 2012 Feb 13.
PubMed 22329531Cartwright-Hatton S, Mather A, Illingworth V, Brocki J, Harrington R, Wells A. Development and preliminary validation of the Meta-cognitions Questionnaire-Adolescent Version. J Anxiety Disord. 2004;18(3):411-22. doi: 10.1016/S0887-6185(02)00294-3.
PubMed 15125986Stevens K. Valuation of the Child Health Utility 9D Index. Pharmacoeconomics. 2012 Aug 1;30(8):729-47. doi: 10.2165/11599120-000000000-00000.
PubMed 22788262Wells, A. (2009). Metacognitive Therapy for Anxiety and Depression. New York: Guilford Press
Wells A, Matthews G. Modelling cognition in emotional disorder: the S-REF model. Behav Res Ther. 1996 Nov-Dec;34(11-12):881-8. doi: 10.1016/s0005-7967(96)00050-2.
PubMed 8990539Wells A. Breaking the Cybernetic Code: Understanding and Treating the Human Metacognitive Control System to Enhance Mental Health. Front Psychol. 2019 Dec 12;10:2621. doi: 10.3389/fpsyg.2019.02621. eCollection 2019.
PubMed 31920769Simonoff E, Pickles A, Charman T, Chandler S, Loucas T, Baird G. Psychiatric disorders in children with autism spectrum disorders: prevalence, comorbidity, and associated factors in a population-derived sample. J Am Acad Child Adolesc Psychiatry. 2008 Aug;47(8):921-9. doi: 10.1097/CHI.0b013e318179964f.
PubMed 18645422Normann N, Morina N. The Efficacy of Metacognitive Therapy: A Systematic Review and Meta-Analysis. Front Psychol. 2018 Nov 14;9:2211. doi: 10.3389/fpsyg.2018.02211. eCollection 2018.
PubMed 30487770Cooper K, Loades ME, Russell AJ. Adapting Psychological Therapies for Autism - Therapist Experience, Skills and Confidence. Res Autism Spectr Disord. 2018 Jan 1;45:43-50. doi: 10.1016/j.rasd.2017.11.002.
PubMed 30245739Barlow, D. H., Nock, M., & Hersen, M. (2008). Single case research designs: Strategies for studying behaviour change.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Metacognitive Therapy be Used to Treat Common Mental Health Problems in Autistic Children and Adolescents: A Systematic Case Series
- ClinicalTrials.gov ID
- NCT05980143
- Acronym / sponsor ID
- 320925
- Conditions
- Anxiety, Depression
- Keywords
- Anxiety symptoms, Depression symptoms, Metacognitive therapy, Children and young people, Autism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust, Pennine Care NHS Foundation Trust
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 7 Aug 2023 (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.
Anxiety and Depression are common in young people (CYP) and especially in CYP with a diagnosis of Autism. Autistic people often say therapy has not been adapted to meet their needs. A recent treatment called metacognitive therapy (MCT) is proving to be helpful, but the investigators do not know how autistic CYP will find MCT, or what changes to the delivery of therapy may be needed to meet their needs. This study hopes to explore whether MCT can help treat anxiety and/or depression in autistic young people.
This study aims to offer five autistic CYP MCT. To take part, they must be between 11-16 years old and have depression and/or anxiety symptoms. The study will involve completing questionnaires at the start, during therapy, at the end and after 6 months. Therapy will be scheduled for at least eight sessions. Therapy involves working on what we think about our worry, rather than on specific worries. What we think about our worry can be positive or negative. For example, 'worrying helps me cope' and 'worrying could make me go mad'. This can affect where our attention goes and how we think. At the end of therapy, participants will be asked to take part in an interview about how they found the therapy.
The questionnaires will help test how useful the measures are, suggest how helpful the therapy might be and whether benefits continue after the therapy has ended. Information will also be gathered through a post treatment interview about how the young people found the therapy. This will help understand whether any changes to the therapy are needed to meet the needs of autistic people. This information is necessary for planning a large-scale trial for autistic CYP. Such studies may improve treatment options and service provision for mental health problems in this population.
Primary Question:
- Is MCT a feasible and acceptable treatment for treating anxiety and depression in autistic CYP?
Secondary Questions:
- Is MCT associated with clinically significant change in outcome measures following the introduction of treatment for autistic CYP?
- Are improvements associated with MCT maintained at 6 month follow up?
- Are improvements associated with MCT replicable across autistic CYP?
- Do the investigators need to modify how MCT is delivered to autistic CYP?
Detailed description
This study is a systematic replication case series utilising an AB design with follow up to deliver MCT to autistic CYP who experience symptoms of anxiety and/or depression. Allocation to baseline lengths will not be randomised, natural baselines will be utilised whereby participants complete the primary outcome measure weekly until they demonstrate stability. Stability will be defined as an absence of decreasing trend of at least three consecutive data points prior to the introduction of treatment.
Recruitment:
Participants will be identified by CAMHS clinicians during routine clinical practice. Potential participants will be provided with information about the study, including the participant information sheet. Those who are identified as eligible and are interested in taking part or finding out more about the study will consent to their details being shared with the researcher. The details will be securely sent to the researcher using the eligibility form. The researcher will then contact potential participants to confirm whether the like to participate and answer any questions they have about the study.
Screening:
Those who wish to participate will then be invited to attend a screening appointment with the researcher. Written consent will be obtained from participants (and parents/guardians where appropriate). Once consent has been obtained, demographic information, baseline measures will be administered.
Baseline:
During the baseline phase, participants will be asked to complete the Personal Rating Scale and the YoCas-1 once a week for a minimum of 3 weeks, until stability is achieved. Only the Personal Rating Scale will be used to measure stability. Stability is defined as the absence of a decreasing trend on three consecutive data points prior to the introduction of treatment. All other outcome measures will be completed at the end of the baseline phase prior to starting treatment.
Intervention:
Participants will be offered a minimum of eight weekly sessions of MCT at their local CAMHS. Each session will last approximately an hour. This will be applied flexibly, and sessions can be extended in response to client progress. This will provide information about whether the investigators need to modify the delivery of MCT to autistic CYP. Participants will be asked to complete sessional measures.
Post Intervention interview:
Participants will be asked to take part in the post intervention interview to gather information about how they found the intervention. This will consider factors such as components of the intervention that were well received, and those which were less well received.
Follow up:
Participants will be asked to complete follow up measures 6 months after the final treatment session.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metacognitive Therapy | Experimental | Other: Metacognitive TherapyMCT will be delivered in accordance with the MCT-PATHWAY treatment manual. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age between 11-16 years
- Consent given
- Formal diagnosis of Autism Spectrum Disorder
- Fluent in English
- Seeking treatment for emotional disorder symptoms (i.e., generalised anxiety disorder, panic disorder, agoraphobia, post-traumatic stress disorder, obsessive compulsive disorder, social anxiety; and/or depression)
Key exclusion criteria (4 listed)
- Presence of significant risk or safeguarding concerns
- Head injury/organic impairment
- Attention Deficit Hyperactivity Disorder (formal diagnosis or under assessment)
- Eating Disorder
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 |
|---|---|---|
| Metacognitive TherapyThe transdiagnostic Metacognitive model suggests that psychological difficulties arise from the activation of a thinking style called the CAS (Cognitive Attentional Syndrome). Metacognitive Therapy (MCT) aims to bring the CAS under control. The therapist helps the patient to learn new ways of relating to stressful thoughts. | Other | Metacognitive Therapy |
Primary outcome
Change in The Revised Children's Anxiety and Depression Scale (RCADS-25) Score
Time frame: Baseline period: baseline time one to end of baseline, 4-6 weeks post baseline; end of treatment:12-16 weeks post-baseline one; and 6 month follow up.
A 25-item screening measure designed to assess anxiety and depressive disorders in CYP aged 8-18. Anxiety (15 items; maximum score 45) and depression (10 items; maximum score = 30). In response to each item, participants must select the appropriate response from 'Always' (score = 3), 'Often' (score = 2), 'Sometimes' (score = 1), 'Never' (score = 0). Total minimum score = 0. Total maximum score = 75. Higher scores indicate worse outcomes.
Measure of Credibility and Expectancy
Time frame: Intervention session 1 (3-6 weeks after 1st baseline measure, dependant on length of baseline)
A 3 item measure developed by the researchers measuring expectancy and credibility on a 10 point scale
Measure of Adherence and User Friendliness
Time frame: Final intervention session (12-16 weeks post baseline dependent on whether sessions are extended in response to participant needs)
A 5 item measure developed by the researchers to measure adherence and user friendliness on a 10 point scale
Post Intervention Interview
Time frame: 12-16 weeks post baseline (dependent on whether sessions are extended in response to participant needs)
A semi structured interview focusing on perceived benefits and challenges of the therapy, as well as specific aspects of the therapy such as the outcome measures or intervention techniques.
Change in Personal Rating Scale Score
Time frame: Weekly during baseline and intervention (across 12-16 weeks dependant on length of baseline and intervention) and at 6 months follow up)
A personal rating scale developed by the researchers, to be administered weekly measuring how distressing the problem has been and how much the problem has interfered with day to day life
3 secondary outcomes
Change in The Youth Cognitive Attentional Syndrome-1 (YoCAS-1) Score
Time frame: Weekly during baseline and intervention (across 12-16 weeks dependant on length of baseline and intervention) and at 6 months follow up)
Change in Metacognitions Questionnaire - Adolescent version (MCQ-A) Score
Time frame: Baseline period: baseline time one and at end of baseline, 4-6 weeks post baseline; end of treatment: at 12-16 weeks post-baseline one; and 6 month follow up.
Change in Child Health Utility -9D (CHU-9D) Score
Time frame: Baseline period: baseline time one and at end of baseline, 4-6 weeks post baseline; end of treatment: at 12-16 weeks post-baseline one; and 6 month follow up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Background: PubMed 22329531Ebesutani C, Reise SP, Chorpita BF, Ale C, Regan J, Young J, Higa-McMillan C, Weisz JR. The Revised Child Anxiety and Depression Scale-Short Version: scale reduction via exploratory bifactor modeling of the broad anxiety factor. Psychol Assess. 2012 Dec;24(4):833-45. doi: 10.1037/a0027283. Epub 2012 Feb 13.
- Background: PubMed 15125986Cartwright-Hatton S, Mather A, Illingworth V, Brocki J, Harrington R, Wells A. Development and preliminary validation of the Meta-cognitions Questionnaire-Adolescent Version. J Anxiety Disord. 2004;18(3):411-22. doi: 10.1016/S0887-6185(02)00294-3.
- Background: PubMed 22788262Stevens K. Valuation of the Child Health Utility 9D Index. Pharmacoeconomics. 2012 Aug 1;30(8):729-47. doi: 10.2165/11599120-000000000-00000.
- BackgroundWells, A. (2009). Metacognitive Therapy for Anxiety and Depression. New York: Guilford Press
- Background: PubMed 8990539Wells A, Matthews G. Modelling cognition in emotional disorder: the S-REF model. Behav Res Ther. 1996 Nov-Dec;34(11-12):881-8. doi: 10.1016/s0005-7967(96)00050-2.
- Background: PubMed 31920769Wells A. Breaking the Cybernetic Code: Understanding and Treating the Human Metacognitive Control System to Enhance Mental Health. Front Psychol. 2019 Dec 12;10:2621. doi: 10.3389/fpsyg.2019.02621. eCollection 2019.
- Background: PubMed 18645422Simonoff E, Pickles A, Charman T, Chandler S, Loucas T, Baird G. Psychiatric disorders in children with autism spectrum disorders: prevalence, comorbidity, and associated factors in a population-derived sample. J Am Acad Child Adolesc Psychiatry. 2008 Aug;47(8):921-9. doi: 10.1097/CHI.0b013e318179964f.
- Background: PubMed 30487770Normann N, Morina N. The Efficacy of Metacognitive Therapy: A Systematic Review and Meta-Analysis. Front Psychol. 2018 Nov 14;9:2211. doi: 10.3389/fpsyg.2018.02211. eCollection 2018.
- Background: PubMed 30245739Cooper K, Loades ME, Russell AJ. Adapting Psychological Therapies for Autism - Therapist Experience, Skills and Confidence. Res Autism Spectr Disord. 2018 Jan 1;45:43-50. doi: 10.1016/j.rasd.2017.11.002.
- BackgroundBarlow, D. H., Nock, M., & Hersen, M. (2008). Single case research designs: Strategies for studying behaviour change.
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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 Metacognitive Therapy in people with Anxiety and Depression, run by University of Manchester 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 6 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 28 Mar 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 Kathryn Wood (0161 529 4180, kathryn.wood-5@postgrad.manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in The Revised Children's Anxiety and Depression Scale (RCADS-25) Score (time frame: Baseline period: baseline time one to end of baseline, 4-6 weeks post baseline; end of treatment:12-16 weeks post-baseline one; and 6 month follow up.). 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?
On the ClinicalTrials.gov record for NCT05980143, which also lists 10 linked publications.
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 28 Mar 2024.