AnxietyNCT04959916

Group-based Metacognitive Therapy for Burns and Plastics Patients

A study testing Group Metacognitive Therapy in people with Anxiety and Low Mood, run by University of Manchester at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Anxiety, Low Mood
What is being tested?: Group Metacognitive Therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited Kingdom
Study dates: 1 Oct 2021to Sep 2022
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

Outpatients at the Adult Burns Centre in Wythenshawe Hospital;
Age 18 or older;
At least one month since the occurrence of the injury;
A competent level of English language skills (able to read, understand and complete questionnaires in English).
In the event that sessions will be conducted remotely, participants will require adequate internet connection and access to Microsoft Teams/Zoom.

Who cannot join

Cognitive impairment which precludes informed consent or ability to participate;
Acute suicidality;
Active psychotic disorders;
Current drug or alcohol abuse;
Individuals engaging in active deliberate self-harm;
Dementia or learning difficulties;
Antidepressant or anxiolytic medications initiated in the previous 8 weeks;
Individuals who intentionally set themselves on fire.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Department of Burns Plastics and Reconstructive Surgery, Wythenshawe Hospital
Manchester, M23 9LT

Other trials in United Kingdom

About this study

Official title: Group-Based Metacognitive Therapy for Anxiety and Mood Symptoms in Burns and Plastics Patients: A Feasibility and Acceptability Study

Serious burns and other traumatic or disfiguring injuries represent a significant public health burden. Survivors often need intense medical or surgical treatment, including plastic surgery. As well as devastating physical injuries, up to 45% of people develop significant mental health difficulties following a traumatic injury. These difficulties include depression, anxiety and post-traumatic stress disorder (PTSD).

Cognitive Behavioural Therapy (CBT) is the most widely offered treatment within the National Health Service (NHS) and the most common treatment provided for burns and plastics patients. However, CBT is limited in efficacy, time-consuming, and focuses on treating the most distressing problem first.

One way to overcome these limitations is to evaluate a group therapy that can treat multiple mental health problems at once. One such treatment is called Metacognitive Therapy (MCT; Wells 2009). MCT targets metacognitive beliefs (beliefs people hold about their thinking) rather than the content of patients' thoughts (i.e. reality testing), which is advantageous over cognitive therapies as often following a burns or plastics injury patients experience realistic negative thoughts (e.g. thoughts about disfigurement). MCT has been shown to be more effective at treating anxiety and depression in mental health settings than CBT, however, more research is needed to evaluate MCT in physical health settings.

The aim of this study is to examine the acceptability and feasibility of group-MCT within the Department of Burns, Plastics and Reconstructive Surgery at Wythenshawe Hospital. We aim to recruit 20 patients to receive six weekly sessions of group-MCT. Sessions will last approximately 90 minutes. Indicators of feasibility and acceptability will be described including rates of referrals, recruitment, and dropout. Data on symptom outcomes (as measured by the PHQ-9 and GAD-7) at pre and post treatment will be assessed and benchmarked against usual treatment delivered. The data will be used to inform a future large-scale trial on the effectiveness of MCT.

Conditions: Anxiety, Low Mood
Being tested: Group Metacognitive Therapy
Medical subject headings: Anxiety Disorders, Consciousness Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Group Metacognitive TherapyBehavioural
Group Meta-Cognitive Therapy (Group-MCT) will consist of six weekly sessions delivered by two trained trainee clinical psychologists over 1-1.5 hours. The aims of the intervention are to help participants develop knowledge that can facilitate control of worry, rumination and attention, and to modify the metacognitive beliefs that maintain these unhelpful patterns of thinking. The treatment follows a manual that has been previously evaluated in the treatment of cardiac patients suffering from anxiety and depression. Sessions include group discussions, experiential learning and homework tasks that participants will be expected to complete between sessions.

Study groups in NCT04959916
Study group	Role	What they receive
Group Meta-Cognitive Therapy	Experimental	Group Meta-Cognitive Therapy (Group-MCT) Receives: Behavioral: Group Metacognitive Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility indicators
Indicators of feasibility of the group-MCT intervention will be described. Specifically, we will describe rates of:
- Referrals - the average number of potential patients that are referred to the study per month
- Recruitment -the average number of patients that meet inclusion, exclusion criteria and that consent to take part in the study, per month.
- Attendance - Participants will be classified as 'attended', if they attend a minimum of four out of the six group-MCT sessions.
- Retention - Participants will be classified as 'retained' if they complete the primary symptom measures (GAD-7 and PHQ-9) at the final follow up. Minimal target criteria for retention is 80% of those recruited completing the study.
Measured: Up to 7 months follow up

Secondary outcomes (7)

Change in Patient Health Questionnaire (PHQ-9; Spitzer et al., 1999).
The Patient Health Questionnaire (PHQ-9) is a 9-item questionnaire that wherein individuals rate the frequency at which they experience symptoms of depression from "0" (not at all) to "3" (nearly every day). Total scores can range from 0 - 21, with higher scores indicating higher depression symptoms (i.e., worse outcome)
*The measure is routinely administered within the service and will be used to benchmark group-MCT against.
Measured: Administered at baseline, 4 month follow up and 7 month follow up,
Change in Generalized Anxiety Disorder 7-item (GAD-7; Spitzer et al., 2006) scale
The Generalized Anxiety Disorder 7-item (GAD-7) is a 7-item screening tool that measures common symptoms of anxiety. Total scores can range from 0 - 21, with higher scores indicating higher anxiety (i.e., worse outcome)
*The measure is routinely administered within the service and will be used to benchmark group-MCT against.
Measured: Administered at baseline, 4 month follow up and 7 month follow up,
Change in Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983)
The Hospital Anxiety and Depression Scale (HADS) is a brief 14-item self-report measure of anxiety and depression symptoms. Total scores for depression and anxiety can range from 0 - 21, with higher scores indicating higher symptoms of anxiety/depression (i.e., worse outcome).
Measured: Administered at baseline, 4 month follow up and 7 month follow up,
Change in Metacognitions Questionnaire (MCQ-30; Wells & Cartwright-Hatton, 2004).
The Metacognitions Questionnaire (MCQ-30) is a 30-item self-report measure assessing metacognitive beliefs. Total score can range from 0 - 120, with a higher score indicating worse outcome.
Measured: Administered at baseline, 4 month follow up and 7 month follow up,
Change in Impact of Event Scale-Revised (IES-R; Weiss & Marmar, 1997).
The Impact of Event Scale-Revised (IES-R) is a 22-item self-report measure that assesses subjective distress caused by traumatic events. Total score ranges from 0 - 88 and higher scores indicate worse trauma symptoms (i.e., worse outcome).
Measured: Administered at baseline, 4 month follow up and 7 month follow up,
Change in Beliefs About Memory Questionnaire (BAMQ; Bennett & Wells, 2010).
The Beliefs About Memory Questionnaire (BAMQ) is a 15-item scale that measures positive and negative beliefs about trauma memory. Scores can range from 0 - 60, higher scores are considered worse outcomes.
Measured: Administered at baseline, 4 month follow up and 7 month follow up,
Change in Cognitive Attentional Syndrome Scale 1 Revised (CAS-1R; Wells, 2015)
This measure assesses a perseverative thinking style that contributes to and maintains emotional distress in the meta-cognitive model (e.g., worry/rumination and other coping strategies, and metacognitive beliefs). Scores can range from 0-1000 and higher scores are considered worse outcomes.
Measured: This will be administered to track any changes in participants' metacognitive beliefs, knowledge or strategies. It will be administered at every group-MCT intervention session (i.e. group-MCT sessions 1, 2, 3, 4, 5 and 6).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 2021Sep 2022

First posted13 Jul 2021
Study start1 Oct 2021
Primary completionJul 2022 (estimated)
Study completionSep 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)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: Other
Allocation: Not applicable
Intervention model: Single group
Model description: This is a benchmark study, whereby a single group will receive the Group-MCT intervention and this group will be compared to (i.e benchmarked against) data from patients who completed 'Treatment as Usual' within the service. The treatment as usual data is collected in the course of normal care. Patients personally identifiable information will be removed from the data base before being shared with the study team
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04959916
Sponsor's protocol ID: IRAS ID: 287367
Status last verified: Feb 2022
First submitted: 15 Jun 2021
Last updated: 25 Feb 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Data may be used for future research at the discretion of the data custodian as long as the data being used is not identifiable and is not combined with any other data which makes it identifiable. Data will only be shared in line with what has been agreed in the informed consent process.

Publications

Wells, A. (2009). Metacognitive therapy for anxiety and depression. New York: Guilford press.
Davydow DS, Katon WJ, Zatzick DF. Psychiatric morbidity and functional impairments in survivors of burns, traumatic injuries, and ICU stays for other critical illnesses: a review of the literature. Int Rev Psychiatry. 2009 Dec;21(6):531-8. doi: 10.3109/09540260903343877.
PubMed 19919206

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Group-Based Metacognitive Therapy for Anxiety and Mood Symptoms in Burns and Plastics Patients: A Feasibility and Acceptability Study
ClinicalTrials.gov ID: NCT04959916
Acronym / sponsor ID: IRAS ID: 287367
Conditions: Anxiety, Low Mood
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 14 participants (actual)
Lead sponsor: University of ManchesterUniversity, hospital or other
Collaborators: Greater Manchester Mental Health NHS Foundation Trust
Study start: 1 Oct 2021 (actual)
Primary completion: Jul 2022 (estimated)
Study completion: Sep 2022 (estimated)
First posted: 13 Jul 2021 (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.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is a benchmark study, whereby a single group will receive the Group-MCT intervention and this group will be compared to (i.e benchmarked against) data from patients who completed 'Treatment as Usual' within the service. The treatment as usual data is collected in the course of normal care. Patients personally identifiable information will be removed from the data base before being shared with the study team

Arm	Type	Receives
Group Meta-Cognitive Therapy	Experimental	Behavioral: Group Metacognitive TherapyGroup Meta-Cognitive Therapy (Group-MCT)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Outpatients at the Adult Burns Centre in Wythenshawe Hospital;
Age 18 or older;
At least one month since the occurrence of the injury;
A competent level of English language skills (able to read, understand and complete questionnaires in English).
In the event that sessions will be conducted remotely, participants will require adequate internet connection and access to Microsoft Teams/Zoom.

Key exclusion criteria (8 listed)

Cognitive impairment which precludes informed consent or ability to participate;
Acute suicidality;
Active psychotic disorders;
Current drug or alcohol abuse;
Individuals engaging in active deliberate self-harm;

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
Group Metacognitive TherapyGroup Meta-Cognitive Therapy (Group-MCT) will consist of six weekly sessions delivered by two trained trainee clinical psychologists over 1-1.5 hours. The aims of the intervention are to help participants develop knowledge that can facilitate control of worry, rumination and attention, and to modify the metacognitive beliefs that maintain these unhelpful patterns of thinking. The treatment follows a manual that has been previously evaluated in the treatment of cardiac patients suffering from anxiety and depression. Sessions include group discussions, experiential learning and homework tasks that participants will be expected to complete between sessions.	Behavioural	Group Meta-Cognitive Therapy

Primary outcome

Feasibility indicators
Time frame: Up to 7 months follow up
Indicators of feasibility of the group-MCT intervention will be described. Specifically, we will describe rates of: * Referrals - the average number of potential patients that are referred to the study per month * Recruitment -the average number of patients that meet inclusion, exclusion criteria and that consent to take part in the study, per month. * Attendance - Participants will be classified as 'attended', if they attend a minimum of four out of the six group-MCT sessions. * Retention - Participants will be classified as 'retained' if they complete the primary symptom measures (GAD-7 and PHQ-9) at the final follow up. Minimal target criteria for retention is 80% of those recruited completing the study.

7 secondary outcomes

Change in Patient Health Questionnaire (PHQ-9; Spitzer et al., 1999).
Time frame: Administered at baseline, 4 month follow up and 7 month follow up,
Change in Generalized Anxiety Disorder 7-item (GAD-7; Spitzer et al., 2006) scale
Time frame: Administered at baseline, 4 month follow up and 7 month follow up,
Change in Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983)
Time frame: Administered at baseline, 4 month follow up and 7 month follow up,
Change in Metacognitions Questionnaire (MCQ-30; Wells & Cartwright-Hatton, 2004).
Time frame: Administered at baseline, 4 month follow up and 7 month follow up,
Change in Impact of Event Scale-Revised (IES-R; Weiss & Marmar, 1997).
Time frame: Administered at baseline, 4 month follow up and 7 month follow up,
Change in Beliefs About Memory Questionnaire (BAMQ; Bennett & Wells, 2010).
Time frame: Administered at baseline, 4 month follow up and 7 month follow up,
Change in Cognitive Attentional Syndrome Scale 1 Revised (CAS-1R; Wells, 2015)
Time frame: This will be administered to track any changes in participants' metacognitive beliefs, knowledge or strategies. It will be administered at every group-MCT intervention session (i.e. group-MCT sessions 1, 2, 3, 4, 5 and 6).

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
BackgroundWells, A. (2009). Metacognitive therapy for anxiety and depression. New York: Guilford press.
Background: PubMed 19919206Davydow DS, Katon WJ, Zatzick DF. Psychiatric morbidity and functional impairments in survivors of burns, traumatic injuries, and ICU stays for other critical illnesses: a review of the literature. Int Rev Psychiatry. 2009 Dec;21(6):531-8. doi: 10.3109/09540260903343877.
Individual participant dataSharing planned: Undecided. Data may be used for future research at the discretion of the data custodian as long as the data being used is not identifiable and is not combined with any other data which makes it identifiable. Data will only be shared in line with what has been agreed in the informed consent process.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Group Metacognitive Therapy in people with Anxiety and Low Mood, run by University of Manchester at 1 site 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 5 inclusion and 8 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 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility indicators (time frame: Up to 7 months follow up). 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 NCT04959916, which also lists 2 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 25 Feb 2022.