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| Name | Class |
|---|---|
| Greater Manchester Mental Health NHS Foundation Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Meta-Cognitive Therapy | Experimental | Group Meta-Cognitive Therapy (Group-MCT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group Metacognitive Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility indicators | Indicators of feasibility of the group-MCT intervention will be described. Specifically, we will describe rates of:
| Up to 7 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Burns Plastics and Reconstructive Surgery, Wythenshawe Hospital | Manchester | M23 9LT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Wells, A. (2009). Metacognitive therapy for anxiety and depression. New York: Guilford press. | ||
| 19919206 | Background | 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. |
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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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 31, 2022 | |
| Reset | Sep 7, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 31, 2022 | Sep 7, 2023 |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003244 | Consciousness Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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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
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|
| 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. | 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). | 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. | 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). | 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. | 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. | 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). |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |