Group-based Metacognitive Therapy for Burns and Plastics Patients

NCT ID: NCT04959916

Last Updated: 2022-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-09-30

Brief Summary

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group Meta-Cognitive Therapy

Group Meta-Cognitive Therapy (Group-MCT)

Group Type: EXPERIMENTAL

Group Metacognitive Therapy

Intervention Type: 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.

Interventions

Group Metacognitive Therapy

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Greater Manchester Mental Health NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University of Manchester

OTHER

Sponsor Role: lead

Responsible Party

Adrian Wells

Professor Adrian Wells

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Burns Plastics and Reconstructive Surgery, Wythenshawe Hospital

Manchester, , United Kingdom

Countries

United Kingdom

References

Wells, A. (2009). Metacognitive therapy for anxiety and depression. New York: Guilford press.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 19919206 (View on PubMed)

Other Identifiers

IRAS ID: 287367

Identifier Type: -

Identifier Source: org_study_id