Group-based Metacognitive Therapy for Burns and Plastics Patients

NCT04959916 | Unknown

• 1 other identifier: IRAS ID: 287367
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 7 months follow up

Secondary Outcomes (7)

• Change in Patient Health Questionnaire (PHQ-9; Spitzer et al., 1999).

  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

  Administered at baseline, 4 month follow up and 7 month follow up,

• Change in Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983)

  Administered at baseline, 4 month follow up and 7 month follow up,

• Change in Metacognitions Questionnaire (MCQ-30; Wells & Cartwright-Hatton, 2004).

  Administered at baseline, 4 month follow up and 7 month follow up,

• Change in Impact of Event Scale-Revised (IES-R; Weiss & Marmar, 1997).

  Administered at baseline, 4 month follow up and 7 month follow up,

Study Arms (1)

Group Meta-Cognitive Therapy

EXPERIMENTAL

Group Meta-Cognitive Therapy (Group-MCT)

Behavioral: Group Metacognitive Therapy

Interventions

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.

Group Meta-Cognitive Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manchester: lead
• Greater Manchester Mental Health NHS Foundation Trust: collaborator

Study Sites (1)

Department of Burns Plastics and Reconstructive Surgery, Wythenshawe Hospital

Manchester, M23 9LT, United Kingdom

Location

Related Publications (2)

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

  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.

  PMID: 19919206 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Consciousness Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Adrian Wells

Model Details: 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

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: July 13, 2021
• Study Start: October 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 25, 2022

Record last verified: 2022-02

Locations

GB (1)