Group-based Metacognitive Therapy for Burns and Plastics Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anxiety; Low Mood
• Intervention / Treatment: Behavioral: Group Metacognitive Therapy

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Group Meta-Cognitive Therapy; Group Meta-Cognitive Therapy (Group-MCT)

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	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.	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).

Collaborators and Investigators

• Sponsor: University of Manchester
• Collaborators: Greater Manchester Mental Health NHS Foundation Trust

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 13, 2021

Study Record Updates

• Last Update Posted (Actual): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Depression; Anxiety Disorders
• Other Study ID Numbers: IRAS ID: 287367

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No