Clinical trial NCT04959916: Group-based Metacognitive Therapy for Burns and Plastics Patients
Official title: Group-Based Metacognitive Therapy for Anxiety and Mood Symptoms in Burns and Plastics Patients: A Feasibility and Acceptability Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Low Mood
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: Greater Manchester Mental Health NHS Foundation Trust
First posted: 2021-07-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Feasibility indicators
timeFrame: Up to 7 months follow up
Secondary outcomes:
measure: Change in Patient Health Questionnaire (PHQ-9; Spitzer et al., 1999).
timeFrame: Administered at baseline, 4 month follow up and 7 month follow up,
measure: Change in Generalized Anxiety Disorder 7-item (GAD-7; Spitzer et al., 2006) scale
timeFrame: Administered at baseline, 4 month follow up and 7 month follow up,
measure: Change in Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983)
timeFrame: Administered at baseline, 4 month follow up and 7 month follow up,
measure: Change in Metacognitions Questionnaire (MCQ-30; Wells & Cartwright-Hatton, 2004).
timeFrame: Administered at baseline, 4 month follow up and 7 month follow up,
measure: Change in Impact of Event Scale-Revised (IES-R; Weiss & Marmar, 1997).
timeFrame: Administered at baseline, 4 month follow up and 7 month follow up,
measure: Change in Beliefs About Memory Questionnaire (BAMQ; Bennett & Wells, 2010).
timeFrame: Administered at baseline, 4 month follow up and 7 month follow up,
measure: Change in Cognitive Attentional Syndrome Scale 1 Revised (CAS-1R; Wells, 2015)
timeFrame: 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).
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Department of Burns Plastics and Reconstructive Surgery, Wythenshawe Hospital
Study officials:
References:
citation: Wells, A. (2009). Metacognitive therapy for anxiety and depression. New York: Guilford press.
citation: 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.