Group-Based Metacognitive Therapy for Anxiety and Mood Symptoms in Burns and Plastics Patients: A Feasibility and Acceptability Study
试验速览
- 阶段
- 不适用
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Feasibility indicators
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Feasibility indicators
时间窗: Up to 7 months follow up
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.
次要结局
- Change in Metacognitions Questionnaire (MCQ-30; Wells & Cartwright-Hatton, 2004).(Administered at baseline, 4 month follow up and 7 month follow up,)
- 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 Beliefs About Memory Questionnaire (BAMQ; Bennett & Wells, 2010).(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,)
- Change in Cognitive Attentional Syndrome Scale 1 Revised (CAS-1R; Wells, 2015)(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).)
研究者
Adrian Wells
Professor Adrian Wells
University of Manchester