A Randomised Waiting List Controlled Study of Group Based Acceptance and Commitment Therapy (ACT) to Promote Psychological Wellbeing in People Living With the Consequences of Stroke or Acquired Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM)
研究概览
简要总结
Stroke and Acquired Brain Injury (ABI) represent a major cause of long-term disability among survivors. Many psychological difficulties can also occur including: depression, anxiety, fatigue, and post-traumatic stress disorder. This has a marked impact on health service usage. Despite certain interventions being offered to support stroke survivors and individuals with brain injury, there is still an outstanding need to increase and improve psychological resources for this population.
This research proposes to evaluate the effectiveness of a group therapy intervention, using a model called Acceptance and Commitment Therapy (ACT), for stroke survivors and adults with ABI. This ACT group aims to promote positive adjustment and improve wellbeing, whilst also aiming to reduce levels of distress.
The research will comprise of two parts (one quantitative and the other qualitative).
详细描述
Stroke and Acquired Brain Injury (ABI) are major health problems and a leading cause of disability. In England and Wales, over 900,000 people are living with the long-term effects of stroke, and 345,000 the long-term effects of brain injury. These can result in survivors being highly dependent on others for their care. A wide range of psychological difficulties have been reported to develop post stroke and brain injury. As well as impacting on psychological wellbeing these problems are associated with poor social outcome, lower quality of life, poor functional outcome, and increased mortality (Fleminger & Ponsford, 2005; Lincoln et al., 2012). This is consistent with data indicating that post stroke and ABI psychological problems can have a significant impact on the usage of health services (Graves et al., 2015; Naylor et al., 2012).
Whilst there is emerging evidence that some psychological interventions improve wellbeing post stroke and ABI, there remains an outstanding need to demonstrate further the effectiveness of psychological interventions within stroke and ABI services.
The model used in this research - Acceptance and Commitment Therapy (ACT) - has a well-established evidence base for reducing psychological distress in individuals with mental illness and physical health conditions (including: cancer, epilepsy and chronic pain). ACT sees psychological distress as a universal aspect of human experience and encourages individuals to be present with their distress whilst simultaneously moving towards values-driven action. As a trans-diagnostic model it seems that ACT is well-placed to support the widespread sequelae experienced by stroke and brain injury survivors.
This research aims to contribute to this area by:
- Evaluating the effectiveness of an adapted Acceptance and Commitment Therapy (ACT) group for stroke survivors and adults with ABI, using outcome data in comparison to a waiting list control across three time points (pre, post and 10-week follow-up). (Quantitative Research)
- Exploring individuals' experiences of attending the group and their perceptions of change from group attendance. (Qualitative Research).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •All participants must be 18 years of age or older.
- •Participants must have a clinical diagnosis of stroke or brain injury
- •Must be able to understand English and communicate responses
- •The target participant has been referred to the adapted ACT group by a clinician, stroke association co-ordinator or senior Headway professional.
- •Participants with a mild to moderate level of psychological need
- •Participants must be capable of giving informed consent
排除标准
- •Candidates with significant cognitive/language/behavioural impairment that would prevent them from engaging with the group
- •Candidates with a diagnosed degenerative condition (e.g. dementia). (NB candidates with a brain tumour diagnosis who are currently stable will be eligible.)
- •Candidates experiencing severe/active psychotic symptoms
- •Candidates with a high level of psychological need that would be better met through a more intensive intervention
- •Candidates receiving other therapies, as part of a multi-component intervention that would prevent any changes specific to the group psychotherapy to be estimated (except drugs for depression and anxiety)
研究组 & 干预措施
Experimental Group Based ACT
Stroke survivors and individuals with brain injury were randomised into an adapted acceptance and commitment therapy (ACT) group-based intervention. This consisted of 2.5 hour sessions over 5 consecutive weeks.
干预措施: Acceptance and Commitment Therapy (ACT) (Behavioral)
Waitlist Control Group -
Stroke survivors and individuals with brain injury were randomised into an adapted acceptance and commitment therapy (ACT) group-based intervention. Participants within the waitlist control arm of the study had to wait six weeks before they were offered the same intervention as the intervention arm. They received treatment as usual.
干预措施: Acceptance and Commitment Therapy (ACT) (Behavioral)
结局指标
主要结局
Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM)
时间窗: Pre (Baseline); Post (5 weeks); Follow Up (10 weeks)
Exploring change CORE-OM, which measures levels of global distress
Dispositional or Adult Hope Scale
时间窗: Pre (Baseline); Post (5 weeks); Follow Up (10 weeks)
Exploring change in this scale which assesses a person's global level of dispositional or trait hope.
Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT)
时间窗: Pre (Baseline); Post (5 weeks); Follow Up (10 weeks)
Exploring change in this measure of psychological flexibility
Euro-Qol: EQ-5D-5L
时间窗: Pre (Baseline); Post (5 weeks); Follow Up (10 weeks)
Exploring change in this scale which measures health-related quality of life.
次要结局
未报告次要终点
研究者
Anna Pennington
Trials Manager
Aneurin Bevan University Health Board