Brief Positive Psychotherapy After Acquired Brain Injury: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Sample retention at 20 weeks from baseline
研究概览
简要总结
Stroke, head injury and other forms of brain injury are a major cause of physical, psychological and social disability in the adult population. Psychological distress is common following brain injury, but the evidence base for specific psychotherapeutic methods in this population is limited, and standard treatment approaches may not be suitable. Recently there has been a growing interest in positive psychology - the study of wellbeing, positive emotions and characteristics, and personal growth. The investigators believe that positive psychotherapy interventions may be beneficial after acquired brain injury, to reduce psychological morbidity. Because such interventions have not previously been applied in this population, the investigators propose to conduct a pilot randomised controlled trial to examine the feasibility of a brief positive psychotherapy intervention in an out-patient setting. This project will produce essential information to allow us to plan future full-scale clinical trials in this area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Aged 18 years or over;
- •Diagnosis of stroke or acquired brain injury (confirmed clinically and/or radiologically);
- •Between 3 and 12 months post-injury at time of recruitment;
- •Presence of emotional distress (score in moderate or above range on at least one sub-scale of the Depression Anxiety Stress Scales; DASS-21);
- •Medically stable;
- •Able to consent to research.
排除标准
- •Significant communication impairments that would preclude participation;
- •Diagnosis of mild traumatic brain injury (due to the known additional complexities contributing to outcome in this population);
- •Comorbid developmental learning disability or degenerative neurological condition.
- •Pre-injury history of mood disorder will not lead to exclusion.
结局指标
主要结局
Sample retention at 20 weeks from baseline
时间窗: 20 weeks
Recruitment rate at 20 weeks from baseline
时间窗: 20 weeks
Treatment adherence at 20 weeks from baseline
时间窗: 20 weeks
次要结局
- Correlation coefficient between first and second baseline administrations of the Authentic Happiness Inventory (AHI) and VIA-IS questionnaires(1 week)
- Likert ratings of participants and therapists experiences of treatment delivery(8 weeks)
- Change in Depression Anxiety Stress Scales (DASS-21) scores at 20 weeks from baseline(20 weeks)
- Changes in AHI scores at 20 weeks from baseline(20 weeks)
- Changes in Mayo-Portland Adaptability Inventory (MPAI-4) scores at 20 weeks at baseline(20 weeks)
- Changes in Modified Caregiver Strain Index (MCSI) scores at 20 weeks from baseline(20 weeks)