A Novel Intervention for Self-criticism in a Primary Care Psychological Therapies Service: Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Do clients find the intervention an acceptable treatment option
研究概览
简要总结
This uncontrolled pilot seeks to develop a novel intervention based on Compassion Focused Therapy (CFT), that reduces self-criticism and improves psychological wellbeing. The researchers aim to assess the the acceptability and feasibility of providing such an intervention within a primary mental health care service; and a preliminary indication of the the effectiveness of this intervention?
详细描述
The intervention is based upon recent unpublished doctoral research that developed this novel treatment within students with high levels of self-criticism. This pilot study aims to adapt the intervention for an Improving Access to Psychological Therapies (IAPT) service, a primary mental-health service in the UK.
Self-criticism is a transdiagnostic process across common mental-health disorders and is therefore, a potential target for psychological intervention. Clients at IAPT are likely to present with high levels of self-criticism. This pilot study may help develop an alternative evidence-based intervention that can be routinely offered within IAPT services.
The researchers aim to recruit 20 clients registered at Talking Therapies Southwark, experiencing a significant impact of self-criticism on their daily life, and requesting help for self-criticism. Clients that provide consent to participate in this study would receive 6 sessions of this intervention and a 2-month follow-up telephone session.
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
- •Written informed consent
- •Registered with and opt into the Southwark IAPT service, Talking Therapies Southwark
- •Score at least 10 on the WSAS questionnaire regarding the impact of self-criticism on their daily life
- •Requesting help for their self-criticism.
排除标准
- •Not being sufficiently proficient in English to fully participate in the sessions with English-speaking therapists or process the written study materials for any reason.
- •Being unable to attend six sessions of assessment/treatment.
- •Presenting with high levels of risk requiring monitoring and assistance beyond the weekly intervention focusing on self-criticism.
- •Current serious mental health problem such as bipolar disorder, anorexia nervosa or a moderate / severe substance use disorder.
- •Cognitive impairment or psychomotor retardation of a degree that would prevent completion of the study treatment protocol with the individual. This would be based on a clinical judgement by potential referrers or by the clinician undertaking the screening assessment.
- •Currently experiencing a degree of life stress (e.g. recent bereavement) that is judged by the assessor to be likely to seriously adversely affect their ability to benefit from the intervention
- •New pharmacological interventions for psychological distress - i.e. a change of medication or dosage in the last 4 weeks.
- •Current participation in another clinical (talking therapy or drug) trial or another psychological intervention.
研究组 & 干预措施
Self-criticism intervention
6 weekly face to face therapy sessions (1st assessment an intervention session of 60 to 90 minutes; sessions 2-5 are 60 minutes each) and a 2 month follow-up telephone call of upto 30 minutes.
干预措施: Self-criticism intervention (Other)
结局指标
主要结局
Do clients find the intervention an acceptable treatment option
时间窗: 3.5 months (from start to end of therapy, including follow-up)
This will be assessed through anonymised written feedback
Work and Social Adjustment Scale (W&SAS) adapted to reflect self-criticism
时间窗: Change from baseline will be measured again at each time-point: session 1,2,3,4,5, 6; and 2 months after session 6.
Measure of the impact of the presenting problem, in this case, self-criticism. Change is being assessed.
Self-Critical Rumination Scale (SCRS)
时间窗: Change from baseline will be measured again at each time-point: session 1,2,3,4,5, 6; and 2 months after session 6.
Measure of self-criticism. Change is being assessed.
Is this intervention feasible to deliver within an IAPT service
时间窗: 9 months - through recruitment until the end of therapy for the final participant.
This will be assessed through recruitment and retention rates
次要结局
- Generalised Anxiety Disorder scale (GAD-7)(Change from baseline will be measured again at each time-point: session 1,2,3,4,5, 6; and 2 months after session 6.)
- Patient Health Questionnaire (PHQ-9)(Change from baseline will be measured again at each time-point: session 1,2,3,4,5, 6; and 2 months after session 6.)
- Rosenberg Self-Esteem Scale(Change from baseline will be measured again at session 1,4,6, and 2 months after session 6.)
- Forms of Self-Criticising/Attacking and Self-Reassuring Scale(Change from baseline will be measured again at session 1,4,6, and 2 months after session 6.)
- Habitual Index of Negative Thinking(Change from baseline will be measured again at session 1,4,6, and 2 months after session 6.)