Randomised Controlled Trial of the Clinical and Cost Effectiveness of NICE Recommended Problem Solving Cognitive Behaviour Therapy (PS CBT) Delivered Remotely Versus Treatment as Usual in Adolescents and Young Adults With Depression Who Repeatedly Self-harm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 8
- 主要终点
- Beck Depression Inventory (V2)
研究概览
简要总结
A randomized controlled trial to test the whether remote delivery of cognitive based therapy (CBT) is clinically and cost effective when compared to treatment as usual in adolescents and young adults with depression who self-harm.
详细描述
Self harm is one of the five leading causes of admission to acute hospital with rates increasing by nearly 50% from 2003-2009 (South West Public Health Observatory, 2012). Re-admission within 30 days is frequent. People who repeatedly self harm are at high risk for suicide and and as a result suicide, self-harm and crisis are priorities for CCGs and HWBs in the East Midlands.
The NICE Clinical Guideline 133 on longer-term treatment of self-harm recommends between 3 to 12 sessions of psychological treatment involving problem solving and alternative coping. Presently however, the biggest at risk group for self-harm and suicide is not offered any psychological treatment.
Studies have shown that mobile phones are a highly acceptable method of engaging adolescents with depression in psychological treatments such as CBT (Whittaker et al 2012). Furthermore a systematic review has show that treatment delivery via remote technology is just as effective as face-to-face in people with anxiety or depression (Bee et al, 2008).
The study therefore has the following aims and objectives:
- To optimise and determine the acceptability and feasibility of engaging and retaining patients with depression who repeatedly self-harm in a remotely delivered (through video calling/telephone) CBT intervention over 10 sessions.
- To outline the barriers and drivers to delivering both the study and the remotely delivered PS CBT intervention and how barriers to the interventions are addressed through a network of practice or other means.
- If the recruitment and retention into the study and the remotely delivered PS therapy are feasible and acceptable, then we will determine the clinical effectiveness and cost effectiveness of the intervention versus treatment as usual.
- If the intervention (pilot study) proves to be clinically effective and cost effective then the barriers and drivers to implementation in all counties in the East Midlands will be explored using a network of practice linking with NHS organisations, strategic clinical networks, and the AHSN (see qualitative analysis of barriers and drivers to the implementation of the intervention below).
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 (Investigator)
入排标准
- 年龄范围
- 16 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>2 self-harm episodes.
- •With high levels of unipolar depressive symptoms (BDI-2 score of 17 or more).
- •Sufficient understanding of English (spoken and written).
- •Ability to give informed consent
排除标准
- •Clinical judgement of high level of suicide risk, other risk to self or others requiring other urgent approaches e.g. admission to mental health unit.
- •Other severe mental illness e.g. psychosis, bipolar disorder, substance use disorder or organic mental disorder e.g. secondary to head injury as the primary mental health problem as determined by a structured psychiatric interview (SCID).
- •Currently receiving structured psychological therapy
研究组 & 干预措施
PS CBT
Problem solving cognitive behaviour therapy (PS CBT) will be delivered remotely by means of telephone or video calling by a cognitive behaviour therapist in addition to their usual care.
The duration of the intervention will be 10 sessions. Research measures will be completed at baseline, 3,6,9 and 12 months
干预措施: Problem solving cognitive behaviour therapy (PS CBT) (Behavioral)
Treatment as Usual
Participants will not receive any CBT therapy in addition to their usual care. Research measures will be completed at baseline,3,6,9 and 12 months.
结局指标
主要结局
Beck Depression Inventory (V2)
时间窗: Baseline to 6 months
The difference of change in self-rated depression as measured by Beck depression inventory (version 2) from baseline to 6 months, between the control and intervention group.
次要结局
- Beck hopelessness scale(Baseline to 12 months)
- Columbia Suicide Severity Rating Scale(Baseline to 12 months)
- Quality of life(Baseline to 12 months)
- Qualitative Interviews(Baseline to 12 months)
- Beck Depression Inventory (V2)(Baseline to 12 months)
- Patient Health Questionnaire 9(Baseline to 12 months)
- Social functioning(Baseline to 12 months)
- Cost Effectiveness(Baseline to 12 months)
- Time to Self-Harm(Baseline to 12 months)