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临床试验/NCT05728138
NCT05728138招募中不适用

Culturally Adapted Psychosocial Intervention for Suicidal Ideation in Individuals With First Episode Psychosis: A Feasibility Randomised Controlled Trial

Pakistan Institute of Living and Learning2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
2
主要终点
Feasibility Indicator

研究概览

简要总结

To check the feasibility and acceptability of Culturally adapted Cognitive Behavioral Therapy for Psychosis (CaCBTp) and Culturally Adapted Manual Assisted Brief Psychological Intervention for Self-harm (CMAP), which we have provisionally called (CMAP Plus) for individuals experiencing Suicidal Ideation (SI) in First Episode Psychosis (FEP).

详细描述

Psychosis is one of the 20 leading causes of disability worldwide, affecting 29 million people. First Episode Psychosis (FEP) occurs at a young age and is thought to be a critical period, influencing the long-term course of the disorder. The early course of psychosis is characterised by repeated relapses with up to 80 % relapsing within five years of an initial episode. It has been reported that individuals diagnosed with psychosis disorders are also identified with developing experiences of self-harm, completed suicide or suicide attempt. A systematic review on identification of correlation between self-harm/suicidality and FEP, also suggested association of suicidal ideation or self-injurious behavior though additional research is highly recommended in this particular subject Psychological therapies are widely used in the high-income countries, but very limited in LMIC like Pakistan due to factors including lack of trained mental health workers and inadequate infrastructure to support secondary mental health services. These factors, amongst others, contribute to the significant treatment gap in LMICs like Pakistan. There are currently no early intervention services in Pakistan and given the shortage of appropriately trained clinicians to deliver psychosocial interventions novel approaches are needed. We have culturally adapted Cognitive Behavior therapy which demonstrated feasibility and acceptability for psychosis in Pakistan. To address suicide specific symptoms, content will be integrated from the life after self-harm manual (CMAP. It is a CBT based problem solving intervention for self-harm which has been adapted in Pakistan in a feasibility trial and a recently completed MRC funded large multicenter trial (n=901)

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

入选标准

  • Individuals diagnosed with, Schizophrenia or Schizoaffective disorder according to DSM-V, confirmed by treating consultant.
  • Age 18 and above years able to understand written and spoken Urdu.
  • A score of 1 (Mild- Frequent thoughts of being better off dead, or occasional thoughts of suicide.) on the Calgary depression Scale item 8 (Suicide) "Have you felt that life wasn't worth living? Did you ever feel like ending it all? What did you think you might do? Did you actually try?"
  • Individuals with a score of 3 or more on any of the positive symptoms on the Positive and Negative Syndrome Scale (PANSS) (e.g., delusions, hallucination).

排除标准

  • Any evidence of organic brain disease, clinically significant comorbid illness or learning disability. Participants deemed actively suicidal by their designated health professional.
  • Those scoring >1 on Calgary depression Scale will be excluded and be referred to a psychiatric service.

结局指标

主要结局

Feasibility Indicator

时间窗: From baseline to 12th week (end of intervention)

feasibility will be determined by collecting data on recruitment and retention rates. The success criterion of feasibility will be to recruit \> 50% of eligible participants

Acceptability Indicator

时间窗: From baseline to 12th week (end of intervention)

Intervention acceptability will be assessed using data on attendance. Criterion for acceptability is a mean attendance rate of \>70%.

次要结局

  • Positive and Negative Syndrome Scale(From baseline to 12th week (end of intervention))
  • Medication Adherence Rating Scale(From baseline to 12th week (end of intervention))
  • EuroQol-5 Dimensions EQ5-D(From baseline to 12th week (end of intervention))
  • Beck Scale for Suicidal Ideation(From baseline to 12th week (end of intervention))
  • The Work and Social Adjustment Scale(From baseline to 12th week (end of intervention))
  • Client Service Receipt Inventory(From baseline to 12th week (end of intervention))
  • Calgary Depression Scale(From baseline to 12th week (end of intervention))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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