Psychosocial Intervention for Suicidal Ideation in Individuals With FEP: A Feasibility Trial

Официальное название

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

Обзор

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).

Подробное описание

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)

Вмешательства

• Поведенческое CMAP Plus CBT
  Culturally Adapted Manual Assisted Problem Solving (CMAP) integrated with Culturally adapted Cognitive Behavior Therapy (CaCBT) CMAP is a manual assisted brief psychological intervention based on the principles of Cognitive Behaviour Therapy (CBT), integrated with Culturally adapted Cognitive Behavior Therapy (CaCBT) including 12 sessions delivered over three months. This intervention includes evaluation of the self-harm attempt, psycho-education, crisis skills, problem-solving and simple and th

Первичные конечные точки

• Feasibility Indicator [Срок оценки: From baseline to 12th week (end of intervention)]
• Acceptability Indicator [Срок оценки: From baseline to 12th week (end of intervention)]

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Karwan e Hayat — Karachi

Идентификаторы

NCT: NCT05728138 · SAHAR M-CMAPPlus FEP 07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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