Clinical trial NCT05728138: Psychosocial Intervention for Suicidal Ideation in Individuals With FEP: A Feasibility Trial
Official title: Culturally Adapted Psychosocial Intervention for Suicidal Ideation in Individuals With First Episode Psychosis: A Feasibility Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Self Harm, First Episode Psychosis
Keywords: Self-harm, First Episode Psychosis, adaptation, problem-solving.
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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)

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Feasibility Indicator
timeFrame: From baseline to 12th week (end of intervention)
measure: Acceptability Indicator
timeFrame: From baseline to 12th week (end of intervention)
Secondary outcomes:
measure: Positive and Negative Syndrome Scale
timeFrame: From baseline to 12th week (end of intervention)
measure: Beck Scale for Suicidal Ideation
timeFrame: From baseline to 12th week (end of intervention)
measure: Medication Adherence Rating Scale
timeFrame: From baseline to 12th week (end of intervention)
measure: Calgary Depression Scale
timeFrame: From baseline to 12th week (end of intervention)
measure: The Work and Social Adjustment Scale
timeFrame: From baseline to 12th week (end of intervention)
measure: EuroQol-5 Dimensions EQ5-D
timeFrame: From baseline to 12th week (end of intervention)
measure: Client Service Receipt Inventory
timeFrame: From baseline to 12th week (end of intervention)
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Karwan e Hayat
state: Sindh
Study officials:
affiliation: Ziauddin Hospital
name: Imran Chaudhry
role: PRINCIPAL_INVESTIGATOR
References: