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

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What is being tested

CMAP Plus CBT

Behavioral
Who is being recruted

Behavior

+ Behavioral Symptoms

+ Self-Injurious Behavior

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2023
See protocol details

Summary

Principal SponsorPakistan Institute of Living and Learning
Study ContactZaib un NisaMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2023

Actual date on which the first participant was enrolled.

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)

Official TitleCulturally Adapted Psychosocial Intervention for Suicidal Ideation in Individuals With First Episode Psychosis: A Feasibility Randomised Controlled Trial
NCT05728138
Principal SponsorPakistan Institute of Living and Learning
Study ContactZaib un NisaMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBehavioral SymptomsSelf-Injurious Behavior

Criteria

4 inclusion criteria required to participate
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).

2 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants with First episode of psychosis, Culturally Adapted Manual Assisted Problem Solving (CMAP) integrated with Culturally adapted Cognitive Behavior Therapy (CaCBT)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Karwan e Hayat

Karachi, PakistanOpen Karwan e Hayat in Google Maps
Recruiting
One Study Center