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

NCT05728138 | Recruiting DMC

• 1 other identifier: SAHAR M-CMAPPlus FEP 07
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Self Harm, First Episode Psychosis

Keywords

Self-harm, First Episode Psychosis, adaptation, problem-solving.

Outcome Measures

Primary Outcomes (2)

• Feasibility Indicator

  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

  From baseline to 12th week (end of intervention)

• Acceptability Indicator

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

  From baseline to 12th week (end of intervention)

Secondary Outcomes (7)

• Positive and Negative Syndrome Scale

  From baseline to 12th week (end of intervention)

• Beck Scale for Suicidal Ideation

  From baseline to 12th week (end of intervention)

• Medication Adherence Rating Scale

  From baseline to 12th week (end of intervention)

• Calgary Depression Scale

  From baseline to 12th week (end of intervention)

• The Work and Social Adjustment Scale

  From baseline to 12th week (end of intervention)

Study Arms (2)

CMAP Plus FEP

EXPERIMENTAL

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

Behavioral: CMAP Plus CBT

treatment as usual

NO INTERVENTION

Participants in this group will continue their routine treatment as prescribed by their responsible clinician. In Pakistan TAU mostly comprise of antipsychotics with few patients having access to psychological therapies. Research staff will record the nature and intensity of the TAU for each participant

Interventions

CMAP Plus CBT BEHAVIORAL

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 thought management

CMAP Plus FEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead

Study Sites (1)

Karwan e Hayat

Karachi, Sindh, 75600, Pakistan

RECRUITING

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Imran Chaudhry

  Ziauddin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zaib un Nisa

CONTACT

021-35871845; Zaibunnisa@pill.org.pk

Ameer Bukhsh

CONTACT

021-35871845; ameer.bukhsh@pill.org.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2023
• First Posted: February 14, 2023
• Study Start: November 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: October 30, 2025
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)