Psychosocial Intervention for Suicidal Ideation in Individuals With FEP: A Feasibility Trial (CMAP-FEP)

• ClinicalTrials.gov Identifier: NCT05728138
• Recruitment Status: Recruiting
• First Posted: February 14, 2023
• Last Update Posted: May 20, 2024
• Sponsor: Pakistan Institute of Living and Learning
• Information provided by (Responsible Party): Pakistan Institute of Living and Learning

Tracking Information

• First Submitted Date: February 4, 2023
• First Posted Date: February 14, 2023
• Last Update Posted Date: May 20, 2024
• Actual Study Start Date: November 1, 2023
• Estimated Primary Completion Date: June 30, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 4, 2023)

• Feasibility Indicator [ Time Frame: 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 [ Time Frame: 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%.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 4, 2023)

• Positive and Negative Syndrome Scale [ Time Frame: From baseline to 12th week (end of intervention) ]
  The Scale will examine the Positive and Negative Syndrome for Schizophrenia and is comprised of 30 items. The 30 items of semi structured questionnaire will measure positive syndromes, like delusions, hallucinations, and conceptual disorganisation whereas negative syndromes include passive or apathetic social avoidance and blunted affect. It will also indicate the magnitude of relation to one another and to psychopathology in generic term (e.g., anxiety, guilt, depression, and lack of insight).
• Beck Scale for Suicidal Ideation [ Time Frame: From baseline to 12th week (end of intervention) ]
  This is a 19-item instrument for detecting and measuring the thoughts of an individual that they might want to kill him/herself during the past week. This scale has been used with schizophrenia, schizoaffective, or bipolar disorders
• Medication Adherence Rating Scale [ Time Frame: From baseline to 12th week (end of intervention) ]
  We will use MARS to check adherence to medications. MARS is a 10-item measure. It incorporates features of both the Drug Attitude Inventory (DAI) and the Morisky Medication Adherence Scale (MMAS). The patient will be asked to choose the answer which best describes their behaviour or attitude towards their medication during the past week.
• Calgary Depression Scale [ Time Frame: From baseline to 12th week (end of intervention) ]
  The scale is specially designed to measure the depression for Psychosis, consist of nine items. CDS will indicate the subjective and qualitative dimensions of depression in Schizophrenia
• The Work and Social Adjustment Scale [ Time Frame: From baseline to 12th week (end of intervention) ]
  Five items scale that measures the perceived impairment of social life, relationships, home management, work and private leisure having scores between 0 to 8 that means 0 (no impairment) and 8 (very severe impairment) with a total score of 40
• EuroQol-5 Dimensions EQ5-D [ Time Frame: From baseline to 12th week (end of intervention) ]
  Quality of life will be measured in five dimensions, including usual activities, anxiety/depression, pain/discomfort, self-care, and mobility.
• Client Service Receipt Inventory [ Time Frame: From baseline to 12th week (end of intervention) ]
  The information will be collected on the use of other health services such as (faith healers/Imams) using CSRI.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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)
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Self Harm, First Episode Psychosis

Intervention

Behavioral: 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 thought management

Study Arms

• Experimental: CMAP Plus FEP
  Participants with First episode of psychosis, Culturally Adapted Manual Assisted Problem Solving (CMAP) integrated with Culturally adapted Cognitive Behavior Therapy (CaCBT)
  Intervention: Behavioral: CMAP Plus CBT
• No Intervention: treatment as usual
  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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 4, 2023): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 30, 2025
• Estimated Primary Completion Date: June 30, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Individuals diagnosed with FEP, Schizophrenia or Schizoaffective disorder according to DSM-V, confirmed by treating consultant.
• Age 18-35 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Zaib un Nisa; 021-35871845; Zaibunnisa@pill.org.pk

Contact: Ameer Bukhsh; 021-35871845; ameer.bukhsh@pill.org.pk

• Listed Location Countries: Pakistan

Administrative Information

• NCT Number: NCT05728138
• Other Study ID Numbers: SAHAR M-CMAPPlus FEP 07
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Pakistan Institute of Living and Learning
• Original Responsible Party: Same as current
• Current Study Sponsor: Pakistan Institute of Living and Learning
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Imran Chaudhry; Ziauddin Hospital

• PRS Account: Pakistan Institute of Living and Learning
• Verification Date: May 2024