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

Primary Purpose

Self Harm, First Episode Psychosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CMAP Plus CBT
Sponsored by
Pakistan Institute of Living and Learning
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Self Harm, First Episode Psychosis focused on measuring Self-harm, First Episode Psychosis, adaptation, problem-solving.

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    CMAP Plus FEP

    treatment as usual

    Arm Description

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

    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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Positive and Negative Syndrome Scale
    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
    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
    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
    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
    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
    Quality of life will be measured in five dimensions, including usual activities, anxiety/depression, pain/discomfort, self-care, and mobility.
    Client Service Receipt Inventory
    The information will be collected on the use of other health services such as (faith healers/Imams) using CSRI.

    Full Information

    First Posted
    February 4, 2023
    Last Updated
    August 25, 2023
    Sponsor
    Pakistan Institute of Living and Learning
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05728138
    Brief Title
    Psychosocial Intervention for Suicidal Ideation in Individuals With FEP: A Feasibility Trial
    Acronym
    CMAP-FEP
    Official Title
    Culturally Adapted Psychosocial Intervention for Suicidal Ideation in Individuals With First Episode Psychosis: A Feasibility Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2024 (Anticipated)
    Study Completion Date
    October 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pakistan Institute of Living and Learning

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Self Harm, First Episode Psychosis
    Keywords
    Self-harm, First Episode Psychosis, adaptation, problem-solving.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CMAP Plus FEP
    Arm Type
    Experimental
    Arm Description
    Participants with First episode of psychosis, Culturally Adapted Manual Assisted Problem Solving (CMAP) integrated with Culturally adapted Cognitive Behavior Therapy (CaCBT)
    Arm Title
    treatment as usual
    Arm Type
    No Intervention
    Arm Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    CMAP Plus CBT
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Feasibility Indicator
    Description
    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
    Time Frame
    From baseline to 12th week (end of intervention)
    Title
    Acceptability Indicator
    Description
    Intervention acceptability will be assessed using data on attendance. Criterion for acceptability is a mean attendance rate of >70%.
    Time Frame
    From baseline to 12th week (end of intervention)
    Secondary Outcome Measure Information:
    Title
    Positive and Negative Syndrome Scale
    Description
    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).
    Time Frame
    From baseline to 12th week (end of intervention)
    Title
    Beck Scale for Suicidal Ideation
    Description
    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
    Time Frame
    From baseline to 12th week (end of intervention)
    Title
    Medication Adherence Rating Scale
    Description
    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.
    Time Frame
    From baseline to 12th week (end of intervention)
    Title
    Calgary Depression Scale
    Description
    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
    Time Frame
    From baseline to 12th week (end of intervention)
    Title
    The Work and Social Adjustment Scale
    Description
    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
    Time Frame
    From baseline to 12th week (end of intervention)
    Title
    EuroQol-5 Dimensions EQ5-D
    Description
    Quality of life will be measured in five dimensions, including usual activities, anxiety/depression, pain/discomfort, self-care, and mobility.
    Time Frame
    From baseline to 12th week (end of intervention)
    Title
    Client Service Receipt Inventory
    Description
    The information will be collected on the use of other health services such as (faith healers/Imams) using CSRI.
    Time Frame
    From baseline to 12th week (end of intervention)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zaib un Nisa
    Phone
    021-35871845
    Email
    Zaibunnisa@pill.org.pk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ameer Bukhsh
    Phone
    021-35871845
    Email
    ameer.bukhsh@pill.org.pk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Imran Chaudhry
    Organizational Affiliation
    Ziauddin Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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