An interventional study of CMAP Plus CBT in Self Harm, First Episode Psychosis, sponsored by Pakistan Institute of Living and Learning. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-03.
Sponsored by Pakistan Institute of Living and Learning · Not applicable, Interventional, and Treatment
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).
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)
303 studies on the registry are indexed under Self-Injurious Behavior; 105 are open to participants now.
This study's planned enrollment of 80 is above the median of 70 across 254 interventional studies indexed under Self-Injurious Behavior.
Browse Self-Injurious Behavior studies →Pakistan Institute of Living and Learning is the lead sponsor of 59 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
Time frame: 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%.
Time frame: From baseline to 12th week (end of intervention)
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).
Time frame: From baseline to 12th week (end of intervention)
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
Time frame: From baseline to 12th week (end of intervention)
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.
Time frame: From baseline to 12th week (end of intervention)
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
Time frame: From baseline to 12th week (end of intervention)
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
Time frame: From baseline to 12th week (end of intervention)
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.
Time frame: From baseline to 12th week (end of intervention)
Client Service Receipt Inventory
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)
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2023 (actual). Primary completion is estimated for Jun 2025, 19 months after the start.
Of 161 non-industry interventional studies with no phase under Self-Injurious Behavior, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 53. This study's planned 19 months is below that.
Counting every sponsor, half of 163 studies reached it within 28 months; a quarter within 15 and three quarters within 52.
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Pakistan Institute of Living and Learning