Psychosocial Intervention for Suicidal Ideation in Individuals With FEP: A Feasibility Trial (CMAP-FEP)
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ClinicalTrials.gov Identifier: NCT05728138 |
Recruitment Status :
Not yet recruiting
First Posted : February 14, 2023
Last Update Posted : August 28, 2023
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Condition or disease | Intervention/treatment | Phase |
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Self Harm, First Episode Psychosis | Behavioral: CMAP Plus CBT | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Culturally Adapted Psychosocial Intervention for Suicidal Ideation in Individuals With First Episode Psychosis: A Feasibility Randomised Controlled Trial |
Estimated Study Start Date : | October 1, 2023 |
Estimated Primary Completion Date : | June 30, 2024 |
Estimated Study Completion Date : | October 30, 2024 |
Arm | Intervention/treatment |
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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)
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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 |
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
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- 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%.
- 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.
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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05728138
Contact: Zaib un Nisa | 021-35871845 | Zaibunnisa@pill.org.pk | |
Contact: Ameer Bukhsh | 021-35871845 | ameer.bukhsh@pill.org.pk |
Principal Investigator: | Imran Chaudhry | Ziauddin Hospital |
Responsible Party: | Pakistan Institute of Living and Learning |
ClinicalTrials.gov Identifier: | NCT05728138 |
Other Study ID Numbers: |
SAHAR M-CMAPPlus FEP 07 |
First Posted: | February 14, 2023 Key Record Dates |
Last Update Posted: | August 28, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Self-harm, First Episode Psychosis, adaptation, problem-solving. |
Psychotic Disorders Mental Disorders Suicidal Ideation Self-Injurious Behavior |
Schizophrenia Spectrum and Other Psychotic Disorders Suicide Behavioral Symptoms |