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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPakistan Institute of Living and Learning

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: CMAP Plus FEPExperimental treatment 1 intervention
Group B: treatment as usualNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)
2

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

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