MIN PLAN VS CBT for Suicide Prevention

A Randomized Controlled Trial Targeting Intervention and Prevention of Suicide Risk (TIPS'r) Among University Students: CBT Vs Min Plan

1. To investigate the effectiveness of Young Adults Culturally Adapted Manual Assisted Psychological Therapy (YA-CMAP) in University students with Suicide Risk
2. To compare the effectiveness of Young Adults Culturally Adapted Manual Assisted Psychological Therapy (YA-CMAP) against MinPlan tool in University students with Suicide Risk

Study Overview

• Status: Recruiting
• Conditions: Suicide Risk
• Intervention / Treatment: Behavioral: Young Adults Culturally Adapted Manual Assisted Psychological Therapy (YA-CMAP); Device: Min Plan Tool

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Syeda Ayat e Zainab Ali, PhD Scholar; Phone Number: +923121319004; Email: zai_nab1@hotmail.com
• Study Contact Backup: Name: Dr Tamkeen Saleem, PhD; Phone Number: (00)92-(0)51-9019887; Email: tamkeen.saleem@iiu.edu.pk

Study Locations

• Pakistan
  • Capital
    • Islamabad, Capital, Pakistan, 44000
      • Recruiting
      • International Islamic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants who are not taking any psychological help or psychotherapy in the past and present.
• Participants who are at risk of suicide without a history of suicidal attempts but with a history of suicidal ideation in the past two months will be included.

Exclusion Criteria:

• Participants with a history of substance misuse/drug dependence/alcohol dependence and psychosis.
• Participants diagnosed with dementia, schizophrenia, delirium, bipolar disorder, and learning disability.
• Participants with a diagnosis of DSM-V mental disorders due to general medical condition.
• Participants who are taking any psychiatric medication.
• Participants residing on a temporary basis in the study area.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Young Adults Culturally Adapted Therapy for Suicidal Prevention; Young Adults Adapted Manual Assisted Psychological Therapy for Suicide Prevention	Behavioral: Young Adults Culturally Adapted Manual Assisted Psychological Therapy (YA-CMAP); YA-CMAP is a manual assisted brief psychological intervention based on the principles of Cognitive Behavior Therapy (CBT), including 8-10 sessions delivered over three months. This intervention includes evaluation of the suicide risk mainly suicidal ideation, psycho education, crisis skills, problem solving and simple cognitive techniques to manage emotions, negative thinking, relapse prevention strategies, training on interoceptive awareness, mood management and behavior.; Other Names: Psychosocial Intervention; Cognitive Behavior Therapy
Active Comparator: MINPLAN TOOL; Research has shown that user engagement, rather than the modality of therapy is the key to achieving successful outcomes and given that just 50% and 13% of patients currently have a choice of when and where they receive therapy, self-help tool apps Like MIN PLAN may not only be equally effective as some forms of traditional psychotherapy but also provide a flexible and pragmatic means of increasing patient access, through removing barriers to treatment that do not respond to financial impetus.	Device: Min Plan Tool; Self-help Tool are common evidence-based methods to help deal with mental health problems.The 'MIN PLAN APP' aims to support people at risk of suicide by letting them create a safety plan based on cognitive therapeutic intervention and behavioral techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suicide Probability Scale	The Suicide Probability Scale (SPS) is a Likert-type scale which will be used to evaluate suicide probability in participants and consists of 36 items.	Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session). Outcome assessment will be used to asses the change from baseline to follow-up.
Suicidal Ideation	The Suicide Probability Scale (SPS) is a Likert-type scale with four subscales (hopelessness=12 items, suicide ideation=8 items, negative self evaluation=9 items and hostility=7 items), which has been developed by Cull and Wayne (1982). Suicidal Ideation will be measure through Suicide Probability Scale.	Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session). Outcome assessment will be used to asses the change from baseline to follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory-21	Beck depression inventory-21 will be used to measure the symptoms of depression.	Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session). Outcome assessment will be used to asses the change from baseline to follow-up.
Psychache scale	Psychache scale is a 13-item scale that will be used to measures psychological/emotional or mental pain as conceptualized by Shneidman (1993).	Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session).Outcome assessment will be used to asses the change from baseline to follow-up.
Hopelessness	The Suicide Probability Scale (SPS) is a Likert-type scale with four subscales (hopelessness=12 items, suicide ideation=8 items, negative self evaluation=9 items and hostility=7 items), which has been developed by Cull and Wayne (1982). Hopelessness will be measure through Suicide Probability Scale.	Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session).Outcome assessment will be used to asses the change from baseline to follow-up.
Negative Self Evaluation	The Suicide Probability Scale (SPS) is a Likert-type scale with four subscales (hopelessness=12 items, suicide ideation=8 items, negative self evaluation=9 items and hostility=7 items), which has been developed by Cull and Wayne (1982). Negative Self Evaluation will be measure through SPS.	Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session).Outcome assessment will be used to asses the change from baseline to follow-up.
Hostility	The Suicide Probability Scale (SPS) is a Likert-type scale with four subscales (hopelessness=12 items, suicide ideation=8 items, negative self evaluation=9 items and hostility=7 items), which has been developed by Cull and Wayne (1982). Hostility will be measure through SPS.	Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session).Outcome assessment will be used to asses the change from baseline to follow-up.
Interpersonal Needs questionnaire	Interpersonal Needs questionnaire will be used to measure participants' beliefs about the extent to which they feel connected to others (i.e., belongingness) and the degree to which they feel they are a burden to others (i.e., burdensomeness).	Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session).Outcome assessment will be used to asses the change from baseline to follow-up.
Problem-Solving Inventory	The Problem-Solving Inventory is a 35-item instrument that measures perceptions of problem-solving behaviors and problem solving attitudes.	Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session).Outcome assessment will be used to asses the change from baseline to follow-up.
Multidimensional Assessment of Interoceptive Awareness (MAIA-2)	The Multidimensional Assessment of Interoceptive Awareness (MAIA-2) is an 8-scale state-trait questionnaire with 37 items to measure multiple dimensions of interoception by self-report.	Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session).Outcome assessment will be used to asses the change from baseline to follow-up.
Client Satisfaction Questionnaire (CSQ)	Client Satisfaction Questionnaire is a brief scale to measure the patient's satisfaction with mental health services.	Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session). This Questionnaire will be used to evaluate client satisfaction with mental health services.

Collaborators and Investigators

• Sponsor: Syeda AYAT E ZAINAB Ali
• Collaborators: Pakistan Institute of Living and Learning; MinPlan Organization
• Investigators: Study Chair: Dr Tamkeen Saleem, PhD, International Islamic University, Islamabad, Pakistan

Publications and helpful links

Helpful Links

• Cognitive behavioral therapy approach for suicidal Thinking and behaviors in depression.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: September 11, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Depression; CBT; Suicidal ideation; Suicide Probability; Self Help Tool; MINPLAN
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide
• Other Study ID Numbers: LWL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No