MIN PLAN VS CBT for Suicide Prevention

Suicide Risk Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05095233
• Other study ID #: LWL
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: March 2023
• Source: International Islamic University, Islamabad
• Contact: Syeda Ayat e Zainab Ali, PhD Scholar
• Phone: +923121319004
• Email: zai_nab1[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Suicide
• Suicide Risk

Intervention

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.

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.

Locations

Country	Name	City	State
Pakistan	International Islamic University	Islamabad	Capital

Sponsors (3)

Lead Sponsor	Collaborator
Syeda AYAT E ZAINAB Ali	MinPlan Organization, Pakistan Institute of Living and Learning

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

External Links

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