MIN PLAN VS CBT for Suicide Prevention

NCT05095233 | Unknown DMC

• 1 other identifier: LWL
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Suicide Risk

Keywords

Suicidal ideation; Suicide Probability; Depression; CBT; Self Help Tool; MINPLAN

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Beck Depression Inventory-21

  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

  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

  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

  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

  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.

Study Arms (2)

Young Adults Culturally Adapted Therapy for Suicidal Prevention

EXPERIMENTAL

Young Adults Adapted Manual Assisted Psychological Therapy for Suicide Prevention

Behavioral: Young Adults Culturally Adapted Manual Assisted Psychological Therapy (YA-CMAP)

MINPLAN TOOL

ACTIVE COMPARATOR

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

Interventions

Young Adults Culturally Adapted Manual Assisted Psychological Therapy (YA-CMAP) BEHAVIORAL

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.

Also known as: Psychosocial Intervention, Cognitive Behavior Therapy

Young Adults Culturally Adapted Therapy for Suicidal Prevention

Min Plan Tool DEVICE

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.

MINPLAN TOOL

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Syeda AYAT E ZAINAB Ali: lead
• Pakistan Institute of Living and Learning: collaborator
• MinPlan Organization: collaborator

Study Sites (1)

International Islamic University

Islamabad, Capital, 44000, Pakistan

RECRUITING

Related Links

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

MeSH Terms

Conditions

Suicidal Ideation; Depression

Interventions

Psychosocial Intervention; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Behavior Therapy

Study Officials

• Dr Tamkeen Saleem, PhD

  International Islamic University, Islamabad, Pakistan

  STUDY CHAIR

Central Study Contacts

Syeda Ayat e Zainab Ali, PhD Scholar

CONTACT

+923121319004; zai_nab1@hotmail.com

Dr Tamkeen Saleem, PhD

CONTACT

(00)92-(0)51-9019887; tamkeen.saleem@iiu.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Scholar

Model Details: The study is based on single blind randomized controlled trial with the randomization of study participants across two groups (1). Young Adults Culturally Adapted Manual Assisted Psychological Therapy (2). MINPLAN Tool

Study Record Dates

• First Submitted: September 11, 2021
• First Posted: October 27, 2021
• Study Start: November 15, 2021
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: March 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)