MIN PLAN VS CBT for Suicide Prevention

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

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

Min Plan Tool

About this trial

This is an interventional treatment trial for Suicide Risk focused on measuring Suicidal ideation, Suicide Probability, Depression, CBT, Self Help Tool, MINPLAN

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

International Islamic UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Young Adults Culturally Adapted Therapy for Suicidal Prevention

MINPLAN TOOL

Arm Description

Young Adults Adapted Manual Assisted Psychological Therapy for Suicide Prevention

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Beck Depression Inventory-21

Beck depression inventory-21 will be used to measure the symptoms of depression.

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).

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.

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.

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.

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).

Problem-Solving Inventory

The Problem-Solving Inventory is a 35-item instrument that measures perceptions of problem-solving behaviors and problem solving attitudes.

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.

Client Satisfaction Questionnaire (CSQ)

Client Satisfaction Questionnaire is a brief scale to measure the patient's satisfaction with mental health services.

Full Information

NCT ID

NCT05095233

First Posted

September 11, 2021

Last Updated

March 2, 2023

Sponsor

Syeda AYAT E ZAINAB Ali

Collaborators

Pakistan Institute of Living and Learning, MinPlan Organization

1. Study Identification

Unique Protocol Identification Number

NCT05095233

Brief Title

MIN PLAN VS CBT for Suicide Prevention

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 15, 2021 (Actual)

Primary Completion Date

April 30, 2023 (Anticipated)

Study Completion Date

April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Syeda AYAT E ZAINAB Ali

Collaborators

Pakistan Institute of Living and Learning, MinPlan Organization

4. Oversight

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

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Suicide Risk

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Young Adults Culturally Adapted Therapy for Suicidal Prevention

Arm Type

Experimental

Arm Description

Young Adults Adapted Manual Assisted Psychological Therapy for Suicide Prevention

Arm Title

MINPLAN TOOL

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

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

Other Intervention Name(s)

Psychosocial Intervention, Cognitive Behavior Therapy

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Min Plan Tool

Intervention Description

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.

Primary Outcome Measure Information:

Title

Suicide Probability Scale

Description

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.

Time Frame

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.

Title

Suicidal Ideation

Description

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.

Time Frame

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 Measure Information:

Title

Beck Depression Inventory-21

Description

Beck depression inventory-21 will be used to measure the symptoms of depression.

Time Frame

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.

Title

Psychache scale

Description

Psychache scale is a 13-item scale that will be used to measures psychological/emotional or mental pain as conceptualized by Shneidman (1993).

Time Frame