Clinical trial NCT05095233: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Suicide Risk
Keywords: Suicidal ideation
Suicide Probability
Depression
CBT
Self Help Tool
MINPLAN
Lead sponsor: International Islamic University, Islamabad
Sponsor class: OTHER
Collaborators: name: Pakistan Institute of Living and Learning
name: MinPlan Organization
First posted: 2021-10-27
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Suicide Probability Scale
timeFrame: 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.
measure: Suicidal Ideation
timeFrame: 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:
measure: Beck Depression Inventory-21
timeFrame: 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.
measure: Psychache scale
timeFrame: 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.
measure: Hopelessness
timeFrame: 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.
measure: Negative Self Evaluation
timeFrame: 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.
measure: Hostility
timeFrame: 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.
measure: Interpersonal Needs questionnaire
timeFrame: 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.
measure: Problem-Solving Inventory
timeFrame: 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.
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA-2)
timeFrame: 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.
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 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.
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: International Islamic University
state: Capital
Study officials:
affiliation: International Islamic University, Islamabad, Pakistan
name: Dr Tamkeen Saleem, PhD
role: STUDY_CHAIR
References: