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临床试验/NCT05095233
NCT05095233招募中不适用

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

Syeda AYAT E ZAINAB Ali1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
64
试验地点
1
主要终点
Suicide Probability Scale

研究概览

简要总结

  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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Young Adults Culturally Adapted Therapy for Suicidal Prevention

Experimental

Young Adults Adapted Manual Assisted Psychological Therapy for Suicide Prevention

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

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.

干预措施: Min Plan Tool (Device)

结局指标

主要结局

Suicide Probability Scale

时间窗: 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.

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

时间窗: 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.

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.

次要结局

  • 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.)
  • Interpersonal Needs questionnaire(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(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)(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)(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.)

研究者

发起方
Syeda AYAT E ZAINAB Ali
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Syeda AYAT E ZAINAB Ali

PhD Scholar

International Islamic University, Islamabad

研究点 (1)

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