跳至主要内容
临床试验/CTRI/2024/11/077389
CTRI/2024/11/077389尚未招募2 期

The correlation between emotional dysregulation, adult attachment, aggression orientation, and trauma symptoms with the occurrence of NSSI was explored. An intervention was applied to selective individuals engaging in NSSI.

ANWESHA BHATTACHARYYA1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2024年12月3日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
800
试验地点
1
主要终点
NSSI occurrence, frequency and outcome were measured by FASM

研究概览

简要总结

For Phase I of the data collection procedure, the authority of the respective educational institutions from each of the five zones mentioned in Kolkata was approached, and permission will be sought. Prevalence studies conducted worldwide reveal that the prevalence of NSSI among the community or student population is roughly 30-31%. Of the 920 participants, the ones detected with the presence of NSSI were selected based on the information schedule, FASM questionnaire, and BPRS (to screen out individuals with psychotic symptoms). On these selected students engaging in NSSI, the scales for the other respective variables were administered to explore the association between NSSI and these variables. Suggested statistical analyses for this phase were descriptive statistics like frequencies, percentages, means and standard deviation, and inferential statistics like Chi-square, t-test, ANOVA, MANOVA, and predictive statistics like binomial regression.

For Phase 2, firstly the participants who significantly engage in NSSI and also have significant symptoms of psychological trauma were randomly allocated to either of the two treatment arms. One clinical group consisted of intervention by trauma-focused CBT (TF-CBT), whereas the other treatment group comprised only supportive therapy and basic emotional regulation training. The participants in the clinical treatment group were provided with a brief report and were also informed about the expected outcome of TF-CBT in the alleviation of the symptoms. An additional consent form was provided to the young adult students who engaged in NSSI and also scored significantly higher in the TSC-40 and volunteered for this intervention program. These individuals were intervened by application of TF-CBT, spanning over an average number of 12-18 sessions across a span of 3-6 months, in contrast to the supportive therapy treatment group. The statistical analyses for the pre-intermediate-post measures were done with non-parametric statistics based on pre-post measures of TSC-40, BDI, BAI and FASM.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • The individuals within age range of 18-24 years, Regular students studying in colleges and universities with English as the medium of instruction and communication, Students belonging to the middle socioeconomic status in Kolkata.

排除标准

  • Chronic physical condition like fibromyalgia, Crohn’s disease, severe diabetes or any terminal illness, traumatic brain injury or any neuropsychological injury or condition Any recent episode of any accident, sudden death of a loved one or any other source of acute psychological trauma Active suicidal ideation or intent or recent history of suicide attempt (within a month of the data collection procedure) needing emergency intervention Individuals belonging to broken homes or separated families.

结局指标

主要结局

NSSI occurrence, frequency and outcome were measured by FASM

时间窗: Baseline measure was done. | Intermediate measure at 6-8 weeks. | Post-intervention measure at 12-16 weeks.

Depression and Anxiety symptoms were measured by BDI and BAI respectively

时间窗: Baseline measure was done. | Intermediate measure at 6-8 weeks. | Post-intervention measure at 12-16 weeks.

Trauma Symptoms were measured by TSC-40

时间窗: Baseline measure was done. | Intermediate measure at 6-8 weeks. | Post-intervention measure at 12-16 weeks.

次要结局

  • The alleviation of symptoms of depression as per BDI (at least below moderate level),and the alleviation of symptoms of anxiety as per BAI (at least below moderate level)(3-6 months)

研究者

发起方
ANWESHA BHATTACHARYYA
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

ANWESHA BHATTACHARYYA

Department of Applied Psychology, UNIVERSITY OF CALCUTTA

研究点 (1)

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