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临床试验/CTRI/2024/01/061602
CTRI/2024/01/061602招募中不适用

Brief Dialectical Behaviour Therapy Group Skills Training as a standalone psychotherapy for Individuals with Borderline Personality Disorder

UGC JRF Scholarship 495(NET-JULY 2018) University Grants Commission1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年2月5日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
BPD symptoms severity

研究概览

简要总结

Borderline Personality Disorder (BPD) is highly prevalent personality disorder associated with intense psychosocial distress to the patient and people around them. Highly cost intensive treatments available for this condition may not be feasible in Indian out-patient psychiatric settings. Brief Dialectical Behaviour Therapy Group Skills Training (DBT-ST) can be a judicious intervention in Indian settings due to the cost-effective nature of the treatment. However, DBT-ST have not been studied in Indian context. Thus, this research aims to study the effect of brief Dialectical Behaviour Therapy Skills Training (DBT- ST) for patient with BPD on various primary and secondary outcome variables.

A single group pre-post design will be used. The study will be conducted in two phases. The Pilot phase will include modification of brief DBT-ST schedule by Soler et al (2009) based on insights from running the DBT skills group with 4-6 participants and expert validation of the same.

The main phase will include administering the modified schedule to 30 participants diagnosed with BPD which will require running 4-6 psychotherapy groups with 6-8 participants. The screening will be done using Diagnostic interview for anxiety, mood, and obsessive-compulsive and related neuropsychiatric disorders (DIAMOND; Tolin et al., 2018) and Structured Clinical Interview for DSM-V Personality Disorders (SCID-V PD; First, 2014). The outcome variables will be assessed at baseline, mid-intervention assessment, post-intervention and at 3-months follow-up using Borderline Evaluation of Severity over Time (BEST; Pfohl & Blum, 1997),  Difficulties in Emotional Regulation Scale-18 (DERS-18; Victor & Klonsky, 2016), DBT ways of coping checklist (DBT-WCCL; Vitaliano, et. al., 1985), Depression, Anxiety and Stress Scale - 21 (DASS-21; Lovibond & Lovibond, 1995) and Global Assessment of Functioning (GAF; DSM-IV-TR, 2000). Clinical Global Impression Scale- Borderline Personality Disorder (CGI- BPD; Perez et al., 2007) will be applied pre- and post intervention whereas Deliberate Self-Harm Inventory (DSHI; Gratz, 2001) will be applied at 3 time points: pre-, post-intervention and 3 month follow up. VAS will be assessed after every session. Focus Group Discussion will be held post-intervention.

Data obtained in each phase will be recorded, coded and analysed using suitable qualitative and quantitative methods. Suitable software may be used to transcribe and organize the qualitative data from FGD. Content analysis will be used to understand the data. The quantitative data will be tabulated and subjected to statistical analysis using Statistical Package for Social Sciences (SPSS version 23). Descriptive statistics (e.g., mean, standard deviation) will be used to describe the demographical and clinical characteristics of the sample. Normality of the data will be assessed using Shapiro-Wilk test. Appropriate tests of association based on the normality of the sample will be carried out to study the association between the different variables considered in this study. The study may use hierarchical linear model to compare the data at different time points. P value less than 0.05 will be considered as statistically significant. The participants will be regularly assessed for suicidal risk. Crisis plan will be made collaboratively with participants and their consent will be taken to involve a designated contact person before commencing the treatment. In case patients require any emergency or psychiatric services, referrals and contacts will be provided for the same.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Age between 18–60 years,
  • meeting diagnostic criteria for BPD according to the Structured Clinical Interview for DSM-V Personality Disorders (SCID-5 PD),
  • able to read and understand English,
  • able to commit to attending 12-13 weeks of DBT skills training in the hospital’s outpatient clinic.
  • All genders.

排除标准

  • Current comorbidity with schizophrenia, drug-induced psychosis, alcohol or other psychoactive substance dependence, bipolar disorder, major depressive episode with current suicidal risk,
  • Symptoms of axis 1 disorders which interfere with engagement in therapy for personality disorder.
  • Having an organic brain disorder or intellectual disability.
  • Have taken DBT psychotherapy in the past or is currently undergoing psychotherapy for personality disorders.

结局指标

主要结局

BPD symptoms severity

时间窗: baseline, post intervention assessment,3-month follow-up and 6-month follow-up (if possible)

次要结局

  • Non-suicidal self-injury (NSSI)(baseline, post intervention assessment, 3-month follow-up and 6-month follow-up (if possible))
  • Emotion regulation(baseline, post intervention assessment, 3-month follow-up and 6-month follow-up (if possible))
  • Anxiety and depressive symptoms(baseline, post intervention assessment,3-month follow-up and 6-month follow-up (if possible))
  • Global Functioning(baseline, post intervention assessment,3-month follow-up and 6-month follow-up (if possible))
  • DBT skill use(Pre-intervention Assessment, after every module, 3-month follow-up and 6-month follow-up (if possible) (Total 7 time points))

研究者

发起方
UGC JRF Scholarship 495(NET-JULY 2018) University Grants Commission
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Diksha Dugar

National Institute of Mental Health and Neurosciences

研究点 (1)

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