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临床试验/CTRI/2024/02/062422
CTRI/2024/02/062422已完成2 期

Development and feasibility Integrated trauma-focused psychotherapy for substance use disorders- role of identity and meaning making.

National Institute of Mental Health and NeuroSciences (NIMHANS)1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年2月16日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
1.Substance use related outcomes: Quantity, frequency, duration and severity of substance use.

研究概览

简要总结

The present study aims to develop and test the feasibility of integrated trauma focussed psychotherapy for individuals with Substance Use Disorders. It further attempts to explore the role of identity and meaning making processes within this intervention. The objectives of the study include developing the therapy module, testing the effectiveness of the module in 20 participants in terms of substance use outcomes, trauma related outcomes (trauma perception, meaning making and Post Traumatic Growth), Identity processes, change mechanisms (Therapeutic Alliance) and overall functioning. A single group pre-post-follow-up mixed methods design is followed. Purposive sampling will be used to recruit clients from the Centre for Addiction Medicine and Adult Psychiatry Units, NIMHANS who meet the inclusion and exclusion criteria and give consent. The study will be conducted in two phases. The therapy module has been developed in the pilot phase based on a detailed needs assessment (interviews, focus-group discussions and review of literature) regarding what components are relevant for trauma focussed psychotherapy in SUD treatment. Based on the pilot data, a total of 15-20 sessions over 2-3 months have been finalized. Expert validation for the intervention modules has been done and the intervention outline has been provided below. The sample size (20 subjects) has been estimated using a combination of pragmatic factors such as how many patients are referred for Substance Use Disorders treatment, drop-out rates estimated based on previous studies conducted in the field of interventions for SUDs, and minimal sample needed to detect a positive change. Analysis will be planned using descriptive measures, repeated measures ANOVA and qualitative analysis. The ethical considerations have been done keeping in mind the guidelines for conducting research in the field of trauma. Psychotherapy intervention outline: 

Sr.No

Name of the phase/module

Targets

Number of sessions

|1

Recruitment and assessment

Informed consent and administering assessments

3

|2

PHASE I- Safety and Stabilization

Ensuring safety, psychoeducation and socializing the patient into treatment

2-4

|3.

Phase II- Resource building

|A. Regulating Substance use

Reduction/ abstinence from substance use

2-3

|B. Optimizing emotional and interpersonal resources

Regulating emotions

Interpersonal skills

3-5

|4

Phase III- Trauma and abuse

5-6

|Exploring trauma narratives- processing and integration

Exposure for traumatic memories

|Making meaning and looking ahead

Meaning making, positive psychological growth post trauma

|5

Termination

Terminating therapy and assessments

2

|ELECTIVES

|1

Managing suicidal thoughts and behaviors

Suicidal ideation, suicide attempts

2-3

|2

Self-care

Sleep hygiene, regular meal times, structure in daily routine

1

|3

Building a network of support- Family and Significant others

Psychoeducation for family members/ significant others; eliciting support from family members/ significant others

2

|4

Enhancing motivation.

Motivation enhancement for substance use

2

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 45.00 Year(s)(—)
性别
All

入选标准

  • Individuals with a file diagnosis Substance Use Disorders, as per DSM-5 diagnostic criteria.
  • Individuals who have been screened for past or current exposure to trauma.
  • 9th grade (high school) reading level for English.

排除标准

  • Individuals under acute intoxication or continuing to have severe withdrawal symptoms.
  • Individuals diagnosed with severe mental health disorders like severe depression, current manic episode, severe suicidal risk and active psychotic symptoms.
  • Individuals diagnosed with Intellectual and developmental disabilities as per file diagnosis.
  • Individuals with frontal lobe syndromes, peripheral neuropathy or any other neurological conditions (as per file diagnosis) that prevents patients from engaging in therapy.
  • Individuals who have undergone structured psychotherapy for more than 8 or more sessions in the past 6 months.

结局指标

主要结局

1.Substance use related outcomes: Quantity, frequency, duration and severity of substance use.

时间窗: 1. Pre-intervention | 2. Post-intervention | 3. One-month follow up

2.Trauma related outcomes:

时间窗: 1. Pre-intervention | 2. Post-intervention | 3. One-month follow up

i.Trauma response

时间窗: 1. Pre-intervention | 2. Post-intervention | 3. One-month follow up

ii.Meaning- Making and Post-traumatic Growth.

时间窗: 1. Pre-intervention | 2. Post-intervention | 3. One-month follow up

3. Changes in Identity functioning

时间窗: 1. Pre-intervention | 2. Post-intervention | 3. One-month follow up

4. Change Mechanisms- Therapeutic alliance and helpful aspects of therapy.

时间窗: 1. Pre-intervention | 2. Post-intervention | 3. One-month follow up

5.General outcome measures- Emotion regulation and Quality of Life.

时间窗: 1. Pre-intervention | 2. Post-intervention | 3. One-month follow up

次要结局

未报告次要终点

研究者

发起方
National Institute of Mental Health and NeuroSciences (NIMHANS)
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Nishita Choudhari

National Institute of Mental Health and NeuroSciences (NIMHANS)

研究点 (1)

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