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临床试验/NCT05476601
NCT05476601已完成不适用

Culturally Adapted Manually Assisted Problem-Solving Intervention (CMAP) Plus CBT Based Motivational Interviewing for Self-Harm in Individuals With Substance Use Disorder in Pakistan: A Feasibility RCT

Pakistan Institute of Living and Learning2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Feasibility Indicator

研究概览

简要总结

Objectives:

To determine the feasibility and acceptability of the culturally adapted CMAP Plus CBT based Motivational Interviewing (MICBT) called CMAP Plus for self-harm in individuals with substance use disorder (SUD) in a feasibility randomised controlled trial.

To explore participants' experiences with CMAP Plus intervention.

Study design and setting:

The study will be a mixed-method feasibility randomised controlled trial of CMAP Plus as an intervention for Self-Harm in individuals with SUD in Pakistan. The study will be conducted in six major cities in Pakistan: Rawalpindi, Karachi, Peshawar, Hyderabad, Multan and Lahore.

Sample size:

A total of N=80 participants will be recruited from hospital settings and addiction rehabilitation centers in participating study sites.

详细描述

The study aims to determine the feasibility and acceptability of culturally Adapted Manually Assisted problem-solving intervention (CMAP) Plus MICBT for self-harm in individuals with SUD. The intervention will include specific strategies to identify and address obstacles in changing self-harm and drug-taking behaviour and offer ways to manage these difficulties from a cognitive-behavioural formulation. The intervention will also include CBT based mindfulness practice that involves learning to purposefully pay attention to ones inner and external experiences with an impartial non judging attitude. It can enable people to change the way they think and feel about their experiences, especially stressful experiences. The study will recruit a total of 80 participants from participating study sites, and prospective participants will be screened against eligibility criteria. Eligible consented participants will then be enrolled in the study. An independent statistician will randomise participants to one of the two study arms: 1) CMAP Plus (Intervention) along with Treatment As Usual (TAU); or 2) TAU alone. Each participant in the intervention arm will receive 12 individual, weekly sessions. Each session will take approximately 50-60 minutes. The sessions will be delivered at a place convenient to the participants. Trained therapists will deliver the intervention. The TAU will be comprised of standard care they will be receiving from participating centres at recruitment sites. Assessment measures will be administered before and after the intervention at 12th week. All assessments will be rater blind. After post-assessments at 12th week, a purposefully selected subset (stratified by age, gender, ethnicity, sexuality, religion, clinical and recovery scores) of participants will be invited for qualitative interviews to explore their experiences and satisfaction with the intervention. Participants will be interviewed within 1 week of their post-intervention by a trained qualitative researcher exploring their experience with CMAP Plus, the barriers and facilitators to engagement, and perceived benefits or negative experiences with the intervention. A sample of up to 15 interviews would be enough to achieve category saturation. On average, interviews will last for 60 minutes. The interview will be face-to-face or through telephone as an alternative to a face-to-face meeting to reduce the number of in-person meetings given the current context of COVID-19.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 and above.
  • Individuals diagnosed with SUD on DSM-5 criteria of mental disorders.
  • Having episodes of self-harm in last three months defined as a deliberate act to harm one's own body including but not limited to self-cutting, self-biting, self-poisoning, self-scratching, self-burning, self-hitting, pulling hair etc. assessed by deliberate self-harm inventory.
  • Capable to give informed consent.
  • Those who have completed detoxification process.

排除标准

  • Participants with DSM-5 criteria of mental disorder other than SUD; due to a general medical condition or dementia, delirium, schizophrenia, bipolar disorder, personality disorders, learning disability or any other condition to the extent that engagement in the intervention would not be possible, e.g. communication difficulties.
  • Unlikely to be available for outcome assessments (temporary residence).

研究组 & 干预措施

CMAP Plus

Experimental

CMAP Plus is comprised of an existing culturally adapted manually assisted problem-solving intervention (CMAP) integrated with CBT based Motivational Interviewing (MICBT) called (CMAP Plus). The TAU of intervention group participants will be continued along with study intervention.

干预措施: CMAP Plus (Behavioral)

TAU alone

No Intervention

This will be comprised of standard care they will be receiving from participating centres at recruitment sites. The standard care for individuals with SUD in Pakistan usually includes a 2-3-week detoxification programme, followed by 2 months of weekly 1:1 session along with some family sessions, followed by a period of support groups programmes.

结局指标

主要结局

Feasibility Indicator

时间窗: From baseline to 12th week (at the end of intervention)

The feasibility will be determined by collecting data on recruitment rates. The success criterion of feasibility will be to recruit \> 50% of eligible participants. We will also record attrition (number of dropouts) and retention rate (the proportion of participants who complete the intervention period).

Acceptability indicator

时间窗: From baseline to 12th week (at the end of intervention)

The acceptability of intervention will be assessed using data on attendance. The criterion for acceptability is a mean attendance rate of \>70% of sessions (at least 9 sessions).

次要结局

  • Beck scale for suicide ideation(From baseline to 12th week (at the end of intervention))
  • Beck Hopelessness Scale(From baseline to 12th week (at the end of intervention))
  • Euro-Qol-5 Dimensions scale(From baseline to 12th week (at the end of intervention))
  • Severity of dependence scale(From baseline to 12th week (at the end of intervention))
  • Depression Anxiety Stress Scale(From baseline to 12th week (at the end of intervention))
  • The deliberate self-harm inventory(From baseline to 12th week (at the end of intervention))
  • Client Service Receipt Inventory(From baseline to 12th week (at the end of intervention))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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