The Feasibility and Potential Efficacy of Adding Addiction-focused EMDR to Regular Addiction Treatment A Multiple Baseline Study in Inpatients Who Use Non-opioid Drugs
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Therapist acceptability
研究概览
简要总结
Rationale: It is well established that Substance Use Disorders (SUD) have severe health consequences. Despite behavioral and pharmacological treatment options, relapse rates remain high. In particular, for non-opioid drugs, such as amphetamines, cocaine, base-coke and cannabis, established, evidence-based pharmacological options to reduce craving, to substitute substance use or to enforce abstinence are lacking. Therefore, there is a need for effective interventions for patients who use non-opioid drugs to reach and maintain long-term abstinence.
A potential interesting intervention is addiction-focused Eye Movement Desensitization and Reprocessing (AF-EMDR) therapy. However, the limited research on AF-EMDR therapy and mixed findings thus far prohibit clinical use. Recently, on the basis of diverse findings thus far, an adjusted AF-EMDR therapy protocol has been developed.
详细描述
Objective: to investigate areas of uncertainty about a possible future pilot RCT using AF-EMDR as an add-on intervention in inpatients who use non-opioid drugs and receive regular, inpatient addiction treatment, by determining:
- Feasibility.
- Potential clinical efficacy.
Study population: adults with a primary non-opioid use disorder, who are admitted to an inpatient addiction care clinic. A total of nine eligible participants will be allocated (allocation ratio 1:1:1) at random, in a non-concurrent fashion to one of three baseline durations.
Intervention: a total of four 90 min. sessions of AF-EMDR twice per week added to TAU.
Main study parameters/endpoints:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, patients must meet the following criteria:
- •Diagnosis of Tobacco Use Disorder according to the DSM-5 (American Psychiatric Association, 2013) criteria.
- •Age ≥ 18 years.
- •Good Dutch language proficiency (based on clinical judgement).
- •Smoking, on average, ≥ 10 cigarettes per day pre-admission.
- •A score of at least 5 on a scale from 0 to 10, for motivation and self-efficacy
- •A planned inpatient stay of ≥ 4 weeks.
- •Written informed consent.
排除标准
- •A patient who meets any of the following criteria will be excluded from participation in this study:
- •Serious therapy interfering behavior or symptoms that also interfere with TAU, based on clinical judgement (e. g. psychiatric or medical crisis that requires immediate intervention).
结局指标
主要结局
Therapist acceptability
时间窗: 1 year
The acceptability of AF-EMDR to therapists in terms of adherence to the protocol, measured by the score of an independent rater on an a-priori established adherence rating protocol; a higher score reflects better adherence. Minimum=0 ;maximum=100
Participants acceptability
时间窗: 1 year
The acceptability of AF-EMDR to participants in terms of compliance, measured by the total number of sessions attended and the proportion of attended versus non attended (planned) sessions; a higher proportion of attended sessions reflects better compliance.
Study adherence of participants
时间窗: 1 year
from randomization until follow-up in terms of completion of tasks. A higher amount of completion means a better outcome.
Experienced (by participants) acceptability and burden
时间窗: 1 year
The number of experienced facilitators and barriers and subjective effectiveness of the AF-EMDR intervention.
次要结局
- Change in Level of Urge (LoU)(1 year)
- Change in: Level of Positive Affect (LoPA)(1 year)
- Change in: Subjective Units of Distress (SUD)(1 year)
- changes in: Positive incentive value (SCCQ)(1 year)
- changes in: Substance use (past 30 days) (MATE section 1)(1 year)
- changes in: Craving-related self-control/self-efficacy (SCCQ)(1 year)
- Change in craving(1 year)
- changes in: Craving (MATE Q1: OCDS-5)(1 year)