Addiction-focused EMDR in Inpatients Who Use Non-opioid Drugs: a Multiple Baseline Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Feasibility issues. Changes in daily craving.

Official Title
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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

Conditions
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Substance Use Disorders

Intervention / Treatment
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* Behavioral: AF-EMDR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Study design: a non-concurrent multiple baseline design is used in which participants are allocated at random to a baseline period of 7, 10, or 13 days after which they proceed to an intervention phase of two weeks in which they receive four 90 min. sessions of AF-EMDR and a follow-up interview after one month. During both the baseline and the AF-EMDR intervention phase, participants also receive Treatment As Usual (TAU: Community Reinforcement Approach (CRA)), aimed at SUD.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AF-EMDR<br>Intervention: a total of four 90 min. sessions of AF-EMDR twice per week added to TAU. | Behavioral: AF-EMDR<br>* Investigational treatment All participants receive four 90 min. AF-EMDR sessions within a timeframe of two weeks following the baseline phase. The AF-EMDR treatment will be provided by the principal investigators, a level II EMDR therapist (RvdH) and an EMDR consultant in training who developed the AF-EMDR protocol. The EMDR therapist (RvdH) will be trained by the EMDR consultant (WM), who is available for consultation. Additionally, both participate monthly in peer-supervision whereby videotaped sessions are discussed. See appendix 1 for a detailed understanding of the AF-EMDR protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment potential | measured by the proportion of patients at the clinic that are potentially eligible and are included versus those that are excluded. A higher amount of included participants means a better outcome. | 1 year | 
| Participants acceptability | 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. | 1 year | 
| Therapist acceptability | 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 | 1 year | 
| Study adherence of participants | from randomization until follow-up in terms of completion of tasks. A higher amount of completion means a better outcome. | 1 year | 
| Experienced (by participants) acceptability and burden | facilitators and barriers and subjective effectiveness of the AF-EMDR intervention. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in: Subjective Units of Distress (SUD) | Within and/or over AF-EMDR sessions change in: Subjective Units of Distress (SUD) (Likert-type scales), a higher score reflects a worse outcome. | 1 year | 
| Change in craving | Within and/or over AF-EMDR sessions change in: Craving (Likert-type scale), a higher score reflects a worse outcome. | 1 year | 
| Change in Level of Urge (LoU) | Within and/or over AF-EMDR sessions change in: Change in Level of Urge (LoU), a higher score reflects a worse outcome. | 1 year | 
| Change in: Level of Positive Affect (LoPA) | Within and/or over AF-EMDR sessions change in: Level of Positive Affect (LoPA), a higher score reflects a better outcome. | 1 year | 
| changes in: Craving (MATE Q1: OCDS-5) | Baseline to follow-up assessment changes in: Craving (MATE Q1: OCDS-5), a higher score reflects a worse outcome | 1 year | 
| changes in: Craving-related self-control/self-efficacy (SCCQ) | Baseline to follow-up assessment changes in: Craving-related self-control/self-efficacy (SCCQ), a higher score reflects a worse outcome | 1 year | 
| changes in: Positive incentive value (SCCQ) | Baseline to follow-up assessment changes in: Positive incentive value (SCCQ), a higher score reflects a worse outcome | 1 year | 
| changes in: Substance use (past 30 days) (MATE section 1) | Baseline to follow-up assessment changes in: Substance use (past 30 days) (MATE section 1), a higher score reflects a worse outcome | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Addiction, EMDR, Non-opioid drug disorder