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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Substance Use Disorders
• Intervention / Treatment: Behavioral: AF-EMDR

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 9
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wiebren Markus; Phone Number: 088 - 606 1396; Email: w.markus@iriszorg.nl
• Study Contact Backup: Name: Reinier van den Haak; Phone Number: 088 - 606 1152; Email: r.haak@iriszorg.nl

Study Locations

• Netherlands
  • Gelderland
    • Tiel, Gelderland, Netherlands, 4001 AG
      • Recruiting
      • Addiction clinic 'Tiel' IrisZorg
      • Contact: Reinier van den Haak, MSc; Email: r.haak@iriszorg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: AF-EMDR; Intervention: a total of four 90 min. sessions of AF-EMDR twice per week added to TAU.

Behavioral: AF-EMDR; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The number of experienced 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

Collaborators and Investigators

• Sponsor: IrisZorg
• Collaborators: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Addiction; EMDR; Non-opioid drug disorder
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Compulsive Behavior; Impulsive Behavior; Substance-Related Disorders; Behavior, Addictive
• Other Study ID Numbers: MBS AF-EMDR NODD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Depending on the final data collection and the journal in which these are published, we will decide on availability of IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No