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

NCT05923697 | Recruiting

• 1 other identifier: MBS AF-EMDR NODD
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Substance Use Disorders

Keywords

Addiction; EMDR; Non-opioid drug disorder

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Change in: Subjective Units of Distress (SUD)

  1 year

• Change in craving

  1 year

• Change in Level of Urge (LoU)

  1 year

• Change in: Level of Positive Affect (LoPA)

  1 year

• changes in: Craving (MATE Q1: OCDS-5)

  1 year

Study Arms (1)

AF-EMDR

EXPERIMENTAL

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

Behavioral: AF-EMDR

Interventions

AF-EMDR BEHAVIORAL

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.

AF-EMDR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• IrisZorg: lead
• Radboud University Medical Center: collaborator

Study Sites (1)

Addiction clinic 'Tiel' IrisZorg

Tiel, Gelderland, 4001 AG, Netherlands

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Central Study Contacts

Reinier van den Haak

CONTACT

088 - 606 1152; r.haak@iriszorg.nl

Wiebren Markus

CONTACT

088 - 606 1396; w.markus@iriszorg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 28, 2023
• Study Start: November 6, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

NL (1)