Addiction-focused EMDR in Inpatients Who Use Non-opioid Drugs: a Multiple Baseline Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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:
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Feasibility.
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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:
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Feasibility issues.
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Changes in daily craving.
Study Design
Arms and Interventions
| 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.
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Outcome Measures
Primary Outcome Measures
- Recruitment potential [1 year]
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.
- Participants acceptability [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.
- Therapist acceptability [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
- Study adherence of participants [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 [1 year]
facilitators and barriers and subjective effectiveness of the AF-EMDR intervention.
Secondary Outcome Measures
- Change in: Subjective Units of Distress (SUD) [1 year]
Within and/or over AF-EMDR sessions change in: Subjective Units of Distress (SUD) (Likert-type scales), a higher score reflects a worse outcome.
- Change in craving [1 year]
Within and/or over AF-EMDR sessions change in: Craving (Likert-type scale), a higher score reflects a worse outcome.
- Change in Level of Urge (LoU) [1 year]
Within and/or over AF-EMDR sessions change in: Change in Level of Urge (LoU), a higher score reflects a worse outcome.
- Change in: Level of Positive Affect (LoPA) [1 year]
Within and/or over AF-EMDR sessions change in: Level of Positive Affect (LoPA), a higher score reflects a better outcome.
- changes in: Craving (MATE Q1: OCDS-5) [1 year]
Baseline to follow-up assessment changes in: Craving (MATE Q1: OCDS-5), a higher score reflects a worse outcome
- changes in: Craving-related self-control/self-efficacy (SCCQ) [1 year]
Baseline to follow-up assessment changes in: Craving-related self-control/self-efficacy (SCCQ), a higher score reflects a worse outcome
- changes in: Positive incentive value (SCCQ) [1 year]
Baseline to follow-up assessment changes in: Positive incentive value (SCCQ), a higher score reflects a worse outcome
- changes in: Substance use (past 30 days) (MATE section 1) [1 year]
Baseline to follow-up assessment changes in: Substance use (past 30 days) (MATE section 1), a higher score reflects a worse outcome
Eligibility Criteria
Criteria
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Addiction clinic 'Tiel' IrisZorg | Tiel | Gelderland | Netherlands | 4001 AG |
Sponsors and Collaborators
- IrisZorg
- Radboud University Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MBS AF-EMDR NODD