Addiction-focused EMDR in Inpatients Who Use Non-opioid Drugs: a Multiple Baseline Study
- Conditions
- Substance Use Disorders
- Interventions
- Behavioral: AF-EMDR
- Registration Number
- NCT05923697
- Lead Sponsor
- IrisZorg
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 9
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.
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AF-EMDR AF-EMDR Intervention: a total of four 90 min. sessions of AF-EMDR twice per week added to TAU.
- Primary Outcome Measures
Name Time Method 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.
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
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.
Experienced (by participants) acceptability and burden 1 year The number of experienced facilitators and barriers and subjective effectiveness of the AF-EMDR intervention.
- Secondary Outcome Measures
Name Time Method 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.
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.
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
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
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.
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
Trial Locations
- Locations (1)
Addiction clinic 'Tiel' IrisZorg
🇳🇱Tiel, Gelderland, Netherlands