Substance Use Disorders
Conditions
Keywords
Addiction, EMDR, Non-opioid drug disorder
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.
Interventions
BEHAVIORALAF-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.
Sponsors
Radboud University Medical Center
IrisZorg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The number of experienced facilitators and barriers and subjective effectiveness of the AF-EMDR intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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: 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: Positive incentive value (SCCQ) | 1 year | Baseline to follow-up assessment changes in: Positive incentive value (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. |
| 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. |
Countries
Netherlands
Contacts
Primary ContactReinier van den Haak
Backup ContactWiebren Markus
Outcome results
None listed