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| Name | Class |
|---|---|
| Radboud University Medical Center | OTHER |
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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AF-EMDR | Experimental | Intervention: a total of four 90 min. sessions of AF-EMDR twice per week added to TAU. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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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).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reinier van den Haak | Contact | 088 - 606 1152 | r.haak@iriszorg.nl | |
| Wiebren Markus | Contact | 088 - 606 1396 | w.markus@iriszorg.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Addiction clinic 'Tiel' IrisZorg | Recruiting | Tiel | Gelderland | 4001 AG | Netherlands |
Depending on the final data collection and the journal in which these are published, we will decide on availability of IPD
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
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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.
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|
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 |
| D001519 |
| Behavior |