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.…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Verslaving
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints (feasibility)
Recruitment potential, measured by the proportion of patients at the clinic
that are potentially eligible and are included versus those that are excluded.
Study adherence of participants from randomization until follow-up in terms of
completion of ratings, assessments and interview.
Acceptability of AF-EMDR to participants in terms of compliance, measured by
the total number of AF-EMDR sessions attended and the proportion of attended
versus non attended (planned) sessions.
Adoption of the AF-EMDR protocol by the EMDR therapists in terms of adherence
to the protocol, measured by an independent rater according to an a-priori
established adherence rating protocol.
Experienced (by participants) acceptability and burden, facilitators and
barriers and subjective effectiveness of the AF-EMDR intervention.
Secondary outcome
Secondary study parameters/endpoints (potential clinical efficacy)
Within and/or over AF-EMDR sessions change in:
Craving (Likert-type scale).
Level of Urge (LoU), Level of Positive Affect (LoPA) and Subjective Units of
Distress (SUD) (Likert-type scales).
Baseline to follow-up assessment changes in:
Craving (MATE Q1: OCDS-5)
Craving-related self-control/self-efficacy (SCCQ).
Positive incentive value (SCCQ).
Substance use (past 30 days) (MATE section 1).
Changes in slope of the (combined) daily craving ratings from the baseline
versus the intervention phase.
Background 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.
Study objective
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 design
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.
Intervention
Intervention: a total of four 90 min. sessions of AF-EMDR twice per week added
to TAU.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: on the basis of previous research, no risks are
expected. The extra burden consists of filling in additional, self-report
questionnaires at baseline- and follow-up (2 x * 15 min.), attending four x 90
min. AF-EMDR sessions, keeping a daily craving score during baseline and
intervention phase (* 5 min.), and participate in a follow-up interview (* 30
min.). All participants receive an incentive (a voucher worth ¤15,-) after
completing the baseline assessment and daily ratings and another voucher (worth
¤15,-) after concluding the follow-up assessment and interview, amounting to a
total of two vouchers (total worth ¤30,-), as a compensation for the extra
burden and possible travel-time involved in the follow-up interview.
Tarweweg 20
Nijmegen 6534AM
NL
Tarweweg 20
Nijmegen 6534AM
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, patients must meet the
following criteria:
Diagnosis of a non-opioid drug use disorder according to the DSM-5 (American
Psychiatric Association, 2013) criteria.
Age >= 18 years.
Good Dutch language proficiency (based on clinical judgement).
High craving past week (score >= 10 on the OCDS-5).
A planned inpatient stay of >= 4 weeks.
Written informed consent.
Exclusion criteria
Respondents who have received AF-EMDR therapy before, or will receive
trauma-focused EMDR therapy during their inpatient stay are excluded as are
patients during a tapering regime (they can be included following successful
tapering however).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05923697 |
| CCMO | NL84818.091.23 |