Rationale: It is well established that tobacco use has severe health consequences. The prevalence of Tobacco Use Disorder (TUD) is among the highest in populations with Substance Use Disorders (SUD). Despite behavioral and pharmacological treatment options, relapse rates remain high. Therefore, there is a need for additional smoking cessation treatment options that aid 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 protocol has been developed.
SUMMARY Rationale: It is well established that tobacco use has severe health consequences. The prevalence of Tobacco Use Disorder (TUD) is among the highest in populations with Substance Use Disorders (SUD). Despite behavioral and pharmacological treatment options, relapse rates remain high. Therefore, there is a need for additional smoking cessation treatment options that aid 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 protocol has been developed. Objective: to investigate areas of uncertainty about a possible future definitive RCT using AF-EMDR as an add-on intervention to a Smoking Cessation Program (SCP), by determining: * Feasibility/process outcomes (e.g. recruitment, adherence, treatment fidelity). * Preliminary clinical efficacy in order to estimate the effect size for a future power analysis. Study design: a pilot study with a two-armed randomized controlled design is used in which AF-EMDR + Treatment As Usual (TAU) (Community Reinforcement Approach (CRA) aimed at SUD + a SCP) is contrasted with TAU-only with an intervention phase of three weeks pre- and post intervention assessments and a follow-up after one and three months. Study population: daily smoking adults, admitted to an inpatient addiction care clinic. A total of 50 eligible participants will be allocated at random to one of two treatment groups. \- In order to be eligible, patients must meet the following criteria: 1) age ≥ 18 years, 2) good Dutch language proficiency, 3) a DSM-5 diagnosis of Tobacco Use Disorder, 4) smoking, on average, ≥ 10 cigarettes per day pre-admission, 5) A score of at least 5 on a scale from 0 to 10, for motivation and self-efficacy, 6) a planned inpatient stay of ≥ 4 weeks, and 7) written informed consent. Respondents who demonstrate serious therapy interfering behavior or symptoms that also interfere with TAU will be excluded from participation in this study (e. g. psychiatric or medical crisis that requires immediate intervention). Intervention: a total of six 45-90 min. sessions of AF-EMDR twice per week added to a SCP embedded in TAU. Main study parameters/endpoints: * Feasibility, design, recruitment and protocol issues. * Changes in tobacco craving and smoking behavior.
A total of six 45-90 min. sessions of AF-EMDR therapy with an average frequency of twice per week added to a SCP embedded in CRA. AF-EMD therapy consists of a rationale, installating a treatment goal, desensitasing mental video's, installation of positive cognition, future template and positive ending.
CRA is a comprehensive cognitive behavioural treatment that focuses on helping people discover and adopt a pleasurable, social and healthy lifestyle that is more rewarding than a lifestyle including substance use. Within CRA a regular smoking cessation program is embedded.
Addiction clinic 'Tiel' IrisZorg
Tiel, Gelderland, Netherlands
Retention of participants
The retention of participants from randomization until the last follow-up.
Time frame: 1 year
Acceptability in terms of compliance
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.
Time frame: 1 year
Acceptability in terms of adherence
The acceptability of AF-EMDR to therapists in terms of adherence to the protocol, measured by the score of an independent rater on a self-developed, a-priori established adherence rating protocol using 47 Likert-type items (range 1-5); a higher score reflects better adherence.
Time frame: 1 year
Proportion of participants
The proportion of patients at the clinic that are potentially eligible and provide informed consent.
Time frame: 1 year
The feasibility of the outcome measures
The feasibility of the outcome measures in terms of completion of questionnaires (% per questionnaire and total).
Time frame: 1 year
Missing data
Amount of missing data, measured by total number of missing values and the proportion of completed versus missing data.
Time frame: 1 year
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3