Tobacco Treatment Using EMDR (ToTEM)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Feasibility and Potential Efficacy of Adding Tobacco Treatment Using EMDR (ToTEM) to a Regular Smoking Cessation Program A Pilot Randomized Controlled Trail in Inpatient Daily Smokers With a Substance Use Disorder

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Behavioral: TAU + Addiction focussed - eye movement desensitization and reprocessing (AF-EMDR)
* Behavioral: TAU only: Community Reinforcement Approach (CRA) + SCP


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAU only: Community Reinforcement Approach (CRA) + a regular smoking cessation program<br>TAU only | Behavioral: TAU only: Community Reinforcement Approach (CRA) + SCP<br>* 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.<br>* Other names: CRA (+SCP);|
| Experimental: TAU + Addiction focussed - eye movement desensitization and reprocessing (AF-EMDR) + TAU (CRA)<br>TAU + Addiction focussed - eye movement desensitization and reprocessing (AF-EMDR) | Behavioral: TAU + Addiction focussed - eye movement desensitization and reprocessing (AF-EMDR)<br>* 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.<br>* Other names: AF-EMDR;Behavioral: TAU only: Community Reinforcement Approach (CRA) + SCP<br>* 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.<br>* Other names: CRA (+SCP);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention of participants | The retention of participants from randomization until the last follow-up. | 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. | 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 an a-priori established adherence rating protocol; a higher score reflects better adherence. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants | The proportion of patients at the clinic that are potentially eligible and provide informed consent. | 1 year | 
| The feasibility of the outcome measures | The feasibility of the outcome measures in terms of completion of questionnaires (% per questionnaire and total). | 1 year | 
| The acceptability of the outcome measures | The acceptability of the outcome measures in terms of Likert-type ratings by participants, therapists and research assistants. | 1 year | 
| Missing data | Amount of missing data, measured by total number of missing values and the proportion of completed versus missing data. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco, Addiction, EMDR