Tobacco Treatment Using EMDR (ToTEM) (ToTEM)

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

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.

Study Overview

• Status: Terminated
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Behavioral: TAU only: Community Reinforcement Approach (CRA) + SCP; Behavioral: TAU + Addiction focussed - eye movement desensitization and reprocessing (AF-EMDR)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Tiel, Gelderland, Netherlands, 4001 AG
      • Addiction clinic 'Tiel' IrisZorg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion 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:

• 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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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 a self-developed, a-priori established adherence rating protocol using 47 Likert-type items (range 1-5); 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
Missing data	Amount of missing data, measured by total number of missing values and the proportion of completed versus missing data.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	Demographics, as inventoried by a structured interview and patient files.	1 year
Smoking history	Smoking (cessation history), inventoried by a structured interview and patient files.	1 year
DSM-5	Current DSM-5 diagnoses, inventoried by a structured interview and patient files.	1 year
Motivation	Motivation to quit smoking, measured by a Likert-type scale from 0 to 10; a higher score reflects a higher motivation.	1 year
Self-efficacy	Smoking cessation self-efficacy, measured by a Likert-type scale from 0 to 10; a higher score reflects a higher self-efficacy.	1 year
Nicotine dependence	Severity of nicotine dependence, measured by the Fagerström Test of Nicotine Dependence, providing a score from 0 to 10; a higher score reflects a more severe dependence.	1 year
Time to relapse	Time to relapse (from the end of the AF-EMDR intervention, if abstinence is achieved), measured in number of days from the end of the AF-EMDR intervention until first cigarette smoked. The higher the number of days, the longer the time to relapse.	1 year
Smoking behavior	Changes from baseline (T0) to T1-T2-T3 in: Smoking behavior, measured by mean number of cigarettes smoked per day over the past 7 days; a higher score means a worse outcome.	1 year
Tobacco craving	Changes from baseline (T0) to T1-T2-T3 in: Tobacco craving, as measured by the total score on the Questionnaire of Smoking Urges - Brief version; a higher score means a worse outcome.	1 year
Level of Urge	Within AF-EMDR session changes in: Mean Level of Urge, measured by a Likert-type scale from 0 to 10; a higher score means a worse outcome.	1 year
Level of Positive Affect	Within AF-EMDR session changes in: Mean Level of Positive Affect, measured by a Likert-type scale from 0 to 10; a higher score means a worse outcome	1 year
Craving related self-control/self-efficacy	Changes from baseline (T0) to T1-T2-T3 in: Craving related self-control/self-efficacy. As measured by a five-item subscale of the Self-control cognitions Questionnaire Likertscales, range 1-5, min 5, max 25); a higher score means a worse outcome.	1 year
Positive incentive value	Changes from baseline (T0) to T1-T2-T3 in: Positive incentive value. As measured by a six-item subscale of the Self-control cognitions Questionnaire (Likert-type scales, range 1-5, min. score 6, max 30); a higher score means a worse outcome.	1 year

Collaborators and Investigators

• Sponsor: IrisZorg
• Collaborators: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2023
• Primary Completion (Actual): April 4, 2023
• Study Completion (Actual): June 27, 2023

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Tobacco; Addiction; EMDR
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: ToTEM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Depending on the final data collection and the journal in which these are published, we will decide on availability of IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No