Clinical trial NCT05594810: Tobacco Treatment Using EMDR (ToTEM)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tobacco Use Disorder
Keywords: Addiction
Tobacco
EMDR
Lead sponsor: IrisZorg
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
First posted: 2022-10-26
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Retention of participants
timeFrame: 1 year
measure: Acceptability in terms of compliance
timeFrame: 1 year
measure: Acceptability in terms of adherence
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of participants
timeFrame: 1 year
measure: The feasibility of the outcome measures
timeFrame: 1 year
measure: Missing data
timeFrame: 1 year
Other outcomes:
measure: Demographics
timeFrame: 1 year
measure: Smoking history
timeFrame: 1 year
measure: DSM-5
timeFrame: 1 year
measure: Motivation
timeFrame: 1 year
measure: Self-efficacy
timeFrame: 1 year
measure: Nicotine dependence
timeFrame: 1 year
measure: Time to relapse
timeFrame: 1 year
measure: Smoking behavior
timeFrame: 1 year
measure: Tobacco craving
timeFrame: 1 year
measure: Craving related self-control/self-efficacy
timeFrame: 1 year
measure: Positive incentive value
timeFrame: 1 year
measure: Level of Urge
timeFrame: 1 year
measure: Level of Positive Affect
timeFrame: 1 year
Locations:
city: Tiel
country: Netherlands
facility: Addiction clinic 'Tiel' IrisZorg
state: Gelderland
Study officials:
References: