Tobacco Treatment Using EMDR (ToTEM)

IrisZorg

Status: Terminated

Conditions: Tobacco Use Disorder

Treatments: Behavioral: TAU only: Community Reinforcement Approach (CRA) + SCP; Behavioral: TAU + Addiction focussed - eye movement desensitization and reprocessing (AF-EMDR)

Study type: Interventional

Funder types: Other

Identifiers

NCT05594810

ToTEM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

TAU only: Community Reinforcement Approach (CRA) + a regular smoking cessation program

Active Comparator group

Description:

TAU only

Treatment:

Behavioral: TAU only: Community Reinforcement Approach (CRA) + SCP

TAU + Addiction focussed - eye movement desensitization and reprocessing (AF-EMDR) + TAU (CRA)

Experimental group

Description:

TAU + Addiction focussed - eye movement desensitization and reprocessing (AF-EMDR)

Treatment:

Behavioral: TAU + Addiction focussed - eye movement desensitization and reprocessing (AF-EMDR)

Behavioral: TAU only: Community Reinforcement Approach (CRA) + SCP