Tobacco Treatment Using EMDR (ToTEM)

NCT ID: NCT05594810

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-21
• Study Completion Date: 2023-06-27

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.

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

TAU only

Group Type: ACTIVE_COMPARATOR

TAU only: Community Reinforcement Approach (CRA) + SCP

Intervention Type: BEHAVIORAL

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.

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

TAU only: Community Reinforcement Approach (CRA) + SCP

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

AF-EMDR; CRA (+SCP)

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: collaborator

IrisZorg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Addiction clinic 'Tiel' IrisZorg

Tiel, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

ToTEM

Identifier Type: -

Identifier Source: org_study_id