Tobacco Treatment Using EMDR (ToTEM)

NCT05594810 | Terminated

• 1 other identifier: ToTEM
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder

Keywords

Addiction; Tobacco; EMDR

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Proportion of participants

  1 year

• The feasibility of the outcome measures

  1 year

• Missing data

  1 year

Other Outcomes (13)

• Demographics

  1 year

• Smoking history

  1 year

• DSM-5

  1 year

Study Arms (2)

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

ACTIVE COMPARATOR

TAU only

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

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

EXPERIMENTAL

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

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

Interventions

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

Also known as: AF-EMDR

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

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

Also known as: CRA (+SCP)

TAU + Addiction focussed - eye movement desensitization and reprocessing (AF-EMDR) + TAU (CRA); TAU only: Community Reinforcement Approach (CRA) + a regular smoking cessation program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• IrisZorg: lead
• Radboud University Medical Center: collaborator

Study Sites (1)

Addiction clinic 'Tiel' IrisZorg

Tiel, Gelderland, 4001 AG, Netherlands

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Behavior, Addictive

Interventions

Urocortins

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: October 7, 2022
• First Posted: October 26, 2022
• Study Start: February 21, 2023
• Primary Completion: April 4, 2023
• Study Completion: June 27, 2023
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)