Tobacco Treatment Using EMDR (ToTEM)

Tobacco Use Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05594810
• Other study ID #: ToTEM
• Status: Terminated
• Phase: N/A
• Start date: February 21, 2023
• Est. completion date: June 27, 2023

Study information

• Verified date: March 2024
• Source: IrisZorg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 27, 2023
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	Addiction clinic 'Tiel' IrisZorg	Tiel	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
IrisZorg	Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographics	Demographics, as inventoried by a structured interview and patient files.	1 year
Other	Smoking history	Smoking (cessation history), inventoried by a structured interview and patient files.	1 year
Other	DSM-5	Current DSM-5 diagnoses, inventoried by a structured interview and patient files.	1 year
Other	Motivation	Motivation to quit smoking, measured by a Likert-type scale from 0 to 10; a higher score reflects a higher motivation.	1 year
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	Retention of participants	The retention of participants from randomization until the last follow-up.	1 year
Primary	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
Primary	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	Proportion of participants	The proportion of patients at the clinic that are potentially eligible and provide informed consent.	1 year
Secondary	The feasibility of the outcome measures	The feasibility of the outcome measures in terms of completion of questionnaires (% per questionnaire and total).	1 year
Secondary	Missing data	Amount of missing data, measured by total number of missing values and the proportion of completed versus missing data.	1 year