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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

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 - ToTEM

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53586
Enrollment
50
Registered
2023-01-30
Start date
2023-03-13
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Verslaving (stoornis in het gebruik van tabak) smoking addiction Tobacco use disorder

Interventions

Intervention: a total of six 45-90 min. sessions of AF-EMDR twice per week added to a SCP embedded in TAU.

Sponsors

IrisZorg
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion 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

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).

Design outcomes

Primary

MeasureTime frame
Main study parameters/endpoints o The retention of participants from randomization until the last follow-up. o 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. o The acceptability of AF-EMDR to therapists in terms of adherence to the protocol, measured by the score of an independent rater on an a-priori established adherence rating protocol; a higher score reflects better adherence.

Secondary

MeasureTime frame
Secondary study parameters/endpoints o Recruitment potential, measured by the proportion of patients at the clinic that are potentially eligible and provide informed consent versus: * Those that are eligible but do not provide informed consent. * Those that are not eligible. o The feasibility of the outcome measures in terms of completion of questionnaires (% per questionnaire and total). o The acceptability of the outcome measures in terms of Likert-type ratings by participants, therapists and research assistants. o Amount of missing data, measured by total number of missing values and the proportion of completed versus missing data. Tertiary study parameters o Demographics, as inventoried by a structured interview and patient files. o Smoking (cessation history), inventoried by a structured interview and patient files. o Current DSM-5 diagnoses, inventoried by a structured interview and patient files. o Motivation to quit smoking, measured by a Likert-type scale from 0 to 10; a higher score reflects a higher motivation. o Smoking cessation self-efficacy, measured by a Likert-type scale from 0 to 10; a higher score reflects a higher self-efficacy. o 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. o 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. Changes from baseline (T0) to T1-T2-T3 in: o Smoking behavior, measured by mean number of cigarettes smoked per day over the past 7 days; a higher score means a worse outcome. o Tobacco craving, as measured by the total score on the Questionnaire of Smoking Urges - Brief version; a higher score means a worse outcome. o Craving related self-control/self-efficacy. As measured

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)