Tobacco Use DisorderToTEMNCT05594810
Tobacco Treatment Using EMDR (ToTEM)
A study testing TAU + Addiction focussed - eye movement desensitization and reprocessing (AF-EMDR) and TAU only: Community Reinforcement Approach (CRA) + SCP in people with Tobacco Use Disorder, run by IrisZorg at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- TAU + Addiction focussed - eye movement desensitization and reprocessing (AF-EMDR) and TAU only: Community Reinforcement Approach (CRA) + SCP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Feb 2023to 27 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Netherlands1 site
Addiction clinic 'Tiel' IrisZorg
Tiel, Gelderland, 4001 AG
About this study
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
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.
Read the 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
- Being tested
- TAU + Addiction focussed - eye movement desensitization and reprocessing (AF-EMDR), TAU only: Community Reinforcement Approach (CRA) + SCP
- Keywords
- Addiction, Tobacco, EMDR
- Medical subject headings
- Tobacco Use Disorder, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAU + Addiction focussed - eye movement desensitization and reprocessing (AF-EMDR)Behavioural
Also called 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) + SCPBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| TAU only: Community Reinforcement Approach (CRA) + a regular smoking cessation program | Active comparator | TAU only Receives: 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) Receives: Behavioral: TAU + Addiction focussed - eye movement desensitization and reprocessing (AF-EMDR); Behavioral: TAU only: Community Reinforcement Approach (CRA) + SCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of participants
The retention of participants from randomization until the last follow-up.
Measured: 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.
Measured: 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.
Measured: 1 year
Secondary outcomes (3)
Proportion of participants
The proportion of patients at the clinic that are potentially eligible and provide informed consent.
Measured: 1 year
The feasibility of the outcome measures
The feasibility of the outcome measures in terms of completion of questionnaires (% per questionnaire and total).
Measured: 1 year
Missing data
Amount of missing data, measured by total number of missing values and the proportion of completed versus missing data.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start21 Feb 2023
- Primary completion4 Apr 2023
- Study completion27 Jun 2023
Why it stopped: Too many eligible patients who did not want to participate, very low inclusion rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- IrisZorg
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594810
- Sponsor's protocol ID
- ToTEM
- Acronym
- ToTEM
- Status last verified
- Mar 2024
- First submitted
- 7 Oct 2022
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Depending on the final data collection and the journal in which these are published, we will decide on availability of IPD
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05594810
- Acronym / sponsor ID
- ToTEM / ToTEM
- Conditions
- Tobacco Use Disorder
- Keywords
- Addiction, Tobacco, EMDR
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too many eligible patients who did not want to participate, very low inclusion rate
- Enrolment
- 3 participants (actual)
- Lead sponsor
- IrisZorgUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| TAU only: Community Reinforcement Approach (CRA) + a regular smoking cessation program | Active comparator | Behavioral: TAU only: Community Reinforcement Approach (CRA) + SCPTAU only |
| TAU + Addiction focussed - eye movement desensitization and reprocessing (AF-EMDR) + TAU (CRA) | Experimental | Behavioral: TAU + Addiction focussed - eye movement desensitization and reprocessing (AF-EMDR), Behavioral: TAU only: Community Reinforcement Approach (CRA) + SCPTAU + Addiction focussed - eye movement desensitization and reprocessing (AF-EMDR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAU + Addiction focussed - eye movement desensitization and reprocessing (AF-EMDR)Also: AF-EMDRA 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. | Behavioural | TAU + Addiction focussed - eye movement desensitization and reprocessing (AF-EMDR) + TAU (CRA) |
| TAU only: Community Reinforcement Approach (CRA) + SCPAlso: 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. | Behavioural | TAU + Addiction focussed - eye movement desensitization and reprocessing (AF-EMDR) + TAU (CRA), TAU only: Community Reinforcement Approach (CRA) + a regular smoking cessation program |
Primary outcome
Retention of participants
Time frame: 1 year
The retention of participants from randomization until the last follow-up.
Acceptability in terms of compliance
Time frame: 1 year
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.
Acceptability in terms of adherence
Time frame: 1 year
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.
3 secondary outcomes
Proportion of participants
Time frame: 1 year
The feasibility of the outcome measures
Time frame: 1 year
Missing data
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Too many eligible patients who did not want to participate, very low inclusion rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No. Depending on the final data collection and the journal in which these are published, we will decide on availability of IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAU + Addiction focussed - eye movement desensitization and reprocessing (AF-EMDR) and TAU only: Community Reinforcement Approach (CRA) + SCP in people with Tobacco Use Disorder, run by IrisZorg at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Too many eligible patients who did not want to participate, very low inclusion rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention of participants (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.