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…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Verslaving (stoornis in het gebruik van tabak)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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 by a subscale of the
Self-control cognitions Questionnaire; a higher score means a worse outcome.
o Positive incentive value. As measured by a subscale of the Self-control
cognitions Questionnaire; a higher score means a worse outcome.
Within AF-EMDR session changes in:
o Mean Level of Urge, measured by a Likert-type scale from 0 to 10; a higher
score means a worse outcome.
o Mean Level of Positive Affect, measured by a Likert-type scale from 0 to 10;
a higher score means a worse outcome.
Background 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.
Study objective
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
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.
Intervention
Intervention: a total of six 45-90 min. sessions of AF-EMDR twice per week
added to a SCP embedded in TAU.
Study burden and risks
Benefits and risks assessment, group relatedness
Potential benefits for participants who receive AF-EMDR are that they receive
treatment which may help to resist urges and reduce smoking behaviour.
Additionally, there is some benefit for all participants in that they will
receive an incentive after each follow up assessment. On the basis of clinical
research and experience with EMDR and AF-EMDR, no destabilization is to be
expected in this population. However, participants who receive AF-EMDR are
instructed to recall memories which elicit craving for smoking. This may cause
some inconvenience during sessions, but clinical experience thus far suggests
that this is well tolerated.
Mr. B.M. Teldersstraat 7
Arnhem 6842CT
NL
Mr. B.M. Teldersstraat 7
Arnhem 6842CT
NL
Listed location countries
Age
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).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05594810 |
| CCMO | NL79955.091.22 |