ST+ABR, ST-only, ST+SHAM
Conditions
Keywords
Approach bias retraining, smoking cessation, cognitive retraining
Brief summary
The present investigation aims to assess the efficacy of an innovative and novel smoking cessation intervention that integrates approach bias retraining (ABR) and standard smoking cessation treatment (ST). Participants will be randomized to either: (1) standard smoking cessation treatment and approach bias retraining (ST+ABR); (2) ST+Sham; or (3) ST-only.
Detailed description
The study employs a randomized controlled design to follow 300 individuals who smoke cigarettes as they engage in a smoking quit attempt following standard smoking cessation treatment (ST). Participants will be randomized to one of three conditions: (1) ST+ABR; (2) ST+Sham; or (3) ST-only. Participants will complete a self-screener, baseline appointment, 7 weeks of smoking cessation treatment, combined with approach bias retraining (if applicable) in the laboratory (with the quit day scheduled for the 6th session), 2x daily ecological momentary assessments (EMAs) for 4-weeks following their quit day, and 1-, 3-, and 6-month follow-ups in the laboratory.
Interventions
BEHAVIORALST+ABR
ST+ABR participants will complete seven weekly sessions of 15 minutes of computerized training (ABR), followed by a 45-minute session of standard smoking cessation treatment (CBT+NRT). Participants will be instructed to pull or push a joystick depending on the tilt, which will be positive-related or smoking-related images.
BEHAVIORALST+Sham
ST+Sham participants will complete seven weekly sessions of 15 minute computerized control sessions (AAT), followed by a 45-minute session of standard smoking cessation treatment (CBT+NRT). Participants will be instructed to pull or push a joystick depending on the tilt, which will be positive-related or smoking-related images.
BEHAVIORALST Only
ST Only will consist of 7 weekly 45-minute sessions of standard treatment (CBT+NRT) for smoking cessation.
Sponsors
University of Houston
University of Texas at Austin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * Ability to speak English fluently * Ability to read English fluently * Ability to write in English fluently * Biochemical verification of self-reported smoking status following minimum study specified smoking rate endorsement * Motivated to quit smoking * Willing to attend in-person visits * Provide written informed consent, accepting study inclusion criteria and the randomized group assignment * English literacy of 7th grade or higher, as indicated by a score of 4 or greater on the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF)
Exclusion criteria
* Having used an e-cigarette in the past 3 months * Having initiated any mental health therapy or pharmacotherapy within the past 3 months * Being currently in therapy for substance abuse (including nicotine dependence) * Being currently enrolled in any other studies at the RESTORE lab to help quit smoking * Currently using any NRT or psychotherapy products for nicotine cessation * Currently using Bupropion as a smoking cessation aid and antidepressant * Currently pregnant or planning to become pregnant * Having high blood pressure that is not under control * Having a heart attack within the past 2 weeks * Having Visual impairments * Hand-motoric impairments * Currently suicidal or high suicide risk or current or past psychotic disorders of any type, bipolar disorder, schizophrenia or schizoaffective disorder, anorexia, bulimia assessed using the Mini Neuropsychiatric Interview * Cognitive impairment, verified via a score of ≥8 on the Six-Item Cognitive Impairment Test (6-CIT)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-day Biochemically Verified Point Prevalence Abstinence (PPA) | 1-week, 2-week, 3-week post-quit, and 1-, 3-, and 6-month follow-ups | PPA will be defined as no cigarette smoking within the past 7 days of assessments and will be biochemically verified via assessment of expired carbon monoxide. |
| Prolonged Abstinence (PA) | 3-week post-quit, 1-, 3-, and 6-month follow-ups | Participants will self report their abstinence by reporting whether or not they have smoked since their quit date following a 2-week grace period. |
Countries
United States
Contacts
CONTACTLorra Garey, PhD
CONTACTAshley Ruiz, B.S.
Outcome results
None listed