Clinical trial NCT02413814: Computerized Anger-Reduction Treatment for Smoking Cessation
Official title: Computerized Anger-Reduction Treatment for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anger
Smoking Cessation
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2015-04-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Problematic anger is a strong predictor of failed attempts at smoking cessation. The investigators proposed study seeks to evaluate whether a novel 8-session computerized anger-reduction treatment improves quit rates among smokers. Smokers with elevated trait anger will be administered transdermal nicotine patch therapy and either anger-reduction treatment or a control intervention. They will be assessed throughout treatment and up until three months after a scheduled mid- treatment quit date. The investigators propose to test whether, compared to the control condition, the anger-reduction treatment will lead to: 1) greater reductions in anger and 2) greater abstinence rates at post-cessation and at follow-up assessments. The investigators will also test whether changes in anger-related symptoms account for group differences in abstinence rates.

Detailed description: The current proposal seeks to evaluate an eight-session, computerized, anger-focused intervention for smokers (Anger Reduction Treatment or ART). The investigators will administer this intervention to smokers (N = 114) who are interested in quitting and have elevated levels of trait anger. Participants will be randomly assigned to receive either: (1) computerized ART, consisting of interpretation bias modification, or (2) a computerized control condition, which consists of health education and relaxing video clips. The computerized sessions (eight total) will take place twice a week for four weeks. All participants will have a scheduled quit date for the beginning of the third week of treatment (i.e., at mid-treatment). All participants will also receive nicotine patch therapy to use at their scheduled quit date. Anger symptoms, smoking cravings, and smoking frequency will be assessed throughout treatment. Smoking status, anger, and other measures of negative affect will also be assessed at baseline and regularly for 12-weeks following the scheduled quit date.

The investigators will test whether, compared to the control condition, the anger-reduction treatment will lead to: 1) greater reductions in anger and 2) greater abstinence rates at post-cessation and at follow-up assessments. The investigators will also test whether changes in anger-related symptoms account for group differences in abstinence rates.

Eligibility criteria: Inclusion Criteria:

* Elevated levels of trait anger (scoring 22 or higher on the STAXI-trait)
* Currently smoking an average of 8 cigarettes per day
* Must be a regular (daily) smoker for at least 1 year
* Willing to make a serious attempt to quit smoking
* Must report motivation to quit in the next month (30 days) of at least 5 on a 10 point scale (0 = no motivation and 10 = extreme motivation)
* Have not decreased the number of cigarettes by more than half in the past six months
* Must be an English speaker

Exclusion Criteria:

* Current substance dependence (excluding nicotine dependence)
* Current use of other tobacco products
* Currently receiving cognitive therapy or therapy for problematic anger
* Evidence of serious suicidal intent requiring hospitalization or immediate treatment
* Limited mental competency and the inability to give informed, written consent
* Evidence of psychotic-spectrum disorders
* Changes in medication over the last month

Primary outcomes:
measure: State-Trait Anger Expression Inventory-2 (STAXI-2; Spielberger, 1999) state and trait subscales
timeFrame: up to 14-weeks following treatment initiation.
measure: Self-reported smoking frequency
timeFrame: up to 14-weeks following treatment initiation.
measure: Carbon monoxide levels
timeFrame: up to 14-weeks following treatment initiation.
Secondary outcomes:
measure: Minnesota Nicotine Withdrawal Scale (Hughes & Hatsukami, 1986)
timeFrame: up to 14-weeks following treatment initiation.
measure: Beck Depression Inventory-II (Beck, Steer, & Brown, 1996)
timeFrame: Baseline and regularly for 14-weeks following treatment initiation.
measure: Clinical Anger Scale (CAS; Snell, Gum, Shuck, Mosley, & Hite, 1995)
timeFrame: up to 14-weeks following treatment initiation.
measure: WSAP-Hostility Scale (Dillon, Cougle, & Fincham, 2015)
timeFrame: up to 14-weeks following treatment initiation.
measure: Hostile Automatic Thoughts Scale (Snyder, Crowson, Houston, Kurylo, & Piorier, 1997)
timeFrame: up to 14-weeks following treatment initiation
measure: Questionnaire of Smoking Urges (Tiffany & Drobes, 1991)
timeFrame: up to 14-weeks following treatment initiation.
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University, Department of Psychology
state: Florida
Study officials:
affiliation: Florida State University
name: Jesse R Cougle, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: