- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02413814
Computerized Anger-Reduction Treatment for Smoking Cessation
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Tallahassee, Florida, United States, 32306
- Florida State University, Department of Psychology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Anger Reduction Treatment
The treatment consists of eight 30-minute IBM sessions.
Participants will be presented with ambiguous scenarios and asked imagine themselves in these situations.
In the first task, the scenario will be followed by a benign interpretation of the situation.
Participants will answer a comprehension question designed to have participants endorse this benign interpretation.
In the second task, participants will be presented with a word denoting an interpretation with either a negative/hostile or positive/benign connotation.
Following this word, an ambiguous scenario will appear.
Participants will indicate whether the word and the scenario were related.
They will receive feedback training them to endorse positive interpretations and reject negative interpretations.
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Eight 30-minute sessions of interpretation modification to reduce angry interpretation biases.
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Placebo Comparator: Control Condition
Participants assigned to the control condition will complete eight computerized sessions consisting of psychoeducation on healthy behaviors (i.e., topics of exercise, diet, hygiene, social support, healthy activities, and sleep, taken from protocols developed from our ongoing research).
These participants will also view relaxing videos consisting of brief guided meditation instructions, pictures of nature scenes, and soft music.
These sessions (psychoeducation and relaxing videos) will be matched for time with the active treatment condition, lasting 30 minutes each.
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Eight 30-minute sessions of informative videos on healthy living and relaxation videos.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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State-Trait Anger Expression Inventory-2 (STAXI-2; Spielberger, 1999) state and trait subscales
Time Frame: up to 14-weeks following treatment initiation.
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up to 14-weeks following treatment initiation.
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Self-reported smoking frequency
Time Frame: up to 14-weeks following treatment initiation.
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up to 14-weeks following treatment initiation.
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Carbon monoxide levels
Time Frame: up to 14-weeks following treatment initiation.
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up to 14-weeks following treatment initiation.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Minnesota Nicotine Withdrawal Scale (Hughes & Hatsukami, 1986)
Time Frame: up to 14-weeks following treatment initiation.
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up to 14-weeks following treatment initiation.
|
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Beck Depression Inventory-II (Beck, Steer, & Brown, 1996)
Time Frame: Baseline and regularly for 14-weeks following treatment initiation.
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Baseline and regularly for 14-weeks following treatment initiation.
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Clinical Anger Scale (CAS; Snell, Gum, Shuck, Mosley, & Hite, 1995)
Time Frame: up to 14-weeks following treatment initiation.
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up to 14-weeks following treatment initiation.
|
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WSAP-Hostility Scale (Dillon, Cougle, & Fincham, 2015)
Time Frame: up to 14-weeks following treatment initiation.
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up to 14-weeks following treatment initiation.
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Hostile Automatic Thoughts Scale (Snyder, Crowson, Houston, Kurylo, & Piorier, 1997)
Time Frame: up to 14-weeks following treatment initiation
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up to 14-weeks following treatment initiation
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Questionnaire of Smoking Urges (Tiffany & Drobes, 1991)
Time Frame: up to 14-weeks following treatment initiation.
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up to 14-weeks following treatment initiation.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jesse R Cougle, Ph.D., Florida State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1R34DA035944-01A1 (U.S. NIH Grant/Contract)
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