Computerized Anger-Reduction Treatment for Smoking Cessation

NCT ID: NCT02413814

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-01
• Study Completion Date: 2019-07-30

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.

Conditions

Anger; Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Anger Reduction Treatment

Intervention Type: BEHAVIORAL

Eight 30-minute sessions of interpretation modification to reduce angry interpretation biases.

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.

Group Type: PLACEBO_COMPARATOR

Control Condition

Intervention Type: BEHAVIORAL

Eight 30-minute sessions of informative videos on healthy living and relaxation videos.

Interventions

Anger Reduction Treatment

Eight 30-minute sessions of interpretation modification to reduce angry interpretation biases.

Intervention Type: BEHAVIORAL

Control Condition

Eight 30-minute sessions of informative videos on healthy living and relaxation videos.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Jesse Cougle

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jesse R Cougle, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

Florida State University, Department of Psychology

Tallahassee, Florida, United States

Countries

United States

Other Identifiers

1R34DA035944-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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