Computerized Anger-Reduction Treatment for Smoking Cessation

January 26, 2021 updated by: Jesse Cougle, Florida State University
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.

Study Overview

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

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Tallahassee, Florida, United States, 32306
        • Florida State University, Department of Psychology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
Eight 30-minute sessions of interpretation modification to reduce angry interpretation biases.
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.
Eight 30-minute sessions of informative videos on healthy living and relaxation videos.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
State-Trait Anger Expression Inventory-2 (STAXI-2; Spielberger, 1999) state and trait subscales
Time Frame: up to 14-weeks following treatment initiation.
up to 14-weeks following treatment initiation.
Self-reported smoking frequency
Time Frame: up to 14-weeks following treatment initiation.
up to 14-weeks following treatment initiation.
Carbon monoxide levels
Time Frame: up to 14-weeks following treatment initiation.
up to 14-weeks following treatment initiation.

Secondary Outcome Measures

Outcome Measure
Time Frame
Minnesota Nicotine Withdrawal Scale (Hughes & Hatsukami, 1986)
Time Frame: up to 14-weeks following treatment initiation.
up to 14-weeks following treatment initiation.
Beck Depression Inventory-II (Beck, Steer, & Brown, 1996)
Time Frame: Baseline and regularly for 14-weeks following treatment initiation.
Baseline and regularly for 14-weeks following treatment initiation.
Clinical Anger Scale (CAS; Snell, Gum, Shuck, Mosley, & Hite, 1995)
Time Frame: up to 14-weeks following treatment initiation.
up to 14-weeks following treatment initiation.
WSAP-Hostility Scale (Dillon, Cougle, & Fincham, 2015)
Time Frame: up to 14-weeks following treatment initiation.
up to 14-weeks following treatment initiation.
Hostile Automatic Thoughts Scale (Snyder, Crowson, Houston, Kurylo, & Piorier, 1997)
Time Frame: up to 14-weeks following treatment initiation
up to 14-weeks following treatment initiation
Questionnaire of Smoking Urges (Tiffany & Drobes, 1991)
Time Frame: up to 14-weeks following treatment initiation.
up to 14-weeks following treatment initiation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jesse R Cougle, Ph.D., Florida State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

July 30, 2019

Study Completion (Actual)

July 30, 2019

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

April 9, 2015

First Posted (Estimate)

April 10, 2015

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 1R34DA035944-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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