Computerized Anger-Reduction Treatment for Smoking Cessation

NCT02413814 | Completed DMC

• 1 other identifier: 1R34DA035944-01A1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anger; Smoking Cessation

Outcome Measures

Primary Outcomes (3)

• State-Trait Anger Expression Inventory-2 (STAXI-2; Spielberger, 1999) state and trait subscales

  up to 14-weeks following treatment initiation.

• Self-reported smoking frequency

  up to 14-weeks following treatment initiation.

• Carbon monoxide levels

  up to 14-weeks following treatment initiation.

Secondary Outcomes (6)

• Minnesota Nicotine Withdrawal Scale (Hughes & Hatsukami, 1986)

  up to 14-weeks following treatment initiation.

• Beck Depression Inventory-II (Beck, Steer, & Brown, 1996)

  Baseline and regularly for 14-weeks following treatment initiation.

• Clinical Anger Scale (CAS; Snell, Gum, Shuck, Mosley, & Hite, 1995)

  up to 14-weeks following treatment initiation.

• WSAP-Hostility Scale (Dillon, Cougle, & Fincham, 2015)

  up to 14-weeks following treatment initiation.

• Hostile Automatic Thoughts Scale (Snyder, Crowson, Houston, Kurylo, & Piorier, 1997)

  up to 14-weeks following treatment initiation

Study Arms (2)

Anger Reduction Treatment

EXPERIMENTAL

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.

Behavioral: Anger Reduction Treatment

Control Condition

PLACEBO COMPARATOR

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.

Behavioral: Control Condition

Interventions

Anger Reduction Treatment BEHAVIORAL

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

Anger Reduction Treatment

Control Condition BEHAVIORAL

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

Control Condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University, Department of Psychology

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Jesse R Cougle, Ph.D.

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: April 10, 2015
• Study Start: April 1, 2015
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: January 28, 2021

Record last verified: 2021-01

Locations

US (1)