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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Anger Reduction Treatment
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.
Behavioral: Control Condition
Eight 30-minute sessions of informative videos on healthy living and relaxation videos.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Florida State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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