AngerNCT02413814
Computerized Anger-Reduction Treatment for Smoking Cessation
A study testing Anger Reduction Treatment in people with Anger and Smoking Cessation, run by Florida State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anger, Smoking Cessation
- What is being tested?
- Anger Reduction Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2015to 30 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University, Department of Psychology
Tallahassee, Florida, 32306
About this study
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.
Read the 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
- Being tested
- Anger Reduction Treatment, Control Condition
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anger Reduction TreatmentBehavioural
Eight 30-minute sessions of interpretation modification to reduce angry interpretation biases.
Control ConditionBehavioural
Eight 30-minute sessions of informative videos on healthy living and relaxation videos.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anger Expression Inventory-2 (STAXI-2; Spielberger, 1999) state and trait subscales
Measured: up to 14-weeks following treatment initiation.
Self-reported smoking frequency
Measured: up to 14-weeks following treatment initiation.
Carbon monoxide levels
Measured: up to 14-weeks following treatment initiation.
Secondary outcomes (6)
Minnesota Nicotine Withdrawal Scale (Hughes & Hatsukami, 1986)
Measured: up to 14-weeks following treatment initiation.
Beck Depression Inventory-II (Beck, Steer, & Brown, 1996)
Measured: Baseline and regularly for 14-weeks following treatment initiation.
Clinical Anger Scale (CAS; Snell, Gum, Shuck, Mosley, & Hite, 1995)
Measured: up to 14-weeks following treatment initiation.
WSAP-Hostility Scale (Dillon, Cougle, & Fincham, 2015)
Measured: up to 14-weeks following treatment initiation.
Hostile Automatic Thoughts Scale (Snyder, Crowson, Houston, Kurylo, & Piorier, 1997)
Measured: up to 14-weeks following treatment initiation
Questionnaire of Smoking Urges (Tiffany & Drobes, 1991)
Measured: up to 14-weeks following treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study start1 Apr 2015
- Primary completion30 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesse Cougle, Florida State University
- Investigators
- Jesse R Cougle, Ph.D., Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413814
- Sponsor's protocol ID
- 1R34DA035944-01A1
- Status last verified
- Jan 2021
- First submitted
- 9 Mar 2015
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Anger-Reduction Treatment for Smoking Cessation
- ClinicalTrials.gov ID
- NCT02413814
- Acronym / sponsor ID
- 1R34DA035944-01A1
- Conditions
- Anger, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 10 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anger Reduction Treatment | Experimental | Behavioral: Anger Reduction TreatmentThe 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. |
| Control Condition | Placebo comparator | Behavioral: Control ConditionParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anger Reduction TreatmentEight 30-minute sessions of interpretation modification to reduce angry interpretation biases. | Behavioural | Anger Reduction Treatment |
| Control ConditionEight 30-minute sessions of informative videos on healthy living and relaxation videos. | Behavioural | Control Condition |
Primary outcome
State-Trait Anger Expression Inventory-2 (STAXI-2; Spielberger, 1999) state and trait subscales
Time frame: up to 14-weeks following treatment initiation.
Self-reported smoking frequency
Time frame: up to 14-weeks following treatment initiation.
Carbon monoxide levels
Time frame: up to 14-weeks following treatment initiation.
6 secondary outcomes
Minnesota Nicotine Withdrawal Scale (Hughes & Hatsukami, 1986)
Time frame: 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.
Clinical Anger Scale (CAS; Snell, Gum, Shuck, Mosley, & Hite, 1995)
Time frame: up to 14-weeks following treatment initiation.
WSAP-Hostility Scale (Dillon, Cougle, & Fincham, 2015)
Time frame: 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
Questionnaire of Smoking Urges (Tiffany & Drobes, 1991)
Time frame: up to 14-weeks following treatment initiation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesse R Cougle, Ph.D. principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anger Reduction Treatment in people with Anger and Smoking Cessation, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anger Expression Inventory-2 (STAXI-2; Spielberger, 1999) state and trait subscales (time frame: up to 14-weeks following treatment initiation.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.