Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 101 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Texas, United States ) | NIH, U.S. Fed

Personalized Feedback for Distress Intolerant Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03918031
Recruitment Status : Not yet recruiting
First Posted : April 17, 2019
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Brooke Kauffman, University of Houston

Brief Summary:
This project will develop and refine a computer-delivered integrated Personalized Feedback Intervention (PFI) that directly addresses smoking and distress tolerance. The PFI will focus on feedback about smoking behavior, distress tolerance, and adaptive coping strategies.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Depression Psychological Distress Tobacco Dependence Smoking, Tobacco Smoking, Cigarette Behavioral: PFI for Smoking & Distress Tolerance Behavioral: PFI for Smoking Only Not Applicable

Detailed Description:
The primary goal of the research study is to investigate the efficacy of a brief, personalized computer-delivered transdiagnostic intervention (PFI) that addresses smoking and distress tolerance to reduce smoking, increase quit attempts, reduce perceived barriers to cessation, increase distress tolerance, reduce anxiety/depressive symptoms, and increase adaptive coping skills compared to a personalized feedback on smoking only control. To address this aim, the investigators will implement a randomized controlled trial that will employ a longitudinal experimental design and involve four stages: (a) phone-screener (pre-screener); (b) baseline appointment consisting of a pre-intervention assessment (eligibility), random assignment to a one-session computer-delivered intervention (Active PFI versus Control PFI with no personalized feedback on distress tolerance), and a post-intervention assessment; (c) 2-week follow-up; (d) 1-month follow-up. Assessments will include a multi-method approach, including biological, behavioral, and self-report methods.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: If participant meets eligibility criteria, the participant will be randomly assigned to complete a one-session computer-delivered intervention: either (1) personalized feedback intervention on ability to handle discomfort and smoking or (2) personalized feedback intervention on smoking only.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Personalized Feedback for Distress Intolerant Smokers
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Smoking

Arm Intervention/treatment
Active Comparator: PFI for Smoking & Distress Tolerance
A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking and distress tolerance.
Behavioral: PFI for Smoking & Distress Tolerance
Personalized Feedback Intervention for smoking and distress tolerance.

Active Comparator: PFI for Smoking Only
A brief, one-session computer-delivered personalized feedback intervention (PFI) that addresses smoking only (no distress tolerance component).
Behavioral: PFI for Smoking Only
Personalized Feedback Intervention for smoking only (no distress tolerance component)




Primary Outcome Measures :
  1. Rulers for Smoking Cessation [ Time Frame: Assess change from baseline to 2-week and 1-month follow-up ]
    The Rulers for Smoking Cessation asks participants to rate three rulers associated with motivation, confidence, and intention to quit smoking. Motivation is indexed by, "How important is stopping smoking to you (0 = Not important at all; 10 = Most important goal of my life)?" with a higher score indicating a better outcome. Confidence is indexed by, "How confident are you that you will quit smoking within the next month (0 = Not at all; 10 = 100% confident)?" with a higher score indicating a better outcome. Intention is indexed by, "How ready are you to quit smoking within the next month (0 = Not at all; 10 = 100% ready)?" with a higher score indicating a better outcome.

  2. Barriers to Cessation Scale [ Time Frame: Assess change from baseline to 2-week and 1-month follow-up ]
    The Barriers to Cessation Scale assesses 19-barriers, or specific stressors, associated with smoking cessation. Participants indicate, according to a 4-point Likert-style scale (0 = Not a barrier to 3 = Large barrier), the extent to which they identify with each of the barriers to cessation. Lower scores indicate a better outcome (range = 0 - 57).

  3. Smoking History Questionnaire [ Time Frame: Assess change from baseline to 2-week and 1-month follow-up ]
    The Smoking History Questionnaire is a self-report questionnaire used that will be used to assess smoking rate and number of quit attempts. This measure contains 30 items including open ended formats in which the individual will self-report their smoking rate per day and number of previous quit attempts. Lower reported smoking rate indicates a better outcome. Higher reported number of quit attempts indicates a better outcome.

  4. Distress Tolerance Scale [ Time Frame: Assess change from baseline to 2-week and 1-month follow-up ]
    The Distress Tolerance Scale is a self-report measure in which respondents indicate, on a 5-point Likert-type scale (1 = 'strongly agree' to 5 = 'strongly disagree'), the extent to which they believe they can experience and withstand distressing emotional states. All items are averaged to create a total mean score ranging from 1 to 5 with higher total scores indicating a better outcome.

  5. Mood and Anxiety Symptom Questionnaire-Short Form [ Time Frame: Assess change from baseline to 2-week and 1-month follow-up ]
    The Mood and Anxiety Symptom Questionnaire-Short Form will be used to assess anxiety/depressive symptoms. Participants indicate how much they have experienced each symptom on a 5-point Likert-type scale (1 = Not at all to 5 = Extremely). Specifically, the Anxious Arousal subscale will be used to measure anxiety and the Anhedonic Depression subscale will be used to measure depression. The Anxious Arousal subscale consists of 17-items with lower scores indicating better outcomes (range = 17 - 85). The Anhedonic Depression subscale consists of 22-items with lower scores indicating better outcomes (range = 22 - 110).

  6. Self-Help Scale [ Time Frame: Assess change from baseline to 2-week and 1-month follow-up ]
    The Self-Help Scale asks participants to indicate whether they would be willing to try each of 10 strategies to help deal with depression and anxiety on a 5-point Likert-type scale from 0 (definitely not) to 4 (extremely willing). Higher scores indicate a better outcome (range = 0 - 40).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Low distress tolerance defined as a DTS mean score of 2.56 or lower
  • Daily smoking for at least one year (minimum 5 cigarettes per day and biochemically confirmed via Carbon Monoxide [CO] analysis at least 5 ppm)
  • Elevated anxiety/depressive symptoms defined as an Anxious Arousal score of at least 32 and Anhedonic Depression score of 70 on the Mood and Anxiety Symptoms Questionnaire.

Exclusion Criteria:

  • Currently engaging in treatment for an alcohol/drug problem including smoking cessation
  • Active Suicidality
  • Psychosis
  • Legal status that will interfere with participating
  • Not being fluent in English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918031


Contacts
Layout table for location contacts
Contact: Brooke Kauffman, M.A. 713-743-8056 bkauffma@central.uh.edu
Contact: Natalie Peraza, B.S. 713-743-8056 natalie.peraza@gmail.com

Locations
Layout table for location information
United States, Texas
Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston Recruiting
Houston, Texas, United States, 77204
Contact: Natalie Peraza, BS    713-743-8056    natalie.peraza@gmail.com   
Principal Investigator: Brooke Kauffman, MA         
Principal Investigator: Michael J. Zvolensky, PHD         
Sponsors and Collaborators
University of Houston
National Institute on Drug Abuse (NIDA)
Investigators
Layout table for investigator information
Principal Investigator: Brooke Kauffman, M.A. University of Houston
Principal Investigator: Michael Zvolensky, Ph.D. University of Houston
  Study Documents (Full-Text)

Documents provided by Brooke Kauffman, University of Houston:

Additional Information:
Layout table for additonal information
Responsible Party: Brooke Kauffman, Principal Investigator, University of Houston
ClinicalTrials.gov Identifier: NCT03918031     History of Changes
Other Study ID Numbers: STUDY00000686
1F31DA046127-01 ( U.S. NIH Grant/Contract )
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brooke Kauffman, University of Houston:
Psychological Distress
Tobacco
Smoking
Feedback
Stress
Anxiety Disorders
Depression

Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Anxiety Disorders
Tobacco Use Disorder
Behavioral Symptoms
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders