Personalized Feedback for Distress Intolerant Smokers

Depression Clinical Trial

Official title:

Personalized Feedback for Distress Intolerant Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03918031
• Other study ID #: STUDY00000686
• Secondary ID: 1F31DA046127-01
• Status: Completed
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: October 24, 2021

Study information

• Verified date: October 2021
• Source: University of Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: October 24, 2021
• Est. primary completion date: October 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Psychological Distress
• Smoking, Cigarette
• Smoking, Tobacco
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Behavioral:
• PFI for Smoking & Distress Tolerance
Personalized Feedback Intervention for smoking and distress tolerance.
• PFI for Smoking Only
Personalized Feedback Intervention for smoking only (no distress tolerance component)

Locations

Country	Name	City	State
United States	Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Houston	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rulers for Smoking Cessation	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.	Assess change from baseline to 2-week and 1-month follow-up
Primary	Barriers to Cessation Scale	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).	Assess change from baseline to 2-week and 1-month follow-up
Primary	Smoking History Questionnaire	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.	Assess change from baseline to 2-week and 1-month follow-up
Primary	Distress Tolerance Scale	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.	Assess change from baseline to 2-week and 1-month follow-up
Primary	Mood and Anxiety Symptom Questionnaire-Short Form	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).	Assess change from baseline to 2-week and 1-month follow-up
Primary	Self-Help Scale	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).	Assess change from baseline to 2-week and 1-month follow-up

External Links

•   Project Website