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Completed

NCT Number: NCT03873337

Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI)

Due to the pandemic, this study was modified from a randomized clinical trial to test the feasibility, initial efficacy, and mechanisms of action of our PTSC-S intervention to a feasibility and acceptability test of our intervention when delivered via telehealth in a single group, within-subjects design.

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Key information

Conditions

Tobacco Use Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Smoking Smoking Cessation Substance-Related Disorders Tobacco Smoking Tobacco Use Cessation Tobacco Use Disorder

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Addiction Psychiatry

New Brunswick, New Jersey, 08901, United States

About this study

The investigators will test the feasibility and acceptability of a telehealth-delivered treatment designed to help smokers with serious mental illness to quit using a therapy approach focused on increasing task persistence.

We will provide free, weekly individual telehealth video counseling sessions for 8 weeks and 10-weeks' worth of the nicotine transdermal patch (an FDA-approved smoking cessation product available over the counter). All sessions will be video recorded for treatment integrity and supervision.

The investigators hypothesize that 1) the PTSC-S intervention will be acceptable to participants, and the study will be feasible to conduct. We will report prolonged and point prevalence abstinence rates at end-of-counseling and at 3-month follow-up (CO verified <8ppm).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be between 18 - 70 years old
  • Must indicate willingness to make a quit attempt in the next 30 days
  • Must report being a daily cigarette smoker (including those labeled "little cigars") for past month
  • Must have a diagnosis of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder on the Structured Clinical Interview for Diagnostic and Statistical Manual (DSM), 5th edition, Research Version (SCID-5-RV)
  • Psychiatric illness must be stable, as indicated by no hospitalizations in previous 8 weeks, and a stable psychotropic medication regimen for 8 weeks
  • Must have a smartphone, tablet, or computer with ability to download apps
  • Must currently receive mental health treatment
  • Must sign release of information for current mental health treatment providers

Exclusion criteria

  • Must not currently (in past 10 days) be taking varenicline (Chantix),
  • Must not currently (in past 10 days) be taking bupropion (Zyban/Wellbutrin) to quit smoking.
  • Must not be taking any nicotine preparations (gum, lozenge, patch, spray, inhaler) daily over the last 10 days
  • Must not report myocardial infarction, unstable angina pectoris, or significant cardiac arrhythmia (including atrial fibrillation) in the past 30 days.
  • Women must not be pregnant, "test positive" on a pregnancy test, nursing, or planning on becoming pregnant in the next three months. Women who can become pregnant may be included if using effective birth control.
  • Must not have pending legal matters with potential to result in jail time
  • Must not be planning on moving outside local area in next 3-months
  • Problematic substance use in the past 3 months (Alcohol Use Disorders Identification Test-Concise (AUDIT-C) ≥5 for men and ≥4 for women, Drug Abuse Screening Test (DAST-10) score of ≥4)
  • Must not have suicidal ideation in the past week with intent, plan, or access to method; must not have attempted suicide in the past year (as assessed on the SCID-RV)

Treatment and study plan

Persistence Targeted Smoking Cessation in SMI (PTSC-S)

Behavioral

All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth

Nicotine patch

Drug

All participants will receive 10 weeks of nicotine patch

Primary outcomes

  1. Acceptability 1: Participant Rating of Usefulness of Intervention

    Time frame: 3-months post quit date (approximately 4-months after baseline assessment)

    After each session, participants (N=33) provided a 1-7 rating of how "easy to understand" and how "helpful" the intervention was. Higher numbers represent greater ease and greater helpfulness, respectfully. There is no official scale title because the scale was developed for this study.

  2. Acceptability 2: Participant Rating of Counseling Session Length

    Time frame: 3-months post quit date (approximately 4 months after baseline assessment)

    After each session, participants (N=33) provided a 1-7 rating of agreement with the statement, "There was too much information in today's session." (as a proxy for appropriateness of session length). Higher numbers represent greater agreement. There is no official scale title because the scale was developed for this study.

  3. Acceptability 3: Participant Rating of Treatment Length / Timing of Target Quit-Date

    Time frame: 3-months post quit date (approximately 4 months after baseline assessment)

    We asked participants how acceptable the placement of the target quit date was to participants (i.e., it was scheduled for session 4). We report the percentage of participants who responded that the quit date was "too soon", "too late", or "just about right".

  4. Feasibility 1: Number of Participants Contacted at 3 Months Post-Quite Date

    Time frame: 3-months post quit date (approximately 4 months after baseline assessment)

    We will calculate follow-up rates to determine if they meet our goal of 80% follow-up rates at the 3-month follow-up.

  5. Feasibility 2: Missing/Unusable Data

    Time frame: 3-months post quit date (approximately 4 months after baseline assessment)

    We will determine the rate of missing or unusable carbon monoxide (CO) data to determine if the rate meets our goal of less than 10% missing/unusable data. There were a possible 340 CO assessment data points.

  6. Feasibility 3: Participant Attendance

    Time frame: 8 weeks of counseling with a 2-week grace period to make up missed sessions (10 weeks)

    Participants in the PTSC-S intervention will attend at least 60% of their sessions

Secondary outcomes

  1. Number of Participants With Seven-day Point Prevalence Abstinence at End-of-counseling

    Time frame: End-of-counseling (8 weeks)

    No smoking on the 7 days before the final counseling session, biochemically verified with CO<8ppm

  2. Number of Participants With Prolonged Abstinence at End-of-counseling

    Time frame: End-of-counseling (8 weeks)

    Prolonged abstinence with a 2-week grace period following the target quit date until end-of-counseling, biochemically verified with CO<8ppm

  3. Number of Participants With Seven-day Point Prevalence Abstinence at 3-month Follow-up

    Time frame: 3-months post target quit date (approximately 4 months after baseline assessment)

    No smoking on the 7 days before the 3-month follow-up, biochemically verified with CO<8ppm

  4. Number of Participants With Prolonged Abstinence at at 3-month Followup

    Time frame: 3-months post target quit date (approximately 4 months after baseline assessment)

    Prolonged abstinence with a 2-week grace period following the target quit date until 3-months post quit-date, biochemically verified with CO<8ppm

  5. Task Persistence Scores

    Time frame: 2 months after baseline assessment and 4 months after baseline assessment

    14-item Thoughts About Smoking Questionnaire (TASQ). Lower scores represent greater task persistence. The total score can range from a minimum of 14 to a maximum of 98.

  6. Cigarettes Per Day

    Time frame: 2 months after baseline assessment and 4 months after baseline assessment

    Hypothesis 3: As compared to baseline, participants will report smoking fewer cigarettes per day at 2- and 4-months post-baseline. Analysis 3: One-tailed, paired sample t-tests will be used to examine decreases in cigarettes smoked per day on the TASQ at each timepoint.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Persistence Targeted Smoking Cessation in Schizophrenia (PTSC-S)

Acronym: PTSC-S

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 13, 2019
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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