Adjunctive Mood Management for Telephone-based Smoking Cessation

NCT02500589 | Completed Results

• 1 other identifier: IIR 11-300
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

Smoking is the leading cause of morbidity and mortality in the U.S. Interventions that increase successful quit attempts among depressed smokers with chronic medical illnesses are particularly important for the VA healthcare system because rates of tobacco use, depression, and chronic medical illnesses are significantly higher among Veterans compared to the general population. Providing smoking cessation services augmented with mood management to Veterans via telephone may increase access to, and utilization of, evidence-based smoking cessation counseling and decrease rates of smoking-related complications for Veterans with chronic medical illnesses and depression. Yet, the reach of smoking cessation telephone counseling has been limited among populations with mental illness. The investigators intend to combine the potency of co-delivered mood management and reach of telephone-delivered interventions by testing the telephone delivery of behavioral mood-management for smoking cessation among smokers with depression and chronic medical illness.

Conditions

Nicotine Dependence

Keywords

smoking; tobacco

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Prolonged Abstinence

  In keeping with the Society for Research on Nicotine and Tobacco recommendations for measuring abstinence, the investigators use prolonged abstinence as the main outcome and allow for a grace period around quit date. During the 6-month follow-ups, patients will be asked about prolonged abstinence, "Since \[end of the grace period\] has the participant ever smoked at least a part of a cigarette on each of 7 consecutive days?" and "After \[end of the grace period\] has the participant smoked any in each of 2 consecutive weeks?" Responding "no" to these questions is considered having obtained prolonged abstinence (ie., smoking cessation). Data below reflect the participants responding "no."

  6 month

• Number of Participants With Prolonged Abstinence

  In keeping with the Society for Research on Nicotine and Tobacco recommendations for measuring abstinence, the investigators use prolonged abstinence as the main outcome and allow for a grace period around quit date. During the 12-month follow-ups, patients will be asked about prolonged abstinence, "Since \[end of the grace period\] has the participant ever smoked at least a part of a cigarette on each of 7 consecutive days?" and "After \[end of the grace period\] has the participant smoked any in each of 2 consecutive weeks?" Responding "no" to these questions is considered having obtained prolonged abstinence (ie., smoking cessation). Data below reflect the participants responding "no."

  12 month

Secondary Outcomes (6)

• Number of Participants With 7 Day Point Prevalent Abstinence

  Month 6

• Change in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 6-months

  change from baseline to 6 month follow up

• Change in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 12 Month Follow up

  change from baseline to 12 month follow up

• Biochemical Verification of Smoking Cessation at 6 Month Follow up

  6 month follow up

• Number of Participants With 7 Day Point Prevalent Abstinence

  12 month

Study Arms (2)

Mood management enhancement

EXPERIMENTAL

In the SMK-MM enhanced arm, behavioral mood management will be integrated into the evidence-based smoking cessation counseling.

Behavioral: Behavioral mood management

Health education control

OTHER

In the contact-equivalent health education condition, participants will receive parallel smoking cessation content on the same schedule as in the MM-enhanced arm; however, health education content will supplant the MM content. The educational content will be based on the VA National Center on Health Promotion and Disease Prevention's "Health Living Messages" on such topics as being safe, eating wisely, getting recommended immunization and screening tests, and being involved with personal health care. Participants also will receive chronic-disease-specific self-management information.

Other: Health education

Interventions

Behavioral mood management BEHAVIORAL

The mood-management sessions are informed by CBT and emphasize psycho-educational and skills-based approaches to CBT. CBT has been used extensively to address mood management. Specifically, SMK-MM enhancement includes behavioral activation, cognitive restructuring (working with automatic thoughts, problem solving, and behavioral skills (i.e., activity scheduling, relaxation training/controlled breathing). The SMK-MM-enhanced participant manual will also include additional worksheets developed for the investigator's pilot based on Lewinsohn's self-help guide to controlling depression. The main objective of the worksheets will be to provide Veterans with an opportunity to gain mastery over selected behavioral and cognitive skills thought to facilitate mood management. As is customary in CBT, homework based on the worksheets will be discussed during counseling calls.

Mood management enhancement

Health education OTHER

In the contact-equivalent health education condition, participants will receive parallel smoking cessation content on the same schedule as in the MM-enhanced arm; however, health education content will supplant the MM content. The educational content will be based on the VA National Center on Health Promotion and Disease Prevention's "Health Living Messages" on such topics as being safe, eating wisely, getting recommended immunization and screening tests, and being involved with the participant's health care. Participants also will receive chronic-disease-specific self-management information.

Health education control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrolled in the Durham VAMC for ongoing care
• Current tobacco smokers planning to quit smoking in the next 30 days
• Having received a diagnosis of a qualifying chronic illness (i.e., cancer, cardiovascular disease, hypertension, diabetes, COPD)
• Have significant burden of depressive symptoms (i.e., meets DSM threshold for \> 3 of the nine MDD criterion symptoms at the threshold of "more than half the days" (one symptom must be depressed mood or anhedonia; endorsing "some days" meets criteria for self-harm) and endorse functional impairment OR receive a summary score 10 or above on PHQ-9.

You may not qualify if:

• Active diagnosis of psychosis or dementia in their medical records
• Severely impaired hearing or speech
• Lack of telephone access
• Enrollment in another research study that might affect the main outcomes of this study
• Terminal illness
• \. Behavioral flag in medical record
• \. Active suicidal ideation flag in medical record
• \. Endorses thoughts of self-harm and is a greater than minimal risk of suicide

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Results Point of Contact

• Title: Jennifer Gierisch
• Organization: Durahm VA Health Care System

jennifer.gierisch@va.gov; j.gierisch@duke.edu

919-286-0411

Study Officials

• Jennifer M Gierisch, PhD MA

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: July 16, 2015
• Study Start: May 31, 2016
• Primary Completion: April 19, 2019
• Study Completion: April 19, 2019
• Last Updated: July 27, 2023
• Results First Posted: December 6, 2021

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)