N/A Completed N=350 Randomized Single-blind Health Services Research

Adjunctive Mood Management for Telephone-based Smoking Cessation

Nicotine Dependence

Source: ClinicalTrials.gov NCT02500589 ↗

Enrolled (actual)

350

Serious AEs

8.6%

Results posted

Dec 2021

Primary outcomePrimary: Number of Participants With Prolonged Abstinence — 36; 40 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Prolonged Abstinence	32; 33	—
SECONDARY Number of Participants With 7 Day Point Prevalent Abstinence	34; 36	—
SECONDARY Change in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 6-months	-4.53; -3.65	—
SECONDARY Change in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 12 Month Follow up	-5.09; -4.84	—
SECONDARY Biochemical Verification of Smoking Cessation at 6 Month Follow up	10; 10	—
SECONDARY Biochemical Verification of Smoking Cessation at 12 Month Follow up	17; 9	—

Eligibility Criteria

Inclusion Criteria

Patients must meet all of the following inclusion criteria:

1.Enrolled in the Durham VAMC for ongoing care
2.Current tobacco smokers planning to quit smoking in the next 30 days
3.Having received a diagnosis of a qualifying chronic illness (i.e., cancer, cardiovascular disease, hypertension, diabetes, COPD)
4.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.

Exclusion Criteria

Patients who meet any one of the following exclusion criteria will be excluded:

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02500589). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.