DBT for Smoking Cessation in High Risk Veterans

Dialectical Behavior Therapy for Smoking Cessation in High Risk Veterans

Individuals prone to suicidality are typically excluded from tobacco cessation interventions even though they are disproportionately likely to smoke, and even though smoking cessation has been linked to improved mood and reduced risk of suicide.

This trial enrolls Veteran smokers at high risk for suicide, and assigns them to receive either cessation treatment as usual, or a novel treatment that incorporates standard behavioral cessation treatment with Dialectical Behavior Therapy (DBT), an evidence-based treatment for suicide risk.

Study Overview

• Status: Completed
• Conditions: Tobacco Dependence; Suicidal
• Intervention / Treatment: Behavioral: DBT-C; Behavioral: Treatment as usual

Detailed Description

Individuals with behavioral health problems are a significant tobacco-related health disparity group in that they are more likely to use tobacco and evidence disproportionate consequences from their use. Cigarette smoking or usage of other nicotine products is strongly associated with symptoms of emotional distress, while cessation is associated with significant reductions in symptoms of anxiety and depression and improved mental health functioning. Individuals with who have difficulty managing negative emotions (emotional dysregulation) may be especially vulnerable to tobacco dependence and have particular difficulties with smoking cessation. Because cessation studies commonly exclude smokers exhibiting emotional dysregulation (such as recent suicidality and/or acute emotional instability), little extant evidence is available to inform optimal treatment approaches for these smokers.

Dialectical behavior therapy skills group (DBT-SG) is an evidence-based approach to addressing dysregulation of emotion, teaching skills to help manage emotions more effectively. Preliminary empirical work suggests DBT may also be an effective approach to addressing smoking cessation. Difficulty managing negative emotions is a common reason for smoking cessation failure, suggesting that group DBT may be an effective intervention for cessation. Investigators propose to conduct a pilot treatment study with veterans at risk for suicide as an initial step to developing and evaluating the utility of DBT for smoking cessation in subgroups with high levels of emotion dysregulation.

The primary aims of the proposed study are to 1) adapt a 12-week, manualized DBT-based group intervention for smoking cessation (DBT-C); 2) conduct a randomized trial testing whether DBT-C has better smoking cessation outcomes than standard smoking cessation treatment (SCCT); 3) evaluate whether DBT-C participants have greater improvements on measures of emotion regulation, mood and suicidality than those in the SSCT conditions; and 4) examine intervention acceptability and feasibility.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161
      • Veterans Medical Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Veteran receiving VA healthcare
• multiple indicators of elevated suicide risk in 6 month period

Exclusion Criteria:

• cognitive impairment
• unable to attend virtual intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DBT; Standard behavioral cessation intervention adapted to incorporate DBT skills for emotion regulation.	Behavioral: DBT-C; Tobacco cessation treatment adapted for high risk population.
Active Comparator: TAU; Standard behavioral cessation intervention.	Behavioral: Treatment as usual; Standard behavioral tobacco cessation treatment.; Other Names: TAU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants who stop using tobacco	Reduction in use or abstinence	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average change per participant in quality of sleep	Change in sleep quality/quantity will be evaluated using the Insomnia Severity Index (ISI), a brief, valid measure of sleep quality. The ISI will be administered at baseline, end of treatment, and end of follow-up. Morin et al. (2011). The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep 34(5), 601-8.	6 months
Average improvement in physical pain per participant	Participants will self-report frequency of pain on scale from 0 (rarely/never) to 7 (always/almost always). They will self-report pain intensity on a similar scale from 0 (no/mild pain) to 7 (severe pain). These measures are completed at baseline, end of treatment, and end of follow-up.	6 months
Average improvement in negative mood per participant	Change in negative mood will be evaluated via the Positive and Negative Affect Schedule (PANAS), administered at each assessment point. The PANAS asks respondents to indicate the extent to which a series of 10 positive and 10 negative affect terms have applied to them over the past 2 weeks. Watson et al (1988). Development and validation of brief measures of positive and negative affect: The PANAS scales. J Pers Soc Psychol, 54(6), 1063.	6 months

Collaborators and Investigators

• Sponsor: Veterans Medical Research Foundation
• Collaborators: University of California
• Investigators: Principal Investigator: Neal M. Doran, Veterans Medical Research Foundation / VA

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: January 24, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Actual): November 13, 2024

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Tobacco Use Disorder; Therapeutics
• Other Study ID Numbers: 101760002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymized data may be made available upon request from the PI if approved by the sponsor.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No