DBT for Smoking Cessation in High Risk Veterans

NCT ID: NCT06687577

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-06-30

Brief Summary

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.

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.

Conditions

Tobacco Dependence; Suicidal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DBT

Standard behavioral cessation intervention adapted to incorporate DBT skills for emotion regulation.

Group Type: EXPERIMENTAL

DBT-C

Intervention Type: BEHAVIORAL

Tobacco cessation treatment adapted for high risk population.

TAU

Standard behavioral cessation intervention.

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: BEHAVIORAL

Standard behavioral tobacco cessation treatment.

Interventions

DBT-C

Tobacco cessation treatment adapted for high risk population.

Intervention Type: BEHAVIORAL

Treatment as usual

Standard behavioral tobacco cessation treatment.

Intervention Type: BEHAVIORAL

Other Intervention Names

TAU

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California

OTHER

Sponsor Role: collaborator

Veterans Medical Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neal M. Doran

Role: PRINCIPAL_INVESTIGATOR

Veterans Medical Research Foundation / VA

Locations

Veterans Medical Research Foundation

San Diego, California, United States

Countries

United States

Other Identifiers

101760002

Identifier Type: -

Identifier Source: org_study_id