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Clinical Trials/NCT06687577
NCT06687577CompletedNot Applicable

Dialectical Behavior Therapy for Smoking Cessation in High Risk Veterans

Veterans Medical Research Foundation1 site in 1 country67 target enrollmentStarted: May 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
67
Locations
1
Primary Endpoint
Proportion of participants who stop using tobacco

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

DBT

Experimental

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

Intervention: DBT-C (Behavioral)

TAU

Active Comparator

Standard behavioral cessation intervention.

Intervention: Treatment as usual (Behavioral)

Outcomes

Primary Outcomes

Proportion of participants who stop using tobacco

Time Frame: 6 months

Reduction in use or abstinence

Secondary Outcomes

  • Average change per participant in quality of sleep(6 months)
  • Average improvement in physical pain per participant(6 months)
  • Average improvement in negative mood per participant(6 months)

Investigators

Sponsor
Veterans Medical Research Foundation
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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