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Completed

NCT Number: NCT06687577

DBT 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.

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Key information

Conditions

Tobacco Dependence Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Suicidal Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Veterans Medical Research Foundation

San Diego, California, 92161, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DBT-C

Behavioral

Tobacco cessation treatment adapted for high risk population.

Treatment as Usual

Behavioral

Standard behavioral tobacco cessation treatment.

Other names: TAU

Primary outcomes

  1. Proportion of participants who stop using tobacco

    Time frame: 6 months

    Reduction in use or abstinence

Secondary outcomes

  1. Average change per participant in quality of sleep

    Time frame: 6 months

    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.

  2. Average improvement in physical pain per participant

    Time frame: 6 months

    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.

  3. Average improvement in negative mood per participant

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Veterans Medical Research Foundation

Other

Collaborators

  • University of California

Registry information

Official study title

Dialectical Behavior Therapy for Smoking Cessation in High Risk Veterans

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 13, 2024
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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