Clinical trial NCT06687577: DBT for Smoking Cessation in High Risk Veterans
Official title: Dialectical Behavior Therapy for Smoking Cessation in High Risk Veterans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Dependence
Suicidal
Lead sponsor: Veterans Medical Research Foundation
Sponsor class: OTHER
Collaborators: name: University of California
First posted: 2024-11-13
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to DBT or to treatment as usual (TAU)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Proportion of participants who stop using tobacco
timeFrame: 6 months
Secondary outcomes:
measure: Average change per participant in quality of sleep
timeFrame: 6 months
measure: Average improvement in physical pain per participant
timeFrame: 6 months
measure: Average improvement in negative mood per participant
timeFrame: 6 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Veterans Medical Research Foundation
state: California
Study officials:
affiliation: Veterans Medical Research Foundation / VA
name: Neal M. Doran
role: PRINCIPAL_INVESTIGATOR
References: