Integrated Treatment for Smoking Cessation & Anxiety in People With HIV

Study Overview
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Brief Summary
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During the 1-year formative phase of a study to develop an integrated treatment for quitting smoking for anxiety-vulnerable HIV+ smokers. During this first phase of the study, start-up activities will include piloting the integrated treatment on a small group of individuals (N = up to 12), obtaining expert consultant and participant feedback, and development of the final treatment manual and procedures. The goal during this phase will be to establish feasibility of treatment delivery, participant acceptability, and potential for a treatment effect before conducting a pilot randomized trial of the treatment. During the two-year pilot RCT phase of the above study, we directly develop and test a novel psychosocial/behavioral and pharmacological smoking cessation intervention for HIV+ smokers with interfering psychological distress.

Detailed Description
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This study represents an important step in treating nicotine dependence in HIV-positive individuals. This study addresses an important public health issue by assessing an intervention that may lead to a more effective application for the treatment of at-risk HIV+ smokers. The 1-year formative phase of the study will develop an integrated treatment for quitting smoking for anxiety-vulnerable HIV+ smokers. The proposed treatment will include cognitive-behavioral talk therapy for quitting smoking, a nicotine patch, and cognitive-behavioral talk therapy for anxiety. The pilot of the proposed treatment will be conducted with a small group of individuals (N = up to 12). This phase will be used to establish feasibility of treatment delivery, and participant acceptability before conducting a pilot randomized trial of the treatment. Additionally, this phase will monitor smoking cessation history through Point Prevalence Abstinence (PPA), as well as anxiety symptoms through the Anxiety Sensitivity Index (ASI) at the baseline and follow-up assessments. This study represents an important step in treating nicotine dependence in HIV-positive individuals. This study addresses an important public health issue by assessing an intervention that may lead to a more effective application for the treatment of at-risk HIV+ smokers. The pilot RCT phase of the study (years 2 and 3), will test the developed cognitive-behavioral intervention in a pilot randomized-controlled trial format. The outcomes for this trial will be to determine the acceptability and feasibility of the intervention and the potential for an effect on increasing point prevalence abstinence and deceasing psychological distress.

Official Title
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Integrated Treatment for Smoking Cessation & Anxiety in People With HIV

Conditions
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HIV, Nicotine Dependence, Symptoms of Anxiety

Intervention / Treatment
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* Behavioral: Integrated cognitive-behavioral therapy for smoking cessation and anxiety
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years old Informed consent Daily smoker Motivated to quit smoking Exclusion Criteria: Use of other tobacco products Untreated or unstable psychiatric disorders Current use of cognitive-behavioral therapy or medication for smoking cessation treatment Insufficient command of English

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Intervention Arm<br>Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress. | Behavioral: Integrated cognitive-behavioral therapy for smoking cessation and anxiety<br>* Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress.<br>* Other names: QUESTT;|
| Other: Control Arm<br>Enhanced Treatment as Usual (ETAU); enhanced standard smoking cessation treatment and nicotine replacement therapy (NRT). | Behavioral: Control<br>* Enhanced standard smoking cessation treatment and NRT.<br>* Other names: Enhanced Treatment as Usual (ETAU);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Acceptability | Acceptability is defined as intervention participant study completion. Study completion was defined by participants attending at least 7/10 treatment sessions. Qualitative interviews were also conducted with participants at the end of the study. | 6 months | 
| Long-term Point Prevalence Abstinence (PPA; Pilot RCT Phase) | Smoking outcomes are assessed at 6-month follow up by comparing the reported 7 day abstinence (assessed through self-report and independent verification) across the randomized conditions controlling for pre-randomization levels. | 6 months | 
| Short-term Point Prevalence Abstinence (PPA; Pilot RCT Phase) | Smoking outcomes are assessed at end of treatment by comparing the reported 7 day abstinence (assessed through self-report and independent verification) across the randomized conditions controlling for pre-randomization levels. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Related Changes in Psychological Distress. | Treatment related changes in psychological distress was measured by combining the SIGH-A, MADRS, STAI-S, and CES-D into one scale score between baseline and the 6-month follow-up. In accordance with published recommendations, each psychological measure was z-scored to put all outcomes on the same scale. A z-score below 0 indicates a level of psychological distress below the mean (lower psychological distress), while a z-score above 0 indicates a level of psychological distress above the mean (higher psychological distress). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nicotine dependence, Smoking, cessation, Quitting, Anxiety symptoms, Cognitive-behavioral therapy