HIV, Nicotine Dependence, Symptoms of Anxiety
Conditions
Keywords
Nicotine dependence, Smoking, cessation, Quitting, Anxiety symptoms, Cognitive-behavioral therapy
Brief summary
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
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.
Interventions
BEHAVIORALIntegrated cognitive-behavioral therapy for smoking cessation and anxiety
Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress.
BEHAVIORALControl
Enhanced standard smoking cessation treatment and NRT.
Sponsors
Southern Methodist University
University of Houston
National Institute on Drug Abuse (NIDA)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
For formative stage of the study, no masking was used as that phase was an open pilot. Outcomes assessor masked during the pilot RCT.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Acceptability | 6 months | 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. |
| Long-term Point Prevalence Abstinence (PPA; Pilot RCT Phase) | 6 months | 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. |
| Short-term Point Prevalence Abstinence (PPA; Pilot RCT Phase) | 10 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Related Changes in Psychological Distress. | 6 months | 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). |
Countries
United States
Participant flow
Pre-assignment details
72 participants were officially consented, 71 participants completed baseline (1 lost to follow-up), and 53 participants attended Session 1 after baseline (10 found ineligible at baseline, 8 lost to follow-up). Randomization occurred at the end of Session 1; therefore, only participants who attended Session 1 (N=53) were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Behavioral Intervention Arm Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress.
Integrated cognitive-behavioral therapy for smoking cessation and anxiety: Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress. | 26 |
| Control Arm Enhanced Treatment as Usual (ETAU); enhanced standard smoking cessation treatment and nicotine replacement therapy (NRT).
Control: Enhanced standard smoking cessation treatment and NRT. | 27 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Completed <7 sessions (intervention) | 2 | 0 |
| Overall Study | Lost to Follow-up | 5 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Behavioral Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Age, Continuous | 49.73 years STANDARD_DEVIATION 7.96 | 51.22 years STANDARD_DEVIATION 8.54 | 50.49 years STANDARD_DEVIATION 8.21 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 23 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 13 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 12 Participants | 13 Participants | 25 Participants |
| Region of Enrollment United States | 26 participants | 27 participants | 53 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Male | 23 Participants | 22 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 27 |
| other Total, other adverse events | 0 / 26 | 3 / 27 |
| serious Total, serious adverse events | 1 / 26 | 4 / 27 |
Outcome results
Primary
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavioral Intervention Arm | Long-term Point Prevalence Abstinence (PPA; Pilot RCT Phase) | 6 Participants |
| Control Arm | Long-term Point Prevalence Abstinence (PPA; Pilot RCT Phase) | 1 Participants |
Primary
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.
Time frame: 10 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavioral Intervention Arm | Short-term Point Prevalence Abstinence (PPA; Pilot RCT Phase) | 10 Participants |
| Control Arm | Short-term Point Prevalence Abstinence (PPA; Pilot RCT Phase) | 2 Participants |
Primary
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavioral Intervention Arm | Treatment Acceptability | 17 Participants |
Secondary
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).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Intervention Arm | Treatment Related Changes in Psychological Distress. | -.06 z-score | Standard Deviation 0.61 |
| Control Arm | Treatment Related Changes in Psychological Distress. | .31 z-score | Standard Deviation 0.55 |