Trial Outcomes & Findings for Integrated Treatment for Smoking Cessation & Anxiety in People With HIV (NCT NCT01393301)
NCT ID: NCT01393301
Last Updated: 2023-05-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
6 months
Results posted on
2023-05-03
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
27
|
|
Overall Study
COMPLETED
|
17
|
24
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Completed <7 sessions (intervention)
|
2
|
0
|
Baseline Characteristics
Integrated Treatment for Smoking Cessation & Anxiety in People With HIV
Baseline characteristics by cohort
| Measure |
Behavioral Intervention Arm
n=26 Participants
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.
|
Control Arm
n=27 Participants
Enhanced Treatment as Usual (ETAU); enhanced standard smoking cessation treatment and nicotine replacement therapy (NRT).
Control: Enhanced standard smoking cessation treatment and NRT.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.73 years
STANDARD_DEVIATION 7.96 • n=5 Participants
|
51.22 years
STANDARD_DEVIATION 8.54 • n=7 Participants
|
50.49 years
STANDARD_DEVIATION 8.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
27 participants
n=7 Participants
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsAcceptability 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.
Outcome measures
| Measure |
Behavioral Intervention Arm
n=26 Participants
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.
|
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.
|
|---|---|---|
|
Treatment Acceptability
|
17 Participants
|
—
|
PRIMARY outcome
Timeframe: 6 monthsSmoking 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.
Outcome measures
| Measure |
Behavioral Intervention Arm
n=13 Participants
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.
|
Control Arm
n=21 Participants
Enhanced Treatment as Usual (ETAU); enhanced standard smoking cessation treatment and nicotine replacement therapy (NRT).
Control: Enhanced standard smoking cessation treatment and NRT.
|
|---|---|---|
|
Long-term Point Prevalence Abstinence (PPA; Pilot RCT Phase)
|
6 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 10 weeksSmoking 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.
Outcome measures
| Measure |
Behavioral Intervention Arm
n=17 Participants
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.
|
Control Arm
n=23 Participants
Enhanced Treatment as Usual (ETAU); enhanced standard smoking cessation treatment and nicotine replacement therapy (NRT).
Control: Enhanced standard smoking cessation treatment and NRT.
|
|---|---|---|
|
Short-term Point Prevalence Abstinence (PPA; Pilot RCT Phase)
|
10 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 monthsTreatment 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).
Outcome measures
| Measure |
Behavioral Intervention Arm
n=13 Participants
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.
|
Control Arm
n=21 Participants
Enhanced Treatment as Usual (ETAU); enhanced standard smoking cessation treatment and nicotine replacement therapy (NRT).
Control: Enhanced standard smoking cessation treatment and NRT.
|
|---|---|---|
|
Treatment Related Changes in Psychological Distress.
|
-.06 z-score
Standard Deviation .61
|
.31 z-score
Standard Deviation .55
|
Adverse Events
Behavioral Intervention Arm
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Behavioral Intervention Arm
n=26 participants at risk
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.
|
Control Arm
n=27 participants at risk
Enhanced Treatment as Usual (ETAU); enhanced standard smoking cessation treatment and nicotine replacement therapy (NRT).
Control: Enhanced standard smoking cessation treatment and NRT.
|
|---|---|---|
|
Endocrine disorders
Hospitalization for dizziness
|
3.8%
1/26 • Number of events 1 • 1 year
Information was collected and reported for both study-related and non-study related adverse events.
|
0.00%
0/27 • 1 year
Information was collected and reported for both study-related and non-study related adverse events.
|
|
Cardiac disorders
Hospitalization for leg blockage
|
0.00%
0/26 • 1 year
Information was collected and reported for both study-related and non-study related adverse events.
|
3.7%
1/27 • Number of events 1 • 1 year
Information was collected and reported for both study-related and non-study related adverse events.
|
|
Psychiatric disorders
Hospitalization for psychiatric reasons
|
0.00%
0/26 • 1 year
Information was collected and reported for both study-related and non-study related adverse events.
|
3.7%
1/27 • Number of events 1 • 1 year
Information was collected and reported for both study-related and non-study related adverse events.
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/26 • 1 year
Information was collected and reported for both study-related and non-study related adverse events.
|
3.7%
1/27 • Number of events 1 • 1 year
Information was collected and reported for both study-related and non-study related adverse events.
|
|
Injury, poisoning and procedural complications
Hospitalization for overdose
|
0.00%
0/26 • 1 year
Information was collected and reported for both study-related and non-study related adverse events.
|
3.7%
1/27 • Number of events 1 • 1 year
Information was collected and reported for both study-related and non-study related adverse events.
|
Other adverse events
| Measure |
Behavioral Intervention Arm
n=26 participants at risk
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.
|
Control Arm
n=27 participants at risk
Enhanced Treatment as Usual (ETAU); enhanced standard smoking cessation treatment and nicotine replacement therapy (NRT).
Control: Enhanced standard smoking cessation treatment and NRT.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/26 • 1 year
Information was collected and reported for both study-related and non-study related adverse events.
|
3.7%
1/27 • Number of events 1 • 1 year
Information was collected and reported for both study-related and non-study related adverse events.
|
|
Psychiatric disorders
Intense Anxiety
|
0.00%
0/26 • 1 year
Information was collected and reported for both study-related and non-study related adverse events.
|
3.7%
1/27 • Number of events 1 • 1 year
Information was collected and reported for both study-related and non-study related adverse events.
|
|
General disorders
Nicotine Patch Negative Effects
|
0.00%
0/26 • 1 year
Information was collected and reported for both study-related and non-study related adverse events.
|
3.7%
1/27 • Number of events 1 • 1 year
Information was collected and reported for both study-related and non-study related adverse events.
|
Additional Information
Dr. Conall O'Cleirigh, PI
Massachusetts General Hospital
Phone: (617) 643-0385
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place