Trial Outcomes & Findings for Implementation of Genomics in Substance Use Disorder Treatment (NCT NCT04768114)
NCT ID: NCT04768114
Last Updated: 2024-01-03
Results Overview
Participants in both groups were asked about their use of several smoking cessation medications (Question: "In the past 30 days, have you used any of the following prescription medications or over-the-counter aids to help you quit or cut back on smoking?"; Response options: 1=Bupropion or Zyban; 2=Varenicline or Chantix; 3=Nicotine patch; 4=Nicotine gum or lozenge; 5=Other (Specify).
COMPLETED
NA
148 participants
Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up
2024-01-03
Participant Flow
The study opened to participant enrollment on 02/08/2021 and closed to participant enrollment on 05/29/2022.
Participant milestones
| Measure |
Genetically-Informed RiskProfile
Participants will meet with a behavioral interventionist to receive their personalized genetically-informed RiskProfile intervention which incorporates smoking-related genetic risk propensity and phenotypic risk (cigarettes smoked per day) into a risk communication tool designed to activate behavior change, specifically, to increase the use of smoking cessation medications and promote smoking-related behavior change.
This is a fully remote trial, with intervention delivered via video conferencing.
|
Brief Cessation Advice
Participants will meet with a behavioral interventionist to receive standardized brief advice to quit smoking and encouragement to use freely-available smoking cessation resources. Participants will receive their personalized RiskProfile after all data collection has been completed.
This is a fully remote trial, with brief cessation advice delivered via video conferencing.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
74
|
|
Overall Study
COMPLETED
|
69
|
63
|
|
Overall Study
NOT COMPLETED
|
5
|
11
|
Reasons for withdrawal
| Measure |
Genetically-Informed RiskProfile
Participants will meet with a behavioral interventionist to receive their personalized genetically-informed RiskProfile intervention which incorporates smoking-related genetic risk propensity and phenotypic risk (cigarettes smoked per day) into a risk communication tool designed to activate behavior change, specifically, to increase the use of smoking cessation medications and promote smoking-related behavior change.
This is a fully remote trial, with intervention delivered via video conferencing.
|
Brief Cessation Advice
Participants will meet with a behavioral interventionist to receive standardized brief advice to quit smoking and encouragement to use freely-available smoking cessation resources. Participants will receive their personalized RiskProfile after all data collection has been completed.
This is a fully remote trial, with brief cessation advice delivered via video conferencing.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
10
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Implementation of Genomics in Substance Use Disorder Treatment
Baseline characteristics by cohort
| Measure |
Genetically-Informed RiskProfile
n=74 Participants
Participants will meet with a behavioral interventionist to receive their personalized genetically-informed RiskProfile intervention which incorporates smoking-related genetic risk propensity and phenotypic risk (cigarettes smoked per day) into a risk communication tool designed to activate behavior change, specifically, to increase the use of smoking cessation medications and promote smoking-related behavior change.
This is a fully remote trial, with intervention delivered via video conferencing.
|
Brief Cessation Advice
n=74 Participants
Participants will meet with a behavioral interventionist to receive standardized brief advice to quit smoking and encouragement to use freely-available smoking cessation resources. Participants will receive their personalized RiskProfile after all data collection has been completed.
This is a fully remote trial, with brief cessation advice delivered via video conferencing.
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
68 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
51 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Trans female / trans w
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Non-binary
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
147 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
74 participants
n=5 Participants
|
74 participants
n=7 Participants
|
148 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-upPopulation: Some participants did not complete assessments at prior to intervention, 30-day follow-up and 6 month follow-up so that is why the number of participants analyzed at these time points does not match the number of participants enrolled.
Participants in both groups were asked about their use of several smoking cessation medications (Question: "In the past 30 days, have you used any of the following prescription medications or over-the-counter aids to help you quit or cut back on smoking?"; Response options: 1=Bupropion or Zyban; 2=Varenicline or Chantix; 3=Nicotine patch; 4=Nicotine gum or lozenge; 5=Other (Specify).
Outcome measures
| Measure |
Genetically-Informed RiskProfile
n=74 Participants
Participants will meet with a behavioral interventionist to receive their personalized genetically-informed RiskProfile intervention which incorporates smoking-related genetic risk propensity and phenotypic risk (cigarettes smoked per day) into a risk communication tool designed to activate behavior change, specifically, to increase the use of smoking cessation medications and promote smoking-related behavior change.
This is a fully remote trial, with intervention delivered via video conferencing.
|
Brief Cessation Advice
n=74 Participants
Participants will meet with a behavioral interventionist to receive standardized brief advice to quit smoking and encouragement to use freely-available smoking cessation resources. Participants will receive their personalized RiskProfile after all data collection has been completed.
This is a fully remote trial, with brief cessation advice delivered via video conferencing.
|
|---|---|---|
|
Change in Use of Smoking Cessation Pharmacotherapy in Past 30 Days
Self-reported use of any smoking cessation medications at baseline
|
11 Participants
|
9 Participants
|
|
Change in Use of Smoking Cessation Pharmacotherapy in Past 30 Days
Self-reported use of any smoking cessation medications at prior to intervention
|
9 Participants
|
2 Participants
|
|
Change in Use of Smoking Cessation Pharmacotherapy in Past 30 Days
Self-reported use of any smoking cessation medications at 30-day follow-up
|
16 Participants
|
8 Participants
|
|
Change in Use of Smoking Cessation Pharmacotherapy in Past 30 Days
Self-reported use of any smoking cessation medications at 6-month follow-up
|
15 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-upPopulation: Some participants did not complete assessments at prior to intervention, 30-day follow-up and 6 month follow-up so that is why the number of participants analyzed at these time points does not match the number of participants enrolled.
Participants in both groups were asked "In the past 30 days, how many days did you smoke cigarettes" and "On the days in which you smoked cigarettes in the past month, about how many cigarettes did you smoke". The values from these questions are multiplied together and then divided by 30 (days) to calculate the number of cigarettes smoked per day for each participant.
Outcome measures
| Measure |
Genetically-Informed RiskProfile
n=74 Participants
Participants will meet with a behavioral interventionist to receive their personalized genetically-informed RiskProfile intervention which incorporates smoking-related genetic risk propensity and phenotypic risk (cigarettes smoked per day) into a risk communication tool designed to activate behavior change, specifically, to increase the use of smoking cessation medications and promote smoking-related behavior change.
This is a fully remote trial, with intervention delivered via video conferencing.
|
Brief Cessation Advice
n=74 Participants
Participants will meet with a behavioral interventionist to receive standardized brief advice to quit smoking and encouragement to use freely-available smoking cessation resources. Participants will receive their personalized RiskProfile after all data collection has been completed.
This is a fully remote trial, with brief cessation advice delivered via video conferencing.
|
|---|---|---|
|
Change in Number of Cigarettes Smoked Per Day
Self-reported cigarettes per day at baseline
|
13.1 cigarettes smoked per day
Standard Deviation 8.2
|
12.3 cigarettes smoked per day
Standard Deviation 7.7
|
|
Change in Number of Cigarettes Smoked Per Day
Self-reported cigarettes per day at prior to intervention
|
12.0 cigarettes smoked per day
Standard Deviation 8.5
|
11.5 cigarettes smoked per day
Standard Deviation 7.5
|
|
Change in Number of Cigarettes Smoked Per Day
Self-reported cigarettes per day at 30-day follow-up
|
9.2 cigarettes smoked per day
Standard Deviation 8.4
|
9.7 cigarettes smoked per day
Standard Deviation 7.5
|
|
Change in Number of Cigarettes Smoked Per Day
Self-reported cigarettes per day at 6-month follow-up
|
7.3 cigarettes smoked per day
Standard Deviation 7.3
|
9.1 cigarettes smoked per day
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-upPopulation: Some participants did not complete assessments at prior to intervention, 30-day follow-up and 6 month follow-up so that is why the number of participants analyzed at these time points does not match the number of participants enrolled.
Participants in both groups were assessed on self-reported stage of readiness to quit smoking. This measure includes one item based on the Transtheoretical Model of Change and measured along stages of Precontemplation, Contemplation, Preparation, and Action. (Question: ""Are you thinking of quitting smoking?""; Response options: 1=No, I am not seriously considering quitting within the next 6 months (Precontemplation); 2=Yes, I am seriously considering quitting within the next 6 months (Contemplation); 3=Yes, I am seriously planning to quit within the next 30 days (Preparation); 4=I have quit smoking within the past 6 months (Action). A higher score represents a higher stage of readiness to quit smoking. "
Outcome measures
| Measure |
Genetically-Informed RiskProfile
n=74 Participants
Participants will meet with a behavioral interventionist to receive their personalized genetically-informed RiskProfile intervention which incorporates smoking-related genetic risk propensity and phenotypic risk (cigarettes smoked per day) into a risk communication tool designed to activate behavior change, specifically, to increase the use of smoking cessation medications and promote smoking-related behavior change.
This is a fully remote trial, with intervention delivered via video conferencing.
|
Brief Cessation Advice
n=74 Participants
Participants will meet with a behavioral interventionist to receive standardized brief advice to quit smoking and encouragement to use freely-available smoking cessation resources. Participants will receive their personalized RiskProfile after all data collection has been completed.
This is a fully remote trial, with brief cessation advice delivered via video conferencing.
|
|---|---|---|
|
Change in Readiness to Quit Smoking
Baseline, Precontemplation count
|
16 Participants
|
22 Participants
|
|
Change in Readiness to Quit Smoking
Baseline, Contemplation count
|
45 Participants
|
37 Participants
|
|
Change in Readiness to Quit Smoking
Baseline, Preparation count
|
13 Participants
|
15 Participants
|
|
Change in Readiness to Quit Smoking
Baseline, Action count
|
0 Participants
|
0 Participants
|
|
Change in Readiness to Quit Smoking
Prior to intervention, Precontemplation count
|
12 Participants
|
13 Participants
|
|
Change in Readiness to Quit Smoking
Prior to intervention, Contemplation count
|
41 Participants
|
39 Participants
|
|
Change in Readiness to Quit Smoking
Prior to intervention, Preparation count
|
17 Participants
|
13 Participants
|
|
Change in Readiness to Quit Smoking
Prior to intervention, Action count
|
1 Participants
|
1 Participants
|
|
Change in Readiness to Quit Smoking
30-day follow-up, Precontemplation count
|
8 Participants
|
12 Participants
|
|
Change in Readiness to Quit Smoking
30-day follow-up, Contemplation count
|
37 Participants
|
36 Participants
|
|
Change in Readiness to Quit Smoking
30-day follow-up, Preparation count
|
22 Participants
|
13 Participants
|
|
Change in Readiness to Quit Smoking
30-day follow-up, Action count
|
4 Participants
|
4 Participants
|
|
Change in Readiness to Quit Smoking
6-month follow-up, Precontemplation count
|
13 Participants
|
4 Participants
|
|
Change in Readiness to Quit Smoking
6-month follow-up, Contemplation count
|
29 Participants
|
43 Participants
|
|
Change in Readiness to Quit Smoking
6-month follow-up, Preparation count
|
16 Participants
|
9 Participants
|
|
Change in Readiness to Quit Smoking
6-month follow-up, Action count
|
10 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-upPopulation: Some participants did not complete assessments at baseline, immediately following intervention, 30-day follow-up and 6 month follow-up so that is why the number of participants analyzed at these time points does not match the number of participants enrolled.
Participants in both groups were assessed on self-reported perceptions of personal susceptibility to smoking-related diseases. This measure includes one item comprising the perceived susceptibility scale (Question: "How likely is it for you to develop a smoking-related disease such as lung cancer or chronic obstructive pulmonary disease (COPD), if you continue to smoke?"; Response options: 1=Very unlikely; 2=Somewhat unlikely; 3=Neither unlikely nor likely; 4=Somewhat likely; 5=Very likely). A higher score represents a higher perceived disease risk.
Outcome measures
| Measure |
Genetically-Informed RiskProfile
n=72 Participants
Participants will meet with a behavioral interventionist to receive their personalized genetically-informed RiskProfile intervention which incorporates smoking-related genetic risk propensity and phenotypic risk (cigarettes smoked per day) into a risk communication tool designed to activate behavior change, specifically, to increase the use of smoking cessation medications and promote smoking-related behavior change.
This is a fully remote trial, with intervention delivered via video conferencing.
|
Brief Cessation Advice
n=72 Participants
Participants will meet with a behavioral interventionist to receive standardized brief advice to quit smoking and encouragement to use freely-available smoking cessation resources. Participants will receive their personalized RiskProfile after all data collection has been completed.
This is a fully remote trial, with brief cessation advice delivered via video conferencing.
|
|---|---|---|
|
Change in Perceived Disease Risk
Baseline
|
4.5 score on a scale
Standard Deviation 0.8
|
4.3 score on a scale
Standard Deviation 0.8
|
|
Change in Perceived Disease Risk
Immediately following intervention receipt
|
4.7 score on a scale
Standard Deviation 0.7
|
4.3 score on a scale
Standard Deviation 1.0
|
|
Change in Perceived Disease Risk
30-day follow-up
|
4.6 score on a scale
Standard Deviation 0.6
|
4.4 score on a scale
Standard Deviation 0.8
|
|
Change in Perceived Disease Risk
6-month follow-up
|
4.6 score on a scale
Standard Deviation 0.8
|
4.5 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-upPopulation: Some participants did not complete assessments at baseline, immediately following intervention, 30-day follow-up and 6 month follow-up so that is why the number of participants analyzed at these time points does not match the number of participants enrolled.
Participants in both groups were assessed on self-reported perceptions of personal health benefits related to quitting smoking. This measure is based on 3 items from the Perceived Risks and Benefits Questionnaire (PRBQ) addressing benefits related to reduced risks of smoking-related diseases, avoidance of future health problems, and increased longevity if the participant were to quit smoking. Response options to individual items were assessed on a 5-point Likert-type scale ranging from 1=Very Unlikely to 5=Very Likely. Individual scores on the 3 items were then averaged together for a total scale range of 1 to 5. A higher score represents higher perceived benefits of cessation.
Outcome measures
| Measure |
Genetically-Informed RiskProfile
n=74 Participants
Participants will meet with a behavioral interventionist to receive their personalized genetically-informed RiskProfile intervention which incorporates smoking-related genetic risk propensity and phenotypic risk (cigarettes smoked per day) into a risk communication tool designed to activate behavior change, specifically, to increase the use of smoking cessation medications and promote smoking-related behavior change.
This is a fully remote trial, with intervention delivered via video conferencing.
|
Brief Cessation Advice
n=73 Participants
Participants will meet with a behavioral interventionist to receive standardized brief advice to quit smoking and encouragement to use freely-available smoking cessation resources. Participants will receive their personalized RiskProfile after all data collection has been completed.
This is a fully remote trial, with brief cessation advice delivered via video conferencing.
|
|---|---|---|
|
Change in Perceived Benefits of Cessation
Self-reported perception of benefits of cessation at baseline
|
4.2 score on a scale
Standard Deviation 0.8
|
4.2 score on a scale
Standard Deviation 0.8
|
|
Change in Perceived Benefits of Cessation
Self-reported perception of benefits of cessation immediately following intervention receipt
|
4.2 score on a scale
Standard Deviation 1.0
|
4.2 score on a scale
Standard Deviation 0.8
|
|
Change in Perceived Benefits of Cessation
Self-reported perception of benefits of cessation at 30-day follow-up
|
4.6 score on a scale
Standard Deviation 0.7
|
4.4 score on a scale
Standard Deviation 0.7
|
|
Change in Perceived Benefits of Cessation
Self-reported perception of benefits of cessation at 6-month follow-up
|
4.6 score on a scale
Standard Deviation 0.6
|
4.4 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-upPopulation: Some participants did not complete assessments at immediately following intervention, 30-day follow-up and 6 month follow-up so that is why the number of participants analyzed at these time points does not match the number of participants enrolled.
Participants in both groups were assessed on self-reported perceptions of the importance of using smoking cessation medications to help quit smoking. This measure includes 4 items modified from the Beliefs and Attitudes about Buproprion Scale which assesses perceived importance of using medications for smoking cessation, perceived confidence in medications as a smoking cessation aid, general expectancy that smoking cessation medications help people stop smoking, and perceived confidence in being able to use smoking cessation medications within the next month. Response options to individual items were assessed on a 5-point Likert-type scale ranging from 1=Not at all to 5=Extremely. Individual scores on the 4 items were then averaged together for at total scale range of 1-5. A higher score represents a higher perceived value of cessation treatment.
Outcome measures
| Measure |
Genetically-Informed RiskProfile
n=74 Participants
Participants will meet with a behavioral interventionist to receive their personalized genetically-informed RiskProfile intervention which incorporates smoking-related genetic risk propensity and phenotypic risk (cigarettes smoked per day) into a risk communication tool designed to activate behavior change, specifically, to increase the use of smoking cessation medications and promote smoking-related behavior change.
This is a fully remote trial, with intervention delivered via video conferencing.
|
Brief Cessation Advice
n=74 Participants
Participants will meet with a behavioral interventionist to receive standardized brief advice to quit smoking and encouragement to use freely-available smoking cessation resources. Participants will receive their personalized RiskProfile after all data collection has been completed.
This is a fully remote trial, with brief cessation advice delivered via video conferencing.
|
|---|---|---|
|
Change in Perceived Value of Cessation Treatments
Baseline
|
3.0 score on a scale
Standard Deviation 0.9
|
3.0 score on a scale
Standard Deviation 0.9
|
|
Change in Perceived Value of Cessation Treatments
Immediately following intervention receipt
|
3.3 score on a scale
Standard Deviation 0.9
|
2.9 score on a scale
Standard Deviation 0.8
|
|
Change in Perceived Value of Cessation Treatments
30-day follow-up
|
3.2 score on a scale
Standard Deviation 1.0
|
2.9 score on a scale
Standard Deviation 0.9
|
|
Change in Perceived Value of Cessation Treatments
6-month follow-up
|
3.0 score on a scale
Standard Deviation 1.1
|
2.8 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-upPopulation: Some participants did not complete assessments at immediately following intervention, 30-day follow-up and 6 month follow-up so that is why the number of participants analyzed at these time points does not match the number of participants enrolled.
Participants in both groups were assessed on self-reported perceptions of personal ability to engage in activities that promote smoking cessation. This measure is based on 3 items modified from the Skill Self-Efficacy Scale and 3 items modified from the Try Self-Efficacy Scale. Skill self-efficacy items address confidence to solicit social support, avoid situations with a high risk of relapse, and distract oneself when experiencing cravings during a quit attempt. Try self-efficacy items address perceived personal ability to smoke fewer cigarettes a day, resist smoking for one week, and resist smoking for one month. Response options to individual items were assessed on a 5-point Likert-type scale ranging from 1=Not at all to 5=Very. Individual scores on the 3 items were then averaged together for a total scale range of 1-5. A higher score represents a higher perceived self-efficacy of cessation.
Outcome measures
| Measure |
Genetically-Informed RiskProfile
n=74 Participants
Participants will meet with a behavioral interventionist to receive their personalized genetically-informed RiskProfile intervention which incorporates smoking-related genetic risk propensity and phenotypic risk (cigarettes smoked per day) into a risk communication tool designed to activate behavior change, specifically, to increase the use of smoking cessation medications and promote smoking-related behavior change.
This is a fully remote trial, with intervention delivered via video conferencing.
|
Brief Cessation Advice
n=74 Participants
Participants will meet with a behavioral interventionist to receive standardized brief advice to quit smoking and encouragement to use freely-available smoking cessation resources. Participants will receive their personalized RiskProfile after all data collection has been completed.
This is a fully remote trial, with brief cessation advice delivered via video conferencing.
|
|---|---|---|
|
Change in Self-efficacy of Cessation
Self-reported skill self-efficacy at baseline
|
3.5 score on a scale
Standard Deviation 0.9
|
3.5 score on a scale
Standard Deviation 0.8
|
|
Change in Self-efficacy of Cessation
Self-reported skill self-efficacy immediately following intervention receipt
|
3.6 score on a scale
Standard Deviation 0.7
|
3.7 score on a scale
Standard Deviation 0.7
|
|
Change in Self-efficacy of Cessation
Self-reported skill self-efficacy at 30-day follow-up
|
3.8 score on a scale
Standard Deviation 1.0
|
3.9 score on a scale
Standard Deviation 0.8
|
|
Change in Self-efficacy of Cessation
Self-reported skill self-efficacy at 6-month follow-up
|
3.9 score on a scale
Standard Deviation 1.0
|
3.9 score on a scale
Standard Deviation 0.9
|
|
Change in Self-efficacy of Cessation
Self-reported try self-efficacy at baseline
|
2.6 score on a scale
Standard Deviation 1.0
|
2.6 score on a scale
Standard Deviation 1.0
|
|
Change in Self-efficacy of Cessation
Self-reported try self-efficacy immediately following intervention receipt
|
2.6 score on a scale
Standard Deviation 1.0
|
2.6 score on a scale
Standard Deviation 1.0
|
|
Change in Self-efficacy of Cessation
Self-reported try self-efficacy at 30-day follow-up
|
2.8 score on a scale
Standard Deviation 1.2
|
3.0 score on a scale
Standard Deviation 1.1
|
|
Change in Self-efficacy of Cessation
Self-reported try self-efficacy at 6-month follow-up
|
3.2 score on a scale
Standard Deviation 1.4
|
3.4 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Immediately following intervention receiptPopulation: Some participants did not complete the assessment immediately following intervention so that is why the number of participants analyzed does not match the number of participants enrolled.
Participants in both groups were assessed on self-reported perceptions of the extent to which the intervention was personally significant and applicable. This measure includes 4 items modified from the Personal Relevance Scale and addresses the extent to which the intervention helped participants learn something about themselves, the role that their personal characteristics play in their smoking, how smoking affects their life, and the impact on their smoking cessation attempts. Response options to individual items were assessed on a 5-point Likert-type scale ranging from 1=Strongly Disagree to 5=Strongly Agree. Individual scores on the 4 items were then averaged together for a total scale range of 1 to 5. A higher score represents a higher perception of personal relevance of the intervention.
Outcome measures
| Measure |
Genetically-Informed RiskProfile
n=72 Participants
Participants will meet with a behavioral interventionist to receive their personalized genetically-informed RiskProfile intervention which incorporates smoking-related genetic risk propensity and phenotypic risk (cigarettes smoked per day) into a risk communication tool designed to activate behavior change, specifically, to increase the use of smoking cessation medications and promote smoking-related behavior change.
This is a fully remote trial, with intervention delivered via video conferencing.
|
Brief Cessation Advice
n=66 Participants
Participants will meet with a behavioral interventionist to receive standardized brief advice to quit smoking and encouragement to use freely-available smoking cessation resources. Participants will receive their personalized RiskProfile after all data collection has been completed.
This is a fully remote trial, with brief cessation advice delivered via video conferencing.
|
|---|---|---|
|
Personal Relevance of Intervention
|
4.5 score on a scale
Standard Deviation 0.6
|
3.7 score on a scale
Standard Deviation 0.8
|
Adverse Events
Genetically-Informed RiskProfile
Brief Cessation Advice
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Genetically-Informed RiskProfile
n=74 participants at risk
Participants will meet with a behavioral interventionist to receive their personalized genetically-informed RiskProfile intervention which incorporates smoking-related genetic risk propensity and phenotypic risk (cigarettes smoked per day) into a risk communication tool designed to activate behavior change, specifically, to increase the use of smoking cessation medications and promote smoking-related behavior change.
This is a fully remote trial, with intervention delivered via video conferencing.
|
Brief Cessation Advice
n=74 participants at risk
Participants will meet with a behavioral interventionist to receive standardized brief advice to quit smoking and encouragement to use freely-available smoking cessation resources. Participants will receive their personalized RiskProfile after all data collection has been completed.
This is a fully remote trial, with brief cessation advice delivered via video conferencing.
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
1.4%
1/74 • Adverse events were collected at baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up.
Adverse events were collected when self-reported by participants during the trial.
|
0.00%
0/74 • Adverse events were collected at baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up.
Adverse events were collected when self-reported by participants during the trial.
|
Additional Information
Alex T. Ramsey, Ph.D.
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place