Trial Outcomes & Findings for mHealth Mood Management Tool (Actify) to Improve Population-Level Smoking Cessation (NCT NCT04525222)

NCT ID: NCT04525222

Last Updated: 2024-03-07

Results Overview

Overall treatment satisfaction is reported on a Likert-type scale, with response choices ranging from "not at all=1" to "very much=5". Higher values are associated with higher level of satisfaction.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 242 participants
• Primary outcome timeframe: At 8 weeks post-randomization
• Results posted on: 2024-03-07

Participant Flow

Two-hundred forty two participants were eligible and enrolled in the study. The final sample comprised 242 participants who were randomized between May 9, 2022 and September 30, 2022.

Participant milestones

Measure	Arm I (Actify, Text Notifications) Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies	Arm II (Current Standard Care, Text Notifications) Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies
Overall Study STARTED	119	123
Overall Study COMPLETED	100	98
Overall Study NOT COMPLETED	19	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

mHealth Mood Management Tool (Actify) to Improve Population-Level Smoking Cessation

Baseline characteristics by cohort

Measure	Arm I (Actify, Text Notifications) n=119 Participants Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies	Arm II (Current Standard Care, Text Notifications) n=123 Participants Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies	Total n=242 Participants Total of all reporting groups
Age, Continuous	48.5 years STANDARD_DEVIATION 11 • n=5 Participants	52 years STANDARD_DEVIATION 9.8 • n=7 Participants	50.3 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants	84 Participants n=7 Participants	167 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	39 Participants n=7 Participants	75 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	112 Participants n=5 Participants	117 Participants n=7 Participants	229 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	4 Participants n=7 Participants	4 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	17 Participants n=5 Participants	21 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) White	95 Participants n=5 Participants	86 Participants n=7 Participants	181 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Smoking Level (in the past 30 days) - High (20+ CIgs/Day)	64 Participants n=5 Participants	66 Participants n=7 Participants	130 Participants n=5 Participants
Smoking Level (in the past 30 days) - Low (<20 Cigs/Day)	55 Participants n=5 Participants	57 Participants n=7 Participants	112 Participants n=5 Participants
Mental Health Condition - Anxiety, Depression, Bipolar, Schizophrenia, Alcohol or Drug Abuse	23 Participants n=5 Participants	34 Participants n=7 Participants	57 Participants n=5 Participants
No Mental Health Condition	96 Participants n=5 Participants	89 Participants n=7 Participants	185 Participants n=5 Participants
Cigarettes per Day in the past 30 days)	18 cigarettes per day STANDARD_DEVIATION 7.7 • n=5 Participants	20.2 cigarettes per day STANDARD_DEVIATION 13.2 • n=7 Participants	19.1 cigarettes per day STANDARD_DEVIATION 10.9 • n=5 Participants

PRIMARY outcome

Timeframe: At 8 weeks post-randomization

Population: Overall number of participants analyzed include those who opened the app at least once AND answered at least one acceptability question in the 8 week follow-up survey.

Overall treatment satisfaction is reported on a Likert-type scale, with response choices ranging from "not at all=1" to "very much=5". Higher values are associated with higher level of satisfaction.

Outcome measures

Measure	Arm I (Actify, Text Notifications) n=90 Participants Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies	Arm II (Current Standard Care, Text Notifications) n=94 Participants Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies
Overall Satisfaction With Assigned Treatment on the Treatment Satisfaction Survey	4.1 units on a scale Standard Deviation 1.0	3.7 units on a scale Standard Deviation 1.1

PRIMARY outcome

Timeframe: At 8 weeks post-randomization

Population: We used negative binomial regression adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), and Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5) to compare number of app openings by treatment arm

Number of app openings during the 8-week treatment period.

Outcome measures

Measure	Arm I (Actify, Text Notifications) n=103 Participants Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies	Arm II (Current Standard Care, Text Notifications) n=110 Participants Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies
Application (App) Utilization	34.3 app openings Standard Deviation 33.7	34.3 app openings Standard Deviation 39.4

SECONDARY outcome

Timeframe: At 8 weeks post-randomization

Self-reported 30-day smoking abstinence at 8 weeks, confirmed via expired carbon monoxide (CO<6ppm)

Outcome measures

Measure	Arm I (Actify, Text Notifications) n=119 Participants Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies	Arm II (Current Standard Care, Text Notifications) n=123 Participants Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies
Biochemically-confirmed 30-day PPA From Smoking No Quit	109 participants	115 participants
Biochemically-confirmed 30-day PPA From Smoking Quit	10 participants	8 participants

SECONDARY outcome

Timeframe: At 6 months post-randomization

Self-reported 30-day abstinence on the survey question of "Have you smoked at all, even a puff, in the last 30 days?"

Outcome measures

Measure	Arm I (Actify, Text Notifications) n=119 Participants Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies	Arm II (Current Standard Care, Text Notifications) n=123 Participants Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies
Self-reported 30-day PPA From Smoking No Quit	97 Participants	108 Participants
Self-reported 30-day PPA From Smoking Quit	22 Participants	15 Participants

SECONDARY outcome

Timeframe: At 6 months post-randomization

Self-reported 30-day smoking abstinence at 6 months, confirmed via expired carbon monoxide (CO<6 ppm)

Outcome measures

Measure	Arm I (Actify, Text Notifications) n=119 Participants Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies	Arm II (Current Standard Care, Text Notifications) n=123 Participants Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies
Biochemically-confirmed 30-day PPA From Smoking No Quit	104 Participants	113 Participants
Biochemically-confirmed 30-day PPA From Smoking Quit	15 Participants	10 Participants

SECONDARY outcome

Timeframe: At 8 weeks post-randomization

Self-reported 7-day abstinence on the survey question of "When was the last time you smoked, or even tried, a cigarette?"

Outcome measures

Measure	Arm I (Actify, Text Notifications) n=119 Participants Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies	Arm II (Current Standard Care, Text Notifications) n=123 Participants Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies
Self-reported 7-day PPA From Smoking No Quit	93 Participants	107 Participants
Self-reported 7-day PPA From Smoking Quit	26 Participants	16 Participants

SECONDARY outcome

Timeframe: At 8 weeks post-randomization

Self-reported 7-day abstinence from smoking, confirmed via expired carbon monoxide (CO < 6ppm)

Outcome measures

Measure	Arm I (Actify, Text Notifications) n=119 Participants Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies	Arm II (Current Standard Care, Text Notifications) n=123 Participants Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies
Biochemically Confirmed 7-day PPA From Smoking Quit	17 Participants	8 Participants
Biochemically Confirmed 7-day PPA From Smoking No Quit	102 Participants	115 Participants

SECONDARY outcome

Timeframe: At 6 months post-randomization

Self-reported 7-day abstinence on the survey question of "When was the last time you smoked, or even tried, a cigarette?"

Outcome measures

Measure	Arm I (Actify, Text Notifications) n=119 Participants Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies	Arm II (Current Standard Care, Text Notifications) n=123 Participants Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies
Self-reported 7-day PPA From Smoking No Quit	95 Participants	105 Participants
Self-reported 7-day PPA From Smoking Quit	24 Participants	18 Participants

SECONDARY outcome

Timeframe: At 6 months post-randomization

Self-reported 7-day abstinence from smoking, confirmed via expired carbon monoxide (CO < 6ppm)

Outcome measures

Measure	Arm I (Actify, Text Notifications) n=119 Participants Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies	Arm II (Current Standard Care, Text Notifications) n=123 Participants Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies
Biochemically Confirmed 7-day PPA From Smoking No Quit	103 Participants	113 Participants
Biochemically Confirmed 7-day PPA From Smoking Quit	16 Participants	10 Participants

SECONDARY outcome

Timeframe: At 8 weeks post-randomization

Self-reported 30-day abstinence on the survey questions of "Have you smoked at all, even a puff, in the last 30 days?" & "In the last 30 days, how often did you use any kind of e-cigarette or vaping product?" & "In the last 30 days, how often did you use any other tobacco products such as chewing tobacco, snus, hookahs, cigars, cigarillos, tobacco pipes, and kreteks?"

Outcome measures

Measure	Arm I (Actify, Text Notifications) n=119 Participants Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies	Arm II (Current Standard Care, Text Notifications) n=123 Participants Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies
Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes No Quit	105 Participants	115 Participants
Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes Quit	14 Participants	8 Participants

SECONDARY outcome

Timeframe: At 8 weeks post-randomization

Self-reported abstinence from cigarettes and other non-medicinal nicotine/tobacco products, including e-cigarettes, confirmed via at home saliva cotinine test and expired carbon monoxide (CO < 6ppm)

Outcome measures

Measure	Arm I (Actify, Text Notifications) n=119 Participants Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies	Arm II (Current Standard Care, Text Notifications) n=123 Participants Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies
Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes No Quit	112 Participants	117 Participants
Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes Quit	7 Participants	6 Participants

SECONDARY outcome

Timeframe: At 6 months post-randomization

Self-reported 30-day abstinence on survey questions of "Have you smoked at all, even a puff, in the last 30 days?" & "In the last 30 days, how often did you use any kind of e-cigarette or vaping product?" & "In the last 30 days, how often did you use any other tobacco products such as chewing tobacco, snus, hookahs, cigars, cigarillos, tobacco pipes, and kreteks?"

Outcome measures

Measure	Arm I (Actify, Text Notifications) n=119 Participants Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies	Arm II (Current Standard Care, Text Notifications) n=123 Participants Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies
Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes No Quit	100 Participants	110 Participants
Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes Quit	19 Participants	13 Participants

SECONDARY outcome

Timeframe: At 6 months post-randomization

Self-reported abstinence from cigarettes and other non-medicinal nicotine/tobacco products, including e-cigarettes, confirmed via at home saliva cotinine test and expired carbon monoxide (CO < 6ppm)

Outcome measures

Measure	Arm I (Actify, Text Notifications) n=119 Participants Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies	Arm II (Current Standard Care, Text Notifications) n=123 Participants Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies
Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes Quit	12 Participants	8 Participants
Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes No Quit	107 Participants	115 Participants

SECONDARY outcome

Timeframe: Baseline to 8 weeks

Population: Follow-up score minus baseline score.

The Patient Health Questionnaire-8 (PHQ-8) is an assessment of depressive symptoms used to detect symptom changes over time as a result of treatment. The PHQ-8 asks the number of days in the past 2 weeks the respondent had experienced a particular depressive symptom. Possible answers are "not at all" or "several days" or "more than half the days" or "nearly every day," with points (0 to 3) assigned to each category. The scores for each item are summed to produce a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe.

Outcome measures

Measure	Arm I (Actify, Text Notifications) n=98 Participants Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies	Arm II (Current Standard Care, Text Notifications) n=101 Participants Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies
Change in Depressive Symptoms Via Patient Health Questionnaire-8 (PHQ-8)	.7 units on a scale Standard Deviation 4.2	2.2 units on a scale Standard Deviation 5.2

SECONDARY outcome

Timeframe: At 8 weeks post-randomization

Self-reported 30-day abstinence on the survey question of "Have you smoked at all, even a puff, in the last 30 days?"

Outcome measures

Measure	Arm I (Actify, Text Notifications) n=119 Participants Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies	Arm II (Current Standard Care, Text Notifications) n=123 Participants Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies
Self-reported 30-day Point Prevalence Abstinence (PPA) From Smoking No Quit	104 Participants	114 Participants
Self-reported 30-day Point Prevalence Abstinence (PPA) From Smoking Quit	15 Participants	9 Participants

SECONDARY outcome

Timeframe: Baseline to 8 weeks post-randomization

The Behavioral Activation for Depression Scale (BADS) is a 25-item scale used to track changes in behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation. BADS items are rated on a 7-point scale ranging from 0 (not at all) to 6 (completely). The behavioral activation subscale contains 7 items, with a scoring range of 0 to 42. Change scores reflect the value of the BADS behavioral activation subscale score at 8-week follow-up minus the baseline score. Positive change values indicate an increase in behavioral activation (i.e, an improvement), whereas negative scores indicate a decrease in behavioral activation.

Outcome measures

Measure	Arm I (Actify, Text Notifications) n=98 Participants Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Actify app): Use Actify app Survey Administration: Ancillary studies	Arm II (Current Standard Care, Text Notifications) n=101 Participants Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Health Promotion and Education: Receive motivational messages and smoking cessation information via text notifications Smoking Cessation Intervention (Current Standard Care app): Use (USCPG) Current Standard Care app Survey Administration: Ancillary studies
Change in Behavioral Activation Subscale Score on the Behavioral Activation for Depression Scale (BADS)	-2.4 score on a scale Standard Deviation 9.6	.8 score on a scale Standard Deviation 8.9

Adverse Events

Arm I (Actify, Text Notifications)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm II (Current Standard Care, Text Notifications)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jaimee Heffner, Ph.D., Associate Professor

Fred Hutchinson Cancer Center

Phone: 206.667.7314

Email: jheffner@fredhutch.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place