Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
Phase 1 Completed N=242 Randomized Single-blind Prevention

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

Cigarette Smoking-Related Carcinoma
Source: ClinicalTrials.gov NCT04525222 ↗
Enrolled (actual)
242
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Overall Satisfaction With Assigned Treatment on the Treatment Satisfaction Survey — 4.1; 3.7 units on a scale — p=0.0088

Summary

This phase I trial investigates a new smartphone application (called Actify) for improving population-level smoking cessation and mood management. Actify delivers behavioral activation therapy for depression as part of a smoking cessation intervention and will be compared to another smoking cessation smartphone application that is based on current clinical practice guidelines. Participants will be randomly assigned to receive one of two smartphone applications and accompanying text notifications to help with quitting smoking and improved mood.

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Satisfaction With Assigned Treatment on the Treatment Satisfaction Survey		 4.1; 3.7 0.0088 sig
PRIMARY
Application (App) Utilization		 34.3; 34.3 0.75
SECONDARY
Biochemically-confirmed 30-day PPA From Smoking		 104; 113; 15; 10 0.25
SECONDARY
Self-reported 30-day PPA From Smoking		 97; 108; 22; 15 0.17
SECONDARY
Biochemically-confirmed 30-day PPA From Smoking		 104; 113; 15; 10 0.25
SECONDARY
Self-reported 7-day PPA From Smoking		 95; 105; 24; 18 0.25
SECONDARY
Biochemically Confirmed 7-day PPA From Smoking		 103; 113; 16; 10 0.17
SECONDARY
Self-reported 7-day PPA From Smoking		 95; 105; 24; 18 0.25
SECONDARY
Biochemically Confirmed 7-day PPA From Smoking		 103; 113; 16; 10 0.17
SECONDARY
Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes		 100; 110; 19; 13 0.21
SECONDARY
Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes		 107; 115; 12; 8 0.30
SECONDARY
Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes		 100; 110; 19; 13 0.21
SECONDARY
Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes		 107; 115; 12; 8 0.30
SECONDARY
Change in Depressive Symptoms Via Patient Health Questionnaire-8 (PHQ-8)		 .7; 2.2 .0072 sig
SECONDARY
Self-reported 30-day Point Prevalence Abstinence (PPA) From Smoking		 104; 114; 15; 9 0.1770
SECONDARY
Change in Behavioral Activation Subscale Score on the Behavioral Activation for Depression Scale (BADS)		 -2.4; .8 0.0025 sig

Eligibility Criteria

Inclusion Criteria

  • Current smoker, averaging at least 5 cigarettes/day for the last 30 days
  • Interested in quitting smoking in the next 30 days
  • Experience downloading and using one or more apps on their smartphone
  • Either screens negative (Patient Health Questionnaire - 9 Item [PHQ-9] score 0-4) for depression or screens positive for mild to moderate current depressive symptoms (PHQ-9 score 5-19)
  • Willing and able to complete all study activities
  • Comfortable reading and writing in English
  • Have a mobile data plan and/or access to WiFi to support the use of the Actify app
  • Reside in the US
  • Have a smartphone either an iPhone (running iOS version 11 or higher) or an Android phone (running version 5.0 or higher)

Exclusion Criteria

  • Currently receiving behavioral treatment for depression (e.g., psychotherapy)
  • Current use of a depression app
  • Severe depression (PHQ-9 >= 20)
  • Receiving other treatment for smoking cessation
  • Previous use of the QuitGuide app
  • Current or recent (within the past year) enrollment in a Fred Hutch smoking cessation study
  • Employees/family of investigator or study center
  • Member of the same household as another participant
  • Woman who is pregnant or breastfeeding, or planning to become pregnant
  • Currently incarcerated
  • Is ineligible per fraud prevention protocol
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04525222). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

Back to search