Personalized Trial ABCCBA for Stress (Psychology)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Institute of Health System Science, New York, NY
Stress (Psychology)
Personalized Trial ABCCBA - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if "Personalized Trials," or within-subject trials, can improve health outcomes for stress management better than standard practice. The study uses three different stress management interventions delivered using a Personalized Trial format to individuals in Arm 1 and Arm 2, while Arm 3 receives the same number of interventions without the established N-of-1 Personalized Trials framework. At the end, all participants will receive a report and satisfaction survey. A clinical trial is underway to test a new online therapy for treating stress, which has been personalized to be as effective as possible for each individual. The therapy, called Personalized Trial ABCCBA, has been approved by the FDA for other conditions, and so far has shown good results in early testing for treating stress. Because the therapy is personalized, there is no need for a placebo group, and everyone who takes part in the trial will receive the treatment.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: EMA pain will be assessed 3 times daily via text message during the baseline assessment period (2 weeks), during intervention period (12 weeks) and during follow-up period (4 weeks), 18 weeks total.

Week 18
Between-Arm Difference in Change in Ecological Momentary Assessment (EMA) of Stress.
Week 18
Agreement of Intervention Selection Between Participant and Researcher.
Week 18
Descriptive Content of Qualitative Interview Data
Mean Fitbit Device Adherence Rate.
Mean Participant Ecological Momentary Assessment (EMA) adherence rate.
Mean Participant Fitbit Sleep Rate.
Mean Participant Personalized Trial Intervention Adherence Rate.
Mean Participant Selection Adherence Rate.
Mean Participant Standard Care Intervention Adherence Rate.
Mean Participant Survey Adherence Rate.
Mean System Usability Score (SUS).
Participant Satisfaction with Personalized Trial Components.
Week 18
Within-Subject Difference in Fitbit Device-Recorded Daily Steps.
Week 18
Within-Subject Difference in Ecological Momentary Assessment (EMA) of Concentration.
Week 18
Within-Subject Difference in Ecological Momentary Assessment (EMA) of Confidence.
Within-Subject Difference in Ecological Momentary Assessment (EMA) of Fatigue.
Within-Subject Difference in Ecological Momentary Assessment (EMA) of Stress.
Week 18
Within-Subject Difference in Ecological Momentary Assessment (EMA) of Mood.
Week 18
Within-Subject Difference in Ecological Momentary Assessment (EMA) of Pain.
Week 18
Within-Subject Difference in Fitbit Device-Recorded Nightly Sleep.
Week 18
Change in Mean Within-Subject Difference in Weekly Perceived Stress.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

Standard Care
1 of 3
Personalized Trial CBAABC
1 of 3
Personalized Trial ABCCBA
1 of 3
Active Control
Experimental Treatment

212 Total Participants · 3 Treatment Groups

Primary Treatment: Personalized Trial ABCCBA · No Placebo Group · Phase 2

Personalized Trial CBAABC
Behavioral
Experimental Group · 1 Intervention: Personalized Trial CBAABC · Intervention Types: Behavioral
Personalized Trial ABCCBA
Behavioral
Experimental Group · 1 Intervention: Personalized Trial ABCCBA · Intervention Types: Behavioral
Standard Care
Behavioral
ActiveComparator Group · 1 Intervention: Stress Management Techniques with No Randomization Sequence (or order) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: ema pain will be assessed 3 times daily via text message during the baseline assessment period (2 weeks), during intervention period (12 weeks) and during follow-up period (4 weeks), 18 weeks total.
Closest Location: Institute of Health System Science · New York, NY
Photo of New York 1Photo of New York 2Photo of New York 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Stress (Psychology)
0 CompletedClinical Trials

Who is running the clinical trial?

National Library of Medicine (NLM)NIH
33 Previous Clinical Trials
103,268 Total Patients Enrolled
Columbia UniversityOTHER
1,266 Previous Clinical Trials
1,573,215 Total Patients Enrolled
3 Trials studying Stress (Psychology)
306 Patients Enrolled for Stress (Psychology)
Northwell HealthLead Sponsor
411 Previous Clinical Trials
290,042 Total Patients Enrolled
Karina Davidson, PhD, MAScPrincipal InvestigatorNorthwell Health
5 Previous Clinical Trials
364 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a score of 20 or higher on the PSS.
You own and can regularly access a smartphone capable of receiving text messages and accessing the internet.
You can wear a Fitbit device.
You live in the United States.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.