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Personalized Stress Management Techniques for Stress

Phase 2
Waitlist Available
Led By Karina Davidson, PhD, MASc
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights

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.

Who is the study for?
This trial is for adults in the U.S. who feel stressed, can wear a Fitbit, and use a smartphone. They must speak English and score at least 20 on the Perceived Stress Scale. It's not for those with severe illnesses, substance abuse history, upcoming surgeries, or advised against walking or yoga.Check my eligibility
What is being tested?
The study tests if 'Personalized Trials' (guided meditation, yoga, brisk walking) tailored to individuals are better than standard stress management techniques. Participants will follow different sequences of these activities or choose without a set order.See study design
What are the potential side effects?
Since this trial involves non-invasive stress management techniques like meditation, yoga, and walking rather than medication or medical procedures; side effects may include muscle soreness from physical activity but are generally minimal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ema mood 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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and ema mood 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Between-Arm Difference in Change in Ecological Momentary Assessment (EMA) of Stress.
Secondary outcome measures
Agreement of Intervention Selection Between Participant and Researcher.
Change in Mean Within-Subject Difference in Weekly Perceived Stress.
Mean System Usability Score (SUS).
+7 more
Other outcome measures
Descriptive Content of Qualitative Interview Data
Mean Fitbit Device Adherence Rate.
Mean Participant Ecological Momentary Assessment (EMA) adherence rate.
+7 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Personalized Trial CBAABCExperimental Treatment1 Intervention
Participants in Arm 2 will receive a Personalized Trial of the 3 stress management interventions in a CBAABC treatment order, where A=mindfulness meditation, B=yoga, and C=brisk walking. Participants in this arm will be prompted to complete 30-minute stress management sessions during applicable treatment weeks. A link to the stress management video will be delivered via text 3 times per week to the participant during applicable intervention periods in the personalized trial arms. Participants will be limited to three views of the study-provided stress management content each week.
Group II: Personalized Trial ABCCBAExperimental Treatment1 Intervention
Participants in Arm 1 will receive a Personalized Trial of the 3 stress management interventions in an ABCCBA treatment order, where A=mindfulness meditation, B=yoga, and C=brisk walking. Participants in this arm will be prompted to complete 30-minute stress management sessions during applicable treatment weeks. A link to the stress management video will be delivered via text 3 times per week to the participant during applicable intervention periods in the personalized trial arms. Participants will be limited to three views of study-provided stress management content each week.
Group III: Standard CareActive Control1 Intervention
Participants in Arm 3 will receive Standard Care of the 3 stress management techniques (mindfulness meditation, yoga, and brisk walking). Participants will receive access to the same number of views of the mindfulness meditation, yoga, and brisk walking content given to participants randomized in Arm 1 and Arm 2. However, they will not be prompted to complete any session according to a randomization sequence. A link to the stress management video will be delivered via text 1 time per week to the participant. Participants will be limited to 36 total views of study-provided stress management content (12 total views per stress management technique).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Personalized Trial ABCCBA
2022
Completed Phase 2
~220
Personalized Trial CBAABC
2022
Completed Phase 2
~220

Find a Location

Who is running the clinical trial?

Columbia UniversityOTHER
1,434 Previous Clinical Trials
2,447,826 Total Patients Enrolled
National Library of Medicine (NLM)NIH
39 Previous Clinical Trials
107,271 Total Patients Enrolled
Northwell HealthLead Sponsor
460 Previous Clinical Trials
470,831 Total Patients Enrolled

Media Library

Personalized Trial ABCCBA Clinical Trial Eligibility Overview. Trial Name: NCT05408832 — Phase 2
Stress Research Study Groups: Personalized Trial CBAABC, Standard Care, Personalized Trial ABCCBA
Stress Clinical Trial 2023: Personalized Trial ABCCBA Highlights & Side Effects. Trial Name: NCT05408832 — Phase 2
Personalized Trial ABCCBA 2023 Treatment Timeline for Medical Study. Trial Name: NCT05408832 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared Personalized Trial ABCCBA for use?

"There is limited data on the safety of Personalized Trial ABCCBA, which received a score of 2."

Answered by AI

How many people are currently enrolled in the trial?

"The trial is recruiting at this time, as reflected in the information available on clinicaltrials.gov. This particular study was originally posted on June 23rd, 20212 and was updated most recently on August 15th, 20212. There is a total of 212 participants needed for the 1 location trial."

Answered by AI

Can people sign up for the trial right now?

"Yes, this information is accurate. The most recent update on clinicaltrials.gov was on 8/15/2022 and the trial was originally posted on 6/23/2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Personalized Trials for Stress Management Against Standard of Care
2022. "Personalized Trials for Stress Management Against Standard of Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05408832.
~75 spots leftby May 2025
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