My Wellbeing Guide: A Novel Tool for Managing Stress and Improving Quality of Life

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT05369429
Status
Recruiting
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Conditions

  • Anxiety
  • Cancer
  • Depressive Symptoms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • My Wellbeing Guide — BEHAVIORAL
    The intervention includes cognitive behavioral therapy management strategies for health-related stress in the form of animated videos, interactive activities, and written content. The intervention will be delivered via an online application over an 7-week period. Intervention participants will also complete four assessments: baseline (at the beginning of the research study), post-intervention (7 weeks after baseline), a 6-month follow-up, and a 12-month follow up.

Study Details

The purpose of this study is to examine the implementation and effectiveness of the psychosocial eHealth intervention, My Wellbeing Guide, on the proposed primary outcome, depressive symptoms, in patients diagnosed with cancer who receive care at Northwestern Medicine and the University of Miami Health System. Eligible patients will be directly contacted by the study team for recruitment. The intervention includes cognitive behavioral therapy management strategies for health-related stress in the form of animated videos, interactive activities, and written content. The intervention will be delivered via an online application over an 7-week period. Intervention participants will also complete four assessments: baseline (at the beginning of the research study), post-intervention (7 weeks after baseline), a 6-month follow-up, and a 12-month follow up. Participants are randomized into either an intervention application (described above) or a control application (which will provide links to helpful resources for patients with cancer, such as the contact information for cancer support services at Northwestern University and the University of Miami, and the link to the National Cancer Institute website, and the American Cancer Society website.) Control participants will also complete four assessments: baseline (at the beginning of the research study), post-intervention (7 weeks after baseline), a 6-month follow-up, and a 12-month follow up.

Key Dates

Start date
Dec 2, 2022
Status verified
May 2026
Primary completion
Jul 5, 2028
Completion
Jul 5, 2028

Study Design

Enrollment
6,516 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention
    The intervention includes cognitive behavioral therapy management strategies for health-related stress in the form of animated videos, interactive activities, and written content. The intervention will be delivered via an online application over an 7-week period. Intervention participants will also complete four assessments: baseline (at the beginning of the research study), post-intervention (7 weeks after baseline), a 6-month follow-up, and a 12-month follow up.
  • No Intervention: Control
    The control application will provide links to helpful resources for patients with cancer, such as the contact information for cancer support services at Northwestern University and the University of Miami, and the link to the National Cancer Institute website, and the American Cancer Society website. Control participants will also complete four assessments: baseline (at the beginning of the research study), post-intervention (7 weeks after baseline), a 6-month follow-up, and a 12-month follow up.

Primary Outcome Measure

Change in depressive symptoms will be evaluated with the Patient-Reported Outcomes Measurement Information System Depression [ Time Frame: T1 (prior to starting intervention), T2 (7 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post-intervention) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Ro Mercer
[email protected]
3125033943

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By research site
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