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PTSD Mobile App for Cancer Survivors

N/A
Recruiting
Led By Sophia K Smith, PhD, MSW
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No prior CBT for PTSD
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks, 12 weeks, and 6 months
Awards & highlights

Summary

This trial is testing a stepped-care approach to treating PTSD symptoms in stem cell transplant survivors, which may help develop targeted treatments for PTSD.

Who is the study for?
This trial is for cancer survivors who've had a stem cell transplant 1-5 years ago and are showing signs of PTSD but haven't received CBT for it. They must be able to use a smart device, read/write English, have their oncologist's approval, and not be severely psychologically impaired.Check my eligibility
What is being tested?
The study tests a mobile app called Cancer Distress Coach (CaDC), with or without additional coaching or mobile CBT (mCBT), against usual care. Participants will be randomly assigned to treatments and assessed over 6 months to see if the app helps reduce PTSD symptoms.See study design
What are the potential side effects?
Since this trial involves non-medical interventions like apps and coaching, traditional side effects related to drugs are not expected. However, participants may experience emotional discomfort while discussing traumatic experiences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have not had cognitive behavioral therapy for PTSD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks, 12 weeks, and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks, 12 weeks, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in PTSD symptoms measured by the PTSD checklist (PCL5)
Change in Quality of Life measured by the PROMIS QOL
Change in anxiety as measured by the PROMIS
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: mCBTExperimental Treatment1 Intervention
Participants in this group will get 8-sessions with a therapist to receive cognitive behavioral therapy (CBT).
Group II: Cancer Distress Coach (CaDC)Experimental Treatment1 Intervention
Participants in this group will get the mHealth CaDC app, which will give them tools based on cognitive behavioral therapy principles to manage their stress.
Group III: CaDC and mCoachingExperimental Treatment1 Intervention
Participants in this group will get both the CaDC app and weekly clinician support.
Group IV: ControlActive Control1 Intervention
Participants in this group can use mental health services commonly available to all cancer patients at their local medical facility but will not receive access to the CaDC app.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,394 Previous Clinical Trials
3,059,086 Total Patients Enrolled
Sophia K Smith, PhD, MSWPrincipal InvestigatorDuke University
2 Previous Clinical Trials
853 Total Patients Enrolled

Media Library

Cancer Distress Coach (CaDC) App Clinical Trial Eligibility Overview. Trial Name: NCT04058795 — N/A
Post-Traumatic Stress Disorder Research Study Groups: CaDC and mCoaching, Cancer Distress Coach (CaDC), Control, mCBT
Post-Traumatic Stress Disorder Clinical Trial 2023: Cancer Distress Coach (CaDC) App Highlights & Side Effects. Trial Name: NCT04058795 — N/A
Cancer Distress Coach (CaDC) App 2023 Treatment Timeline for Medical Study. Trial Name: NCT04058795 — N/A
~35 spots leftby Nov 2024