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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.
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.
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 belowSelect...
I have not had cognitive behavioral therapy for PTSD.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 weeks, 12 weeks, and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks, 12 weeks, and 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
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 moreTrial 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.
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,424 Previous Clinical Trials
3,065,684 Total Patients Enrolled
Sophia K Smith, PhD, MSWPrincipal InvestigatorDuke University
2 Previous Clinical Trials
853 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to do a one-hour interview.You have severe PTSD symptoms related to cancer, which may include flashbacks, nightmares, or avoidance of certain situations. Or you have mild PTSD symptoms, such as re-experiencing events related to cancer and a few other symptoms.I have not had cognitive behavioral therapy for PTSD.I had a stem cell transplant between 1 and 5 years ago.My cancer is in remission and I may be on preventive treatment.You have a device like a phone or tablet that can connect to the internet and send emails.
Research Study Groups:
This trial has the following groups:- Group 1: CaDC and mCoaching
- Group 2: Cancer Distress Coach (CaDC)
- Group 3: Control
- Group 4: mCBT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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