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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

No Placebo-Only Group

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 below

Select...

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

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

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 1Eligibility criteria met