Cancer, Posttraumatic Stress Disorder
Conditions
Keywords
PTSD, Depression, Anxiety, Distress, Digital Health, mHealth
Brief summary
The purpose of this study is to use a stepped-care approach in treating symptoms of posttraumatic stress disorder (PTSD). The information learned by doing this study may help us to develop some target treatments for PTSD symptoms in survivors of stem cell transplant. Participants in this study will be randomized to a mobile app or usual care. An assessment will be made after 4 weeks and a determination made of adding more intensive treatment. Participants will be asked to complete a questionnaire 4 times over a period of 6 months, at the time your participation is complete.
Interventions
BEHAVIORALCancer Distress Coach (CaDC) App
an app that provides participants with tools to manage their stress in the moment they experience it.
BEHAVIORALCaDC + mCoaching
The CaDC app plus weekly clinician support which provides support in navigating the app, encouraging adherence to the use of the CaDC, and providing guidance in choosing treatment strategies.
BEHAVIORALmCBT
8 mobile sessions with a therapist to receive cognitive behavioral therapy.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Completion of autologous or allogeneic HCT 1-5 years previously * Partial or complete remission (NED), may be receiving chemoprevention * Absence of severe psychological impairment (eg hospitalization for suicidality) * Approved for contact by oncologist * Able and willing to participate in a one-hour baseline interview * No prior CBT for PTSD * Owns a smart device with internet and email access * Able to read and write English * Significant PTSD symptoms as indicated by at least one of the following two criteria: probable cancer-related PTSD on the PCL5 by using the symptom cluster criteria; subthreshold or partial PTSD symptoms as determined by endorsement of reexperiencing cluster and less than or equal to 1 other symptom cluster
Exclusion criteria
* If the participant does not fulfill the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PTSD symptoms measured by the PTSD checklist (PCL5) | baseline, 4 weeks, 12 weeks | PCL5 is 20 item instrument scored 0-4, with 0 being Not at all and 4 being Extremely |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PTSD symptoms measured by the PTSD checklist (PCL5) | baseline, 12 weeks, 6 months | PCL5 is 20 item instrument scored 0-4, with 0 being Not at all and 4 being Extremely |
| Change in Quality of Life measured by the PROMIS QOL | baseline, 4 weeks, 12 weeks, and 6 months | PROMIS QOL is a 10 item instrument scored 1-5, with 1 being Never and 5 being Always |
| Change in depression as measured by the PROMIS | baseline, 4 weeks, 12 weeks, and 6 months | PROMIS is an 8 item instrument scored 1-5, with 1 being Never and 5 being Always |
| Change in distress measured by the Distress Thermometer v. 2018 | baseline, 4 weeks, 12 weeks, and 6 months | Distress Thermometer v. 2018 is a one item instrument scored 0-10, with 0 being No distress and 10 being Extreme distress |
| Change in self-efficacy as measured by the Self-efficacy for Chronic Disease | baseline, 4 weeks, 12 weeks, and 6 months | Self-efficacy for Chronic Disease is a 6 item instrument scored 1-10, with 1 being Not at all confident and 10 being totally confident |
| User satisfaction as measured by a survey | baseline, 4 weeks, 12 weeks, and 6 months | Team developed survey that will include questions regarding the participant's experience |
| Change in anxiety as measured by the PROMIS | baseline, 4 weeks, 12 weeks, and 6 months | PROMIS is an 8 item instrument scored 1-5, with 1 being Never and 5 being Always |
Countries
United States
Outcome results
None listed