PTSD Mobile App for Cancer Survivors

Duke University524 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

524

Conditions

Posttraumatic Stress Disorder Cancer

Interventions

Cancer Distress Coach (CaDC) AppBEHAVIORAL

an app that provides participants with tools to manage their stress in the moment they experience it.

CaDC + mCoachingBEHAVIORAL

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.

mCBTBEHAVIORAL

8 mobile sessions with a therapist to receive cognitive behavioral therapy.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (3)

Memorial Sloan Kettering

New York, New York, United States

Duke University

Durham, North Carolina, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Outcomes

Primary Outcomes

Change in PTSD symptoms measured by the PTSD checklist (PCL5)

PCL5 is 20 item instrument scored 0-4, with 0 being "Not at all" and 4 being "Extremely"

Time frame: baseline, 4 weeks, 12 weeks

Secondary Outcomes

Change in distress measured by the Distress Thermometer v. 2018

Distress Thermometer v. 2018 is a one item instrument scored 0-10, with 0 being "No distress" and 10 being "Extreme distress"

Time frame: baseline, 4 weeks, 12 weeks, and 6 months

Change in PTSD symptoms measured by the PTSD checklist (PCL5)

PCL5 is 20 item instrument scored 0-4, with 0 being "Not at all" and 4 being "Extremely"

Time frame: baseline, 12 weeks, 6 months

Change in Quality of Life measured by the PROMIS QOL

PROMIS QOL is a 10 item instrument scored 1-5, with 1 being "Never" and 5 being "Always"

Time frame: baseline, 4 weeks, 12 weeks, and 6 months

Change in depression as measured by the PROMIS

PROMIS is an 8 item instrument scored 1-5, with 1 being "Never" and 5 being "Always"

Time frame: baseline, 4 weeks, 12 weeks, and 6 months

Change in anxiety as measured by the PROMIS

PROMIS is an 8 item instrument scored 1-5, with 1 being "Never" and 5 being "Always"

Time frame: baseline, 4 weeks, 12 weeks, and 6 months

Change in self-efficacy as measured by the Self-efficacy for Chronic Disease

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"

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.