PTSD Mobile App for Cancer Survivors

Not Applicable

Recruiting

• Conditions: Cancer; Posttraumatic Stress Disorder
• Interventions: Behavioral: CaDC + mCoaching; Behavioral: Cancer Distress Coach (CaDC) App; Behavioral: mCBT

• Registration Number: NCT04058795
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-14
• Study First Submitted QC: 2019-08-14
• Study First Posted: 2019-08-16
• Study Start: 2021-01-24
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-12
• Primary Completion: 2024-11-30
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

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Exclusion Criteria

• If the participant does not fulfill the inclusion criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CaDC and mCoaching	CaDC + mCoaching	Participants in this group will get both the CaDC app and weekly clinician support.
Cancer Distress Coach (CaDC)	Cancer Distress Coach (CaDC) App	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.
mCBT	mCBT	Participants in this group will get 8-sessions with a therapist to receive cognitive behavioral therapy (CBT).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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"
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"
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 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 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"
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"

Trial Locations

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