PTSD Mobile App for Cancer Survivors

Duke University

Status: Completed

Conditions: Posttraumatic Stress Disorder; Cancer

Treatments: Behavioral: Cancer Distress Coach (CaDC) App; Behavioral: mCBT; Behavioral: CaDC + mCoaching

Study type: Interventional

Funder types: Other

Identifiers

NCT04058795

Pro00103154

Details and patient eligibility

About

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.

Enrollment: 524 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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524 participants in 4 patient groups

Cancer Distress Coach (CaDC)

Experimental group

Description:

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.

Treatment:

Behavioral: Cancer Distress Coach (CaDC) App

CaDC and mCoaching

Experimental group

Description:

Participants in this group will get both the CaDC app and weekly clinician support.

Treatment:

Behavioral: CaDC + mCoaching

mCBT

Experimental group

Description:

Participants in this group will get 8-sessions with a therapist to receive cognitive behavioral therapy (CBT).

Treatment:

Behavioral: mCBT

Control

No Intervention group

Description:

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.