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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

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

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

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,367 Previous Clinical Trials

3,424,947 Total Patients Enrolled

Sophia K Smith, PhD, MSWPrincipal InvestigatorDuke University

2 Previous Clinical Trials

853 Total Patients Enrolled

Media Library

Cancer Distress Coach (CaDC) App Clinical Trial Eligibility Overview. Trial Name: NCT04058795 — N/A

Post-Traumatic Stress Disorder Research Study Groups: CaDC and mCoaching, Cancer Distress Coach (CaDC), Control, mCBT

Post-Traumatic Stress Disorder Clinical Trial 2023: Cancer Distress Coach (CaDC) App Highlights & Side Effects. Trial Name: NCT04058795 — N/A

Cancer Distress Coach (CaDC) App 2023 Treatment Timeline for Medical Study. Trial Name: NCT04058795 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are seniors aged 60 and above able to participate in this medical trial?

"Eligibility for the trial requires that prospective participants are over 18 and under 85 years of age."

Answered by AI

How many individuals are projected to join this experiment?

"Affirmative, according to the clinicaltrials.gov information this trial is currently seeking participants. This research project was first published on 24th January 2021 and received its most recent update on 26th January 2022; it seeks 400 individuals from 2 locations."

Answered by AI

Does this clinical trial still require participants?

"As per clinicaltrials.gov, the medical trial is actively seeking out patients; this investigation was published on January 24th 2021 and underwent its last amendment on January 26th 2022."

Answered by AI

What criteria must a person meet to qualify for the research trial?

"This study is seeking 400 individuals aged 18 to 85 with diagnosed malignancies. In addition, qualified participants must have either undergone autologous or allogeneic hematopoietic stem cell transplantation 1-5 years prior; achieved partial or complete remission (NED); not suffer from serious psychological impairment such as suicidality requiring hospitalization; be approved by their oncologist for participation in the trial; agree to a one hour baseline interview; not had CBT previously for PTSD; own and operate an internet capable device with email access; possess basic literacy of English language, and exhibit probable cancer related post traumatic stress"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PTSD Mobile App for Cancer Survivors

2021. "PTSD Mobile App for Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04058795.

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