PTSD Mobile App for Cancer Survivors

Recruiting at 2 trial locations

Overseen by Sophia K Smith, PhD, MSW

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Duke University

Disqualifiers: Severe psychological impairment, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that PTSD Mobile App for Cancer Survivors is an effective treatment?

The available research shows that mobile app-based interventions, like the PTSD Mobile App for Cancer Survivors, can help reduce symptoms of distress in cancer survivors. For example, one study highlights that these apps can increase access to mental health care for survivors of women's cancer, who often face barriers to in-person treatment. Another review suggests that mobile health applications can improve mental health in breast cancer survivors. While specific data on the PTSD Mobile App for Cancer Survivors is limited, these findings suggest that mobile health interventions can be beneficial for managing psychological distress in cancer survivors. ^{1 2 3 4 5}

What safety data exists for the PTSD Mobile App for Cancer Survivors?

The available research does not directly address safety data for the PTSD Mobile App for Cancer Survivors. However, related studies on app-based cognitive-behavioral stress management interventions for cancer survivors, such as Stress Proffen, indicate positive outcomes in reducing stress, anxiety, and self-regulatory fatigue, and improving quality of life. These studies suggest that such interventions are generally well-received and considered useful and accessible by participants, but specific safety data is not detailed in the provided abstracts. ^{6 7 8 9 10}

Is the Cancer Distress Coach (CaDC) App a promising treatment for cancer survivors with PTSD?

Yes, the Cancer Distress Coach (CaDC) App is a promising treatment because it offers a personalized approach to help cancer survivors manage PTSD symptoms. It uses a smart design to adapt to each person's needs, making it easier for them to get the right support. Mobile apps like this can also make mental health care more accessible to people who might not be able to attend in-person therapy. ^{1 2 11 12 13}

Research Team

Sophia K Smith, PhD, MSW

Principal Investigator

Duke University

Eligibility Criteria

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.

Inclusion Criteria

I am willing and able to do a one-hour interview.

You have severe PTSD symptoms related to cancer, which may include flashbacks, nightmares, or avoidance of certain situations. Or you have mild PTSD symptoms, such as re-experiencing events related to cancer and a few other symptoms.

I have not had cognitive behavioral therapy for PTSD.

Exclusion Criteria

If the participant does not fulfill the inclusion criteria

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants are randomized to a mobile app or usual care. An assessment will be made after 4 weeks.

4 weeks

1 visit (virtual)

Intensive Treatment

Based on the 4-week assessment, more intensive treatment may be added.

8 weeks

Weekly sessions (virtual or in-person)

Follow-up

Participants are monitored for changes in distress, anxiety, self-efficacy, PTSD symptoms, depression, and quality of life.

6 months

4 visits (virtual)

Treatment Details

Interventions

• CaDC + mCoaching (Behavioural Intervention)
• Cancer Distress Coach (CaDC) App (Behavioural Intervention)
• mCBT (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: mCBT Experimental Treatment 1 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 Treatment 1 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 mCoaching Experimental Treatment 1 Intervention

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

Group IV: Control Active Control 1 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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

Findings from Research

The study is evaluating the effectiveness of the Cancer Distress Coach mobile app versus usual care in 400 hematopoietic stem cell transplantation survivors experiencing PTSD symptoms, aiming to improve their quality of life.

Using a novel stepped-care SMART design, the trial will adapt treatment based on individual responses, potentially leading to more personalized and effective PTSD interventions for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A SMART approach to optimizing delivery of an mHealth intervention among cancer survivors with posttraumatic stress symptoms. Smith, SK., Somers, TJ., Kuhn, E., et al.[2023]

The iCanThrive app, combined with phone coaching, significantly reduced symptoms of depression and sleep disruption among 28 survivors of women's cancer over a 6-week period, indicating its potential efficacy as a mental health intervention.

With an 87% completion rate and positive user feedback, the app shows promise for scalability and accessibility in addressing the mental health needs of cancer survivors, warranting further validation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Mobile Phone App Intervention With Phone Coaching to Reduce Symptoms of Depression in Survivors of Women's Cancer: Pre-Post Pilot Study. Chow, PI., Drago, F., Kennedy, EM., et al.[2020]

A systematic review of 11 randomized trials involving 2249 breast cancer survivors found that psychological mobile health interventions, primarily based on cognitive behavioral therapy, showed limited effectiveness in improving mental health outcomes, with only a few studies reporting significant short-term benefits for psychological distress.

Despite some short-term improvements in specific areas like distress and anxiety, there was no evidence of long-term benefits beyond three months, and a notable percentage of participants either did not start or discontinued the interventions, highlighting the need for better-designed studies in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review on the effectiveness of mobile health applications on mental health of breast cancer survivors. Horn, A., Jírů-Hillmann, S., Widmann, J., et al.[2023]

This systematic review analyzed 76 articles on interventions for Post-Traumatic Stress Symptoms (PTSS) and Post-Traumatic Growth (PTG) in cancer survivors, highlighting that most studies focused on promoting PTG through methods like psychotherapy and mindfulness.

Key recommendations for future research include designing interventions based on clear mechanisms, ensuring better representation of cancer survivors in studies, and identifying factors that enhance the effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-traumatic stress symptoms, post-traumatic stress disorder, and post-traumatic growth among cancer survivors: a systematic scoping review of interventions. Capaldi, JM., Shabanian, J., Finster, LB., et al.[2023]

The Distress Thermometer and Problem List (DT&PL) was implemented in a study with 220 cancer patients undergoing treatment, but it did not significantly improve psychological distress or quality of life outcomes over 12 months.

Despite being a quick and inexpensive tool, costing £19 ($28) per patient, the DT&PL did not reduce healthcare costs or lead to referrals for psychological support, indicating a need for better strategies to address patient distress in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are needs assessments cost effective in reducing distress among patients with cancer? A randomized controlled trial using the Distress Thermometer and Problem List. Hollingworth, W., Metcalfe, C., Mancero, S., et al.[2022]

In a study involving 449 patients with nonmetastatic cancer, those using an app-based cognitive behavioral stress management (CBSM) showed significant reductions in anxiety and depression symptoms over 12 weeks compared to a health education sham app.

Patients using the CBSM app reported a greater perception of improvement in their anxiety and depression symptoms, indicating that this digital intervention is effective in managing emotional distress in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Cognitive Behavioral Digital Therapeutic on Anxiety and Depression Symptoms in Patients With Cancer: A Randomized Controlled Trial. Zion, SR., Taub, CJ., Heathcote, LC., et al.[2023]

The Stress Proffen app-based intervention for cancer survivors showed significant reductions in stress, anxiety, and self-regulatory fatigue, along with improvements in health-related quality of life, based on a pilot study with 25 participants.

Participants found the app to be a valuable and accessible tool for stress management, with 67% completing at least 7 out of 10 modules, indicating good engagement and usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot testing an app-based stress management intervention for cancer survivors. Børøsund, E., Varsi, C., Clark, MM., et al.[2022]

Routine screening for distress in cancer survivors is increasingly recommended, with the single-item distress thermometer being the preferred tool for identifying patients in need of support.

While screening can improve timely referrals for distress management, challenges remain in delivering effective treatments due to patients declining help and insufficient support services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for distress in survivorship. Girgis, A., Smith, AB., Durcinoska, I.[2019]

A new electronic stress management intervention called StressProffen was developed for cancer survivors, based on user-centered design principles and input from 48 stakeholders, including cancer survivors and healthcare providers.

The intervention was tailored to be mobile-friendly and user-friendly, emphasizing brief content and easy access, which aligns with cancer survivors' preferences for managing stress effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Stress Management App Intervention for Cancer Survivors: Design, Development, and Usability Testing. Børøsund, E., Mirkovic, J., Clark, MM., et al.[2020]

The Distress Thermometer (DT) is an effective screening tool for detecting psychological issues like anxiety and depression in early cancer survivors, showing high accuracy with an area under the curve of 0.85 to 0.87 in a study of 1,323 participants.

The optimal cut-off score for the DT varies based on its use: a score of ≥2 is best for clinical settings, while ≥4 is more suitable for research, indicating that the DT should be tailored to the context in which it is used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How does the Distress Thermometer compare to the Hospital Anxiety and Depression Scale for detecting possible cases of psychological morbidity among cancer survivors? Boyes, A., D'Este, C., Carey, M., et al.[2022]

The Swedish version of the PTSD Coach app was found to be slightly to moderately helpful and satisfactory for users, with 11 participants reporting nominal reductions in posttraumatic stress symptoms (PTSS) and depression after four weeks of use.

Despite some positive feedback on specific features like symptom monitoring and breathing exercises, participants reported lower engagement with the app than expected, indicating a need for improvements in app structure and user guidance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of user satisfaction and perceived helpfulness of the Swedish version of the mobile app PTSD Coach. Cernvall, M., Sveen, J., Bergh Johannesson, K., et al.[2023]

The introduction of PTSD as a diagnosis for cancer patients highlights the need to adjust trauma criteria specifically for this group, indicating that their experiences may differ from traditional PTSD cases.

There is a lack of comprehensive data on risk factors for PTSD in cancer patients, emphasizing the need for prospective, longitudinal studies to better understand its prevalence and to identify at-risk individuals for timely assessment and intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of posttraumatic psychological problems in cancer patients. Schmitt, A., Singer, S., Schwarz, R.[2019]

Clinicians rated the PTSD Coach Australia app as having an 'average' to 'good' quality, viewing it as a useful tool for tracking symptoms and enhancing engagement between therapy sessions.

Despite its potential benefits, clinicians raised concerns about the app's user-friendliness and technical issues, such as freezing on Android devices, highlighting the need for improvements to ensure better usability for Defence members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinicians' perceptions of PTSD Coach Australia. Strodl, E., Shakespeare-Finch, J., Alichniewicz, KK., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A SMART approach to optimizing delivery of an mHealth intervention among cancer survivors with posttraumatic stress symptoms. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

A Novel Mobile Phone App Intervention With Phone Coaching to Reduce Symptoms of Depression in Survivors of Women's Cancer: Pre-Post Pilot Study. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Systematic review on the effectiveness of mobile health applications on mental health of breast cancer survivors. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Post-traumatic stress symptoms, post-traumatic stress disorder, and post-traumatic growth among cancer survivors: a systematic scoping review of interventions. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Are needs assessments cost effective in reducing distress among patients with cancer? A randomized controlled trial using the Distress Thermometer and Problem List. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of a Cognitive Behavioral Digital Therapeutic on Anxiety and Depression Symptoms in Patients With Cancer: A Randomized Controlled Trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Pilot testing an app-based stress management intervention for cancer survivors. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Screening for distress in survivorship. [2019]

9. Canada pubmed.ncbi.nlm.nih.gov

A Stress Management App Intervention for Cancer Survivors: Design, Development, and Usability Testing. [2020]

10. Germany pubmed.ncbi.nlm.nih.gov

How does the Distress Thermometer compare to the Hospital Anxiety and Depression Scale for detecting possible cases of psychological morbidity among cancer survivors? [2022]

11. United States pubmed.ncbi.nlm.nih.gov

A pilot study of user satisfaction and perceived helpfulness of the Swedish version of the mobile app PTSD Coach. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of posttraumatic psychological problems in cancer patients. [2019]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Clinicians' perceptions of PTSD Coach Australia. [2022]