Post-traumatic Stress DisorderNCT04626050
General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to Occupational Trauma
A study testing Medical Music, Narrative Writing and Prolonged Exposure Therapy in people with Post-traumatic Stress Disorder and Moral Injury, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
It is expected that large numbers of healthcare workers experience a broad range of psychological reactions and symptoms including anxiety, depression, moral distress, and trauma symptoms that will cause both significant suffering as well as occupational and social impairment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic Stress Disorder, Moral Injury
- What is being tested?
- Medical Music, Narrative Writing and Prolonged Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2022to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any healthcare worker providing medical care or support who has experienced occupational-related trauma
- English-speaking
- Age >18
- Medically stable
- Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments
- If on psychotropic medication stable for prior 60 days
- For phase II additional inclusion criteria:
- Current diagnosis of PTSD
Who cannot join
- Current significant unstable medical illness precluding regular session attendance or assessment completion
- Participants who in the investigator's judgment pose a current homicidal, suicidal, or other risk
- Lifetime or current diagnosis of schizophrenia or other psychotic disorder
- Participation in a clinical trial or concurrent evidence-based treatment for psychiatric conditions or PTSD during the previous 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Olivia Baryluk, BS
JoAnn Difede, PhD
About this study
Official title: A Brief Phased Two-Step Intervention for Treating General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to Occupational Trauma
It is expected that large numbers of healthcare workers experience a broad range of psychological reactions and symptoms including anxiety, depression, moral distress, and trauma symptoms that will cause both significant suffering as well as occupational and social impairment. The purpose of this study is to find interventions which are helpful in treating psychological distress in healthcare workers adversely affected by occupational-related trauma.
There are two phases of the study. All participants will take part in Phase I, which consists of 4 sessions over a two-week period of either a narrative writing intervention or a medical music intervention. Participants will be randomly assigned to the narrative writing intervention or medical music intervention.
After Phase I, participants will be re-assessed. Healthcare workers who meet criteria for PTSD will be given the option to participate in Phase II of the study, in which they will be offered a choice between one of two evidence-based treatments for PTSD: Interpersonal Therapy (IPT) or Exposure Therapy (ET). Both treatments are comprised of ten 75-minute sessions scheduled twice weekly. Participants will be allowed to choose a preferred treatment in Phase II. After Phase II participants will complete a final assessment concluding the study. All interventions will be offered using distance technology.
- Conditions
- Post-traumatic Stress Disorder, Moral Injury
- Being tested
- Medical Music, Narrative Writing, Prolonged Exposure Therapy, Interpersonal Psychotherapy
- Keywords
- PTSD, Moral Injury, Psychological Distress, Healthcare Workers, Occupational Trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical MusicBehavioural
Participants randomized to this condition will complete 4 medical music sessions over the course of 2 weeks
Narrative WritingBehavioural
Participants randomized to this condition will complete 4 narrative writing sessions over the course of 2 weeks
Prolonged Exposure TherapyBehavioural
Psychotherapy including imaginal exposure for PTSD
Interpersonal PsychotherapyBehavioural
Psychotherapy that focuses on the effects of PTSD on current interpersonal functioning
| Study group | Role | What they receive |
|---|---|---|
| Medical Music (Phase I) | Experimental | Participants will complete four medical music sessions that are 20 minutes in length each. Receives: Behavioral: Medical Music |
| Narrative Writing (Phase I) | Experimental | Participants will complete four narrative writing sessions that are 20 minutes in length each. Receives: Behavioral: Narrative Writing |
| Interpersonal Psychotherapy (Phase II) | Active comparator | IPT is comprised of ten 75-minute sessions scheduled twice weekly. Receives: Behavioral: Interpersonal Psychotherapy |
| Prolonged Exposure Therapy (Phase II) | Active comparator | ET is comprised of ten 75-minute sessions scheduled twice weekly. Receives: Behavioral: Prolonged Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Indicator: Recruitment (Phase I)
Feasibility assessment will include recruitment defined as number of individuals interested in the intervention.
Measured: Baseline
Feasibility Indicator: Recruitment (Phase II)
Feasibility assessment will include: recruitment defined as number of individuals interested in the intervention.
Measured: Post-Phase I Assessment at week 2
Feasibility Indicator: Enrollment (Phase I)
Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.
Measured: Baseline
Feasibility Indicator: Enrollment (Phase II)
Feasibility assessment will include enrollment defined as number of individuals beginning phase II.
Measured: Post-Phase I Assessment at approximately week 2
Feasibility Indicator: Retention (Phase I)
Feasibility assessment will include retention defined as the number of participants completing the full course of Phase I interventions.
Measured: Post-Phase I Assessment at approximately week 2
Feasibility Indicator: Retention (Phase II)
Feasibility assessment will include retention defined as the number of participants completing the full course of Phase II interventions.
Measured: Post-Phase II Assessment at approximately week 7
Acceptability Indicator: Satisfaction (Phase I)
Acceptability and treatment satisfaction will be rated with a Likert scale.
Measured: Post-Phase I Assessment at approximately week 2
Acceptability Indicator: Satisfaction (Phase II)
Acceptability and treatment satisfaction will be rated with a Likert scale.
Measured: Post-Phase II Assessment at approximately week 7
Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase I)
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.
Measured: Start of Phase I to approximately 2 weeks
Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase II)
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.
Measured: Start of Phase II to approximately 5 weeks
Secondary outcomes (28)
Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase I)
Scored between 0-21:
Cut offs:
0-4 = None 5-9 = Mild anxiety 10-14 = Moderate anxiety 15-21 = Severe anxiety
Higher scores indicate greater symptom severity.
Measured: Start of Phase I to approximately 2 weeks
Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase II)
Scored between 0-21:
Cut offs:
0-4 = None 5-9 = Mild anxiety 10-14 = Moderate anxiety 15-21 = Severe anxiety
Higher scores indicate greater symptom severity.
Measured: Start of Phase II to approximately 5 weeks
Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomology (Phase I)
16-item self-report measure. Scored between 0-3. Higher scores indicate greater symptom severity
Measured: Start of Phase I to approximately 2 weeks
Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomology (Phase II)
16-item self-report measure. Scored between 0-3. Higher scores indicate greater symptom severity.
Measured: Start of Phase II to approximately 5 weeks
Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase I)
24 item self-report measure. 19 questions are evaluated. Each item in the scale is rated between 0 (no distress) and 3 (serious distress). The total PSQI score ranges from 0-21. Sleep quality of the patients with a total score of 5 and below is considered "good". A score of greater than 5 refers to poor sleep quality.
Measured: Start of Phase I to approximately 2 weeks
Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase II)
24 item self-report measure. 19 questions are evaluated. Each item in the scale is rated between 0 (no distress) and 3 (serious distress). The total PSQI score ranges from 0-21. Sleep quality of the patients with a total score of 5 and below is considered "good". A score of greater than 5 refers to poor sleep quality.
Measured: Start of Phase II to approximately 5 weeks
Change in score on the Moral Injury Symptom Scale: Healthcare Professionals Version (Phase I)
11 item self-report measure measuring one's experiences as a healthcare professional and how they are feeling currently. Scored between 1-10. Higher scores indicate greater moral distress.
Measured: Start of Phase I to approximately 2 weeks
Change in score on the Moral Injury Symptom Scale: Healthcare Professionals Version (Phase II)
11 item self-report measuring one's experiences as a healthcare professional and how they are feeling currently. Scored between 1-10. Higher scores indicate greater moral distress.
Measured: Start of Phase II to approximately 5 weeks
Change in score on the Modified Moral Injury Events Scale (Phase I)
11 item self-report measure that measures moral injury. Statements related to distress or feelings of betrayal related to potentially morally injurious events are rated on a 6 point scale ranging from 1 (strongly agree) to 6 (strongly disagree). Score range is 11-66, with higher scores reflecting greater moral injury.
Measured: Start of Phase I to approximately 2 weeks
Change in score on the Modified Moral Injury Events Scale (Phase II)
11 item self-report measure that measures moral injury. Statements related to distress or feelings of betrayal related to potentially morally injurious events are rated on a 6 point scale ranging from 1 (strongly agree) to 6 (strongly disagree). Score range is 11-66, with higher scores reflecting greater moral injury.
Measured: Start of Phase II to approximately 5 weeks
Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase I)
The well-validated PCL-5 will assess self-reported PTSD symptom severity. Scores range from 0-80. Higher scores indicate greater symptom severity.
Measured: Start of Phase I to approximately 2 weeks
Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase II)
The well-validated PCL-5 will assess self-reported PTSD symptom severity. Scores range from 0-80. Higher scores indicate greater symptom severity.
Measured: Start of Phase II to approximately 5 weeks
Change in score on the Sheehan Disability Scale (SDS) (Phase I)
10 point visual analog scale to rate the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms. The 3 items can be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).
Measured: Start of Phase I to approximately 2 weeks
Change in score on the Sheehan Disability Scale (SDS) (Phase II)
10 point visual analog scale to rate the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms. The 3 items can be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).
Measured: Start of Phase II to approximately 5 weeks
Change in score on the World Health Organization Quality of Life Scale - Brief (Phase I)
The minimum score is 0 and the maximum score is 100. High score shows better result.
Measured: Start of Phase I to approximately 2 weeks
Change in score on the World Health Organization Quality of Life Scale - Brief (Phase II)
The minimum score is 0 and the maximum score is 100. High score shows better result.
Measured: Start of Phase II to approximately 5 weeks
Change in score on the Work and Social Adjustment Scale (WSAS) (Phase I)
5 items measuring one's social functioning on items covering ability to work, home management, social leisure activities, private leisure activities, and close relationships. Each item is scored between 0-8. Lower scores are better.
Measured: Start of Phase I to approximately 2 weeks
Change in score on the Work and Social Adjustment Scale (WSAS) (Phase II)
5 items measuring one's social functioning on items covering ability to work, home management, social leisure activities, private leisure activities, and close relationships. Each item is scored between 0-8. Lower scores are better.
Measured: Start of Phase II to approximately 5 weeks
Change in Score on the Occupational Stress Inventory Revised (OSI-R) (Phase I)
The scale is comprised of 140 items total. The measure is comprised of 14 different scales and respondents indicate on a 5-point scale the frequency of a stress-related event.
Measured: Start of Phase I to approximately 2 weeks
Change in Score on the Occupational Stress Inventory Revised (OSI-R) (Phase II)
The scale is comprised of 140 items total. The measure is comprised of 14 different scales and respondents indicate on a 5-point scale the frequency of a stress-related event.
Measured: Start of Phase II to approximately 5 weeks
Change in Score on the Multidimensional Scale of Perceived Social Support (MSPSS) (Phase I)
12-item scale with a seven-point scale (from 1=strongly disagree to 7=strongly agree), resulting in a total score in the range of 12-84. Higher scores indicate higher perceived social support by Friends and Family/Significant Others.
Measured: Start of Phase I to approximately 2 weeks
Change in Score on the Multidimensional Scale of Perceived Social Support (MSPSS) (Phase II)
12-item scale with a seven-point scale (from 1=strongly disagree to 7=strongly agree), resulting in a total score in the range of 12-84. Higher scores indicate higher perceived social support by Friends and Family/Significant Others.
Measured: Start of Phase II to approximately 5 weeks
Change in score on the Posttraumatic Cognitions Inventory (Phase I)
33-item self-report measure is designed to assess the degree to which a participant agrees with thoughts and beliefs that have been found to be common for individuals who suffer from PTSD. The measure is rated between 1 (Totally disagree) to 7 (Totally agree). The score range is 33-231. Higher scores indicate greater symptom severity.
Measured: Start of Phase I to approximately 2 weeks
Change in score on the Posttraumatic Cognitions Inventory (Phase II)
33-item self-report measure is designed to assess the degree to which a participant agrees with thoughts and beliefs that have been found to be common for individuals who suffer from PTSD. The measure is rated between 1 (Totally disagree) to 7 (Totally agree). The score range is 33-231. Higher scores indicate greater symptom severity.
Measured: Start of Phase II to approximately 5 weeks
Change in score on the Difficulties in Emotion Regulation Scale-18 (DERS-18) (Phase I)
The Difficulties in Emotion Regulation Scale-18 (DERS) is a 18-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation.
Measured: Start of Phase I to approximately 2 weeks
Change in score on the Difficulties in Emotion Regulation Scale-18 (Phase II)
The Difficulties in Emotion Regulation Scale-18 (DERS-18) is a 18-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation.
Measured: Start of Phase II to approximately 5 weeks
Change in score on the Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS_20)
The Pittsburgh Insomnia Rating Scale is a 20 item self report measure. Items are rated on a scale from 0-3. Higher scores indicate higher insomnia severity.
Measured: Start of Phase I to approximately 2 weeks
Change in score on the Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS_20)
The Pittsburgh Insomnia Rating Scale is a 20 item self report measure. Items are rated on a scale from 0-3. Higher scores indicate higher insomnia severity.
Measured: Start of Phase II to approximately 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start20 Jan 2022
- Primary completionJan 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JoAnn Difede, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626050
- Sponsor's protocol ID
- 20-04021913
- Status last verified
- Jun 2026
- First submitted
- 10 Nov 2020
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang CC, Difede J. A Two-Phased Telehealth Model to Treat Post-Traumatic Stress Disorder in a Health Care Worker due to the COVID-19 Pandemic: A Case Report. Telemed J E Health. 2024 Feb;30(2):601-606. doi: 10.1089/tmj.2023.0326. Epub 2023 Aug 16.
PubMed 37585569
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Phased Two-Step Intervention for Treating General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to Occupational Trauma
- ClinicalTrials.gov ID
- NCT04626050
- Acronym / sponsor ID
- 20-04021913
- Conditions
- Post-traumatic Stress Disorder, Moral Injury
- Keywords
- PTSD, Moral Injury, Psychological Distress, Healthcare Workers, Occupational Trauma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is expected that large numbers of healthcare workers experience a broad range of psychological reactions and symptoms including anxiety, depression, moral distress, and trauma symptoms that will cause both significant suffering as well as occupational and social impairment. The purpose of this study is to find interventions which are helpful in treating psychological distress in healthcare workers adversely affected by occupational-related trauma.
There are two phases of the study. All participants will take part in Phase I, which consists of 4 sessions over a two-week period of either a narrative writing intervention or a medical music intervention. Participants will be randomly assigned to the narrative writing intervention or medical music intervention.
After Phase I, participants will be re-assessed. Healthcare workers who meet criteria for PTSD will be given the option to participate in Phase II of the study, in which they will be offered a choice between one of two evidence-based treatments for PTSD: Interpersonal Therapy (IPT) or Exposure Therapy (ET). Both treatments are comprised of ten 75-minute sessions scheduled twice weekly. Participants will be allowed to choose a preferred treatment in Phase II. After Phase II participants will complete a final assessment concluding the study. All interventions will be offered using distance technology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Medical Music (Phase I) | Experimental | Behavioral: Medical MusicParticipants will complete four medical music sessions that are 20 minutes in length each. |
| Narrative Writing (Phase I) | Experimental | Behavioral: Narrative WritingParticipants will complete four narrative writing sessions that are 20 minutes in length each. |
| Interpersonal Psychotherapy (Phase II) | Active comparator | Behavioral: Interpersonal PsychotherapyIPT is comprised of ten 75-minute sessions scheduled twice weekly. |
| Prolonged Exposure Therapy (Phase II) | Active comparator | Behavioral: Prolonged Exposure TherapyET is comprised of ten 75-minute sessions scheduled twice weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Any healthcare worker providing medical care or support who has experienced occupational-related trauma
- English-speaking
- Age >18
- Medically stable
- Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments
Key exclusion criteria (4 listed)
- Current significant unstable medical illness precluding regular session attendance or assessment completion
- Participants who in the investigator's judgment pose a current homicidal, suicidal, or other risk
- Lifetime or current diagnosis of schizophrenia or other psychotic disorder
- Participation in a clinical trial or concurrent evidence-based treatment for psychiatric conditions or PTSD during the previous 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical MusicParticipants randomized to this condition will complete 4 medical music sessions over the course of 2 weeks | Behavioural | Medical Music (Phase I) |
| Narrative WritingParticipants randomized to this condition will complete 4 narrative writing sessions over the course of 2 weeks | Behavioural | Narrative Writing (Phase I) |
| Prolonged Exposure TherapyPsychotherapy including imaginal exposure for PTSD | Behavioural | Prolonged Exposure Therapy (Phase II) |
| Interpersonal PsychotherapyPsychotherapy that focuses on the effects of PTSD on current interpersonal functioning | Behavioural | Interpersonal Psychotherapy (Phase II) |
Primary outcome
Feasibility Indicator: Recruitment (Phase I)
Time frame: Baseline
Feasibility assessment will include recruitment defined as number of individuals interested in the intervention.
Feasibility Indicator: Recruitment (Phase II)
Time frame: Post-Phase I Assessment at week 2
Feasibility assessment will include: recruitment defined as number of individuals interested in the intervention.
Feasibility Indicator: Enrollment (Phase I)
Time frame: Baseline
Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.
Feasibility Indicator: Enrollment (Phase II)
Time frame: Post-Phase I Assessment at approximately week 2
Feasibility assessment will include enrollment defined as number of individuals beginning phase II.
Feasibility Indicator: Retention (Phase I)
Time frame: Post-Phase I Assessment at approximately week 2
Feasibility assessment will include retention defined as the number of participants completing the full course of Phase I interventions.
Feasibility Indicator: Retention (Phase II)
Time frame: Post-Phase II Assessment at approximately week 7
Feasibility assessment will include retention defined as the number of participants completing the full course of Phase II interventions.
Acceptability Indicator: Satisfaction (Phase I)
Time frame: Post-Phase I Assessment at approximately week 2
Acceptability and treatment satisfaction will be rated with a Likert scale.
Acceptability Indicator: Satisfaction (Phase II)
Time frame: Post-Phase II Assessment at approximately week 7
Acceptability and treatment satisfaction will be rated with a Likert scale.
Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase I)
Time frame: Start of Phase I to approximately 2 weeks
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.
Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase II)
Time frame: Start of Phase II to approximately 5 weeks
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.
28 secondary outcomes
Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase I)
Time frame: Start of Phase I to approximately 2 weeks
Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase II)
Time frame: Start of Phase II to approximately 5 weeks
Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomology (Phase I)
Time frame: Start of Phase I to approximately 2 weeks
Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomology (Phase II)
Time frame: Start of Phase II to approximately 5 weeks
Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase I)
Time frame: Start of Phase I to approximately 2 weeks
Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase II)
Time frame: Start of Phase II to approximately 5 weeks
Change in score on the Moral Injury Symptom Scale: Healthcare Professionals Version (Phase I)
Time frame: Start of Phase I to approximately 2 weeks
Change in score on the Moral Injury Symptom Scale: Healthcare Professionals Version (Phase II)
Time frame: Start of Phase II to approximately 5 weeks
Change in score on the Modified Moral Injury Events Scale (Phase I)
Time frame: Start of Phase I to approximately 2 weeks
Change in score on the Modified Moral Injury Events Scale (Phase II)
Time frame: Start of Phase II to approximately 5 weeks
Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase I)
Time frame: Start of Phase I to approximately 2 weeks
Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase II)
Time frame: Start of Phase II to approximately 5 weeks
Change in score on the Sheehan Disability Scale (SDS) (Phase I)
Time frame: Start of Phase I to approximately 2 weeks
Change in score on the Sheehan Disability Scale (SDS) (Phase II)
Time frame: Start of Phase II to approximately 5 weeks
Change in score on the World Health Organization Quality of Life Scale - Brief (Phase I)
Time frame: Start of Phase I to approximately 2 weeks
Change in score on the World Health Organization Quality of Life Scale - Brief (Phase II)
Time frame: Start of Phase II to approximately 5 weeks
Change in score on the Work and Social Adjustment Scale (WSAS) (Phase I)
Time frame: Start of Phase I to approximately 2 weeks
Change in score on the Work and Social Adjustment Scale (WSAS) (Phase II)
Time frame: Start of Phase II to approximately 5 weeks
Change in Score on the Occupational Stress Inventory Revised (OSI-R) (Phase I)
Time frame: Start of Phase I to approximately 2 weeks
Change in Score on the Occupational Stress Inventory Revised (OSI-R) (Phase II)
Time frame: Start of Phase II to approximately 5 weeks
Change in Score on the Multidimensional Scale of Perceived Social Support (MSPSS) (Phase I)
Time frame: Start of Phase I to approximately 2 weeks
Change in Score on the Multidimensional Scale of Perceived Social Support (MSPSS) (Phase II)
Time frame: Start of Phase II to approximately 5 weeks
Change in score on the Posttraumatic Cognitions Inventory (Phase I)
Time frame: Start of Phase I to approximately 2 weeks
Change in score on the Posttraumatic Cognitions Inventory (Phase II)
Time frame: Start of Phase II to approximately 5 weeks
Change in score on the Difficulties in Emotion Regulation Scale-18 (DERS-18) (Phase I)
Time frame: Start of Phase I to approximately 2 weeks
Change in score on the Difficulties in Emotion Regulation Scale-18 (Phase II)
Time frame: Start of Phase II to approximately 5 weeks
Change in score on the Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS_20)
Time frame: Start of Phase I to approximately 2 weeks
Change in score on the Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS_20)
Time frame: Start of Phase II to approximately 5 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Derived from this study: PubMed 37585569Wang CC, Difede J. A Two-Phased Telehealth Model to Treat Post-Traumatic Stress Disorder in a Health Care Worker due to the COVID-19 Pandemic: A Case Report. Telemed J E Health. 2024 Feb;30(2):601-606. doi: 10.1089/tmj.2023.0326. Epub 2023 Aug 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
JoAnn Difede, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Music, Narrative Writing and Prolonged Exposure Therapy in people with Post-traumatic Stress Disorder and Moral Injury, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivia Baryluk, BS (212-821-0783, olb4002@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Indicator: Recruitment (Phase I) (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04626050, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.