Trial Outcomes & Findings for Early Psychological Intervention to Prevent Cardiovascular Event-Induced PTSD (REACH Sub-study) (NCT NCT03605693)

Last Updated: 2020-09-16

Results Overview

This is to measure PTSD symptoms due to the index cardiovascular event. The PCL-S is self-report measure of the symptoms of PTSD. Respondents rate how much they were bothered by 20 symptoms, each rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely), such that total scores range from 0-80. The PCL-S (specific stressor) asks respondents about symptoms in relation to an identified stressful experience. The PCL-S aims to link symptom endorsements to the index cardiovascular event

Recruitment status

TERMINATED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

1 month after hospital discharge

Results posted on

2020-09-16

Participant Flow

Participant milestones

Participant milestones
Measure	Early Psychological Intervention Those assigned to Early Psychological Intervention will receive Written Exposure Therapy, a 5 session treatment in which participants write about their trauma event in a specified manner. Written Exposure Therapy: Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner.	Usual Care Those assigned to usual care will complete study assessments but will not be referred to any psychological treatment
Overall Study STARTED	5	5
Overall Study COMPLETED	0	5
Overall Study NOT COMPLETED	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Early Psychological Intervention Those assigned to Early Psychological Intervention will receive Written Exposure Therapy, a 5 session treatment in which participants write about their trauma event in a specified manner. Written Exposure Therapy: Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner.	Usual Care Those assigned to usual care will complete study assessments but will not be referred to any psychological treatment
Overall Study Lost to Follow-up	4	0
Overall Study Physician Decision	1	0

Baseline Characteristics

Early Psychological Intervention to Prevent Cardiovascular Event-Induced PTSD (REACH Sub-study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early Psychological Intervention n=5 Participants Those assigned to Early Psychological Intervention will receive Written Exposure Therapy, a 5 session treatment in which participants write about their trauma event in a specified manner. Written Exposure Therapy: Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner.	Usual Care n=5 Participants Those assigned to usual care will complete study assessments but will not be referred to any psychological treatment	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	49.60 years STANDARD_DEVIATION 13.15 • n=5 Participants	52.20 years STANDARD_DEVIATION 27.67 • n=7 Participants	50.90 years STANDARD_DEVIATION 20.47 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month after hospital discharge

Population: Not all participants were able to be contacted for 1-month follow-up assessment.

Outcome measures

Outcome measures
Measure	Early Psychological Intervention n=3 Participants Those assigned to Early Psychological Intervention will receive Written Exposure Therapy, a 5 session treatment in which participants write about their trauma event in a specified manner. Written Exposure Therapy: Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner.	Usual Care n=2 Participants Those assigned to usual care will complete study assessments but will not be referred to any psychological treatment
PTSD Checklist - Stressor Specific (PCL-S) Score	14.0 score on a scale Interval 4.0 to 24.0	13.5 score on a scale Interval 0.0 to 27.0

SECONDARY outcome

Timeframe: Approximately 1 month after hospital discharge

Population: This outcome only applies to patients randomized to the Early Psychological Intervention. Data were not collected on this variable for patients randomized to usual care.

This is to measure the feasibility of the therapy - completion to all 5 sessions among participants assigned to the intervention group

Outcome measures

Outcome measures
Measure	Early Psychological Intervention n=5 Participants Those assigned to Early Psychological Intervention will receive Written Exposure Therapy, a 5 session treatment in which participants write about their trauma event in a specified manner. Written Exposure Therapy: Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner.	Usual Care Those assigned to usual care will complete study assessments but will not be referred to any psychological treatment
Number of Subjects Completing the Written Exposure Therapy	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Approximately 1 month after hospital discharge

Population: Not all participants completed the self-reported medication adherence questionnaire.

This is measured by the scoring from the Dose-Nonadherence questionnaire (3-items). Participants were categorized as adherent if they reported "none of the time" on all 3 items. Participants were categorized as nonadherent if they reported "at least some of the time" on any of the 3 items.

Outcome measures

Outcome measures
Measure	Early Psychological Intervention n=1 Participants Those assigned to Early Psychological Intervention will receive Written Exposure Therapy, a 5 session treatment in which participants write about their trauma event in a specified manner. Written Exposure Therapy: Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner.	Usual Care n=1 Participants Those assigned to usual care will complete study assessments but will not be referred to any psychological treatment
Adherent to Cardiovascular Medications	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, 1 month after hospital discharge

Population: Some participants were unable to be contacted at 1-month to complete this questionnaire.

This is to measure change in depressive symptoms. The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies. Scores range from 0 - 24 and a score of 10 or greater is consistent with at least moderate depressive symptoms.

Outcome measures

Outcome measures
Measure	Early Psychological Intervention n=1 Participants Those assigned to Early Psychological Intervention will receive Written Exposure Therapy, a 5 session treatment in which participants write about their trauma event in a specified manner. Written Exposure Therapy: Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner.	Usual Care n=2 Participants Those assigned to usual care will complete study assessments but will not be referred to any psychological treatment
PHQ-8 Score	0 score on a scale Interval 0.0 to 0.0	6.5 score on a scale Interval 0.0 to 13.0

SECONDARY outcome

Timeframe: Approximately 6 months after hospital discharge

Population: 0 patients were analyzed as 6-month data were not collected.

This is to measure quality of life. A health survey that uses 12 questions to measure functional health and well-being from the patient's point of view. This measure was not collected at 6-months in any participants due to the study being terminated early.

Outcome measures

Outcome data not reported

Adverse Events

Early Psychological Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ian Kronish

Center for Behavioral Cardiovascular Health, Columbia University Irving Medical Center

Phone: 212-342-1335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place