Trial Outcomes & Findings for Resolving Psychological Stress (NCT NCT03996876)

Last Updated: 2021-12-07

Results Overview

The PTSD Checklist-5 (PCL- 5) was administered via the mobile application to assess changes in PTSD symptoms. The PCL-5 is a well validated and widely used structured 20-item diagnostic interview for assessing symptomology of PTSD corresponding to a DSM-5 diagnosis. PCL scores range from 0-80, with a score of 33 or above indicating clinically significant PTSD symptoms. Participants were asked about the severity of symptoms over the past week.

Recruitment status

COMPLETED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

15 days apart

Results posted on

2021-12-07

Participant Flow

Participant milestones

Participant milestones
Measure	Threat ABM Training Attention Bias Modification Training with threatening words RePS (Resolving Psychological Stress) - Threat ABM Training: This mobile "app" will aim to reduce neurobiological threat sensitivity with the ultimate goal of developing novel treatments for PTSD. The app can be used on an iPhone Operating System (iOS) compatible phone and involves a training program that aims to directly reduce threat sensitivity by modifying attention. The contents of the app will be the same for each user.	Neutral Attention Training Non-active version of ABM Training RePS (Resolving Psychological Stress) - Neutral Attention Training: This app will be a placebo attention bias modification that will be used on an iOS compatible phone. The placebo will contain only neutral words.
Overall Study STARTED	14	14
Overall Study COMPLETED	12	10
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Threat ABM Training Attention Bias Modification Training with threatening words RePS (Resolving Psychological Stress) - Threat ABM Training: This mobile "app" will aim to reduce neurobiological threat sensitivity with the ultimate goal of developing novel treatments for PTSD. The app can be used on an iPhone Operating System (iOS) compatible phone and involves a training program that aims to directly reduce threat sensitivity by modifying attention. The contents of the app will be the same for each user.	Neutral Attention Training Non-active version of ABM Training RePS (Resolving Psychological Stress) - Neutral Attention Training: This app will be a placebo attention bias modification that will be used on an iOS compatible phone. The placebo will contain only neutral words.
Overall Study Incomplete Data	2	4

Baseline Characteristics

1 participant did not complete the PCL at baseline.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Threat ABM Training n=14 Participants All participants used the same REPS app to complete their training. At the end of their training they answered general questions about the app that did not pertain to the specific type of training they received.	Neutral Attention Training n=14 Participants All participants used the same REPS app to complete their training. At the end of their training they answered general questions about the app that did not pertain to the specific type of training they received.	Total n=28 Participants Total of all reporting groups
Age, Continuous	44.57 years STANDARD_DEVIATION 9.25 • n=14 Participants	39.30 years STANDARD_DEVIATION 11.57 • n=14 Participants	44 years STANDARD_DEVIATION 11.57 • n=28 Participants
Sex: Female, Male Female	4 Participants n=14 Participants	9 Participants n=14 Participants	13 Participants n=28 Participants
Sex: Female, Male Male	10 Participants n=14 Participants	5 Participants n=14 Participants	15 Participants n=28 Participants
Race/Ethnicity, Customized American Indian/Alaskan	1 Participants n=14 Participants	0 Participants n=14 Participants	1 Participants n=28 Participants
Race/Ethnicity, Customized Asian	1 Participants n=14 Participants	0 Participants n=14 Participants	1 Participants n=28 Participants
Race/Ethnicity, Customized Hawaiian or other Pacific Islander	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=28 Participants
Race/Ethnicity, Customized Hispanic/Latinx	0 Participants n=14 Participants	2 Participants n=14 Participants	2 Participants n=28 Participants
Race/Ethnicity, Customized African American/Black	2 Participants n=14 Participants	5 Participants n=14 Participants	7 Participants n=28 Participants
Race/Ethnicity, Customized Caucasian/European American	9 Participants n=14 Participants	4 Participants n=14 Participants	13 Participants n=28 Participants
Race/Ethnicity, Customized Other	0 Participants n=14 Participants	0 Participants n=14 Participants	0 Participants n=28 Participants
Race/Ethnicity, Customized More than one ethnicity	1 Participants n=14 Participants	3 Participants n=14 Participants	4 Participants n=28 Participants
Region of Enrollment United States	14 participants n=14 Participants	14 participants n=14 Participants	28 participants n=28 Participants
PTSD Checklist-5 (PCL-5) Score	36.07 units on a scale STANDARD_DEVIATION 17.17 • n=14 Participants • 1 participant did not complete the PCL at baseline.	37.62 units on a scale STANDARD_DEVIATION 20.99 • n=13 Participants • 1 participant did not complete the PCL at baseline.	36.81 units on a scale STANDARD_DEVIATION 18.75 • n=27 Participants • 1 participant did not complete the PCL at baseline.

PRIMARY outcome

Timeframe: 15 days apart

Population: All participants used in analyses completed at least 16/20 items of the PCL-5 (total 20 items) on both Day 1 (Pre) and Day 15 (Post).

Outcome measures

Outcome measures
Measure	Threat ABM Training n=12 Participants Attention Bias Modification Training with threatening words RePS (Resolving Psychological Stress) - Threat ABM Training: This mobile "app" will aim to reduce neurobiological threat sensitivity with the ultimate goal of developing novel treatments for PTSD. The app can be used on an iPhone Operating System (iOS) compatible phone and involves a training program that aims to directly reduce threat sensitivity by modifying attention. The contents of the app will be the same for each user.	Neutral Attention Training n=10 Participants Non-active version of ABM Training RePS (Resolving Psychological Stress) - Neutral Attention Training: This app will be a placebo attention bias modification that will be used on an iOS compatible phone. The placebo will contain only neutral words.
PTSD Symptoms Using PTSD Checklist-5 (PCL-5) at Baseline and 15 Days Pre PCL Score	33.2 units on a scale Standard Deviation 16.1	36.6 units on a scale Standard Deviation 20.9
PTSD Symptoms Using PTSD Checklist-5 (PCL-5) at Baseline and 15 Days Post PCL Score	31.2 units on a scale Standard Deviation 15.8	28.2 units on a scale Standard Deviation 21.9

PRIMARY outcome

Timeframe: 15 days apart

Population: Due to technical difficulties, we were unable to calculate heart rate variability for the participants in this study. Thus, HRV data was not collected in this study.

Participants will perform computerized tasks designed to assess threat sensitivity. The task contains three different "threat" conditions, regarding the possibility of receiving a small, electric shock via an electrode on the hand (shock level is set by the participant). The three conditions are: shock not possible, shock possible, and shock may be possible. HRV is measured during all conditions and differences between the three conditions are scored.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 15 days

Population: Analyses included all participants that completed the usability assessment questionnaire.

A usability assessment questionnaire was administered with multiple feasibility and acceptability questions regarding the REPS Mobile Application (Ease of use, Convenience, Enjoyment, Comfort with the app and Overall satisfaction). The responses were measured on a Five-Point Scale with 1 meaning "Not at all" and 5 meaning "Very much"." Analyses included all participants that completed the usability assessment questionnaire.

Outcome measures

Outcome measures
Measure	Threat ABM Training n=12 Participants Attention Bias Modification Training with threatening words RePS (Resolving Psychological Stress) - Threat ABM Training: This mobile "app" will aim to reduce neurobiological threat sensitivity with the ultimate goal of developing novel treatments for PTSD. The app can be used on an iPhone Operating System (iOS) compatible phone and involves a training program that aims to directly reduce threat sensitivity by modifying attention. The contents of the app will be the same for each user.	Neutral Attention Training n=10 Participants Non-active version of ABM Training RePS (Resolving Psychological Stress) - Neutral Attention Training: This app will be a placebo attention bias modification that will be used on an iOS compatible phone. The placebo will contain only neutral words.
Rating of the Resolving Psychological Stress (Reps) Mobile Application on a Five-Point Scale for Multiple Feasibility and Acceptability Items After the Intervention, at 15 Days Ease of use	4.56 score on a scale Standard Deviation 0.74	4.52 score on a scale Standard Deviation 0.90
Rating of the Resolving Psychological Stress (Reps) Mobile Application on a Five-Point Scale for Multiple Feasibility and Acceptability Items After the Intervention, at 15 Days Convenience	4.02 score on a scale Standard Deviation 1.06	3.92 score on a scale Standard Deviation 1.16
Rating of the Resolving Psychological Stress (Reps) Mobile Application on a Five-Point Scale for Multiple Feasibility and Acceptability Items After the Intervention, at 15 Days Enjoyable	3.29 score on a scale Standard Deviation 1.13	3.18 score on a scale Standard Deviation 1.22
Rating of the Resolving Psychological Stress (Reps) Mobile Application on a Five-Point Scale for Multiple Feasibility and Acceptability Items After the Intervention, at 15 Days Comfort with the app	4.44 score on a scale Standard Deviation 0.80	4.41 score on a scale Standard Deviation 0.83
Rating of the Resolving Psychological Stress (Reps) Mobile Application on a Five-Point Scale for Multiple Feasibility and Acceptability Items After the Intervention, at 15 Days Overall satisfaction	4.17 score on a scale Standard Deviation 0.87	4.05 score on a scale Standard Deviation 1.02

Adverse Events

Threat ABM Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Neutral Attention Training

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

Aoife O'Donovan, Associate Professor of Psychiatry

University of California, San Francisco

Phone: 4152214810

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place