Trial Outcomes & Findings for RCT for Innovating Stress-related eHealth (NCT NCT05305235)
NCT ID: NCT05305235
Last Updated: 2025-03-05
Results Overview
The Treatment Adherence/Acceptability Scale (TAAS) is a 10-item measure of treatment acceptability (e.g., I would recommend this treatment to a friend) and adherence (e.g., I would be able to finish \[this treatment\]) that participants rate on a 7-point Likert scale with scores ranging from 10-70. Higher scores indicate higher acceptability.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
1 Week
Results posted on
2025-03-05
Participant Flow
Of the 75 participants who signed informed consent, only 60 completed the required one-week follow up and were randomly assigned to a treatment intervention.
Participant milestones
| Measure |
RISE Guide
The RISE (RCT for Innovating Stress-related eHealth) Guide is based on Cognitive Anxiety Sensitivity Treatment (CAST), an anxiety sensitivity intervention effective in reducing anxiety sensitivity, posttraumatic stress, depression, and anxiety. RISE Guide delivers psychoeducation and cognitive-behavioral therapy principles in an interactive, audio-visual format discussing the stress response, myth-busting cognitive distortions related to stress, and facilitating safe exposure to feared sensations. Participants then complete a validated cognitive bias modification (CBM-I) for interpretation biases related to anxiety sensitivity. Finally, intervention principles are reinforced using ecological momentary intervention (EMI), in which surveys and personalized reminders are delivered based on symptoms reported during ecological momentary assessments (EMAs)
RISE Guide delivered by smartphone via Qualtrics and is completed in \~45 minutes over 2 weeks, with EMI weeks 1-7 post-assault.
RISE Guide: Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.
|
Relaxation Control
Breathe2Relax is a mobile application that instructs users on diaphragmatic breathing, a coping tool in which slow breathing through the diaphragm reduces anxiety. Participants in the control condition will download Breathe2Relax to their smartphones and receive short message service (SMS) reminders to engage with the app. The control intervention is expected to reduce symptoms, but not as much as the cognitive-behavioral therapy strategies taught in RISE Guide.
Relaxation Control: Guides users through relaxation techniques.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
33
|
|
Overall Study
COMPLETED
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
8
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RCT for Innovating Stress-related eHealth
Baseline characteristics by cohort
| Measure |
RISE Guide
n=27 Participants
The RISE (RCT for Innovating Stress-related eHealth) Guide is based on CAST, an anxiety sensitivity intervention effective in reducing anxiety sensitivity, posttraumatic stress, depression, and anxiety. RISE Guide delivers psychoeducation and cognitive-behavioral therapy principles in an interactive, audio-visual format discussing the stress response, myth-busting cognitive distortions related to stress, and facilitating safe exposure to feared sensations. Participants then complete a validated cognitive bias modification (CBM-I) for interpretation biases related to anxiety sensitivity. Finally, intervention principles are reinforced using ecological momentary intervention (EMI), in which surveys and personalized reminders are delivered based on symptoms reported during ecological momentary assessments (EMAs)
RISE Guide delivered by smartphone via Qualtrics and is completed in \~45 minutes over 2 weeks, with EMI weeks 1-7 post-assault.
RISE Guide: Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.
|
Relaxation Control
n=33 Participants
Breathe2Relax is a mobile application that instructs users on diaphragmatic breathing, a coping tool in which slow breathing through the diaphragm reduces anxiety. Participants in the control condition will download Breathe2Relax to their smartphones and receive short message service (SMS) reminders to engage with the app. The control intervention is expected to reduce symptoms, but not as much as the cognitive-behavioral therapy strategies taught in RISE Guide.
Relaxation Control: Guides users through relaxation techniques.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.80 years
STANDARD_DEVIATION 6.90 • n=99 Participants
|
25.38 years
STANDARD_DEVIATION 6.64 • n=107 Participants
|
25.56 years
STANDARD_DEVIATION 6.70 • n=206 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
27 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 WeekPopulation: This measure was only provided to participants in the active (RISE Guide) condition. Data are reported for all RISE Guide participants who opted to complete the TAAS.
The Treatment Adherence/Acceptability Scale (TAAS) is a 10-item measure of treatment acceptability (e.g., I would recommend this treatment to a friend) and adherence (e.g., I would be able to finish \[this treatment\]) that participants rate on a 7-point Likert scale with scores ranging from 10-70. Higher scores indicate higher acceptability.
Outcome measures
| Measure |
RISE Guide
n=17 Participants
The RISE (RCT for Innovating Stress-related eHealth) Guide is based on CAST, an anxiety sensitivity intervention effective in reducing anxiety sensitivity, posttraumatic stress, depression, and anxiety. RISE Guide delivers psychoeducation and cognitive-behavioral therapy principles in an interactive, audio-visual format discussing the stress response, myth-busting cognitive distortions related to stress, and facilitating safe exposure to feared sensations. Participants then complete a validated cognitive bias modification (CBM-I) for interpretation biases related to anxiety sensitivity. Finally, intervention principles are reinforced using ecological momentary intervention (EMI), in which surveys and personalized reminders are delivered based on symptoms reported during ecological momentary assessments (EMAs)
RISE Guide delivered by smartphone via Qualtrics and is completed in \~45 minutes over 2 weeks, with EMI weeks 1-7 post-assault.
RISE Guide: Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.
|
Relaxation Control
Breathe2Relax is a mobile application that instructs users on diaphragmatic breathing, a coping tool in which slow breathing through the diaphragm reduces anxiety. Participants in the control condition will download Breathe2Relax to their smartphones and receive short message service (SMS) reminders to engage with the app. The control intervention is expected to reduce symptoms, but not as much as the cognitive-behavioral therapy strategies taught in RISE Guide.
Relaxation Control: Guides users through relaxation techniques.
|
|---|---|---|
|
Treatment Adherence/Acceptability Scale
|
57.53 score on a scale
Standard Deviation 7.70
|
—
|
SECONDARY outcome
Timeframe: 7 WeekPopulation: All data collected are reported, some were missing due to attrition. Some participants chose to opt out of certain questionnaires.
Credibility/Expectancy Questionnaire (CEQ; 1 week) 6-item measure of treatment credibility and expectancy of treatment to improve symptoms. Items are rated on 9-to-11-point Likert scales. 11-point scales (0-100% in 10% intervals are recoded to align with the 1-9 scales). Higher scores indicate higher credibility/expectancy. Scores can range from 4 to 56.
Outcome measures
| Measure |
RISE Guide
n=21 Participants
The RISE (RCT for Innovating Stress-related eHealth) Guide is based on CAST, an anxiety sensitivity intervention effective in reducing anxiety sensitivity, posttraumatic stress, depression, and anxiety. RISE Guide delivers psychoeducation and cognitive-behavioral therapy principles in an interactive, audio-visual format discussing the stress response, myth-busting cognitive distortions related to stress, and facilitating safe exposure to feared sensations. Participants then complete a validated cognitive bias modification (CBM-I) for interpretation biases related to anxiety sensitivity. Finally, intervention principles are reinforced using ecological momentary intervention (EMI), in which surveys and personalized reminders are delivered based on symptoms reported during ecological momentary assessments (EMAs)
RISE Guide delivered by smartphone via Qualtrics and is completed in \~45 minutes over 2 weeks, with EMI weeks 1-7 post-assault.
RISE Guide: Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.
|
Relaxation Control
n=22 Participants
Breathe2Relax is a mobile application that instructs users on diaphragmatic breathing, a coping tool in which slow breathing through the diaphragm reduces anxiety. Participants in the control condition will download Breathe2Relax to their smartphones and receive short message service (SMS) reminders to engage with the app. The control intervention is expected to reduce symptoms, but not as much as the cognitive-behavioral therapy strategies taught in RISE Guide.
Relaxation Control: Guides users through relaxation techniques.
|
|---|---|---|
|
Credibility/Expectancy Questionnaire
|
22.85 score on a scale
Standard Deviation 10.98
|
18.61 score on a scale
Standard Deviation 13.37
|
SECONDARY outcome
Timeframe: 7 WeekPopulation: All data collected are reported, some were missing due to attrition. Some participants chose to opt out of certain questionnaires.
6 items self-report survey created for the current study on a 5-point Likert scale, such as How often did you log in? How interested were you? and 4 open-ended questions; e.g., What did you like about RISE Guide?; What did you not like? Lower scores indicate higher treatment utilization and acceptability. Scores range from 6-30.
Outcome measures
| Measure |
RISE Guide
n=22 Participants
The RISE (RCT for Innovating Stress-related eHealth) Guide is based on CAST, an anxiety sensitivity intervention effective in reducing anxiety sensitivity, posttraumatic stress, depression, and anxiety. RISE Guide delivers psychoeducation and cognitive-behavioral therapy principles in an interactive, audio-visual format discussing the stress response, myth-busting cognitive distortions related to stress, and facilitating safe exposure to feared sensations. Participants then complete a validated cognitive bias modification (CBM-I) for interpretation biases related to anxiety sensitivity. Finally, intervention principles are reinforced using ecological momentary intervention (EMI), in which surveys and personalized reminders are delivered based on symptoms reported during ecological momentary assessments (EMAs)
RISE Guide delivered by smartphone via Qualtrics and is completed in \~45 minutes over 2 weeks, with EMI weeks 1-7 post-assault.
RISE Guide: Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.
|
Relaxation Control
n=19 Participants
Breathe2Relax is a mobile application that instructs users on diaphragmatic breathing, a coping tool in which slow breathing through the diaphragm reduces anxiety. Participants in the control condition will download Breathe2Relax to their smartphones and receive short message service (SMS) reminders to engage with the app. The control intervention is expected to reduce symptoms, but not as much as the cognitive-behavioral therapy strategies taught in RISE Guide.
Relaxation Control: Guides users through relaxation techniques.
|
|---|---|---|
|
Treatment Utilization and Acceptability
|
12.45 score on a scale
Standard Deviation 4.51
|
10.89 score on a scale
Standard Deviation 6.58
|
SECONDARY outcome
Timeframe: From first to last participant approached (up to 20 months)The purpose of this outcome is to measure feasibility across the entirety of successful recruitment and randomization.
Outcome measures
| Measure |
RISE Guide
n=60 Participants
The RISE (RCT for Innovating Stress-related eHealth) Guide is based on CAST, an anxiety sensitivity intervention effective in reducing anxiety sensitivity, posttraumatic stress, depression, and anxiety. RISE Guide delivers psychoeducation and cognitive-behavioral therapy principles in an interactive, audio-visual format discussing the stress response, myth-busting cognitive distortions related to stress, and facilitating safe exposure to feared sensations. Participants then complete a validated cognitive bias modification (CBM-I) for interpretation biases related to anxiety sensitivity. Finally, intervention principles are reinforced using ecological momentary intervention (EMI), in which surveys and personalized reminders are delivered based on symptoms reported during ecological momentary assessments (EMAs)
RISE Guide delivered by smartphone via Qualtrics and is completed in \~45 minutes over 2 weeks, with EMI weeks 1-7 post-assault.
RISE Guide: Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.
|
Relaxation Control
Breathe2Relax is a mobile application that instructs users on diaphragmatic breathing, a coping tool in which slow breathing through the diaphragm reduces anxiety. Participants in the control condition will download Breathe2Relax to their smartphones and receive short message service (SMS) reminders to engage with the app. The control intervention is expected to reduce symptoms, but not as much as the cognitive-behavioral therapy strategies taught in RISE Guide.
Relaxation Control: Guides users through relaxation techniques.
|
|---|---|---|
|
Average Number of Participants Successfully Randomized Per Month Over the Entirety of the Study
|
2 Participants recruited and randomized
Standard Deviation 2.52
|
—
|
SECONDARY outcome
Timeframe: 7 Weeks Follow Up, 6 Month Follow Up (up to 7 months)The proportion of participants who complete follow-ups (i.e., 7-week, 6 months) will be used to evaluate feasibility of retaining the target sample (goal retention=75% or higher).
Outcome measures
| Measure |
RISE Guide
n=27 Participants
The RISE (RCT for Innovating Stress-related eHealth) Guide is based on CAST, an anxiety sensitivity intervention effective in reducing anxiety sensitivity, posttraumatic stress, depression, and anxiety. RISE Guide delivers psychoeducation and cognitive-behavioral therapy principles in an interactive, audio-visual format discussing the stress response, myth-busting cognitive distortions related to stress, and facilitating safe exposure to feared sensations. Participants then complete a validated cognitive bias modification (CBM-I) for interpretation biases related to anxiety sensitivity. Finally, intervention principles are reinforced using ecological momentary intervention (EMI), in which surveys and personalized reminders are delivered based on symptoms reported during ecological momentary assessments (EMAs)
RISE Guide delivered by smartphone via Qualtrics and is completed in \~45 minutes over 2 weeks, with EMI weeks 1-7 post-assault.
RISE Guide: Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.
|
Relaxation Control
n=33 Participants
Breathe2Relax is a mobile application that instructs users on diaphragmatic breathing, a coping tool in which slow breathing through the diaphragm reduces anxiety. Participants in the control condition will download Breathe2Relax to their smartphones and receive short message service (SMS) reminders to engage with the app. The control intervention is expected to reduce symptoms, but not as much as the cognitive-behavioral therapy strategies taught in RISE Guide.
Relaxation Control: Guides users through relaxation techniques.
|
|---|---|---|
|
Final Proportion of Participants Who Completed Follow-ups
7 Weeks
|
0.85 proportion of participants
|
0.67 proportion of participants
|
|
Final Proportion of Participants Who Completed Follow-ups
6 Months
|
0.70 proportion of participants
|
0.52 proportion of participants
|
SECONDARY outcome
Timeframe: up to approximately 7 monthsInvestigators will examine whether unexpected adverse events occur throughout each participant's participation in the study.
Outcome measures
| Measure |
RISE Guide
n=27 Participants
The RISE (RCT for Innovating Stress-related eHealth) Guide is based on CAST, an anxiety sensitivity intervention effective in reducing anxiety sensitivity, posttraumatic stress, depression, and anxiety. RISE Guide delivers psychoeducation and cognitive-behavioral therapy principles in an interactive, audio-visual format discussing the stress response, myth-busting cognitive distortions related to stress, and facilitating safe exposure to feared sensations. Participants then complete a validated cognitive bias modification (CBM-I) for interpretation biases related to anxiety sensitivity. Finally, intervention principles are reinforced using ecological momentary intervention (EMI), in which surveys and personalized reminders are delivered based on symptoms reported during ecological momentary assessments (EMAs)
RISE Guide delivered by smartphone via Qualtrics and is completed in \~45 minutes over 2 weeks, with EMI weeks 1-7 post-assault.
RISE Guide: Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.
|
Relaxation Control
n=33 Participants
Breathe2Relax is a mobile application that instructs users on diaphragmatic breathing, a coping tool in which slow breathing through the diaphragm reduces anxiety. Participants in the control condition will download Breathe2Relax to their smartphones and receive short message service (SMS) reminders to engage with the app. The control intervention is expected to reduce symptoms, but not as much as the cognitive-behavioral therapy strategies taught in RISE Guide.
Relaxation Control: Guides users through relaxation techniques.
|
|---|---|---|
|
Unexpected Adverse Events by Event
|
0 adverse events
|
0 adverse events
|
Adverse Events
RISE Guide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Relaxation Control
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
Nicole Short, PhD
University of North Carolina at Chapel Hill
Phone: 702-895-3305
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place