Trial Outcomes & Findings for Perceptual Retraining to Reduce Suicide Risk (NCT NCT02845700)
NCT ID: NCT02845700
Last Updated: 2019-01-14
Results Overview
A participant's ability to detect an array of threatening malodor in neutral dilution gradients will be tested at baseline and after the second and final intervention session (one week after baseline). Perceptual bias is calculated as the percentage of correct responses (i.e., yes or no to detecting the malodor) on an odor over 6 trials for each of the 8 odors, at 25% and 33% dilution (i.e., over 96 trials). Larger positive percentages indicate greater habituation to the malodor, and therefore a training effect toward reducing threat bias (i.e., a positive effect on intervention outcomes).
COMPLETED
NA
13 participants
Baseline, Week 1
2019-01-14
Participant Flow
Participants were recruited from the community. Assessments occurred at the Florida State University Anxiety and Behavioral Health Clinic. In total, 16 individuals were assessed for eligibility. Of these, 15 participants were randomized to an intervention condition, and 1 was excluded because they were not combat exposed.
Of the 15 participants randomized to condition, 2 did not receive their allocated intervention (both in the Sensory Retraining Treatment \[i.e., active\] condition), because they withdrew from the study before the baseline appointment.
Participant milestones
| Measure |
Perceptual Retraining Treatment (PRT)
The retraining portion (PRT) will also involve the systematic presentation of diluted malodors. For each individual, vials on either side of their initial ideographic detection threshold established in the bias assessment phase will be presented. Participants will be given feedback to shift their bias away from the malodorous target stimuli. In the context of diluted solutions participants will be given the feedback that they are "correct" when a "neutral" response is given to solutions that are above the starting threshold (stronger malodor) and "incorrect" when a target is endorsed that is below the starting threshold (weaker malodor).
|
Sham Neutral Training (SNT)
Approximately half of the participants will be randomized to the Sham Neutral Training (SNT) ondition designed to control for the effects of time and learning. In the SNT condition, participants will complete the same assessments (including the olfactory bias assessment), as well as a sham training consisting of neutral/neutral odor pairing dilutions, rather than the combat/neutral odor pairings as in the PRT. Following the one-month assessment, they will be given the option to complete the PRT.
|
|---|---|---|
|
Baseline Appointment
STARTED
|
6
|
7
|
|
Baseline Appointment
COMPLETED
|
6
|
7
|
|
Baseline Appointment
NOT COMPLETED
|
0
|
0
|
|
Intervention Session 1
STARTED
|
5
|
6
|
|
Intervention Session 1
COMPLETED
|
5
|
6
|
|
Intervention Session 1
NOT COMPLETED
|
0
|
0
|
|
Intervention Session 2
STARTED
|
5
|
6
|
|
Intervention Session 2
COMPLETED
|
5
|
6
|
|
Intervention Session 2
NOT COMPLETED
|
0
|
0
|
|
Month 1 Follow-Up
STARTED
|
2
|
4
|
|
Month 1 Follow-Up
COMPLETED
|
2
|
4
|
|
Month 1 Follow-Up
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Perceptual Retraining to Reduce Suicide Risk
Baseline characteristics by cohort
| Measure |
Sensory Retraining Treatment (SRT)
n=6 Participants
The retraining portion (SRT) will also involve the systematic presentation of diluted malodors. For each individual, vials on either side of their initial ideographic detection threshold established in the bias assessment phase will be presented. During the retraining, participants will be given feedback to shift their bias away from the malodorous target stimuli. For example, in the context of diluted solutions participants will be given the feedback that they are "correct" when a "neutral" response is given to solutions that are above the starting threshold (stronger malodor) and "incorrect" when a target is endorsed that is below the starting threshold (weaker malodor).
|
Sham Neutral Training (SNT)
n=7 Participants
Approximately half of the participants will be randomized to the SNT condition designed to control for the effects of time and learning. In the SNT condition, participants will complete the same assessments (including the olfactory bias assessment), as well as a sham training consisting of neutral/neutral odor pairing dilutions, rather than the combat/neutral odor pairings as in the SRT. Following the one-month assessment, they will be given the option to complete the SRT.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
37.33 years
STANDARD_DEVIATION 13.63 • n=99 Participants
|
32.71 years
STANDARD_DEVIATION 6.21 • n=107 Participants
|
34.85 years
STANDARD_DEVIATION 10.12 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 1A participant's ability to detect an array of threatening malodor in neutral dilution gradients will be tested at baseline and after the second and final intervention session (one week after baseline). Perceptual bias is calculated as the percentage of correct responses (i.e., yes or no to detecting the malodor) on an odor over 6 trials for each of the 8 odors, at 25% and 33% dilution (i.e., over 96 trials). Larger positive percentages indicate greater habituation to the malodor, and therefore a training effect toward reducing threat bias (i.e., a positive effect on intervention outcomes).
Outcome measures
| Measure |
Perceptual Retraining Treatment (PRT)
n=5 Participants
The retraining portion (PRT) will also involve the systematic presentation of diluted malodors. For each individual, vials on either side of their initial ideographic detection threshold established in the bias assessment phase will be presented. Participants will be given feedback to shift their bias away from the malodorous target stimuli. In the context of diluted solutions participants will be given the feedback that they are "correct" when a "neutral" response is given to solutions that are above the starting threshold (stronger malodor) and "incorrect" when a target is endorsed that is below the starting threshold (weaker malodor).
|
Sham Neutral Training (SNT)
n=6 Participants
Approximately half of the participants will be randomized to the SNT condition designed to control for the effects of time and learning. In the SNT condition, participants will complete the same assessments (including the olfactory bias assessment), as well as a sham training consisting of neutral/neutral odor pairing dilutions, rather than the combat/neutral odor pairings as in the SRT. Following the one-month assessment, they will be given the option to complete the SRT.
|
|---|---|---|
|
Percent Change in Olfactory Perceptual Bias
|
21.33 Percent of correctly identified odors
Standard Deviation 25.67
|
-5 Percent of correctly identified odors
Standard Deviation 23.7
|
SECONDARY outcome
Timeframe: Baseline, month 1The Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (CAPS-5) was administered at the baseline appointment and 1-month follow-up appointment to assess PTSD symptom severity. All 20 of the CAPS-5 items are scored 0-4 and summed to calculate a total score, which ranges from 0-80. Higher scores indicate greater PTSD symptom severity. A difference score was calculated by subtracting the CAPS-5 score at 1-month from baseline, and averaged across each condition; thus, higher (positive) change scores are indicative of increases in PTSD symptom severity, whereas lower (negative) change scores are indicative of decreases in PTSD symptom severity.
Outcome measures
| Measure |
Perceptual Retraining Treatment (PRT)
n=2 Participants
The retraining portion (PRT) will also involve the systematic presentation of diluted malodors. For each individual, vials on either side of their initial ideographic detection threshold established in the bias assessment phase will be presented. Participants will be given feedback to shift their bias away from the malodorous target stimuli. In the context of diluted solutions participants will be given the feedback that they are "correct" when a "neutral" response is given to solutions that are above the starting threshold (stronger malodor) and "incorrect" when a target is endorsed that is below the starting threshold (weaker malodor).
|
Sham Neutral Training (SNT)
n=3 Participants
Approximately half of the participants will be randomized to the SNT condition designed to control for the effects of time and learning. In the SNT condition, participants will complete the same assessments (including the olfactory bias assessment), as well as a sham training consisting of neutral/neutral odor pairing dilutions, rather than the combat/neutral odor pairings as in the SRT. Following the one-month assessment, they will be given the option to complete the SRT.
|
|---|---|---|
|
Change From Baseline in Mean Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at 1 Month
|
-16.00 Score on the CAPS-5
Standard Deviation 19.80
|
2.00 Score on the CAPS-5
Standard Deviation 16.71
|
SECONDARY outcome
Timeframe: Baseline, month 1The Depressive Symptom Inventory - Suicidality Subscale (DSI-SS) was administered at the baseline appointment and 1 month follow-up appointment to assess the severity of thoughts related suicidal ideation. All four items of the DSI-SS are scored on a 0-3 scale, with total possible sum scores ranging from 0-12; higher scores indicate greater severity of suicidal ideation. For the outcome measure reported, a difference score was calculated by subtracting DSI-SS scores at 1 month from DSI-SS scores at baseline, and averaged across conditions. DSI-SS change scores of zero reflect no change from baseline to 1 month.
Outcome measures
| Measure |
Perceptual Retraining Treatment (PRT)
n=2 Participants
The retraining portion (PRT) will also involve the systematic presentation of diluted malodors. For each individual, vials on either side of their initial ideographic detection threshold established in the bias assessment phase will be presented. Participants will be given feedback to shift their bias away from the malodorous target stimuli. In the context of diluted solutions participants will be given the feedback that they are "correct" when a "neutral" response is given to solutions that are above the starting threshold (stronger malodor) and "incorrect" when a target is endorsed that is below the starting threshold (weaker malodor).
|
Sham Neutral Training (SNT)
n=4 Participants
Approximately half of the participants will be randomized to the SNT condition designed to control for the effects of time and learning. In the SNT condition, participants will complete the same assessments (including the olfactory bias assessment), as well as a sham training consisting of neutral/neutral odor pairing dilutions, rather than the combat/neutral odor pairings as in the SRT. Following the one-month assessment, they will be given the option to complete the SRT.
|
|---|---|---|
|
Change in Suicidal Ideation Assessed Using the Depressive Symptom Inventory - Suicidality Subscale
|
0 Scores on the DSI-SS
Standard Deviation 0
|
0 Scores on the DSI-SS
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline, month 1The Beck Suicide Scale (BSS) was administered at the baseline appointment and 1-month follow-up appointment to assess thoughts and behaviors related to suicidal ideation, desire, and attempts. The BSS comprises 21 items rated on a 0-3 scale. The first 19 items are sum scored with total possible scores ranging from 0 - 38, with higher scores indicating greater severity of suicide risk. A difference scores was calculated by subtracting the BSS score at 1 month from BSS scores at baseline. Mean change scores of 0 reflect no change in BSS scores from baseline to 1 month.
Outcome measures
| Measure |
Perceptual Retraining Treatment (PRT)
n=2 Participants
The retraining portion (PRT) will also involve the systematic presentation of diluted malodors. For each individual, vials on either side of their initial ideographic detection threshold established in the bias assessment phase will be presented. Participants will be given feedback to shift their bias away from the malodorous target stimuli. In the context of diluted solutions participants will be given the feedback that they are "correct" when a "neutral" response is given to solutions that are above the starting threshold (stronger malodor) and "incorrect" when a target is endorsed that is below the starting threshold (weaker malodor).
|
Sham Neutral Training (SNT)
n=4 Participants
Approximately half of the participants will be randomized to the SNT condition designed to control for the effects of time and learning. In the SNT condition, participants will complete the same assessments (including the olfactory bias assessment), as well as a sham training consisting of neutral/neutral odor pairing dilutions, rather than the combat/neutral odor pairings as in the SRT. Following the one-month assessment, they will be given the option to complete the SRT.
|
|---|---|---|
|
Change in Beck Suicide Scale Scores From Baseline to 1 Month
|
0 Scores on the BSS
Standard Deviation 0
|
0 Scores on the BSS
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline, month 1The Beck Anxiety Inventory-II (BAI) was administered at the baseline appointment and 1-month follow-up appointment to assess symptom severity associated with anxious arousal. The BAI comprises 21 items rated on a 0-3 scale, which can be sum scored to calculate total scores ranging from 0 - 63. Higher scores on the BAI are indicative of greater anxious arousal. A difference scores was calculated by subtracting the BAI score at 1 month from BAI scores at baseline; thus, higher (positive) change scores are indicative of increases in anxious arousal, whereas lower (negative) change scores are indicative of decreases in anxious arousal.
Outcome measures
| Measure |
Perceptual Retraining Treatment (PRT)
n=2 Participants
The retraining portion (PRT) will also involve the systematic presentation of diluted malodors. For each individual, vials on either side of their initial ideographic detection threshold established in the bias assessment phase will be presented. Participants will be given feedback to shift their bias away from the malodorous target stimuli. In the context of diluted solutions participants will be given the feedback that they are "correct" when a "neutral" response is given to solutions that are above the starting threshold (stronger malodor) and "incorrect" when a target is endorsed that is below the starting threshold (weaker malodor).
|
Sham Neutral Training (SNT)
n=4 Participants
Approximately half of the participants will be randomized to the SNT condition designed to control for the effects of time and learning. In the SNT condition, participants will complete the same assessments (including the olfactory bias assessment), as well as a sham training consisting of neutral/neutral odor pairing dilutions, rather than the combat/neutral odor pairings as in the SRT. Following the one-month assessment, they will be given the option to complete the SRT.
|
|---|---|---|
|
Change in the Beck Anxiety Inventory-II From Baseline to 1 Month
|
-3.50 Scores on the BAI
Standard Deviation .71
|
-1.75 Scores on the BAI
Standard Deviation 3.5
|
Adverse Events
Sensory Retraining Treatment (SRT)
Sham Neutral Training (SNT)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place