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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

Baseline, Week 1

Results posted on

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

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

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 1

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).

Outcome measures

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 1

The 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

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 1

The 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

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 1

The 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

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 1

The 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

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)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sham Neutral Training (SNT)

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. Wen Li

Florida State University

Phone: 850-645-1409

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place