Perceptual Retraining to Reduce Suicide Risk

NCT02845700 | Completed Results

• 1 other identifier: A-16054.13a
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

The study will use a prospective design consisting of three phases. The phases are:

1. 1.the development of the perceptual retraining treatment (PRT),
2. 2.the evaluation of the treatment's feasibility and acceptability, and
3. 3.an assessment of its efficacy.

Conditions

Perceptual Olfactory Bias

Outcome Measures

Primary Outcomes (1)

• Percent Change in Olfactory Perceptual Bias

  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).

  Baseline, Week 1

Secondary Outcomes (4)

• Change From Baseline in Mean Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at 1 Month

  Baseline, month 1

• Change in Suicidal Ideation Assessed Using the Depressive Symptom Inventory - Suicidality Subscale

  Baseline, month 1

• Change in Beck Suicide Scale Scores From Baseline to 1 Month

  Baseline, month 1

• Change in the Beck Anxiety Inventory-II From Baseline to 1 Month

  Baseline, month 1

Study Arms (2)

Perceptual Retraining Treatment (PRT)

ACTIVE COMPARATOR

The Perceptual Retraining Treatment will involve systematic presentation of diluted malodors. For each individual, vials on either side of their initial ideographic detection threshold 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). Each training session will consist of 4 training blocks.

Behavioral: Perceptual Retraining Treatment

Sham Neutral Training (SNT)

PLACEBO COMPARATOR

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 PRT. Following the one-month assessment, they will be given the option to complete the PRT.

Behavioral: Sham Neutral training

Interventions

Perceptual Retraining Treatment BEHAVIORAL

Perceptual retraining involves the systematic presentation of diluted malodors (i.e., odors perceived as threatening). For each individual, vials on either side of a pre-determined and ideographic detection threshold 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).

Perceptual Retraining Treatment (PRT)

Sham Neutral training BEHAVIORAL

Control condition using systematic presentation of diluted neutral-neutral odor pairs.

Sham Neutral Training (SNT)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• evidence of olfactory perceptual bias toward military-relevant stimuli (e.g., burning rubber, decay, fuel).
• military combat exposure in Operation Iraqi Freedom, Enduring Freedom, or New Dawn.
• Age 18-60.

You may not qualify if:

• Significant medical illness that compromises olfactory perception or tolerance (e.g., significant olfactory disease or dysfunction, cardiovascular disease, respiratory disorders, renal disease, epilepsy, stroke, and uncontrolled hypertension or migraines).
• Evidence of imminent suicidal intent
• Evidence of current or past psychotic-spectrum disorders, or uncontrolled bipolar disorder.
• English speakers.

Sponsors & Collaborators

• Florida State University: lead
• United States Department of Defense: collaborator
• Southeast Louisiana Veterans Health Care System: collaborator

Study Sites (2)

Florida State University

Tallahassee, Florida, 32306, United States

Location

Southeast Louisiana Veterans Health Care System

New Orleans, Louisiana, 70112, United States

Location

Limitations and Caveats

Overall sample size was limited due to delays of project approval at the Southeast Louisiana Veterans Health Care System site. Early terminations at the Florida State University site further lead to small numbers of subjects to be analyzed

Results Point of Contact

• Title: Dr. Wen Li
• Organization: Florida State University

wenli@neuro.fsu.edu

850-645-1409

Study Officials

• Wen Li, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

• Laurel Franklin, PhD

  Southeastern Louisiana Veterans Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: July 27, 2016
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 14, 2019
• Results First Posted: January 14, 2019

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)