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OSA PAP Treatment for Veterans With SUD and PTSD on Residential Treatment Unit

Primary Purpose

Post Traumatic Stress Disorder, Obstructive Sleep Apnea, Substance Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive Airway Pressure Device
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring Veteran, PTSD, Obstructive Sleep Apnea, Substance Use Disorder, PAP Treatment, Residential Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • a Veteran of the U.S. military or Reserve/National Guard member
  • at least 18 years of age
  • have an AHI 5 per hour
  • experienced trauma that occurred in childhood or adulthood; at least one month post-trauma
  • have current DSM-5 diagnoses of SUD via SCID-SUD module with a minimum 20 days of substance use in the last 90 days (Timeline Follow-back)
  • Full PTSD diagnosis via clinician administered PTSD scale
  • are literate in English
  • are on the PTSD track of the SARRTP unit
  • are capable of giving informed consent

Exclusion Criteria:

  • have central sleep apnea (AHI >=5 and > 50% central apneas)
  • arrives on the SARRTP unit already using a PAP device (Veteran's previously diagnosed with OSA, but not using PAP therapy will be eligible)
  • the SARRTP medical staff advises against the study based on medical history and physical examination; d) history of severe cognitive impairment (via MOCA < 26)
  • history of psychosis or mania independent of substance use will be excluded because the presence of these disorders can impede therapy progress

Sites / Locations

  • VA San Diego Healthcare System, San Diego, CARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PAP Treatment on SARRTP Unit

Waitlist Control

Arm Description

Veterans will receive Positive Airway Pressure device while on the 28-day SARRTP Unit.

Veterans will not receive PAP device until after 3-month Follow Up.

Outcomes

Primary Outcome Measures

Change in WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Change in functional impairment across multiple domains. The WHODAS 2.0 is a 36-item questionnaire that assess functional impairment across 5 subscales: cognitions (understanding and communicating), mobility, self-care getting along with others, household responsibilities, work responsibilities, and community participation.
Change in Timeline Follow-Back (TLFB) % days drinking/using in last 90 days
Examining change in percentage of substance use in the past 90 days.
Change in Clinician Administered PTSD Scale (CAPS-5)
Change in PTSD symptom severity will be assessed using CAPS-5 in the past month. The CAPS-5 is a 30-item structured interview.
Change in The Columbia-Suicide Severity Rating Scale (C-SSRS)
Change in suicidal ideation severity using the C-SSRS. The C-SSRS is a standardized 8-point clinician-administered suicidal rating system designed to track suicidal adverse events across a treatment trial and covering the wide spectrum of suicidality

Secondary Outcome Measures

PAP adherence rates
Examining average number of nights used positive airway pressure is use over the last 30 days.

Full Information

First Posted
November 30, 2021
Last Updated
January 12, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05156112
Brief Title
OSA PAP Treatment for Veterans With SUD and PTSD on Residential Treatment Unit
Official Title
Examining Early Intervention Obstructive Sleep Apnea Treatment on Long-Term Outcomes in Veterans With SUD/PTSD in a Residential Treatment Program
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2023 (Actual)
Primary Completion Date
May 31, 2027 (Anticipated)
Study Completion Date
May 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Substance use disorder (SUD) and posttraumatic stress disorder (PTSD) frequently co-occur and having both disorders is associated with greater psychological and functional impairment than having either disorder alone. This is especially true in residential settings where both disorders are more severe than outpatient settings. Obstructive sleep apnea (OSA) is highly comorbid with both disorders and untreated OSA is associated with worse functional impairment across multiple domains, worse quality of life, worse PTSD, higher suicidal ideation, and higher substance use and relapse rates. Treating OSA with evidence-based positive airway pressure (PAP) in Veterans with SUD/PTSD on a residential unit is a logical way to maximize treatment adherence and treatment outcomes. This study compares OSA treatment while on a SUD/PTSD residential unit to a waitlist control group. The investigators hypothesize that treating OSA on the residential unit, compared to the waitlist control, will have better functional, SUD, and PTSD outcomes.
Detailed Description
Substance use disorder (SUD) and posttraumatic stress disorder (PTSD) frequently co-occur and having one condition worsens the course of the other. Individuals with both disorders exhibit worse functioning across a number of domains than individuals with either disorder alone. This is especially true in residential settings where both disorders are more severe than outpatient settings. Compared to Veterans with a single disorder, Veterans with SUD/PTSD also are more likely to have suicidal ideation and to have attempted suicide. Examining treatable conditions that are associated with improved SUD and PTSD outcomes, such as obstructive sleep apnea (OSA), can maximize treatment efficacy for Veterans at a critical time in recovery. OSA is highly comorbid with both PTSD and SUD with upwards of 67 to 83% of Veterans with SUD or PTSD also having OSA. Further, untreated OSA is associated with worse functional impairment across multiple domains, worse quality of life, worse PTSD, and higher substance use and relapse rates. Importantly, untreated OSA also contributes to higher suicide attempts and completion. Positive airway pressure (PAP) is the gold standard treatment for OSA with large effects on multiple domains of functioning, quality of life, PTSD symptoms, physical functioning, lower depression, and better emotional coping. Unfortunately, screening and treating Veterans for OSA is not a part of clinical practice for SUD or PTSD treatment; as such the average wait time for individuals to get PAP therapy is upward of two years. Despite the widespread dissemination of knowledge regarding the detrimental effects of untreated OSA and the incredible effectiveness of PAP treatment, OSA is rarely screened for or treated in patients with SUD or PTSD, with approximately 80% to 90% of Veterans with OSA remaining undiagnosed and untreated. Methodology. The investigators aim to examine the effects of PAP treatment on Veterans with PTSD and SUD on a 28-day residential unit. The investigators are proposing a randomized controlled study comparing two groups: an early intervention PAP treatment group receiving PAP treatment while on the residential unit, compared to a waitlist control group who will receive PAP treatment at 3-months post-discharge follow-up. Participants will be 194 male and female Veterans on the residential SUD and PTSD unit with SUD, PTSD, and OSA. The primary aim is to determine the relative efficacy of PAP treatment on the SUD/PTSD unit, as compared to waitlist control, in reducing problematic substance use, PTSD symptoms, and suicidal ideation, while improving functioning among Veterans with comorbid SUD/PTSD at 3-months post-treatment follow-up. The investigators will also compare PAP adherence rates on PTSD/SUD/functioning outcomes within the PAP treatment group (3-months). Finally, the investigators plan on comparing adherence rates between the two treatment groups at the 6-months post-treatment follow-up assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Obstructive Sleep Apnea, Substance Use Disorder, Residential Treatment Program
Keywords
Veteran, PTSD, Obstructive Sleep Apnea, Substance Use Disorder, PAP Treatment, Residential Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The investigators aim to examine the effects of PAP treatment on Veterans with PTSD and SUD on a 28-day residential unit. The investigators are proposing a randomized controlled study comparing two groups: an early intervention PAP treatment group receiving PAP treatment while on the residential unit, compared to a waitlist control group who will receive PAP treatment at 3-months post-discharge follow-up.
Masking
Outcomes Assessor
Masking Description
All assessors will be blinded to treatment condition to minimize bias in outcome assessments
Allocation
Randomized
Enrollment
194 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PAP Treatment on SARRTP Unit
Arm Type
Experimental
Arm Description
Veterans will receive Positive Airway Pressure device while on the 28-day SARRTP Unit.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
Veterans will not receive PAP device until after 3-month Follow Up.
Intervention Type
Device
Intervention Name(s)
Positive Airway Pressure Device
Other Intervention Name(s)
PAP; CPAP; Auto-PAP
Intervention Description
Each PAP treatment initiation meeting will include 1) mask fitting; 2) psycho-education to what to expect and reviewing PAP machine problem solving; and 3) setting up correct PAP treatment (e.g., auto PAP or in rare conditions, bi-level PAP).
Primary Outcome Measure Information:
Title
Change in WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Description
Change in functional impairment across multiple domains. The WHODAS 2.0 is a 36-item questionnaire that assess functional impairment across 5 subscales: cognitions (understanding and communicating), mobility, self-care getting along with others, household responsibilities, work responsibilities, and community participation.
Time Frame
Baseline, Post-SARRTP Unit (28 Days), 3-Month Follow up (90 Days)
Title
Change in Timeline Follow-Back (TLFB) % days drinking/using in last 90 days
Description
Examining change in percentage of substance use in the past 90 days.
Time Frame
Baseline, 3-Month Follow up (90 Days)
Title
Change in Clinician Administered PTSD Scale (CAPS-5)
Description
Change in PTSD symptom severity will be assessed using CAPS-5 in the past month. The CAPS-5 is a 30-item structured interview.
Time Frame
Baseline, Post-SARRTP Unit (28 Days), 3-Month Follow up (90 Days)
Title
Change in The Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
Change in suicidal ideation severity using the C-SSRS. The C-SSRS is a standardized 8-point clinician-administered suicidal rating system designed to track suicidal adverse events across a treatment trial and covering the wide spectrum of suicidality
Time Frame
Baseline, Post-SARRTP Unit (28 Days), 3-Month Follow up (90 Days)
Secondary Outcome Measure Information:
Title
PAP adherence rates
Description
Examining average number of nights used positive airway pressure is use over the last 30 days.
Time Frame
3-Month Follow up (90 Days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a Veteran of the U.S. military or Reserve/National Guard member at least 18 years of age have an AHI 5 per hour experienced trauma that occurred in childhood or adulthood; at least one month post-trauma have current DSM-5 diagnoses of SUD via SCID-SUD module with a minimum 20 days of substance use in the last 90 days (Timeline Follow-back) Full PTSD diagnosis via clinician administered PTSD scale are literate in English are on the PTSD track of the SARRTP unit are capable of giving informed consent Exclusion Criteria: have central sleep apnea (AHI >=5 and > 50% central apneas) arrives on the SARRTP unit already using a PAP device (Veteran's previously diagnosed with OSA, but not using PAP therapy will be eligible) the SARRTP medical staff advises against the study based on medical history and physical examination; d) history of severe cognitive impairment (via MOCA < 26) history of psychosis or mania independent of substance use will be excluded because the presence of these disorders can impede therapy progress
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Colvonen, PhD
Phone
(858) 552-8585
Ext
2468
Email
peter.colvonen@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Colvonen, PhD
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerhard H Schulteis, PhD
Phone
858-642-3657
Email
gerhard.schulteis@va.gov
First Name & Middle Initial & Last Name & Degree
Peter Colvonen, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

OSA PAP Treatment for Veterans With SUD and PTSD on Residential Treatment Unit

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