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Safety Aid Reduction Treatment for Rural Veterans (START)

Primary Purpose

Emotional Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Safety Aid Reduction Treatment
Sponsored by
Southeast Louisiana Veterans Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Emotional Disorder focused on measuring transdiagnostic treatment, emotional disorders, veterans, rural

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age and older
  • Veterans must be diagnosed with an emotional disorder (e.g., anxiety disorder, obsessive-compulsive and related disorder, trauma-and stressor-related disorder, depressive disorder).
  • And be primarily served at a CBOC location.

Exclusion Criteria:

  • < 18 years of age
  • Currently dependent upon substances and in need of detoxification
  • Evidence of active psychosis
  • Acutely suicidal or homicidal
  • Uncontrolled bipolar disorder (e.g., not stable on medications)

Sites / Locations

  • Southeast Louisiana Veterans Health Care System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

START

Arm Description

The Safety Aid Reduction Treatment (START) protocol will consist of eight group sessions, delivered once weekly, lasting approximately one hour in duration. START will be delivered in-person by the PI and group co-leader.

Outcomes

Primary Outcome Measures

START Qualitative Treatment Questionnaire
The START Qualitative Treatment Questionnaire is a brief, structured short-answer qualitative questionnaire that was developed by the research team to assess Veterans experience with the START protocol.

Secondary Outcome Measures

Overall Anxiety Severity and Impairment Scale (OASIS)
The OASIS is a brief 5-item self-report questionnaire that can be used to assess anxiety severity and impairment across a number of anxiety diagnoses. Participants will be asked to respond to items regarding their experience with anxiety and fear over the past week using a zero (No anxiety) to four (Constant anxiety) Likert-type scale. Items are summed to create a total score with higher scores indicating greater anxiety severity.
Overall Depression Severity and Impairment Scale (ODSIS)
The ODSIS is a brief 5-item self-report questionnaire that can be used to assess depression severity and impairment across heterogeneous mood disorders. Participants will be asked to respond to items regarding their experience with depression over the past week using a zero (No depression) to four (Constant depression) Likert-type scale. Items are summed to create a total score with higher scores indicating greater depression severity.
Safety Behavior Assessment Form (SBAF)
The SBAF is a 41-item self-report questionnaire designed to assess safety behavior usage. Participants will be asked to read a list of behaviors that people sometimes use to make themselves feel more comfortable and pick the response that most accurately describes how often they engage in that behavior using a zero (Never) to three (Always) Likert-type scale. Items are summed to create a total score with higher scores indicating greater safety aid usage.
Work and Social Adjustment Scale (WSAS)
The WSAS is a 5-item descriptive measure of subjective interference of psychiatric symptoms in various life domains (i.e., work, home, leisure, and family). Participants will be asked to read a list of problems and determine how much the problem impairs their ability to carry out the activity using a zero (Not at all) to eight (Very severely) Likert-type scale. Items are summed to create a total score with higher scores indicating greater impairment.

Full Information

First Posted
July 12, 2017
Last Updated
February 27, 2020
Sponsor
Southeast Louisiana Veterans Health Care System
Collaborators
South Central Mental Illness Research Education and Clinical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03285516
Brief Title
Safety Aid Reduction Treatment for Rural Veterans
Acronym
START
Official Title
Improving Access to Evidence Based Care Among Rural Veterans Using a Transdiagnostic Treatment Approach
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
April 2, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast Louisiana Veterans Health Care System
Collaborators
South Central Mental Illness Research Education and Clinical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary aim of the current proposal is to test the acceptability and feasibility of a group-based transdiagnostic treatment, termed Safety Aid Reduction Treatment (START), delivered to rural Veterans. The anticipated results of the proposed study include: 1) START will be both acceptable and feasible to Veterans and mental health care providers, alike and 2) START will lead to meaningful reductions in symptoms of anxiety and depression.
Detailed Description
This is an intervention pilot project examining the acceptability, feasibility, and utility of a group-based transdiagnostic treatment delivered to rural Veterans. Approximately 5.2 million Veterans reside in rural communities across the United States, making it difficult for them to access quality medical and mental health (MH) care. The Department of Veterans Affairs (VA) established Community Based Outpatient Clinics (CBOCs) to improve access to healthcare for rural Veterans; however, these clinics often lack MH specialists including psychiatrists and psychologists, limiting the breadth of specialty services available. As such, MH care is often delivered by primary care providers or MH clinicians who (a) lack familiarity with evidence-based interventions and (b) lack the time needed to implement such intensive therapies. Group-based cognitive behavioral protocols that target a number of different diagnoses are likely to be more attractive in these settings and therefore more readily disseminated. Such protocols, often referred to as transdiagnostic treatments, are based on the theory that emotional disorders share common features and therefore respond to common therapeutic procedures. One such treatment, termed Safety Aid Reduction Treatment (START), has received increasing empirical support. This group-based transdiagnostic treatment is designed to address cognitive and behavioral strategies, otherwise known as safety aids, that are common across a number of psychiatric conditions (e.g., anxiety disorders, trauma- and stressor-related disorders, obsessive-compulsive and related disorders, and depressive disorders) and used to reduce anxiety. START has been found to effectively reduce psychopathology in community-based clinical samples and more recently among Veterans at the Southeast Louisiana Veterans Health Care System (SLVHCS). However, the utility of this treatment has yet to be examined in rural settings. Thus, the primary aim of the current proposal is to test the acceptability and feasibility of a group-based transdiagnostic treatment, termed START, delivered to rural Veterans at CBOCs. Because this is a pilot project, we will not emphasize symptom reduction, as we will likely be underpowered to detect treatment effects. Nevertheless, a secondary aim of the project is to examine the utility of START by gathering data on symptom change, which will be used as pilot data for a subsequent grant proposal. For this pilot project, Veterans (N = 24) will be recruited from two of the five Southeast Louisiana Veterans Health Care System (SLVHCS) CBOCs. The anticipated results of the proposed study include: 1) START will be both acceptable and feasible to Veterans and mental health care providers, alike and 2) START will lead to meaningful reductions in symptoms of anxiety and depression. Findings from the current study will help to advance our understanding of the amelioration of anxiety and depressive disorders among Veterans.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Disorder
Keywords
transdiagnostic treatment, emotional disorders, veterans, rural

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
START
Arm Type
Experimental
Arm Description
The Safety Aid Reduction Treatment (START) protocol will consist of eight group sessions, delivered once weekly, lasting approximately one hour in duration. START will be delivered in-person by the PI and group co-leader.
Intervention Type
Behavioral
Intervention Name(s)
Safety Aid Reduction Treatment
Intervention Description
START includes many of the key elements found in empirically supported treatments for emotional disorders including a) psychoeducation regarding the nature of distress and b) exposure to internal sensations and external situations that are connected to one's distress response via identification and reduction in safety aids. Safety aids discussed in the current protocol include cognitive avoidance, situational avoidance, checking behaviors, reassurance seeking, avoidance of bodily sensations, companions, and use of alcohol and other substances.
Primary Outcome Measure Information:
Title
START Qualitative Treatment Questionnaire
Description
The START Qualitative Treatment Questionnaire is a brief, structured short-answer qualitative questionnaire that was developed by the research team to assess Veterans experience with the START protocol.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Overall Anxiety Severity and Impairment Scale (OASIS)
Description
The OASIS is a brief 5-item self-report questionnaire that can be used to assess anxiety severity and impairment across a number of anxiety diagnoses. Participants will be asked to respond to items regarding their experience with anxiety and fear over the past week using a zero (No anxiety) to four (Constant anxiety) Likert-type scale. Items are summed to create a total score with higher scores indicating greater anxiety severity.
Time Frame
Baseline and 8 weeks and 12 weeks
Title
Overall Depression Severity and Impairment Scale (ODSIS)
Description
The ODSIS is a brief 5-item self-report questionnaire that can be used to assess depression severity and impairment across heterogeneous mood disorders. Participants will be asked to respond to items regarding their experience with depression over the past week using a zero (No depression) to four (Constant depression) Likert-type scale. Items are summed to create a total score with higher scores indicating greater depression severity.
Time Frame
Baseline and 8 weeks and 12 weeks
Title
Safety Behavior Assessment Form (SBAF)
Description
The SBAF is a 41-item self-report questionnaire designed to assess safety behavior usage. Participants will be asked to read a list of behaviors that people sometimes use to make themselves feel more comfortable and pick the response that most accurately describes how often they engage in that behavior using a zero (Never) to three (Always) Likert-type scale. Items are summed to create a total score with higher scores indicating greater safety aid usage.
Time Frame
Baseline and 8 weeks and 12 weeks
Title
Work and Social Adjustment Scale (WSAS)
Description
The WSAS is a 5-item descriptive measure of subjective interference of psychiatric symptoms in various life domains (i.e., work, home, leisure, and family). Participants will be asked to read a list of problems and determine how much the problem impairs their ability to carry out the activity using a zero (Not at all) to eight (Very severely) Likert-type scale. Items are summed to create a total score with higher scores indicating greater impairment.
Time Frame
Baseline and 8 weeks and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age and older Veterans must be diagnosed with an emotional disorder (e.g., anxiety disorder, obsessive-compulsive and related disorder, trauma-and stressor-related disorder, depressive disorder). And be primarily served at a CBOC location. Exclusion Criteria: < 18 years of age Currently dependent upon substances and in need of detoxification Evidence of active psychosis Acutely suicidal or homicidal Uncontrolled bipolar disorder (e.g., not stable on medications)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda M. Raines, Ph.D.
Organizational Affiliation
Southeast Louisiana Veterans Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southeast Louisiana Veterans Health Care System
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data sets underlying this project will not be shared outside the VA, except as required under the Freedom of Information Act (FOIA), for a number of reasons. First, data will be used by the research team to answer additional research questions. Further, veterans may be hesitant to participate in research in which the data will be shared outside the VA and this may act as a barrier to participation and/or benefit from treatment.
Citations:
Citation
Veterans Health Administration Office of Rural Health. ORH Fact Sheet. 2014; Available from: http://www.ruralhealth.va.gov.
Results Reference
background
Citation
Allen, L.B., R.K. McHugh, and D.H. Barlow, Emotional disorders: A unified protocol. 2008.
Results Reference
background
PubMed Identifier
22697441
Citation
Schmidt NB, Buckner JD, Pusser A, Woolaway-Bickel K, Preston JL, Norr A. Randomized controlled trial of false safety behavior elimination therapy: a unified cognitive behavioral treatment for anxiety psychopathology. Behav Ther. 2012 Sep;43(3):518-32. doi: 10.1016/j.beth.2012.02.004. Epub 2012 Mar 9.
Results Reference
background
PubMed Identifier
27397584
Citation
Riccardi CJ, Korte KJ, Schmidt NB. False Safety Behavior Elimination Therapy: A randomized study of a brief individual transdiagnostic treatment for anxiety disorders. J Anxiety Disord. 2017 Mar;46:35-45. doi: 10.1016/j.janxdis.2016.06.003. Epub 2016 Jun 18.
Results Reference
background

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Safety Aid Reduction Treatment for Rural Veterans

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