- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03285516
Safety Aid Reduction Treatment for Rural Veterans (START)
February 27, 2020 updated by: C Laurel Franklin, PhD, Southeast Louisiana Veterans Health Care System
Improving Access to Evidence Based Care Among Rural Veterans Using a Transdiagnostic Treatment Approach
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112
- Southeast Louisiana Veterans Health Care System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: START
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
START Qualitative Treatment Questionnaire
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Anxiety Severity and Impairment Scale (OASIS)
Time Frame: Baseline and 8 weeks and 12 weeks
|
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.
|
Baseline and 8 weeks and 12 weeks
|
Overall Depression Severity and Impairment Scale (ODSIS)
Time Frame: Baseline and 8 weeks and 12 weeks
|
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.
|
Baseline and 8 weeks and 12 weeks
|
Safety Behavior Assessment Form (SBAF)
Time Frame: Baseline and 8 weeks and 12 weeks
|
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.
|
Baseline and 8 weeks and 12 weeks
|
Work and Social Adjustment Scale (WSAS)
Time Frame: Baseline and 8 weeks and 12 weeks
|
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.
|
Baseline and 8 weeks and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Amanda M. Raines, Ph.D., Southeast Louisiana Veterans Health Care System
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Veterans Health Administration Office of Rural Health. ORH Fact Sheet. 2014; Available from: http://www.ruralhealth.va.gov.
- Allen, L.B., R.K. McHugh, and D.H. Barlow, Emotional disorders: A unified protocol. 2008.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 16, 2018
Primary Completion (Actual)
April 2, 2019
Study Completion (Actual)
April 30, 2019
Study Registration Dates
First Submitted
July 12, 2017
First Submitted That Met QC Criteria
September 14, 2017
First Posted (Actual)
September 18, 2017
Study Record Updates
Last Update Posted (Actual)
March 2, 2020
Last Update Submitted That Met QC Criteria
February 27, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 351 (IRB Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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