Safety Aid Reduction Treatment for Rural Veterans (START)
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|ClinicalTrials.gov Identifier: NCT03285516|
Recruitment Status : Completed
First Posted : September 18, 2017
Last Update Posted : May 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Emotional Disorder||Behavioral: Safety Aid Reduction Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Improving Access to Evidence Based Care Among Rural Veterans Using a Transdiagnostic Treatment Approach|
|Actual Study Start Date :||April 16, 2018|
|Actual Primary Completion Date :||April 2, 2019|
|Actual Study Completion Date :||April 30, 2019|
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.
Behavioral: Safety Aid Reduction Treatment
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.
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285516
|United States, Louisiana|
|Southeast Louisiana Veterans Health Care System|
|New Orleans, Louisiana, United States, 70112|
|Principal Investigator:||Amanda M. Raines, Ph.D.||Southeast Louisiana Veterans Health Care System|