An interventional study of False Safety Behavioral Elimination Treatment (FSET) and Enhanced Standard Care in Anxiety Disorders and Post-traumatic Stress Disorder, sponsored by Massachusetts General Hospital. Recruiting at 1 site in South Africa. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-17.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
The purpose of this study is to examine the use of a brief transdiagnostic treatment for anxiety disorders and (post-traumatic stress disorder (PTSD) in South Africa. The intervention will be delivered by non-specialist providers (e.g., nurses) in primary care clinics. The brief intervention group will be compared to an enhanced standard care control group.
Post-traumatic stress disorder (PTSD) and anxiety disorders are highly prevalent and a leading cause of disability in low and middle-income countries (LMICs). Despite the development of evidence-based treatments (EBTs), an overwhelming majority of those in need (i.e., 85%) in LMICs do not receive treatment and, when they do, it is not empirically based. Despite the clear need for EBTs in LMICs, there are three primary barriers associated with the implementation of EBTs in these areas. These barriers include: (1) EBTs tend to be single disorder focused only treating one disorder at a time, (2) they are long in duration (e.g., 12-16 treatment sessions to treat one disorder), and (3) they tend to be complex and require a high level of skill to administer. Given the low availability of highly trained providers in LMICs, using an approach that is brief, culturally congruent, and less complex than typical EBTs is ideal for reducing these barriers. The current study aims to evaluate the use of a brief transdiagnostic treatment for anxiety disorders and PTSD (False Safety Behavior Elimination Treatment; F-SET) in South African primary care clinics. The current study is a Type 1 hybrid effectiveness-implementation trial assessing the effectiveness of the adapted brief transdiagnostic intervention and to explore facilitators and barriers to implementation. The adapted intervention is being compared to an enhanced standard care control condition.
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Exclusion Criteria:
The anxiety disorders and post-traumatic stress disorder (PTSD) transdiagnostic treatment (FSET) is brief, 5-session, cognitive-behavioral intervention designed to treat symptoms associated with anxiety disorders and PTSD. The treatment is administered by lay providers (e.g., nurses) in primary care clinics in South Africa.
Behavioral: False Safety Behavioral Elimination Treatment (FSET)
The enhanced standard care group is the condition. Those in the enhanced standard care control group will receive standard care plus referrals. Upon completion of the study, they will be offered the anxiety disorder and post-traumatic stress disorder treatment (FSET).
Behavioral: Enhanced Standard Care
5-session transdiagnostic treatment for anxiety disorders and post-traumatic stress disorder (PTSD)
Participants in the enhanced standard care control group will receive treatment as usual and a list referrals.
Structured Clinical Interview for the DSM-5 (SCID-5)
Diagnostic assessment assessing the presence or absence of a mental health diagnosis.
Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Clinician-Administered PTSD Scale for the DSM-5 (CAPS)
Diagnostic assessment assessing the presence or absence of post-traumatic stress disorder (PTSD)
Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Work Social Adjustment Scale (WSAS)
Assessment of functional impairment. Scores range from 0 to 40 with higher scores indicating higher levels of functional impairment.
Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
General Anxiety Disorder-7 (GAD-7)
General measure of anxiety. Scores range from 0 to 21 with higher scores indicating greater level of anxiety.
Time frame: pre-treatment, immediately after the last treatment session, and 3-month follow-up
Beck Anxiety Inventory (BAI)
Measure of anxiety symptoms. Scores range from 0 to 63 with higher scores indicating greater levels of anxiety.
Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Safety Aid Scale (SAS)
Assessment of safety aid utilization and avoidance in anxiety disorders and PTSD. Higher scores indicate greater safety aid utilization.
Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Post-traumatic Disorder Checklist (PCL-5 PTSD Checklist (PCL-5)
PTSD symptom measure. Scores range from 0 to 80 with higher scores indicating greater level of post-traumatic stress symptoms.
Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Patient Health Questionnaire - 9 (PHQ-9)
Measure of emotional distress. Scores range from 0 to 20 with higher scores indicating greater emotional distress.
Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Beck Depression Inventory (BDI)
Measure of depressive symptoms. Scores range from 0 to 63 with higher scores indicating greater levels of depression.
Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Anxiety Sensitivity Index -3
Assessment of anxiety sensitivity. Scores range from 0 to 72 with higher scores indicated higher levels of anxiety sensitivity.
Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Life Events Checklist (LEC)
Assessment of exposure to traumatic events. Endorsement of events indicates the degree to which one has been exposed to traumatic events.
Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Alcohol Use Disorders Identification Test (AUDIT)
Assessment of alcohol use. Scores range from 0 to 40 with higher scores indicating possible problematic alcohol use.
Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
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