Anxiety Disorders, Post-traumatic Stress Disorder
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALFalse Safety Behavioral Elimination Treatment (FSET)
5-session transdiagnostic treatment for anxiety disorders and post-traumatic stress disorder (PTSD)
BEHAVIORALEnhanced Standard Care
Participants in the enhanced standard care control group will receive treatment as usual and a list referrals.
Sponsors
University of Stellenbosch
Fogarty International Center of the National Institute of Health
Harvard Medical School (HMS and HSDM)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This is a Type 1 hybrid-effectiveness implementation trial. Study participants are randomized into the brief transdiagnostic treatment for anxiety disorders and post-traumatic stress disorder (PTSD) or an enhanced standard care control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants diagnosed with a primary anxiety disorder (panic disorder, generalized anxiety disorder, social anxiety disorder, or obsessive-compulsive disorder) or post-traumatic stress disorder.
Exclusion criteria
* Participants who are acutely suicidal, have severe alcohol of substance use disorder, or are engaged in another form of psychotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Aid Scale (SAS) | pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up | Assessment of safety aid utilization and avoidance in anxiety disorders and PTSD. Higher scores indicate greater safety aid utilization. |
| Structured Clinical Interview for the DSM-5 (SCID-5) | pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up | Diagnostic assessment assessing the presence or absence of a mental health diagnosis. |
| Clinician-Administered PTSD Scale for the DSM-5 (CAPS) | pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up | Diagnostic assessment assessing the presence or absence of post-traumatic stress disorder (PTSD) |
| Work Social Adjustment Scale (WSAS) | pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up | Assessment of functional impairment. Scores range from 0 to 40 with higher scores indicating higher levels of functional impairment. |
| General Anxiety Disorder-7 (GAD-7) | pre-treatment, immediately after the last treatment session, and 3-month follow-up | General measure of anxiety. Scores range from 0 to 21 with higher scores indicating greater level of anxiety. |
| Beck Anxiety Inventory (BAI) | pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up | Measure of anxiety symptoms. Scores range from 0 to 63 with higher scores indicating greater levels of anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-traumatic Disorder Checklist (PCL-5 PTSD Checklist (PCL-5) | pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up | PTSD symptom measure. Scores range from 0 to 80 with higher scores indicating greater level of post-traumatic stress symptoms. |
| Patient Health Questionnaire - 9 (PHQ-9) | pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up | Measure of emotional distress. Scores range from 0 to 20 with higher scores indicating greater emotional distress. |
| Beck Depression Inventory (BDI) | pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up | Measure of depressive symptoms. Scores range from 0 to 63 with higher scores indicating greater levels of depression. |
| Anxiety Sensitivity Index -3 | pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up | Assessment of anxiety sensitivity. Scores range from 0 to 72 with higher scores indicated higher levels of anxiety sensitivity. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Life Events Checklist (LEC) | pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up | Assessment of exposure to traumatic events. Endorsement of events indicates the degree to which one has been exposed to traumatic events. |
| Alcohol Use Disorders Identification Test (AUDIT) | pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up | Assessment of alcohol use. Scores range from 0 to 40 with higher scores indicating possible problematic alcohol use. |
Countries
South Africa
Contacts
Primary ContactKristina Korte, PhD
Outcome results
None listed