Anxiety DisordersNCT06289621
Brief Transdiagnostic Treatment for Anxiety Disorders and Post-traumatic Stress Disorder (PTSD) in South Africa
A study testing False Safety Behavioral Elimination Treatment (FSET) in people with Anxiety Disorders and Post-traumatic Stress Disorder, run by Massachusetts General Hospital at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Disorders, Post-traumatic Stress Disorder
- What is being tested?
- False Safety Behavioral Elimination Treatment (FSET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Africa
- Study dates
- 8 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants diagnosed with a primary anxiety disorder (panic disorder, generalized anxiety disorder, social anxiety disorder, or obsessive-compulsive disorder) or post-traumatic stress disorder.
Who cannot join
- Participants who are acutely suicidal, have severe alcohol of substance use disorder, or are engaged in another form of psychotherapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
Stellenbosch University
Cape Town, 8005
Soraya Seedat, MD, sseedat@sun.ac.za
About this study
Official title: Brief Transdiagnostic Treatment for Anxiety Disorders and PTSD in South Africa: A Hybrid-Effectiveness-Implementation Trial
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.
Read the 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.
- Conditions
- Anxiety Disorders, Post-traumatic Stress Disorder
- Being tested
- False Safety Behavioral Elimination Treatment (FSET), Enhanced Standard Care
- Medical subject headings
- Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
False Safety Behavioral Elimination Treatment (FSET)Behavioural
5-session transdiagnostic treatment for anxiety disorders and post-traumatic stress disorder (PTSD)
Enhanced Standard CareBehavioural
Participants in the enhanced standard care control group will receive treatment as usual and a list referrals.
| Study group | Role | What they receive |
|---|---|---|
| Anxiety Disorders and Post-traumatic Stress Disorder (PTSD) Transdiagnostic Treatment ( FSET) | Experimental | 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. Receives: Behavioral: False Safety Behavioral Elimination Treatment (FSET) |
| Enhanced Standard Care Group | Other | 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). Receives: Behavioral: Enhanced Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structured Clinical Interview for the DSM-5 (SCID-5)
Diagnostic assessment assessing the presence or absence of a mental health diagnosis.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start8 May 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Stellenbosch, Fogarty International Center of the National Institute of Health, Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Kristina Korte, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289621
- Sponsor's protocol ID
- 2024P000420
- Other IDs
- K01TW012180
- Status last verified
- Jul 2024
- First submitted
- 25 Jan 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27397584Korte KJ, Norr AM, Schmidt NB. Targeting Safety Behaviors in the Treatment of Anxiety Disorders: A Case Study of False Safety Behavior Elimination Treatment. Am J Psychother. 2018 Jul 1;71(1):9-20. doi: 10.1176/appi.psychotherapy.20180001. Epub 2018 May 7.
PubMed 29733676Schmidt 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.
PubMed 22697441
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Transdiagnostic Treatment for Anxiety Disorders and PTSD in South Africa: A Hybrid-Effectiveness-Implementation Trial
- ClinicalTrials.gov ID
- NCT06289621
- Acronym / sponsor ID
- 2024P000420
- Conditions
- Anxiety Disorders, Post-traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of Stellenbosch, Fogarty International Center of the National Institute of Health, Harvard Medical School (HMS and HSDM)
- Study start
- 8 May 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Anxiety Disorders and Post-traumatic Stress Disorder (PTSD) Transdiagnostic Treatment ( FSET) | Experimental | Behavioral: False Safety Behavioral Elimination Treatment (FSET)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. |
| Enhanced Standard Care Group | Other | Behavioral: Enhanced Standard CareThe 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants diagnosed with a primary anxiety disorder (panic disorder, generalized anxiety disorder, social anxiety disorder, or obsessive-compulsive disorder) or post-traumatic stress disorder.
Key exclusion criteria (1 listed)
- Participants who are acutely suicidal, have severe alcohol of substance use disorder, or are engaged in another form of psychotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| False Safety Behavioral Elimination Treatment (FSET)5-session transdiagnostic treatment for anxiety disorders and post-traumatic stress disorder (PTSD) | Behavioural | Anxiety Disorders and Post-traumatic Stress Disorder (PTSD) Transdiagnostic Treatment ( FSET) |
| Enhanced Standard CareParticipants in the enhanced standard care control group will receive treatment as usual and a list referrals. | Behavioural | Enhanced Standard Care Group |
Primary outcome
Structured Clinical Interview for the DSM-5 (SCID-5)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Safety Aid Scale (SAS)
Time frame: 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.
4 secondary outcomes
Post-traumatic Disorder Checklist (PCL-5 PTSD Checklist (PCL-5)
Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Patient Health Questionnaire - 9 (PHQ-9)
Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Beck Depression Inventory (BDI)
Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Anxiety Sensitivity Index -3
Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Background: PubMed 27397584Riccardi 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.
- Background: PubMed 29733676Korte KJ, Norr AM, Schmidt NB. Targeting Safety Behaviors in the Treatment of Anxiety Disorders: A Case Study of False Safety Behavior Elimination Treatment. Am J Psychother. 2018 Jul 1;71(1):9-20. doi: 10.1176/appi.psychotherapy.20180001. Epub 2018 May 7.
- Background: PubMed 22697441Schmidt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing False Safety Behavioral Elimination Treatment (FSET) in people with Anxiety Disorders and Post-traumatic Stress Disorder, run by Massachusetts General Hospital at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristina Korte, PhD (6177268205, kkorte@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structured Clinical Interview for the DSM-5 (SCID-5) (time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06289621, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.