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NCT Number: NCT06289621

Brief Transdiagnostic Treatment for Anxiety Disorders and Post-traumatic Stress Disorder (PTSD) in South Africa

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stellenbosch University

Cape Town, 8005, South Africa

Location status: Recruiting

Location contact

Soraya Seedat, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

False Safety Behavioral Elimination Treatment (FSET)

Behavioral

5-session transdiagnostic treatment for anxiety disorders and post-traumatic stress disorder (PTSD)

Enhanced standard care

Behavioral

Participants in the enhanced standard care control group will receive treatment as usual and a list referrals.

Primary outcomes

  1. 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.

  2. 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)

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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

    PTSD symptom measure. Scores range from 0 to 80 with higher scores indicating greater level of post-traumatic stress symptoms.

  2. Patient Health Questionnaire - 9 (PHQ-9)

    Time frame: 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.

  3. Beck Depression Inventory (BDI)

    Time frame: 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.

  4. Anxiety Sensitivity Index -3

    Time frame: 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 outcomes

  1. Life Events Checklist (LEC)

    Time frame: 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.

  2. Alcohol Use Disorders Identification Test (AUDIT)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristina Korte, PhD

CONTACT

[email protected]

6177268205

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Fogarty International Center of the National Institute of Health
  • Harvard Medical School (HMS and HSDM)
  • University of Stellenbosch

Registry information

Official study title

Brief Transdiagnostic Treatment for Anxiety Disorders and PTSD in South Africa: A Hybrid-Effectiveness-Implementation Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2024
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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