A pilot trial of feasibility, acceptability, tolerability, and efficacy of accelerated bilateral theta burst repetitive transcranial magnetic stimulation treatment for MDD in people with HIV in South Africa

A pilot pre- post trial of the feasibility, acceptability, tolerability, and efficacy of accelerated bilateral theta-burst stimulation for depression in adults with HIV in South Africa

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202404890252448

Enrollment

Registered

2024-04-10

Start date

2024-04-08

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS Mental and Behavioural Disorders

Interventions

Bilateral TBS treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults (= 18 years) diagnosed with HIV On ART for an uninterrupted period of at least six months Current comorbid MDD diagnosis confirmed by a diagnostic interview. Able to attend the treatment and monitoring visits at the university campus during office hours. Able to provide written informed consent. For participants on psychotropic medication, a stable dose (=2 months) will be required before the pre-treatment assessment. These participants will continue with their current treatment regimens for the duration of their trial participation. Participants will also be required not to engage in other interventions (i.e., psychotherapy) during the study period (six weeks from pre-treatment to one-month follow-up).

Exclusion criteria

Exclusion criteria: Pregnant Known with life-threatening medical illnesses (e.g., cancer), or serious psychiatric conditions (e.g., psychosis, mania). Participants with specific TMS-associated contraindications (e.g., metal implants close to the skull area or uncontrolled epilepsy) will also be excluded.

Design outcomes

Primary

Measure	Time frame
Recruitment and study enrolment rate, attrition rate, reported adverse events, and participant’s self-reported perceptions.;Change in Hamilton Rating Scale for Depression (HAM-D) 17-item total scores from pre- to post-treatment (Time 1 – 3).;Change in Montreal Cognitive Assessment (MoCA) total scores from pre- to post-treatment (Time 1 – 3).	—

Secondary

Measure	Time frame
Change in HAM-D (17-item) total score from pre-treatment and longitudinal follow-up (Time 1 - 4). Change in self-reported depressive symptoms on the Beck's Depression Inventory (BDI) 21-item total score from pre- to post-treatment (Time 1 – 3). Change in BDI (21-item) score from pre-treatment and longitudinal follow-up (Time 1- 4) ;Change in MoCA score from pre-treatment and longitudinal follow-up (Time 1- 4). ;Evaluation of participant experiences of this treatment modality, including tolerability, by reviewing detailed treatment folder notes and qualitative sub-study (answers to a semi-structured questionnaire).	—

Measure

Time frame

Change in HAM-D (17-item) total score from pre-treatment and longitudinal follow-up (Time 1 - 4). Change in self-reported depressive symptoms on the Beck's Depression Inventory (BDI) 21-item total score from pre- to post-treatment (Time 1 – 3). Change in BDI (21-item) score from pre-treatment and longitudinal follow-up (Time 1- 4) ;Change in MoCA score from pre-treatment and longitudinal follow-up (Time 1- 4). ;Evaluation of participant experiences of this treatment modality, including tolerability, by reviewing detailed treatment folder notes and qualitative sub-study (answers to a semi-structured questionnaire).

—

Countries

South Africa

Contacts

Public ContactErine Brocker

Faculty of Medicine and Health Sciences Stellenbosch University

erineb@sun.ac.za27219380587

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026