PTSD Coach Study

Not Applicable

Recruiting

• Conditions: Mental and Behavioural Disorders

• Registration Number: PACTR202108755066871
• Lead Sponsor: Faculty of Medicine and Health Sciences Stellenbosch Unviersity

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-19
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Participants (18 - 65 years) must be able to read and understand English, able to provide written informed consent, and able to attend weekly sessions (active study procedures and follow-ups) at the Faculty of Medicine and Health Science during office hours (Monday – Friday, 08:00 – 17:00).
Basic English skills (trained volunteer counsellor in the event that they struggle with language and or technical aspects)
Current diagnosis of PTSD
Participants using psychotropic medications will be required to have been on a stable dose for at least 2 months before their pre-intervention assessment (T0)

Exclusion Criteria

Participants with active alcohol or drug use disorder (past 6 months).
High risk for suicide
Presence of an organic disorder or cognitive impairment that will compromise uptake of the intervention.
Participants will be withdrawn from the study if (i) there is a serious adverse event where the risks of continued participation outweigh the benefits; (ii) a participant is not capable of continuing the study (e.g., relocation) or (iii) a participant voluntarily decides to discontinue the study (withdraw).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess and compare the change in PTSD symptoms over the course of treatment and follow-up between the intervention arms (PTSD Coach-CS and e-TAU).

Secondary Outcome Measures

Name	Time	Method
To assess and compare the change in anxiety, and depression over the course of treatment and follow-up between the intervention arms.<br>To assess and compare neurocognitive function alterations over the course of the intervention between the two arms.<br>To track hair cortisol levels as a long-term neuroendocrine marker of PTSD symptom severity and treatment response between two treatment arms.<br>To gather qualitative feedback from participants about their use of PTSD Coach to augment the quantitative findings.<br>