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Ongoing Treatment of Posttraumatic Stress Disorder After Traumatic Injury

Randomised Controlled Trial of Enhanced Monitoring or Treatment As Usual for Adults to Treat Posttraumatic Stress Disorder Following Traumatic Injury

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000438550
Enrollment
200
Registered
2015-05-07
Start date
2017-01-09
Completion date
2018-12-31
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

The rationale of the study is to evaluate the efficacy of enhanced monitoring and referral to specialist services as a means of reducing PTSD after traumatic injury. This study compares the relative effectiveness of (a) Enhanced Monitoring and Referral, and (b) Treatment as Usual in reducing posttraumatic stress disorder symptoms. It is hypothesised that Enhanced Monitoring and will lead to greater symptom reduction than Treatment as Usual.

Interventions

There are two arms to this trial. Arm 1: Enhanced Monitoring. Arm 2: Treatment as Usual. Enhanced Monitoring involves patients being assessed by telephone after hospital discharge at 1, 3, and 9 months by a psychologist, and if patient indicates psychological problems they are referred to local specialists for treatment. Treatment as Usual involves being assessed by telephone by a psychologist at 1, 3, and 9 months but there is no specific referrals. The duration of the study for any participant

There are two arms to this trial. Arm 1: Enhanced Monitoring. Arm 2: Treatment as Usual. Enhanced Monitoring involves patients being assessed by telephone after hospital discharge at 1, 3, and 9 months by a psychologist, and if patient indicates psychological problems they are referred to local specialists for treatment. Treatment as Usual involves being assessed by telephone by a psychologist at 1, 3, and 9 months but there is no specific referrals. The duration of the study for any participant will conclude after the 9-month follow-up assessment, resulting in participation duration of 9.5 months.

Sponsors

University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults survivors of traumatic injury who are admitted to hospital following injury

Exclusion criteria

1. Patients with a moderate to severe traumatic brain injury as defined by a. A GCS score < 12 – as per the Emergency Department (ED) assessment b. Ongoing Post Traumatic Amnesia (PTA) testing > 72 hours c. NOTE: Refer to MTBI decision making tree (appendix) if there are other reasons for altered GCS or PTA score (e.g., intubation of patient) 2. Patients unable to understand the study procedures, consent, or willingly participate in the study protocol 3. Patients with moderate dementia or severe cognitive impairment 4. Patients with severe suicidal ideation (i.e., if the injury was the result of a suicide attempt, as defined by the electronic medical records at Royal North Shore Hospital). 5. Patients with psychosis (as defined by the electronic medical records at Royal North Shore Hospital).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026