ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622000951752p

Ethics application status

Submitted, not yet approved

Date submitted

22/06/2022

Date registered

6/07/2022

Date last updated

6/07/2022

Date data sharing statement initially provided

6/07/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Narrative Discourse Therapy for Patients in Post-Traumatic Amnesia (PTA): A feasibility study

Scientific title

Narrative Discourse Therapy for Patients in Post-Traumatic Amnesia (PTA): A feasibility study

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Nil Known

Trial acronym

NDT-PTA

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Post-traumatic amnesia

Narrative discourse impairment

Cognitive-communication impairment

Traumatic Brain Injury

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will partake in a 30-minute 1:1 therapy sessions five times a week, aimed at developing narrative discourse skills, until they are deemed out of PTA (scoring 12 for 3 consecutive days on the Westmead PTA scale) or up to 10 sessions (whichever occurs first). The intervention will be delivered face-to-face. on our Acquired Brain Injury ward.

The therapy will be conducted by a member of the speech pathology team. The speech pathology team at Epworth HealthCare is experienced in cognitive-communication therapy and brain injury but will receive additional training and support. Training will occur through use of the manual and by the two Epworth Speech Pathologists involved in the study. The manual has been designed specifically for this study. Clinicians who will be administering the intervention will participate in 1x 60 minute face-to-face training session at least 2 weeks prior to delivering the first intervention.

Each treatment session will consist of the elements described below:

Part 1: Narrative discourse task with picture prompts
The participant will be shown a narrative picture sequence and then supported by the clinician to describe all the story elements. The participant will then be asked to tell the story from start to finish without any prompting, to see if they are able to retain the narrative structure and include the story elements. Note: participants will be shown a different narrative pictures sequence during each session.

Part 2: Narrative generation task
The participant will then be asked to tell the clinician a personal anecdote describing a time where they have had a similar experience to the story they just described. The clinician will document whether the patient included the same story elements as they were supported to do in the first task.

Where the intervention has been delivered by a clinician outside of the research team, a member of the research team will check-in with the clinician to ensure all measures have been completed accurately and respond to any queries from the clinician.

In addition to formal outcome measure for monitor tolerance and participation in the intervention by tracking the duration of each session and number of sessions attended.

Intervention code [1]

Rehabilitation

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Participation/ engagement using the Pittsburgh Rehabilitation Participation Scale (Lenze et al., 2004). A clinician-rated 6-point Likert-type item measuring patient participation in inpatient rehabilitation sessions.

Timepoint [1]

Measured throughout each intervention session

Primary outcome [2]

Agitation using the Agitated Behaviour Scale (Corrigan, 1989). A 14-item scale developed to monitor agitation during the acute phase of recovery from acquired brain injury.

Timepoint [2]

Measured during each intervention session

Secondary outcome [1]

Length of session assessed using a standard wall clock (record time at the start of the session and time at the end of the session to calculate duration).

Timepoint [1]

Duration of each intervention session

Secondary outcome [2]

Patient enjoyment of the intervention tasks- participants will be asked if they enjoyed the task (i.e. a yes/no response)

Timepoint [2]

At the end of each intervention session

Secondary outcome [3]

Narrative discourse skills will be assessed using the Flowerpot Story (Huber, W., and Gleber, J., 1982). This is an assessment of discourse structure which will be taken prior to treatment and then afterwards and the pre-post outcome measure. An audio recording will be taken to allow for analysis after the session.

Timepoint [3]

Assessment using the flowerpot story will be completed prior to the first intervention session (between 1 and 3 days before commencing intervention and immediately post-intervention completion.

Secondary outcome [4]

Task completion. Participants will be rated on how well they complete the therapy tasks on a scale of 0-2 (o = nil, 1 = partial and 2 = complete)

Timepoint [4]

At the end of each intervention session

Secondary outcome [5]

Number of sessions attended. Audit of session attendance checklist.

Timepoint [5]

Cumulative data will be assessed at the conclusion of the study.

Eligibility

Key inclusion criteria

Has a next of kin who can provide consent to participate

Adequate communication to participate in structure therapy targeting narrative skills as determined by their treating speech pathologist

Ability to participate in a structured therapy session as determined by the clinician who is screening the patient

English speaking

Maximum score on The Westmead Post-Traumatic Amnesia Scale (WPTAS) <11 within 24 hours of admission

Adult (i.e. over 18 years old)

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Previously diagnosed dementia or conditions impacting communication

Visual impairments which cannot be compensated for to see picture stimuli

Inability to sustain alertness for sufficient period of time to participate in the intervention

Medically unstable as determined by treating medical team

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

11/07/2022

Actual

Date of last participant enrolment

Anticipated

3/10/2022

Actual

Date of last data collection

Anticipated

14/10/2022

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Epworth Richmond - Richmond

Recruitment postcode(s) [1]

3121 - Richmond

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Epworth Medical Foundation

Address [1]

89 Bridge Rd, Richmond VIC 3121

Country [1]

Australia

Primary sponsor type

Hospital

Name

Epworth Healthcare

Address

89 Bridge Rd, Richmond VIC 3121

Country

Australia

Secondary sponsor category [1]

None

Name [1]

n/a

Address [1]

n/a

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Monash Health Ethics

Ethics committee address [1]

Level 2, I Block, Monash Medical Centre, 246 Clayton Road,  Clayton, 3168, VIC

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/05/2022

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Post-traumatic Amnesia (PTA) is a state of confusion after someone experiences a TBI. Speech Pathologists (SPs) currently undertake a range of practices for patients with PTA but what they do is under-reported and requires further investigation (Steel et al., 2013). It is common practice that when patients are in PTA, direct therapy is kept to a minimum in case activities lead to agitation. However recent studies have demonstrated that patients in PTA can participate in some therapies such as physiotherapy or occupational therapy. Cognitive-communication deficits are a common sequelae of Traumatic Brain Injury (TBI) with 80–100% experiencing this type of communication impairment (MacDonald & Wiseman-Hakes, 2010). Part of this cognitive-communication profile is the ability to structure verbal narration of an event or a series of events (i.e. narrative discourse). 

This research project aims to investigate the feasibility of conducting structured narrative discourse therapy with people in PTA in order to improve their cognitive-communication skills. It is hypothesised that patients will tolerate participating in this specialised novel therapy program without any adverse effects and we expect to see improvement in their narrative discourse skills. We also hypothesise that people in PTA will have impaired narrative discourses.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mrs Aashna Vazirani

Address

Epworth Healthcare, 29 Erin Street, Richmond, VIC, 3121

Country

Australia

Phone

+61 03 9426 8726

Fax

aashna.vazirani@epworth.org.au

Contact person for public queries

Name

Aashna Vazirani

Address

Epworth Healthcare, 29 Erin Street, Richmond, VIC, 3121

Country

Australia

Phone

+61 03 9426 8726

Fax

aashna.vazirani@epworth.org.au

Contact person for scientific queries

Name

Aashna Vazirani

Address

Epworth Healthcare, 29 Erin Street, Richmond, VIC, 3121

Country

Australia

Phone

+61 03 9426 8726

Fax

aashna.vazirani@epworth.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Individual participant data underlying published results only

When will data be available (start and end dates)?

Data will be available in published results in Jan/ Feb 2023, no end date determined

Available to whom?

Case-by-case basis at the discretion of Primary Sponsor,

Available for what types of analyses?

Only to achieve the aims in the approved proposal and for IPD meta-analyses

How or where can data be obtained?

Access subject to approvals by Principal Investigator (aashna.vazirani@epworth.org.au)

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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