Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001033730
Ethics application status
Approved
Date submitted
1/07/2022
Date registered
25/07/2022
Date last updated
15/07/2024
Date data sharing statement initially provided
25/07/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Co-Designed Psychoeducation Practices and Guidelines for Addressing Sexuality After Traumatic Brain Injury
Scientific title
Assessing the Impact of Psychoeducation on Sexuality following Moderate-to-Severe Traumatic Brain Injury in Adults
Secondary ID [1] 307463 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic brain injury 326855 0
Condition category
Condition code
Physical Medicine / Rehabilitation 324070 324070 0 0
Other physical medicine / rehabilitation
Neurological 324152 324152 0 0
Other neurological disorders
Injuries and Accidents 324153 324153 0 0
Other injuries and accidents
Public Health 324154 324154 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Basic psychoeducation on post-TBI sexuality rarely occurs in Traumatic Brain Injury (TBI) rehabilitation healthcare settings. Psychoeducation practices and guidelines will be produced through a series of co-design focus group sessions with rehabilitation health professionals who work with individuals with TBI at the Epworth Healthcare Acquired Brain Injury (ABI) Rehabilitation Unit. These focus group sessions and the co-designed outcomes are expected to create a system-level change at the unit. From which point, all patients admitted at the unit will receive basic psychoeducation on post-TBI sexuality as part of routine care.
Clinician participants of the co-design focus group study attended two separate two-hour sessions. The commencement of the focus group sessions marked the commencement of the co-design and implementation process within the rehabilitation unit.

Patient-related intervention deliverables that were produced by the end of the project included a patient brochure and changes in routine clinical practice in at least one member of the rehabilitation team will attempt to broach the topic of sexuality before discharge with every patient. Broaching the topic would include asking permission from the patient to speak about sexuality and handing them to brochure, and may include types of sexuality-related changes that can happen, what patients may experience sexually after returning home, and who to approach if there were issues.

To monitor adherence to the intervention, patients are asked to complete a study-specific questionnaire requiring them to reflect on whether they were provided any sexuality support either verbally, in print, or in written format.
Intervention code [1] 323920 0
Rehabilitation
Comparator / control treatment
Source:
The majority of patients with TBI who were admitted from the ABI rehabilitation unit for TBI would have provided consent to be approached for research through a longitudinal follow up study that has been run at the unit by the Monash-Epworth Rehabilitation Research Centre over the past 30 years.

Time period:
Patients who provided consent to be contacted for research will be recruited for this psychoeducation intervention study approximately six months post-discharge, and asked to complete the survey. This historical, treatment-as-usual control group will be recruited over a period of a year. It will be ensured that, at the time of recruitment, these patients would have been discharged from the unit prior to the commencement of focus group sessions and implementation of the intervention at the unit.
Control group
Historical

Outcomes
Primary outcome [1] 331854 0
The Brain Injury Questionnaire of Sexuality (BIQS; Stolwyk et al., 2013) is a 15-item self-report questionnaire comprising three subscales measuring sexual functioning, relationship quality and self-esteem, and mood.
Timepoint [1] 331854 0
Participants will be contacted for recruitment approximately 6 months after discharge from hospital. Participants are expected to complete the survey by 14 days after providing consent.
Primary outcome [2] 331855 0
For the purposes of this study, the authors developed a rating scale to measure participants' subjective satisfaction with their sexuality. Participants are asked to rate the following question ‘How satisfied are you with your current sexuality?’ on a 5-point Likert scale ranging from “extremely unsatisfied” to “extremely satisfied”.
Timepoint [2] 331855 0
Participants will be contacted for recruitment approximately 6 months after discharge from hospital. Participants are expected to complete the survey by 14 days after providing consent.
Primary outcome [3] 331856 0
Participants rate their experiences and satisfaction on different areas of their rehabilitation experience. This is to indicate whether participants received the intervention and if so, to measure satisfaction ratings and feedback of the intervention. Open-text questions allow for the provision of any other feedback regarding satisfaction of sexuality support received, if any.
Timepoint [3] 331856 0
Participants will be contacted for recruitment approximately 6 months after discharge from hospital. Participants are expected to complete the survey by 14 days after providing consent.
Secondary outcome [1] 411403 0
The Hospital Anxiety and Depression Scale (HADS; Snaith & Zigmund, 1994) is used as a 14-item measure of anxiety and depression symptoms. Each item consists of a statement about a symptom (e.g., “I feel tense or wound up”) and respondents indicate the degree to which they experienced that symptom over the past week on a 4-point Likert scale ranging from “not at all” to “most of the time”.
Timepoint [1] 411403 0
Participants will be contacted for recruitment approximately 6 months after discharge from hospital. Participants are expected to complete the survey by 14 days after providing consent.
Secondary outcome [2] 411760 0
This is a primary outcome.
Participants are asked to rate how they feel 'at the moment' on the following question, "I feel confident in my ability to take care of my own sexual needs" on a 5-point Likert scale ranging from “Strongly disagree” to “Strongly agree”.
Timepoint [2] 411760 0
Participants will be contacted for recruitment approximately 6 months after discharge from hospital. Participants are expected to complete the survey by 14 days after providing consent.
Secondary outcome [3] 411761 0
This is a primary outcome.
Participants are asked to rate how they feel 'at the moment' on the following question, "I feel comfortable initiating sexual activities" on a 5-point Likert scale ranging from “Strongly disagree” to “Strongly agree”.
Timepoint [3] 411761 0
Participants will be contacted for recruitment approximately 6 months after discharge from hospital. Participants are expected to complete the survey by 14 days after providing consent.
Secondary outcome [4] 411762 0
This is a primary outcome.
Participants are asked to rate how they feel 'at the moment' on the following question, "I worry about the sexual aspects of my life" on a 5-point Likert scale ranging from “Strongly disagree” to “Strongly agree”.
Timepoint [4] 411762 0
Participants will be contacted for recruitment approximately 6 months after discharge from hospital. Participants are expected to complete the survey by 14 days after providing consent.
Secondary outcome [5] 411763 0
This is a primary outcome.
Participants are asked to rate how they feel 'at the moment' on the following question, "I feel discouraged when I think about my sex life" on a 5-point Likert scale ranging from “Strongly disagree” to “Strongly agree”.
Timepoint [5] 411763 0
Participants will be contacted for recruitment approximately 6 months after discharge from hospital. Participants are expected to complete the survey by 14 days after providing consent.
Secondary outcome [6] 411764 0
This is a primary outcome.
Participants are asked to rate how they feel 'at the moment' on the following question, "I am disappointed with the quality of my sexual experiences" on a 5-point Likert scale ranging from “Strongly disagree” to “Strongly agree”.
Timepoint [6] 411764 0
Participants will be contacted for recruitment approximately 6 months after discharge from hospital. Participants are expected to complete the survey by 14 days after providing consent.
Secondary outcome [7] 437551 0
Questions of experience in seeking help for sexuality after injury (Y/N), and likelihood of seeking help in the future should it arise (5 point likert scale; Extremely Likely to Extremely Unlikely.
Timepoint [7] 437551 0
Secondary outcome [8] 437552 0
Questions of experience in seeking help for sexuality after injury (Y/N), and likelihood of seeking help in the future should it arise (5 point likert scale; Extremely Likely to Extremely Unlikely.
Timepoint [8] 437552 0
Participants will be contacted for recruitment approximately 6 months after discharge from hospital. Participants are expected to complete the survey by 14 days after providing consent.

Eligibility
Key inclusion criteria
- community dwelling individuals with traumatic brain injury aged 18 and above.
- Adequate English and cognitive skills to complete questionnaires independently
- Moderate to severe TBI as defined by a post-traumatic amnesia duration of more than 24 hours
- Admission to the Epworth Healthcare ABI Rehabilitation Unit for TBI
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Inadequate cognitive capacity to provide informed consent

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a cross-sectional study that utilizes a historical control group that will be recruited prior to the development of the intervention. The intervention group will be recruited after the intervention has been developed and implemented.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The minimum number of participants required was determined by an a priori power analysis using G*Power3 (Faul et al., 2007) to test the difference between two independent group means using a two-tailed test, a large effect size (d = .80) and an alpha of .05. Results showed that a total sample of 84 with two equal sized groups of n = 42 is required to achieve a power of .95.
The research survey responses will be downloaded from Qualtrics at the end of the study period. Data cleaning and analyses will be conduction with Rstudio. Missing data will be calculated to investigate whether nonresponse is an issue for specific items. If missing data is determined to be missing completely at random or if proportions of missing data are below approximately 5%, complete case analysis or pairwise deletion may be applied (Kang, 2013). Should the proportions of missing data be above 5% and determined to be missing at random or missing not at random, multiple imputation will be applied (Jakobsen et al., 2017).
For comparison of BIQS scores between the treatment-as-usual control group and intervention group, a subscale score will only be computed for a participant if all items on that subscale is completed. A total BIQS score for each participant will only be computed if a score on each of the 3 subscales is available.
Descriptive statistics will be computed for each group for the BIQS subscales and total, as well as the HADS and remaining survey questions. A series of independent samples t-tests will be used to compare the intervention and historical control group on measures of sexuality, mood, and satisfaction with sexuality support during the rehabilitation process at six months after discharge from hospital and return to community. Group differences in age, sex and injury severity will be controlled for.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/03/2022
Date of last participant enrolment
Anticipated
1/08/2024
Actual
Date of last data collection
Anticipated
30/08/2024
Actual
Sample size
Target
90
Accrual to date
81
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22657 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 37933 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 311736 0
Government body
Name [1] 311736 0
National Health and Medical Research Council
Country [1] 311736 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton VIC 3800
Australia
Country
Australia
Secondary sponsor category [1] 313198 0
None
Name [1] 313198 0
Address [1] 313198 0
Country [1] 313198 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311183 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 311183 0
Ethics committee country [1] 311183 0
Australia
Date submitted for ethics approval [1] 311183 0
16/11/2021
Approval date [1] 311183 0
24/01/2022
Ethics approval number [1] 311183 0
80518

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120246 0
Prof Jennie Ponsford
Address 120246 0
Monash Epworth Rehabilitation Research Centre
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton VIC 3800
Country 120246 0
Australia
Phone 120246 0
+61 419 320 671
Fax 120246 0
+61399053948
Email 120246 0
[email protected]
Contact person for public queries
Name 120247 0
Jennie Ponsford
Address 120247 0
Monash Epworth Rehabilitation Research Centre
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton VIC 3800
Country 120247 0
Australia
Phone 120247 0
+61 419 320 671
Fax 120247 0
+61399053948
Email 120247 0
[email protected]
Contact person for scientific queries
Name 120248 0
Jennie Ponsford
Address 120248 0
Monash Epworth Rehabilitation Research Centre
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton VIC 3800
Country 120248 0
Australia
Phone 120248 0
+61 419 320 671
Fax 120248 0
+61399053948
Email 120248 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be available in data dictionaries. We do not have ethical approval for this.


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.