Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001660875
Ethics application status
Approved
Date submitted
18/10/2021
Date registered
2/12/2021
Date last updated
27/04/2025
Date data sharing statement initially provided
2/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Development and Evaluation of an Novel Treatment Adapting a Cognitive Behaviour Therapy Approach for Sexuality Problems After Traumatic Brain Injury
Scientific title
An Adapted Cognitive Behaviour Therapy Approach to Treat Sexuality Problems After Traumatic Brain Injury
Secondary ID [1] 305567 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
CBT-SWELL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic brain injury 323980 0
Condition category
Condition code
Physical Medicine / Rehabilitation 321481 321481 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment consists of eight weekly, individual-administered therapy sessions of approximately 60 minutes, combining behavioural, cognitive, and educational strategies. The sessions are delivered by two licensed clinical psychologists with clinical experience and expertise in CBT, sexuality and brain injury. Participants have the choice of attending sessions via videoconference or in person. Therapists adopt a patient centred and goal oriented approach, whilst following a treatment guide. The development of the treatment guide has been informed by empirical literature on treatment of sexual dysfunction after TBI (Aloni & Katz, 2003; Blackerby, 1990; Bélanger, 2009; Deschênes, Lamontagne, Gagnon, & Moreno, 2019; Dombrowski, Petrick, & Strauss, 2000; Simpson, 2001; Simpson et al., 2013, 2016), the manual for cognitive behaviour therapy for sexual dysfunction (Metz et al., 2017) and published clinical guidelines for treatment of sexual dysfunction (Avasthi et al., 2017), with an emphasis on accommodating TBI-related impairments. The contents of the treatment guide are organised into twelve modules with accompanying handouts. The first two sessions focus on case formulation and goal setting. The third session marks the beginning of the active treatment and includes targeted psychoeducation on sexuality and sexuality after TBI. Modules are flexibly selected and delivered across sessions. Content is adapted based on each individual’s clinical formulation and goals. The structure of each session will vary depending on participant’s goals. Some participants may spend 8 sessions focused on 2-3 modules whilst others may work through more. Among other adaptations, written handouts and summaries, repetition, and simplification of concepts will be utilised to ensure that this is an appropriate intervention for individuals who may have cognitive impairments. For those who attend sessions via videoconference, handouts will be delivered via email or hardcopy post depending on the participants preference. Participants' adherence to the intervention will be monitored using a session attendance checklist.
Intervention code [1] 321966 0
Rehabilitation
Comparator / control treatment
There is no untreated control group. Participants will serve as their own controls through comparison of change occurring during a non-treatment baseline phase with that during the intervention and follow-up phases. Participants will be randomised to non-treatment baseline phase length of 3, 4, or 6 weeks. The efficacy of the intervention for subjective sexuality satisfaction will be evaluated using a case-series design with multiple baselines.
Control group
Active

Outcomes
Primary outcome [1] 329261 0
For the purposes of this study, the authors developed a rating scale to measure participants' subjective satisfaction with their sexuality (Krasny-Pacini & Evans, 2018). Participants are asked to rate the following question ‘How satisfied are you with your current sexuality?’ on a 7-point Likert scale ranging from “extremely unsatisfied” to “extremely satisfied”. To encourage participants to think holistically about their sexuality, a brief paragraph is displayed outlining, ‘There is no one size fits all when it comes to sexuality. A person’s sexuality is a combination of different things including sexual desire and activity, pleasure, self-esteem, body image, communicating with others, social skills, motivation, and relationships. Rate how you feel about your sexuality today. Think about what it means to you.’
Timepoint [1] 329261 0
Subjective satisfaction with sexuality is assessed three times per week across all three study phases (baseline, intervention, and follow-up to 8 weeks post-conclusion of the intervention) to provide a continuous measure of rate of change. The maximum duration that this will be assessed is 22 weeks or 154 days.
Secondary outcome [1] 401936 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] 401936 0
Completed at five time points; - At the beginning of the baseline period - Prior to the intervention (conclusion of the baseline period) - At the conclusion of the intervention - Eight weeks post conclusion of the intervention – Sixteen weeks post conclusion of the intervention
Secondary outcome [2] 401937 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 [2] 401937 0
Completed at four time points; - At the beginning of the baseline period - Prior to the intervention (conclusion of the baseline period) - At the conclusion of the intervention - Eight weeks post conclusion of the intervention
Secondary outcome [3] 401938 0
The Rosenberg Self-Esteem Scale (RSES; Rosenberg, 1965) is a 10-item measure of self-esteem with previous research supporting its use in TBI populations. Each item consists of a statement relating to self-esteem (e.g., “I feel that I have a number of good qualities”) and respondents indicate the degree to which they agree with the statement on a 4-point Likert scale ranging from “strongly disagree” to “strongly agree”.
Timepoint [3] 401938 0
Completed at four time points; - At the beginning of the baseline period - Prior to the intervention (conclusion of the baseline period) - At the conclusion of the intervention - Eight weeks post conclusion of the intervention
Secondary outcome [4] 401939 0
Goal attainment scaling (GAS; Kiresuk & Sherman, 1968) is used to set individualised goals, allowing for measurement of personally meaningful progress (Grant & Ponsford, 2014).
Timepoint [4] 401939 0
Completed at three time points; -Prior to the intervention (conclusion of the Baseline period) - At the conclusion of the intervention - Eight weeks post conclusion of the intervention

Eligibility
Key inclusion criteria
Inclusion criteria are as follows: (a) aged 18 and over (b) sustained complicated mild to very severe TBI, (b) greater than three months post injury, (c) self-reported sexuality disturbance with post injury onset, (d) adequate English and cognitive skills to provide informed consent AND complete questionnaires AND therapy tasks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The following exclusion criteria will be used: (a) presence of serious neurological disorder other than TBI, (b) history of psychotic disorder, (c) current alcohol or drug abuse, and (d) insufficient English language or cognitive capacity to provide informed consent and complete questionnaires and therapy tasks.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was "off-site".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a multiple-baseline study design. Participants will be randomly allocated to one of either a 3, 4, or 6 week baseline period prior to commencing the intervention. Participants in all baseline groups will receive the same intervention at the conclusion of the baseline period.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be generated for all variables of interest. For cognitive measures, raw scores will be converted to standardised z-scores using age- and education-based normative data.

A multilevel modelling (MLM) will be used to analyse the data and obtain an average effect size for the intervention across participants (Onghena et al., 2018). A MLM approach allows to account for the hierarchical structure of the data, with repeated measurements (level 1) nested within participants (level 2). This average effect size can be interpreted similarly to other effect sizes such as Cohen’s d or Hedges’ g (Moeyaert & Yang, 2021). This application has been growing (Baek et al., 2023; Chen et al., 2024; DeHart & Kaplan, 2019; Moeyaert et al., 2024). Recent developments have overcome historical limitations, such as small sample size and autocorrelation of errors in similar study design (Petit-Bois et al., 2016).

Statistical analyses will be conducted using R (Version 4.1.0; R Core Team, 2021). The predictor variable will be the intervention condition (baseline, intervention, follow-up), while the outcome variable will be the subjective satisfaction with sexuality. Random intercepts will be included for participants to account for individual variability. An autoregressive structure will be applied to account for the correlation between repeated measures over time. Restricted maximum likelihood (REML) will be used to estimate overall intervention effect (Heyvaert et al., 2017; Pustejovsky et al., 2014). Fixed effects will be estimated for the intervention condition and time, with interactions between these variables also assessed. Demographic variables (age at time of injury, gender, level of education, pre-injury relationship status and relationship status at baseline) and injury-related variables (PTA duration and time post-injury) will be included as covariates. The significance threshold will be set at a = .05, and effect sizes will be reported using standardised coefficients. Model fit will be evaluated using the Akaike Information Criterion (AIC).

Assumptions underlying the multilevel model will be tested. Normality of residuals will be
examined using Q-Q plots and Shapiro-Wilk’s test. Homoscedasticity will be evaluated by plotting residuals against fitted values to ensure that variance is constant across levels of the predictor variable. The assumption of linearity will be checked by inspecting scatterplots of residuals versus predicted values. Multicollinearity among covariates will be assessed using variance inflation factors (VIFs), with values above 10 indicating potential issues. Independence of residuals will be violated but accounted for by the inclusion of autoregression. The autoregressive structure of the model will be validated by examining autocorrelation plots of residuals to confirm that the model appropriately accounts for serial correlation in the repeated measures. If any violations are detected, appropriate transformations or adjustments will be considered to ensure the robustness of the model.

Randomisation tests have been recommended to test for the significance of effect sizes in MLM for similar study designs (Heyvaert et al., 2017; Michiels et al., 2017; Onghena et al., 2018). Randomisation tests are a non-parametric approach which makes no assumption of random sampling or distribution.

Functional change on participants’ individual GAS goals will be descriptively explored with any change considered to constitute clinical significance (Perdices, 2005). NVivo software will be used to store, index and retrieve textual material and to identify illustrative quotations, which remain anonymous.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
19/03/2021
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
50
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20783 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 35596 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 309931 0
Charities/Societies/Foundations
Name [1] 309931 0
Summer Foundation
Country [1] 309931 0
Australia
Funding source category [2] 312746 0
Charities/Societies/Foundations
Name [2] 312746 0
Epworth Medical Foundation
Country [2] 312746 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton VIC 3800
Australia
Country
Australia
Secondary sponsor category [1] 310962 0
None
Name [1] 310962 0
Address [1] 310962 0
Country [1] 310962 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309650 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 309650 0
Ethics committee country [1] 309650 0
Australia
Date submitted for ethics approval [1] 309650 0
07/11/2020
Approval date [1] 309650 0
16/11/2020
Ethics approval number [1] 309650 0
26148
Ethics committee name [2] 317432 0
Alfred Hospital Ethics Committee
Ethics committee address [2] 317432 0
Ethics committee country [2] 317432 0
Australia
Date submitted for ethics approval [2] 317432 0
04/03/2025
Approval date [2] 317432 0
10/04/2025
Ethics approval number [2] 317432 0
116551

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

Contacts
Principal investigator
Name 114902 0
Prof Jennie Ponsford
Address 114902 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 Australia
Country 114902 0
Australia
Phone 114902 0
+61 419 320 671
Fax 114902 0
+61399053948
Email 114902 0
[email protected]
Contact person for public queries
Name 114903 0
Jennie Ponsford
Address 114903 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 Australia
Country 114903 0
Australia
Phone 114903 0
+61 419 320 671
Fax 114903 0
+61399053948
Email 114903 0
[email protected]
Contact person for scientific queries
Name 114904 0
Jennie Ponsford
Address 114904 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 Australia
Country 114904 0
Australia
Phone 114904 0
+61 419 320 671
Fax 114904 0
+61399053948
Email 114904 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No 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.