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Development and Evaluation of an Novel Treatment Adapting a Cognitive Behaviour Therapy Approach for Sexuality Problems After Traumatic Brain Injury

An Adapted Cognitive Behaviour Therapy Approach to Treat Sexuality Problems After Traumatic Brain Injury

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001660875
Acronym
CBT-SWELL
Enrollment
32
Registered
2021-12-02
Start date
2021-03-19
Completion date
2026-12-31
Last updated
2026-06-15

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

Conditions

None listed

Brief summary

You don’t have to be having sex or be able to function sexually from a biological perspective as prerequisites for sexuality. Sexuality is very multi-dimensional. Beyond sexual function, it includes sexual orientation, preferences, motivation, pleasure, body image, self-esteem, intimacy, relationships and communication. Sexuality is a fundamental part of being human and following traumatic brain injury (TBI), sexuality doesn’t end, but it can change. Up to 50% of people who have had a traumatic brain injury experience a significant change. The majority report a global reduction in sexuality, including reduced frequency of sexual encounters and lower quality when they do occur, as well as reduced libido, arousal, and orgasm. There have been only two single case study intervention studies that have explored remediation of sexuality disturbance after TBI. Indeed, the lack of evidence-based treatments for sexuality problems after TBI is a significant barrier to addressing this topic in rehabilitation settings. The aim of this study is to evaluate the preliminary efficacy of an individualised intervention using a cognitive behavioural therapy (CBT) framework to treat sexuality problems after TBI. Treatment consists of eight weekly, individual therapy sessions, combining behavioural, cognitive, and educational strategies to address a diverse range of sexuality problems. Clinical psychologists adopt a patient-centred and goal-oriented approach whilst following a treatment guide and accommodating TBI-related impairments. This research will assist clinicians and services providers improve their knowledge and skills and further inform the development of guidelines to support the management of sexuality across the continuum of care.

Interventions

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

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.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 21, 2026