**3. Results**

#### *3.1. Case Description*

Nine community dwelling adults with a diagnosis of TBI were recruited into the study (five female, four male). Participants varied in age (31–64 years), severity of injury as measured by PTA duration (<1–70 days), and time since injury (0.90–33 years), and most displayed impairment on at least one measure of cognition. Five participants were receiving psychological intervention for other issues, unrelated to sexuality, at the time of study participation. The majority completed the treatment via teleconference (videocall), with only one participant (AA) attending sessions in person. Participant DD withdrew during the treatment phase due to extenuating circumstances that meant they did not have the time or capacity to continue with the study. All other participants completed the study in its entirety. No adverse events were recorded for any participant across the duration of the study.

With regards to presenting problems in the current sample, all participants presented with sexuality issues consistent with reduced sexuality, or hyposexuality, regardless of age, sex, marital status, or time post injury. Individuals endorsed reductions in sexual desire and arousal and ability to climax (AA, BB, CC, DD, EE, FF, GG, HH, II), self-esteem (DD, HH), body image (BB, DD, II), and communication (FF, GG, II). Of the four males, three (AA, CC, EE) presented with erectile dysfunction, and for those who had partners, there was a consistent reduction in frequency of, and satisfaction with, sexual intimacy within the relationship (CC, DD, EE, HH, II). Despite overlap in the nature of participants' sexuality

complaints, establishing the probable aetiological basis of the individual's issue through comprehensive assessment and formulation was a crucial first step of the intervention. For two participants (AA, FF), this also involved undergoing medical review to clarify the relative contributions of injury-related, neurological, and/or biological factors.

Given the diversity in presenting problems, it was of the utmost importance that treatment planning and delivery were individualised and tailored. To illustrate how this was implemented in this study, it can be helpful to briefly describe and compare cases with similar characteristics. CC and EE were both males in their 60 s and married, and both reported a loss of intimacy in their relationship related to the post-injury onset of erectile dysfunction. For CC, treatment involved increasing his awareness of factors related to erectile dysfunction and trialling psychosexual skill exercises. By the final session, CC was able to successfully obtain an erection. On the other hand, EE's erectile dysfunction was a direct result of damage sustained to his pelvis and genital area in the accident. As a result, treatment focused on expanding EE's understanding of sexuality and masculinity and working on ways in which EE could facilitate emotional closeness and connectedness' with his wife outside of sexual intercourse. Single and actively dating, AA was the third participant who presented with erectile dysfunction. In this case, low self-esteem, high levels of performance anxiety, and lifestyle factors (weight, alcohol, smoking) were key contributing factors. Among other things, the therapist worked with AA on defining his personal strengths, recognising that sexual intercourse is only one part of sexuality, and specifying what has facilitated and inhibited desire and arousal for AA in the past. Cognitive impairment combined with unrealistic treatment expectations, however, limited his ability to engage in CBT techniques aimed at modifying thoughts, challenging unrealistic standards regarding sexual function, and engaging in behavioural experiments.

For female participants, there was equal variability in factors contributing to reduced sexual drive, desire, and arousal. FF experienced changes in sensations, which meant she was unable to tolerate touch. Trialling remedial massage in a non-intimate context was one behavioural experiment that FF and the therapist subsequently worked on. Negative body image formed part of the clinical formulation for three participants' (BB, DD, and II), although treatment needed to be tailored to address other relevant factors including anticipatory anxiety to chronic fatigue relapses (BB), high levels of self-blame (DD) and irritability and anger outbursts (II).

Only two participants, II and HH, completed the treatment with their partner. The latter was a unique case in that HH's partner had taken on a carer's role in his recovery, and at one-year post-injury, it was his partner who was reporting low sexual desire and arousal, whilst HH himself struggled with low self-esteem and difficulties communicating his sexual needs. In this case, a core facet of the treatment was delineating intimacy and sexuality from sexual intercourse and enhancing the couple's comfort and communication on the topic. Overall, the case descriptions offer insight into the complexities of the presentations and treatment of sexuality after TBI, highlighting the need to adopt a flexible and individualised approach predicated on comprehensive assessment and formulation.

#### *3.2. Treatment Adherence and Integrity*

Completed by a clinical psychologist, integrity monitoring of the delivery of the treatment indicated 'acceptable' to 'excellent' ratings for overall delivery (mean 5.76 [range 4.5–7.5]), adherence (mean 6.24 [range 4.5–8]), and competency (mean 5.55 [range 4–7]). An overview of each participant's target behaviour (sexuality satisfaction, with improvements reflected by higher scores) is presented in text and in Figure 2.

 *Clin. Med.* **2022**, *11*, 3525

*J.*

**Figure 2.**

Participants'

self-reported

 subjective sexuality satisfaction

 across baseline,

intervention,

 and follow up phases.

#### *3.3. Self-Reported Subjective Sexuality Satisfaction*

The application of the stability envelope suggested stability of baseline phase for participants AA, EE, FF, and II. Participants GG and HH demonstrated decreasing baseline trend, whilst participants BB, CC, and DD showed increasing baseline trend. For the latter participants, a visual trend correction using the split middle method was applied. Participants AA, CC, FF, GG, HH, and II showed an increasing trend in the therapeutic direction following the introduction of the intervention. Therapeutic gains were maintained between treatment and follow-up phases for participants CC, FF, HH, and II, whilst a decreasing trend was shown in follow-up phase data for participants AA and GG. Although participant BB and EE showed no significant trend change in sexuality satisfaction during the treatment phase, an increasing trend was shown during the follow-up phase suggestive of the delayed onset of therapeutic gains following the delivery of the intervention.

With respect to the between phase change, the introduction of treatment was associated with a median level increase in subjective sexuality satisfaction for participants AA, CC, FF, GG, and II. Participant HH demonstrated a marginal between phase increase in sexuality satisfaction, whilst the introduction of the intervention was associated with a delayed median level change in sexuality satisfaction for participants BB and EE, occurring during the follow-up phase of the study.

Tau-U analysis was used to determine statistically significant changes in subjective satisfaction with sexuality between baseline and treatment phases and treatment and followup phases. Sexuality satisfaction significantly increased between the baseline and treatment phases for participants AA, CC, FF, GG, and II. Tau-U analyses further demonstrated statistically significant increases in subjective sexuality satisfaction between treatment and follow-up phases for participants AA, BB, CC, EE, HH, and II (See Table 3).


**Table 3.** Tau-U planned comparison for self-reported ratings of sexuality satisfaction.

\* Significance at *<sup>p</sup>* < 0.05; \*\* Significance at *<sup>p</sup>* ≤ 0.001. <sup>b</sup> Blank cells represent missing data due to participant withdrawal.

#### *3.4. Secondary Outcome Measures*

Descriptive analyses of the BIQS, HADS-A, HADS-D, RSES, and PART-O revealed variable results (see Table 4). On the BIQS, all participants' pre-treatment total sexuality scores were classified as decreased from pre-injury sexuality status. All participants displayed increased sexuality scores at post-treatment. The participants who commenced treatment with elevated symptoms of anxiety (AA, FF, GG) and depression (FF, GG) recorded no meaningful change on the HADS at post-treatment. With regards to self-esteem, however, those who were classified as having low self-esteem at pre-treatment (AA and HH) demonstrated significantly improved self-esteem at post-treatment, which was maintained at follow-up. Social participation measured by the PART-O was considered a more distal secondary outcome measure and did not show any convincing change between pre-treatment, post-treatment, and follow-up measurements.


**Table 4.** Participants' pre-treatment, post-treatment, and follow-up raw scores for secondary outcome questionnaire measures.

BIQS; Brain Injury Questionnaire of Sexuality; HADS-A, anxiety subscale from the Hospital Anxiety and Depression Scale; HADS-D, depression subscale from the Hospital Anxiety and Depression Scale; RSES, Rosenberg Self-Esteem Scale; PART-O, Participation Assessment with Recombined Tools-Objective. Note: Data represents participants' raw scores for each measure. <sup>b</sup> Blank cells represent missing data due to participant withdrawal.

All participants reported improvement in at least one goal area following treatment, which was generally maintained, and even showed improvement for participants BB, EE, HH, and II when rated at the conclusion of the eight-week follow-up period. Although participant AA reported the attainment of goals following the intervention, this change was not maintained for two of the goals at follow-up (see Table 5).



GAS, goal attainment scaling; TBI, traumatic brain injury. <sup>b</sup> Blank cells represent missing data due to participant withdrawal.

#### **4. Discussion**

This study served to evaluate the preliminary efficacy of a novel intervention using a CBT framework that aimed to improve individuals' satisfaction with sexuality following TBI. Hyposexuality problems identified in this study included erectile dysfunction, reduced sex drive and orgasm, negative changes in self-esteem and body image, loss of relationship intimacy, and difficulty establishing new intimate partnerships. Five participants showed treatment response in the therapeutic direction following the introduction of the intervention, whilst an additional three participants demonstrated delayed treatment response. Gains in sexuality satisfaction were generally maintained at two months following the

completion of treatment. The finding that participants varied in their response to treatment was not unexpected given the individualised nature of the intervention. Signals of efficacy were also identified on secondary outcome measures of sexuality, functional goal attainment, and self-esteem. The intervention demonstrated good feasibility and adequate treatment adherence. Although the findings are encouraging, it is of note that only three participants recorded feeling 'satisfied' with their sexuality on the primary outcome measure at post-treatment and four at follow-up timepoints. Furthermore, one participant demonstrated the limited maintenance of treatment gains on the primary outcome measure and functional goals. Factors that may have contributed to this included the participants' expectation that the treatment would resolve all physical sexual issues, as well as ongoing pandemic-related lockdowns that prevented socialisation and dating.

The comparison of results with previous research is limited by the lack of studies that have previously reported on the treatment of persistent or complex post-TBI sexuality problems, with none having taken a CBT approach but rather delivered standard sex therapy and medical techniques [44,45]. Certainly, the current findings align with recommendations regarding the need for evidence-based interventions to be accessible and available at the Intensive Therapy level of the PLISSIT/Ex-PLISSIT model [14]. The proposition that intensive therapy may be offered at any stage of recovery is supported by the current research [31]. Indeed, the primary barrier to implementing intensive therapy is the lack of evidence regarding what specific techniques and tools are efficacious in ameliorating persistent post-TBI sexuality disturbances and how treatments should be tailored to suit the needs of individuals and couples following TBI [7,17]. The case descriptions outlined in this research demonstrate the complexity and nuance that needs to be considered in sexuality assessment and treatment after TBI. The continued development of interventions that are purposefully designed to meet the needs of individuals and couples following TBI is necessary to facilitate the clinical implementation of structured approaches to sexuality management, such as the PLISSIT/Ex-PLISSIT model.

#### *4.1. Clinical Implications and Future Research*

This study offers provisional support for the development of an evidence-based adapted CBT therapeutic intervention for people experiencing persistent and complex sexuality difficulties after TBI. The findings have important clinical implications for the treatment of sexuality in a TBI population. Given the heterogeneous nature of TBI, any one or combination of factors may lead to sexuality changes after TBI. Medical issues, TBI sequelae, pain, chronicity of TBI, profile of cognitive impairment, marital status, length of relationship, age, and lifestyle factors were all intricately interwoven with the sexuality problems addressed in this study. As such, adopting a holistic, flexible, and patient-centred approach is necessary to ensure tailored treatment planning and delivery.

Beyond consideration of the multifactorial aetiology of sexuality changes after TBI, there are implications associated with using a CBT framework delivered by a clinical psychologist that are worth highlighting. Specifically, it is important to note that in cases where there has been permanent alteration in an individual's physiological sexual response, an eight-week CBT intervention is unlikely to improve physical sexual function. At best, treatment will help to facilitate the emotional acceptance of the primary dysfunction, a greater understanding of sexuality, and ways to facilitate intimacy in ways other than sexual intercourse. Furthermore, there are cases where sexuality changes may directly reflect injury-related physical limitations, such as pain, increased or decreased sensitivity, and muscle weakness or spasticity, which influence body positioning and movement. In these instances, a psychological-based intervention characterised by eight sessions with a clinical psychologist may not be beneficial, rather a different discipline, such as physiotherapy or occupational therapy, may be better placed to address the issues. Indeed, there is a strong consensus that interdisciplinary sexuality service delivery is required to meet the needs of the TBI population [17,29,30].

Although further studies are required, this research provides a model for how sexuality changes may be addressed in this clinical population. Future studies evaluating sexuality treatment for individuals with TBI may benefit from larger or targeted sampling, which may allow for the evaluation of the extent to which the nature of the presenting sexuality issues or factors, such as cognitive impairment, cultural background, age, sex, gender, sexual orientation, marital status, duration of time post-injury, and other biopsychosocial variables influence responses to treatment. Increasing understanding of the potential impact of such variables will assist the design and implementation of interventions and further increase clinicians' awareness of factors to consider when addressing TBI-related sexuality changes. Additional research is needed to identify the optimal number and length of sessions and support the development and dissemination of the treatment guide and associated resources. Finally, there is a need for greater recognition and inclusion of participants with diverse gender and sexuality backgrounds, including those who identify as LGBTIQ+, in future research.

## *4.2. Limitations*

There are several limitations to this study. First, the small number of participants included in this study limits the interpretation of the results. Participants had also undergone rehabilitation in the context of a no-fault accident compensation system, which may limit the generalisability of study findings to individuals with TBI who have not received rehabilitation. In addition to the sample consisting of white cisgender, heterosexual participants, it is worth noting the lack of recruited participants aged between 18 and 30 years, which may represent a unique period in the life cycle for sexual health and wellbeing. The results may also not extrapolate to individuals with TBI from non-Western countries or cultural backgrounds, especially those with more conservative attitudes towards sexuality. Although the diversity in sexuality problems highlighted in the current research is likely indicative of that seen in the community, the lack of uniformity prevents comparisons between individuals in terms of level and rate of improvement. Furthermore, it is unclear which components of the intervention influenced therapy response, given that an individualised approach was adopted, and a variety of therapeutic techniques were utilised. Importantly, however, the single-case experimental design did allow for the evaluation of a tailored intervention in a heterogeneous group of adults with TBI at an individual level. Other limitations, such as the lack of participants and therapist blinding and potential measurement error, also apply. GAS ratings may be subject to Rater bias as they were completed by non-blinded participants in cooperation with therapists and, therefore, should be interpreted cautiously. The authors acknowledge that the primary outcome measure was not psychometrically validated, however, there were no other validated measures that would be considered appropriate to use in this specific study. Indeed, there continues to be a lack of precision in TBI sexuality measurement, evidenced by the variability in measures utilised in the few treatment studies completed to date [44,45]. Another limitation to this intervention is the lack of involvement from occupational therapists and physiotherapists in the assessment, as well as treatment planning and delivery process. Finally, a longer follow-up (e.g., 6 to 12 months) would have been valuable to see whether improvements on outcome measures were maintained in the longer term.
