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Evaluation of an Internet-Based Psychological Intervention for the Treatment of Erectile Dysfunctio

Abstract
Recent research on the treatment of erectile dysfunction (ED) has focused on medical interventions, in particular oral medications. The current study examined the effectiveness of an internet-based psychological intervention for this condition. In total, 31 men (12 in treatment group, 19 in control group) completed the program. The results demonstrated that men who completed the program reported improved erectile functioning and sexual relationship satisfaction and quality. The implications of these findings for the treatment of ED are discussed.

Introduction
Masters and Johnson[1] were among the first researchers to document outcomes associated with psychological treatments for erectile dysfunction (ED). They found that behavioral sex therapy was effective for treating a range of sexual dysfunctions, with the rate of treatment failure for men with primary ED being 40.6% and for men with secondary ED being 26.3%. A more recent study has demonstrated the effectiveness of a cognitive behavior treatment (CBT) for a range of sexual dysfunctions.[2] The treatment was a 10-session CBT program that focused on enhancing communication between partners, increasing sexual skills and decreasing sexual anxiety. McCabe[2] found that the proportion of men who were diagnosed with ED decreased from 71.1% at pre-test to 35.6% at post-test. Hawton, Catalan and Fagg[3] also reported that with a CBT program, ED was found to be completely resolved for 41.7% of men and largely resolved for a further 27.8% of men. At 3-month follow-up, these percentages had decreased to 38.9 and 16.7%, respectively. However, without a control group, the possibility that these outcomes occurred as a result of spontaneous recovery cannot be ruled out.

Although substantial improvements in medical treatments have occurred in recent times, innovative developments, regarding psychological approaches for ED, have been limited.[4,5] Difficulties discussing ED with a clinician is an important factor that may influence treatment-seeking behavior among men with ED. Researchers have estimated that between 40 and 70% of men with ED do not consult a physician regarding their disorder.[6,7,8,9]

Internet-based treatment offers potential relief to the large proportion of men who would like treatment for ED, but who are too anxious or embarrassed to request this help in person. Internet-based treatment is likely to be particularly well-suited to men with ED, as this form of therapy removes the anxiety and embarrassment about discussing sexual problems in the company of a clinician.[10,11,12] Several researchers have recognized the benefits of the internet for addressing sexual health concerns. Hall[11] conducted a pilot study of an online task-based sex therapy program for treating various male and female sexual dysfunctions. Following treatment, seven out of eight couples experienced improvements in sexual function. Improvements in self-awareness, awareness of partner, understanding relationship and sexual knowledge were also evident among the participants.

Leusink and Aarts[12] investigated the effectiveness of using the internet to provide electronic consultation (e-consultation) to men with ED. After completing an assessment questionnaire, treatment recommendations were provided for men to pursue. For example, if medication was indicated following e-consultation, men would be e-mailed a letter to provide to their local doctor. Leusink and Aarts[12] found that men who participated in e-consultation experienced significant improvements in erectile function. In addition, 81% of men indicated that their erections had improved after consulting the website. While e-consultation was associated with favourable outcomes, Leusink and Aarts' study did not include a comparison group, making it difficult to assess whether similar outcomes would have been achieved following face-to-face consultation, or was due to spontaneous recovery.

The current study extended past research by evaluating the effectiveness of an internet-based treatment program for ED by comparing outcome measures for men utilizing this program to a no-treatment control group. It was expected that the internet intervention would lead to improvement in sexual and relationship functioning compared to the control conditions. A control group was included to eliminate the confounding effects of time.

Participants
Eligibility criteria for participation consisted of the following: (1) persistent or recurrent difficulties attaining or maintaining an erection during sexual activity; (2) being aged 18 years or over; (3) absence of major medical or psychiatric problems; (4) involvement in a stable heterosexual relationship; (5) willingness and motivation from partners to participate in treatment and (6) regular internet access. Information on these criteria were provided by participants, although, as detailed in the procedure, a medical screen was provided by some participants' general practitioners (GPs). Men who were unable to meet the above criteria were excluded from the study. The initial and final numbers of participants are outlined in the Procedure.

Participants were prohibited from taking part in additional psychological treatment while participating in the study. However, as it was expected that many participants would already be using oral PDE5 inhibitors, medical treatment for ED was permitted during the study. Cessation of medical treatment upon commencing the study would have been likely to influence responsiveness to psychological treatment. Men were instructed to maintain a record of their usage of medical treatment for ED during the study. There were no major differences on assessed variables between the men using PDE5 inhibitors and those not using medication. Fifty percent of the men were using PDE5 inhibitors throughout the study. Data were not gathered on whether or not the frequency of medication usage varied throughout the study. No men started on PDE5 inhibitors during the study.

Materials
The International Index of Erectile Function. The international index of erectile function (IIEF) is a 15-item self-report measure that was developed to assess sexual function among men with ED.[13] The IIEF instructs respondents to answer items according to functioning during the past 4 weeks. Responses to items are summed to determine the total IIEF score (range=5–75). Rosen et al.[13] reported high internal consistency, for the total IIEF scale (α=0.91), as well as high test-retest reliability (r=0.82).

Kansas Marital Satisfaction Scale. The Kansas marital satisfaction scale (KMSS) is a brief, self-report measure of relationship satisfaction.[14] The KMSS includes three items and scores on the KMSS range between 3 and 21, with higher scores indicate greater relationship satisfaction. High Cronbach's alphas have been reported for male (α=0.89) and female (α=0.93) respondents.[15]

Index of Sexual Satisfaction. The index of sexual satisfaction (ISS) is a 25-item, self-report questionnaire that measures severity of dissatisfaction within the sexual relationship.[16] Scores range between 0 and 100, with higher scores being representative of sexual dissatisfaction. Hudson et al.[16] reported Cronbach's alphas between 0.91 and 0.92 for the three participants that were tested. High test–retest reliability (r=0.93) was also found following an interval of one week.

Self-esteem and Relationship Questionnaire. The self-esteem and relationship questionnaire (SEAR) questionnaire is a self-report 14 item measure of self-esteem, confidence and relationships among men with ED.[17] The SEAR questionnaire was developed to measure treatment-related changes among men with ED in areas other than sexual function. High internal consistency was reported for the total SEAR questionnaire (α=0.93). Good test–retest reliability was also reported for the SEAR questionnaire (r=0.79).[17] Only the sexual relationship subscale was used in the current study.

Treatment
The treatment evaluated during this study was an internet-based CBT program for men with ED and their partners. This program, named Rekindle, focused on the resolution of psychological and relationship factors related to ED (web address is http://www.med.monash.edu.au/mentalhealth/rekindle). Rekindle consisted of three main treatment components, including sensate focus, communication exercises and email contact with a therapist. Rekindle was completed over the course of five modules, with earlier modules providing a foundation for later modules. Men with ED and their partners were encouraged to spend approximately 2 weeks completing each of the modules. Therefore, Rekindle was designed as a 10-week program.

Each of the five modules comprised a similar format, commencing with a list of goals that couples were required to achieve throughout the module. This was followed by the communication exercises, the sensate focus activities and a reminder that email contact was available for those seeking further support. The modules commenced with general body pleasuring, then advanced to genital contact and then intercourse. The focus was on enjoying the sensations of the sexual interactions and not on performance. Communication exercises were completed prior to each sensate focus session and were designed to allow partners to express their feelings about the program and their relationships. Discussion of these issues allowed problems to be resolved. All modules concluded with a hurdle requirement, which comprised a list of statements that couples were required to agree with before they could continue. After passing the hurdle requirement, couples received the username and password needed to access the next module.

Unlimited email contact with a therapist was provided to participants while they completed Rekindle. The therapist maintained contact with participants at least once a fortnight. If two weeks had passed without contact, the therapist would send an email to the participant to facilitate engagement and ensure that the participant was not experiencing any difficulties. The main purpose of email contact was to resolve any individual or relationship problems that the men experienced as a result of the sensate focus or communication exercises. These primarily centered on performance anxieties, different expectations of both partners in the relationship and difficulties in balancing priorities.

Procedure
Ethics approval to complete this study was obtained from the Human Ethics Committee. In total, 66 of 91 men who initially contacted the researchers returned their consent form. These men then completed a medical screen. About half of these screens were completed by the men's GP, but if the GP failed to return the medical screen, the men self-reported any medical or psychiatric problems. The medical screen provided information on prostate cancer, significant neurological damage, peripheral vascular disease, carotid artery disease, heart disease, psychotic illness, major depressive disorder and substance abuse/dependency disorder. After the completion of this medical screen, 12 men were referred back to their GP for medical treatment and informed that they were ineligible to participate in the study. A further 10 men did not proceed with the study due to the following reasons: they decided not to continue (n=2); not involved in a stable relationship (n=1); they could not meet the time commitment (n=3); no regular internet access (n=4). Men were randomly allocated to the treatment (n=24) or control condition (n=20). Men in the control group were told that they were placed on a wait list for the program. Men in the control condition enrolled in the treatment program after post-test completion of the questionnaire. All men completed the questionnaire measures at pre test, post test (after the completion of therapy for the treatment group, after 10 weeks for the control group) and at 3 months follow up (initial treatment group only). In total, 12 men in the treatment group completed the program and 8 of these were available for follow-up. In contrast, 19 of the control participants completed the post-test questionnaire. Reasons for attrition included: separation from partner, unable to commit sufficient time to the program and partner was unwilling to participate in the program. There were no significant differences in any of the pre-test scores on any of the variables between treatment completers and dropouts.

Results
Differences between the treatment and control group in changes in sexual function revealed a significant interaction effect for group by time, F(4, 26)=6.9, P<0.01, η2=0.31. The treatment group reported significantly greater improvements in erectile function from pre-test to post-test than the control group, F(1, 29)=7.6, P<0.01, η2=0.21, but not the other areas of sexual functioning (see Table 1 ). Frequency of ED decreased over time for the treatment group. A similar reduction in frequency of ED did not occur for participants in the control group (see Table 2 ). The percentage of participants in the treatment group who had experienced erections that were either almost fully erect or fully erect increased from 41.67% at pre-test to 83.33% at post-test. Similar improvements in erectile strength were not observed for participants in the control group.

A mixed model multivariate analysis of variance revealed a significant group by time interaction in overall relationship satisfaction, sexual relationship satisfaction and sexual relationship quality, F(3, 27)=7.4, P<0.05, partial η2=0.27. Relative to the control group, the treatment group experienced significantly greater improvements in sexual relationship satisfaction, F(1, 29)=7.24, P<0.01, η2=0.20 and sexual relationship quality, F(1, 29)=6.41, P<0.01, η2=0.18 but not relationship satisfaction (see Table 3 ).

Among men who completed Rekindle, the proportion who experienced ED 75% of the time or more during sexual activity in the last month reduced from 58.33% at pre-test to 25% at post-test, while the proportion who experienced ED 25% of the time or less during sexual activity in the last month increased from 25% at pre-test to 41.67% at post-test. Furthermore, the proportion of men who reported obtaining erections during sexual activity that were fully erect or almost fully erect increased from 41.67% at pre-test to 83.33% after completing Rekindle. For men who received no treatment, similar reductions in ED frequency were not observed over time, and erection hardness decreased slightly.

Sexual function and relationships were compared at post-test and 3-month follow-up for the treatment group (n=8). Repeated measures multivariate analysis of variance revealed no significant time effects for sexual function, F(4, 4)=2.5, P>0.05, η2=0.49 or relationships, F(3, 5)=2.7, P>0.05, η2=0.28. Overall, the results indicated that treatment gains remained stable during the 3-month follow-up period (see Table 4 ). Participants who completed Rekindle were able to maintain reductions in frequency of ED and improvements in erection hardness during the follow-up period. Some participants experienced even further gains in these areas of erectile function after completing the program. The percentage of participants who experienced ED 50% of the time or more during sexual activity in the last month decreased from 62.5% at post-test to 37.5% at 3-month follow-up. In addition, the percentage of participants who experienced full erections during sexual activity in the last month increased from 12.5% at post-test to 50% at 3-month follow-up
Discussion
Improvements in erectile function were significantly greater among men who completed the program compared to those who received no treatment. Rekindle was not associated with significant improvements in orgasmic function, sexual desire and overall satisfaction. As Rekindle was specifically designed as a treatment for ED, it was not surprising that participants who completed this program experienced more substantial gains in erectile function compared to other areas of sexual function.

On average, men who completed Rekindle reported post-test scores for erectile function that were indicative of mild to moderately severe ED.[18] A substantial proportion of men who completed Rekindle also reported experiencing ED 50% of the time or more at post-test. However, the finding that men continued to report difficulties with sexual function despite completing Rekindle was not considered to be a limitation of internet-based treatment. Face-to-face psychological treatments for ED have also been associated with incomplete reversal of sexual dysfunction.[2,3,19,20,21,22] Further, given that men who completed Rekindle had, on average, been experiencing ED for a significant length of time (M=5.19 years), it was unrealistic to expect restored sexual function after only 10 weeks of treatment.

Improvements in sexual relationship satisfaction and sexual relationship quality, but not general relationship satisfaction were, significantly greater among men completing Rekindle compared with those received no treatment. The finding that Rekindle had a stronger impact on the sexual relationship than the overall relationship was not surprising, given that the sexual relationship was more directly targeted during the program. These findings are consistent with outcomes associated with face-to-face psychological treatments for ED.[3,19,21]

Improvements in sexual function and relationships remained stable during the 3-month follow-up period for men in the treatment group. For some men, reductions in the frequency of ED during sexual activity and improvements in erection hardness during sexual activity were extended even further during the 3-month follow-up period. These findings are consistent with investigations of psychological treatments for ED that have been conducted over a similar duration.[3,23] The findings from this study highlight the suitability of the internet for providing psychological interventions to men with ED and their partners. Internet-based treatment is likely to be of particular benefit to men with ED who have barriers preventing them from attending face-to-face psychological therapy, such as embarrassment about discussing sexual problems with a clinician in person, geographical isolation, time constraints or limited finances.

It is likely that Rekindle is not satisfactory for resolving all cases of ED. In cases where ED is more severe or has been established for a significant period of time, a more intensive intervention that can be offered in the context of a 10-week internet-based CBT program may be required. When other comorbid sexual dysfunctions are present, or when the level of discord within the general relationship is high, Rekindle may also need to be supplemented with additional treatment. Certainly, Matic and McCabe[24] demonstrated that men with ED experienced deficits in multiple psychological and relationship domains that may be resistant to treatment.

There are a number of limitations to this study. First, as a result of attrition, the number of participants available to evaluate the effectiveness of Rekindle was small. This attrition rate is higher than for face-to-face psychological treatment for ED, and may reflect difficulties that the therapist experiences in engaging patients in therapy over the internet. This small sample may have affected the reliability of the results by restricting the power of statistical analyses to detect significant differences. The high attrition rate may also have resulted in a selected, perhaps highly motivated group of men. Second, in the absence of face-to-face contact with participants, there was limited capacity for clinical assessment of ED. For some participants, a diagnosis of ED had been assigned by their GP. For others, the disorder was self-diagnosed. Therefore, the study needs to be replicated using a more objective measure of ED.

A third limitation of this research was that data were not collected from partners. A more comprehensive understanding of the effects of Rekindle is likely to be gained by examining the experiences of both individuals. Fourth, there was no control over factors such as type of medical treatment, frequency or dosage. Data were collected on whether or not men used PDE5 inhibitors, but future studies need to more closely examine the nature of this usage, and whether or not it reduced during the treatment program. Changes in medical treatment usage from pre-test to post-test were minimal for participants, and did not differ between men who completed Rekindle and those in the control group.

The findings in this study need to be replicated using a larger sample of participants. The effectiveness of Rekindle beyond 3-month follow-up also requires further research. The development and evaluation of internet-based CBT programs for treating ED, as well as other types of sexual dysfunction, requires further research among a variety of populations, including heterosexual couples, same-sex couples and individuals who are not involved in a stable relationship.

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