Assessing Feasibility and Acceptability of Web-Based Enhanced Relapse Prevention for Bipolar Disorder (ERPonline): A Randomized Controlled Trial

Abstract

BackgroundInterventions that teach people with bipolar disorder (BD) to recognize and respond to early warning signs (EWS) of relapse are recommended but implementation in clinical practice is poor.ObjectivesThe objective of this study was to test the feasibility and acceptability of a randomized controlled trial (RCT) to evaluate a Web-based enhanced relapse prevention intervention (ERPonline) and to report preliminary evidence of effectiveness.MethodsA single-blind, parallel, primarily online RCT (n=96) over 48 weeks comparing ERPonline plus usual treatment with “waitlist (WL) control” plus usual treatment for people with BD recruited through National Health Services (NHSs), voluntary organizations, and media. Randomization was independent, minimized on number of previous episodes (<8, 8-20, 21+). Primary outcomes were recruitment and retention rates, levels of intervention use, adverse events, and participant feedback. Process and clinical outcomes were assessed by telephone and Web and compared using linear models with intention-to-treat analysis.ResultsA total of 280 people registered interest online, from which 96 met inclusion criteria, consented, and were randomized (49 to WL, 47 to ERPonline) over 17 months, with 80% retention in telephone and online follow-up at all time points, except at week 48 (76%). Acceptability was high for both ERPonline and trial methods. ERPonline cost approximately £19,340 to create, and £2176 per year to host and maintain the site. Qualitative data highlighted the importance of the relationship that the users have with Web-based interventions. Differences between the group means suggested that access to ERPonline was associated with: a more positive model of BD at 24 weeks (10.70, 95% CI 0.90 to 20.5) and 48 weeks (13.1, 95% CI 2.44 to 23.93); increased monitoring of EWS of depression at 48 weeks (−1.39, 95% CI −2.61 to −0.163) and of hypomania at 24 weeks (−1.72, 95% CI −2.98 to −0.47) and 48 weeks (−1.61, 95% CI −2.92 to −0.30), compared with WL. There was no evidence of impact of ERPonline on clinical outcomes or medication adherence, but relapse rates across both arms were low (15%) and the sample remained high functioning throughout. One person died by suicide before randomization and 5 people in ERPonline and 6 in WL reported ideas of suicide or self-harm. None were deemed study related by an independent Trial Steering Committee (TSC).ConclusionsERPonline offers a cheap accessible option for people seeking ongoing support following successful treatment. However, given high functioning and low relapse rates in this study, testing clinical effectiveness for this population would require very large sample sizes. Building in human support to use ERPonline should be considered.Trial registrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 56908625; http://www.isrctn.com/ISRCTN56908625 (Archived by WebCite at http://www.webcitation.org/6of1ON2S0)

Factors affecting implementation of digital health interventions for people with psychosis or bipolar disorder, and their family and friends: a systematic review

“…[28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44] The only study published prior to 2007 involved a telehealth digital intervention. 45 Most of the studies used mixed methods, 28,29,31,32,34,35,[37][38][39][40][41][42][43][44][45][46][47][48][49][50] four used quantitative methods 30,33,36,51 and two studies used qualitative methodology. 52,53 The majority of the studies were feasibility and acceptability trials (42%), 29, 35, 36, 38, 40, 42-44, 50, 53 eight were designed to look specifically at implementation (31%), 28, 30, 32, 45-47, 49, 52 five were pilot studies (19%), 31,39,…”

“…52,53 The majority of the studies were feasibility and acceptability trials (42%), 29, 35, 36, 38, 40, 42-44, 50, 53 eight were designed to look specifically at implementation (31%), 28, 30, 32, 45-47, 49, 52 five were pilot studies (19%), 31,39,41,48,51 and two were RCTs (8%). 33,34 Seven of the studies included participants with schizophreniform disorders (27%), 29,30,37,38,43,44,51 seven those with bipolar disorder (27%), 28,33,36,40,41,49,53 and the remaining were for both illnesses (46%). 31, 32, 34, 35, 45-48, 50, 52 None of the digital interventions targeted family or friends and most of the digital interventions (78%) utilised direct support from staff or peers in their delivery.…”

“…48 A webbased digital intervention that was used both independently and then with a facilitator was reported to help guide discussions; "without the website we wouldn't have had nearly as much to talk about". 44 However, others spoke of digital interventions without any human support feeling impersonal, 38,40 saying that more emphasis should be "not on automation but a real life man with deep psychological problems". 38 Some users echoed this saying they preferred face-to-face communication 44 and indicated that the younger generation were more accepting of digital interventions.…”

“…Although digital interventions are promoted as long term cost-saving opportunities, in the shorter term cost was considered an important implementation factor across all types of digital interventions, with lack of staff, training, space, and necessary equipment all being attributed to a financial deficit. 40,45,47,50,52 Only one study completed a formal cost analysis 50 but others reported on removing human facilitation to reduce cost, 40 and the impact of care providers agreeing to absorb the cost of implementation on uptake and sustainability within private healthcare systems. 28…”

“…Attitudes and beliefs about digital interventions were crucial implementation factors for both staff and users. Positive beliefs that the intervention would help management of symptoms, 38,42 enthusiasm and interest in the intervention, 34,46,52 trust in the team delivering the intervention, and the knowledge that it had been developed by other service users 40 were all cited as factors in increasing end user engagement. However, negative attitudes to IT generally, 52 the preference for face-to-face interventions and lack of interest in digital interventions meant that while users may formally complete sessions, these sessions were less successful as they were more interested in browsing other websites, did not interact with staff in sessions, and did not utilise the available peer support.…”