Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 Mar 24;19(3):e85.
doi: 10.2196/jmir.7008.

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

Fiona Lobban  1 , Alyson L Dodd  1   2 , Adam P Sawczuk  1   3 , Ozgur Asar  4   5 , Dave Dagnan  6 , Peter J Diggle  5 , Martin Griffiths  1 , Mahsa Honary  1 , Dawn Knowles  1 , Rita Long  1 , Richard Morriss  7 , Rob Parker  1 , Steven Jones  1
Affiliations
Randomized Controlled Trial

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

Fiona Lobban et al. J Med Internet Res. .

Abstract

Background: Interventions 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.

Objectives: The 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.

Methods: A 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.

Results: A 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).

Conclusions: ERPonline 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 registration: International Standard Randomized Controlled Trial Number (ISRCTN): 56908625; http://www.isrctn.com/ISRCTN56908625 (Archived by WebCite at http://www.webcitation.org/6of1ON2S0).

Keywords: Internet; bipolar disorder; feasibility studies; randomized controlled trial.

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest: ERPonline was developed by the authors and therefore this is not an independent evaluation. Prof Morriss is the Mood Disorders Theme Lead for the NIHR MindTech Health Technology Co-operative. He also chaired the NICE Clinical Guideline Development Group for bipolar disorder that recommended psychological treatment for long-term maintenance of bipolar disorder.

Figures

Figure 1
Figure 1
The online enhanced relapse prevention intervention (ERPonline) home page - top of page.
Figure 2
Figure 2
The online enhanced relapse prevention intervention (ERPonline) home page - bottom of the page.
Figure 3
Figure 3
The online enhanced relapse prevention intervention (ERPonline) consort diagram.
See this image and copyright information in PMC

References

    1. Whiteford HA, Degenhardt L, Rehm J, Baxter AJ, Ferrari AJ, Erskine HE, Charlson FJ, Norman RE, Flaxman AD, Johns N, Burstein R, Murray CJ, Vos T. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010. Lancet. 2013 Nov 09;382(9904):1575–86. doi: 10.1016/S0140-6736(13)61611-6.S0140-6736(13)61611-6 - DOI - PubMed
    1. McCrone P. Paying the Price: The Cost of Mental Health Care in England to 2026. London: King's Fund Publishing; 2008.
    1. National Institute for HealthClinical Excellence . NICE. London: National Institute for Health and Care Excellence; 2014. Nov 24, [2017-03-02]. Bipolar disorder: assessment and management (clinical guideline 185) https://www.nice.org.uk/guidance/cg185/resources/bipolar-disorder-assess... .
    1. Malhi GS, Bassett D, Boyce P, Bryant R, Fitzgerald PB, Fritz K, Hopwood M, Lyndon B, Mulder R, Murray G, Porter R, Singh AB. Royal Australian and New Zealand college of psychiatrists clinical practice guidelines for mood disorders. Aust N Z J Psychiatry. 2015 Dec;49(12):1087–206. doi: 10.1177/0004867415617657.49/12/1087 - DOI - PubMed
    1. Lehman AF, Lieberman JA, Dixon LB, McGlashan TH, Miller AL, Perkins DO, Kreyenbuhl J, American Psychiatric Association. Steering Committee on Practice Guidelines Practice guideline for the treatment of patients with schizophrenia, second edition. Am J Psychiatry. 2004 Feb;161(2 Suppl):1–56. - PubMed

Publication types

Associated data