A web-based Enhanced Relapse Prevention (ERP-online) intervention for bipolar disorder

Not Applicable

Completed

• Conditions: Topic: Mental Health Research Network; Bipolar affective disorder, unspecified; Subtopic: Bipolar affective disorder; Disease: Bipolar affective disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN56908625
• Lead Sponsor: ancaster University (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-26
• Last Update Posted: 20 November 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

1. Male and female, over 18 years of age
2. Access to a computer and the internet. ERP-online will only be accessible via the internet, so computer and internet access is necessary. However, it is up to individual participants where they wish to access the intervention, so we have not stipulated that they must own a computer, in order to allow those who access computers in public areas or at the homes of friends/family to take part.
3. Meet SCID research diagnostic criteria for bipolar disorder type 1 or 2. ERP in face-to-face form has been evaluated among individuals with this diagnosis, and it was specifically developed to help service users to identify the triggers and early warning signs of mania/depression (symptoms of bipolar disorder), and how to manage these.
4. Have had 3 relapses in their lifetime, with 1 falling in the preceding 2 years. This is to ensure we have a sample considered high risk for relapse for which this kind of intervention is most appropriate.
5. Unfortunately our budget is not sufficient to cover the costs of a translating the online intervention content and some of the questionnaire measures used in this study are not validated in other languages. For this reason we have made one of our inclusion criteria the ability to understand spoken and written English.

Exclusion Criteria

1. An organic cause for the disorder
2. Primary diagnosis of alcohol or substance misuse
3. Unable/unwilling to give informed consent
4. In current episode (or in episode within previous 4 weeks) this is because the intervention focuses on the identification and management of early warning signs of relapse and therefore is not intended for those currently in episode who would benefit from a different kind of approach.
5 Currently taking part in another intervention study (or follow-up period). This is to reduce burden of research participation on any one individual and to control for the effects of involvement in another intervention study at the same time.
6. Currently being treated under a section of the mental health act.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
From 10/10/2017:<br>Feasibility and acceptability (recruitment, retention, data completion, ERPonline website usage, adverse events, participant feedback).<br><br>Prior to 10/10/2017:<br>Weeks well; Timepoint(s): 12, 24, 36, 48 weeks

Secondary Outcome Measures

Name	Time	Method
From 10/10/2017:<br>Estimates of impact on participant outcomes [weeks well (time spent euthymic), relapse, depression, mania, quality of life, functioning, personal recovery) and potential mechanisms of change (medication adherence, illness perceptions, early warning signs monitoring)]. <br><br>Prior to 10/10/2017:<br>No secondary outcome measures.