TY - JOUR

T1 - An online randomised controlled trial to assess the feasibility, acceptability and potential effectiveness of 'Living with Bipolar': a web-based self-management intervention for Bipolar Disorder.

T2 - trial design and protocol

AU - Todd, Nicholas

AU - Solis-Trapala, Ivonne

AU - Jones, Steven

AU - Lobban, Fiona

PY - 2012/7

Y1 - 2012/7

N2 - Background Bipolar Disorder (BD) is a common and severe form of mental illness. Pharmacotherapy is the main treatment offered, but has limited effectiveness, and there is increasing evidence that people with BD respond well to psychological interventions. Inequalities in access to face-to-face psychological interventions mean many people seek support outside of routine health services. Aim To assess a recovery informed web-based self-management intervention for BD to increase access to psychological support. Method A small online randomised controlled trial (RCT) will evaluate the feasibility, acceptability and potential effectiveness of the intervention compared to treatment as usual (TAU). Feasibility and acceptability will be assessed by recruitment, adherence and dropout rates, website usage statistics, user satisfaction scales and a series of qualitative interviews. Effectiveness will be assessed on a range of outcome measures including quality of life, mood symptoms, coping, recovery, and illness beliefs. Analysis Rates of adherence and dropout will be analysed using logistic regression models with health, socioeconomic and treatment factors as explanatory variables. Changes in quality of life mean scores, contrasting between arms, will be assessed using random effects models. An exploratory analysis will be performed on the secondary outcomes. Thematic analysis (Braun & Clarke, 2006) will be used to analyse the qualitative interviews. Discussion The benefits, challenges and methodological challenges of developing a web-based intervention and conducting an RCT online are discussed. Conclusion The results of this trial will inform a definitive trial; and the implementation phase will aim to assess the potential for use within the NHS.

AB - Background Bipolar Disorder (BD) is a common and severe form of mental illness. Pharmacotherapy is the main treatment offered, but has limited effectiveness, and there is increasing evidence that people with BD respond well to psychological interventions. Inequalities in access to face-to-face psychological interventions mean many people seek support outside of routine health services. Aim To assess a recovery informed web-based self-management intervention for BD to increase access to psychological support. Method A small online randomised controlled trial (RCT) will evaluate the feasibility, acceptability and potential effectiveness of the intervention compared to treatment as usual (TAU). Feasibility and acceptability will be assessed by recruitment, adherence and dropout rates, website usage statistics, user satisfaction scales and a series of qualitative interviews. Effectiveness will be assessed on a range of outcome measures including quality of life, mood symptoms, coping, recovery, and illness beliefs. Analysis Rates of adherence and dropout will be analysed using logistic regression models with health, socioeconomic and treatment factors as explanatory variables. Changes in quality of life mean scores, contrasting between arms, will be assessed using random effects models. An exploratory analysis will be performed on the secondary outcomes. Thematic analysis (Braun & Clarke, 2006) will be used to analyse the qualitative interviews. Discussion The benefits, challenges and methodological challenges of developing a web-based intervention and conducting an RCT online are discussed. Conclusion The results of this trial will inform a definitive trial; and the implementation phase will aim to assess the potential for use within the NHS.

U2 - 10.1016/j.cct.2012.02.011

DO - 10.1016/j.cct.2012.02.011

M3 - Journal article

VL - 33

SP - 679

EP - 688

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

SN - 1559-2030

IS - 4

ER -