Living With Bipolar: a web-based self management intervention
| ISRCTN | ISRCTN64826171 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64826171 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/08/2011
- Registration date
- 12/09/2011
- Last edited
- 19/01/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Background and study aims
Bipolar disorder is a condition that affects your moods, which can swing from one extreme to another. Medication is the main treatment offered but its effectiveness is limited and there is increasing evidence that people with bipolar disorder respond well to psychological therapy. The aim of this study is to test a website that helps patients to manage their bipolar disorder.
Who can participate?
Patients aged over 18 with bipolar disorder.
What does the study involve?
Participants are randomly allocated to one of two groups. One group uses the 'Living with Bipolar' website while the other group receives normal treatment and is given access to the website at the end of the study. Participants in both groups complete questionnaires about their quality of life, mood symptoms, coping, recovery and illness beliefs.
What are the possible benefits and risks of participating?
The results of this study will be used to develop a larger study to test the use of the website within the National Health Service (NHS).
Where is the study run from?
Lancaster University (UK).
When is the study starting and how long is it expected to run for?
September 2011 to February 2012.
Who is funding the study?
Mersey Care NHS Trust (UK).
Who is the main contact?
Nicholas Todd
n.todd@lancaster.ac.uk
Contact information
Mr Nicholas Todd
Scientific
Scientific
Spectrum Centre for Mental Health Research
Division of Health Research
Faculty of Health and Medicine
Lancaster University
Lancaster
LA1 4YT
United Kingdom
| Phone | +44 (0)152 459 2768 |
|---|---|
| n.todd@lancaster.ac.uk |
Study information
| Study design | Phase II randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | http://www.livingwithbipolar.co.uk/rct.php |
| Scientific title | 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 |
| Study acronym | LWB |
| Study hypothesis | The aims of this study are to assess the feasibility, acceptability and potential effectiveness of the 'Living with Bipolar' intervention, a new recovery informed web-based self-management intervention for Bipolar Disorder. The specific objectives are to: 1. Assess whether it is feasible to deliver a web-based intervention for individuals with a diagnosis of Bipolar Disorder 2. Assess whether the LWB intervention is acceptable to individuals with a diagnosis of Bipolar Disorder 3. Assess whether the LWB intervention is effective on psychological outcome 4. Pilot methods for a larger scale (Phase III) randomised controlled trial (e.g. recruitment, randomisation, follow-up, suitability of measures) |
| Ethics approval(s) | School of Health & Medicine Ethics Committee at Lancaster University, 06/07/2011, ref: SHMREC1000005 |
| Condition | Bipolar Affective Disorder |
| Intervention | Group 1 : Waiting list control group - participants receive normal treatment and are given access to the intervention at the end of the trial Group 2 : The 'Living with Bipolar' intervention aims to support individuals with a diagnosis of Bipolar Disorder to: 1. Learn more about themselves, their condition and how it is affecting their lives 2. Increase their self-esteem and self-efficacy to self-manage their condition and pursue personally meaningful recovery goals 3. Learn self-management techniques to effectively manage their condition and 4. Learn practical and interpersonal skills to live a fulfilling life alongside their condition After an extensive development phase involving a systematic review of the literature and a period service user consultancy, 10 comprehensive modules were developed. The core content of the modules is presented as an audio-visual slide show presentation with voice narration. Worksheets to enhance learning and make the content personal can be downloaded and printed out. Participants can also interact directly with the material by completing online quizzes, monitoring their mood and recording goals for the future. The modules are delivered distance-based with minimal external support. To maintain participation there are two means of external support: Motivational emails prompts and an online peer support forum for you to talk to other people using the intervention about the content. The 'Living with Bipolar' modules: 1. Recovery & Me - The process of recovery, fostering the development of self-esteem and self-efficacy 2. Bipolar & Me - The characteristics and course of Bipolar Disorder 3. Self-Management & Me - Introduction to the philosophy of self-management 4. Medication & Me - Medication, the myths, facts and managing a regime 5. Getting to know you - Exploring the individual experience of mood swings including life charting 6. Staying well with Bipolar - Self-management techniques to maintain wellness including lifestyle and early warning signs 7. Depressive Relapse & Me - Self-management techniques to manage depressive relapse 8. Hypo/Manic Relapse & Me - Self-management techniques to manage hypo/manic relapse 9. Talking about my diagnosis - Talking to family, friends, employers and services 10. Crisis & Me - Developing a crisis plan and using advance directives |
| Intervention type | Other |
| Primary outcome measure | 1. The primary aims of this trial are to assess the feasibility and acceptability of the LWB intervention 1.1. Feasibility will be assessed quantitatively by analysing recruitment rates and retention rates and qualitatively through the research team's experience, considering the practicalities and barriers of delivery 1.2. Acceptability will be assessed quantitatively by analysing website usage statistics including patterns and frequency of use and a specifically designed user satisfaction scale, and qualitatively in a series of in-depth qualitative interviews 2. The secondary aim is to assess the potential effectiveness of the intervention on psychological outcome 2.1. The Quality of Life in Bipolar Disorder scale (Brief version) (QOL.BD-Brief) 2.2. The World health Organisation Quality of Life assessment tool, brief version (WHOQOL-BREF) Measured at 3 months (half way through trial) and 6 months (trial end) |
| Secondary outcome measures | 1. Internal State Scale (Bauer et al., 1991) 2. Social Adaption Self-evaluation Scale (SASS) (Bosc et al., 1997) 3. Bipolar Recovery Questionnaire (Jones, In Preparation) 4. The Brief Illness perception questionnaire (BIPQ) adapted for Bipolar Disorder (Broadbent et al., 2006) 5. The Self Efficacy for Managing Chronic Disease Scale, Brief Version (Lorig et al., 2001) 6. The Hayward Stigma and Self Esteem Questionnaire (Hayward et al., 2002) 7. Hypomanic Interpretations Questionnaire (HIQ-10) (Jones et al., 2006) 8. Interpretations of Depression Questionnaire (IDQ-10) (Jones & Day, 2008) 9. Coping Inventory for Prodromes of Mania (Wong & Lam, 1999) 10. Response Styles to Depression Questionnaire (Nolen-Hoeksema & Morrow, 1991) 11. Stephenson Medication Adherence Interview (Stephenson et al., 1993) adapted for use as a self-report instrument Measured at 3 months (half way through trial) and 6 months (trial end) |
| Overall study start date | 01/09/2011 |
| Overall study end date | 29/02/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Participant inclusion criteria | 1. Aged over 18 years 2. Living in the United Kingdom 3. Have a diagnosis of Bipolar Disorder (type I or type II) by a mental health professional and meet criteria on the Mood Disorders Questionnaire (MDQ) 4. Must be able to understand written English and have access to the internet a printer and an email account |
| Participant exclusion criteria | 1. They are aged under 18 years 2. They are living outside the United Kingdom 3. They don't have a health professional diagnosis of Bipolar Disorder and don't meet criteria on the Mood Disorders Questionnaire (MDQ) 4. They can't understand written English and don't have access to the internet, a printer or an email account |
| Recruitment start date | 01/09/2011 |
| Recruitment end date | 29/02/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Lancaster University
Lancaster
LA1 4YT
United Kingdom
LA1 4YT
United Kingdom
Sponsor information
Lancaster University (UK)
University/education
University/education
c/o Director of Research & Enterprise Services
Research and Enterprise Services
University House
Lancaster
LA1 4YW
England
United Kingdom
| Website | http://www.lancaster.ac.uk |
|---|---|
"ROR" |
https://ror.org/04f2nsd36 |
Funders
Funder type
Hospital/treatment centre
Mersey Care NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2014 | Yes | No |
Editorial Notes
19/01/2018: Publication reference added.
