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21 March 2013
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| [ Print-friendly version ] |
| AMP WellBeing Intervention trial |
| ISRCTN | ISRCTN68572159 |
| DOI | 10.1186/ISRCTN68572159 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | AMP WellBeing Intervention trial |
| Scientific title | Exploratory randomised controlled trial of a wellbeing intervention for under-served groups |
| Acronym | AMP WBI |
| Serial number at source | NIHR Clinical Research Portfolio Database Study ID 8326 |
| Study hypothesis | A wellbeing intervention based on cognitive-behavioural principles, with an emphasis on social participation, would be acceptable and more effective than treatment as usual for under-served patients with symptoms of depression or anxiety. |
| Lay summary |
Background and study aims
People experiencing low mood or anxiety may benefit from a wellbeing programme designed specifically for older people or people who are members of minority ethnic communities. The primary aim of the study was to explore the potential benefit of trained advisors offering personalised wellbeing plans. We also evaluated whether people find these types of services acceptable. Another aim of the study was to enhance patients’ coping skills and self-management strategies by encouraging the development of informal support networks. Who can participate? The study was open to people with low mood or anxiety who were registered with one of 16 general practices in four deprived neighbourhoods in Liverpool and Manchester. In two neighbourhoods the study was open to people aged fifty or above. In the third neighbourhood it was open to people of Somali heritage, and in the fourth it was open to people of South Asian heritage. What does the study involve? People who agreed to take part were allocated to one of two groups, those receiving personalised well-being care plans and those receiving usual care. The groups were selected by a computer which had no information about the individual. People chosen to be in the usual care group received everything they would have received if they had not taken part in the study. In addition, we monitored the effects of their care. People selected to receive a personalised wellbeing plan were allocated a case manager who offered a range of interventions. They had choice about whether to take part in individual sessions, group sessions or other types of activities. They developed the plan together, setting goals and targets and meeting with the case manager on at least 3 occasions over a 4 month period. While being part of the study, which ever group they were in, people were asked to complete four short questionnaires at the end of the study, and for some information including age, education and personal circumstances. At the end of the study people were also asked to take part in an interview to discuss their experiences of the wellbeing programme. What are the possible benefits and risks of participating? We hoped that people’s mood and sense of wellbeing would improve whichever group they were allocated to. The information gained from the study will also help us to improve healthcare services in the future for people who need help with regards to their mood and wellbeing. Regarding risks, people in the wellbeing group may have been asked to take part in activities that they did not usually do. However, the case manager was available for support, and to offer assistance with child care and interpreters. Being part of the usual care group did not have any side effects. Where is the study run from? The study was run from two centres, one in the University of Liverpool and the other in the University of Manchester. When is the study starting and how long is it expected to run for? The study started in September 2010 and ran until December 2011. Who is funding the study? The study was funded by the National Institute for Health Research, under its Programme for Applied Research. Who is the main contact? Prof Christopher Dowrick cfd@liv.ac.uk |
| Ethics approval | North-West 8 Research Ethics Committee, 29 July 2010, (reference 10/H1003/38). |
| Study design | Exploratory multi-centre single-blind randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Anxiety and/or depression |
| Participants - inclusion criteria |
1. Male and female aged 50 and over for Croxteth and Wythenshawe participants
2. Aged 18 and over for Picton and Longsight participants 3. Somali heritage in Picton and South Asian (Pakistani or Bangladeshi) in Longsight; registered with one of the 16 primary care practices working with the AMP Development Partnership 4. Scoring 10 or more on the Patient Health Questionnaire 9 (PHQ)-9 and/or the Generalized Anxiety Disorder 7 (GAD-7) |
| Participants - exclusion criteria |
1. Currently deemed to be at significant risk to themselves or others
2. Significant learning disabilities and cognitive impairment |
| Anticipated start date | 20/09/2010 |
| Anticipated end date | 31/12/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 100 |
| Interventions |
One third of participants were randomised to receive treatment as usual, i.e. no clinical intervention from the research team.
Two thirds of participants were randomised to receive the wellbeing intervention. The wellbeing intervention focused on brief cognitive behavioural strategies aimed at decreasing anxiety and depression and social isolation. The title wellbeing was designed to maximise engagement and reduce stigma, and to enhance linkage with our community engagement interventions. We incorporated a patient-centred interview and shared problem statements, goals and wellbeing plans. The intervention was delivered by wellbeing facilitators. Participants were offered an initial patient-centred assessment session with a wellbeing facilitator, and collaboratively devised a wellbeing plan. The wellbeing plan specified desired health or social care changes based on self-identified goals. Significant emphasis was placed on the patient as the ‘agent of change’, incorporating patients’ prior experience and coping strategies into the intervention and addressing stigma, expectations, and illness trajectory to better engage patients. Once the goals had been identified, the participant chose up to three ways to obtain support to achieve them: individual sessions with their wellbeing facilitator; group sessions with other participants; or direction (signposting) to appropriate public or third sector services in their locality. |
| Primary outcome measure(s) | CORE-OM, a 34-item self report scale designed to measure global distress, including subjective well being, life/social functioning and risk measured at baseline and 20 weeks |
| Secondary outcome measure(s) |
1. PHQ-9 for depression
2. GAD-7 for anxiety 3. The Work and Social Adjustment Scale 4. The EQ-5D for quality of life Measured at baseline and 20 weeks |
| Sources of funding | NIHR (UK) - Programme Grant RP-PG-0606-1071 |
| Trial website | http://www.amproject.org.uk |
| Publications | |
| Contact name | Prof Christopher Dowrick |
| Address |
B121 Waterhouse Buildings
University of Liverpool |
| City/town | Liverpool |
| Zip/Postcode | L69 3GL |
| Country | United Kingdom |
| cfd@liv.ac.uk | |
| Sponsor | University of Liverpool (UK) |
| Address |
Faculty Support Office
Faculty of Health and Life Sciences Duncan Building Daulby Street |
| City/town | Liverpool |
| Zip/Postcode | L69 3GA |
| Country | United Kingdom |
| slflet@liv.ac.uk | |
| Sponsor website: | http://www.liv.ac.uk |
| Date applied | 05/02/2013 |
| Last edited | 25/02/2013 |
| Date ISRCTN assigned | 25/02/2013 |
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| © 2013 ISRCTN unless otherwise stated. | |
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