- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03945994
Connecting People Implementation Study
Study Overview
Status
Intervention / Treatment
Detailed Description
People with mental health problems require a range of support to help them in their recovery. Alongside medical and psychological support, people may need support with engaging in meaningful activities and developing relationships. The focus of this study is on advancing understanding of how services can improve the support they offer to people around social relationships.
In a previous study, a Connecting People programme was developed which supported people to make plans for developing their network of contacts in the community. When delivered fully, it helped people feel more included in society and better able to access advice, information and practical support from people they know.
This research project aims to look at how Connecting People can be effectively established within community mental health teams by social workers trained as part of the 'Think Ahead' initiative. The investigators want to know how to implement the Connecting People programme well, assessing whether tools such as manuals, guidance and specific training help or hinder this process. The investigators want to know when implemented, compared to standard care, whether the programme benefits mental health service users and is cost-effective.
The study will last 15 months and is organised into two phrases:
- Implementation of the programme in community mental health teams in five areas in England. Outcome data will be collected from each participating team and results will be compared between teams who implemented the programme and those that only offered standard care.
- Exploration of how successful implementation was across the five areas, using a check-list and in-depth individual and group interviews to understand the features that supported or hindered the process.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Durham, United Kingdom, DL2 2TS
- Tees, Esk And Wear Valley NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults with mental health problems under CMHTs
Exclusion Criteria:
- Children
- Adults with mental health problems who are not under CMHTs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Connecting People Control Group
CMHTs (Community Mental Health Teams) will continue to support people with mental health problems using their standard care.
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Experimental: Connecting People Intervention Group
CMHTs will receive training on how to implement Connecting People programme.
They will receive implementation toolkit to improve their practice in contrast to standard care.
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Improve the resourcefulness of social networks of people with mental health problems
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resource Generator-UK (RG-UK)
Time Frame: 6 months
|
Questionnaire; Measure of access to social capital (knowing people with particular skills or resources within your social network).
The name of the scale is the Resource Generator-UK.
Example questions include: Do you currently have access to someone who is able to lend you a small amount of money?
Do you currently have access to someone who works for the local authority?
Answers are 'Yes' or 'No'; though further information is obtained on the relation of the person to the individual.
Scale has 27 items and is scored 0-27 with high scores indicating high access to social capital.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Goal Attainment Scaling (GAS)
Time Frame: 6 months
|
Questionnaire; GAS is a method of scoring the extent to which service users' individual goals are achieved in the course of intervention.
In effect, each service user has their own outcome measure but this is scored in a standardised way as to allow statistical analysis.
The name of the scale is the Goal Attainment Scaling (GAS).
Importance from 0 (not at all) to 3 (very important).
Difficulty: from 0 (not at all) to 3 (very difficult).
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6 months
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Questionnaire about the process of recovery (QPR)
Time Frame: 6 months
|
Questionnaire; Measurement of people's perception of their recovery from mental health problems.
Items include, for example, 'I feel better abut myself', 'I feel that my life has a purpose'.
The scale has 15 items which are answered using a 5-point likert scale from 'strongly disagree' to 'strongly agree'.
Responses are scored 1-5 and summed, with totals from 15-75.
Higher values represent a better recovery.
|
6 months
|
EQ-5D-5L
Time Frame: 6 months
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Questionnaire measurement of health related quality of life. The first part comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems and the participant is asked to select the most appropriate for them. The digits for the five dimensions are combined into a 5-digit number that describes the participant's health state. High numbers indicate poor health-related quality of life. The second part records the participant's self-rated health on a vertical visual analogue scale (VAS), where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the participant's own judgement from 0-100. High scores indicate better self-rated health. |
6 months
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The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Time Frame: 6 months
|
Questionnaire measurement of mental well-being.
The scale includes 14 items such as 'I've been feeling optimistic about the future'.
'I've been feeling relaxed', 'I've been feeling confident'.
Each item is answered using a 5-point likert scale from 'none of the time' to 'all of the time', with values of 1-5 ascribed to each response.
The scale is a sum of item values ranging from 15 to 70 with higher values indicating higher mental well-being
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Micheal Barber, PhD, University of York
Publications and helpful links
General Publications
- Webber M, Reidy H, Ansari D, Stevens M, Morris D. Enhancing social networks: a qualitative study of health and social care practice in UK mental health services. Health Soc Care Community. 2015 Mar;23(2):180-9. doi: 10.1111/hsc.12135. Epub 2014 Dec 1.
- Webber M, Fendt-Newlin M. A review of social participation interventions for people with mental health problems. Soc Psychiatry Psychiatr Epidemiol. 2017 Apr;52(4):369-380. doi: 10.1007/s00127-017-1372-2. Epub 2017 Mar 12.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 225304
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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