Social IsolationNCT03945994
Connecting People Implementation Study
A study testing Connecting People Intervention in people with Social Isolation and Mental Health Wellness 1, run by University of York at 1 site in United Kingdom.
Trial summary
This study aims to investigate if the Connecting People (CP) Programme can be implemented by social care practitioners with high fidelity in community mental health teams (CMHTs) and improve the resourcefulness of social networks of people with mental health problems. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Social Isolation, Mental Health Wellness 1, Social Interaction
- What is being tested?
- Connecting People Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Feb 2018to 28 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with mental health problems under CMHTs
Who cannot join
- Children
- Adults with mental health problems who are not under CMHTs
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Tees, Esk And Wear Valley NHS Foundation Trust
Durham, DL2 2TS
About this study
This study aims to investigate if the Connecting People (CP) Programme can be implemented by social care practitioners with high fidelity in community mental health teams (CMHTs) and improve the resourcefulness of social networks of people with mental health problems.
Read the 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.
- Being tested
- Connecting People Intervention
- Keywords
- Improve Social Capital, Improve mental health
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connecting People InterventionOther
Improve the resourcefulness of social networks of people with mental health problems
| Study group | Role | What they receive |
|---|---|---|
| Connecting People Control Group | No intervention | CMHTs (Community Mental Health Teams) will continue to support people with mental health problems using their standard care. |
| Connecting People Intervention Group | Experimental | 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. Receives: Other: Connecting People Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resource Generator-UK (RG-UK)
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.
Measured: 6 months
Secondary outcomes (4)
Goal Attainment Scaling (GAS)
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).
Measured: 6 months
Questionnaire about the process of recovery (QPR)
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.
Measured: 6 months
EQ-5D-5L
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.
Measured: 6 months
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start14 Feb 2018
- Primary completion29 Jul 2018
- Study completion28 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Social IsolationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study will use multiple methods to answer our research questions. It will consist of: 1. a natural experiment in the form of a non-randomised wait-list controlled pre-post study to evaluate the outcomes of the CP programme, when implemented in CMHTs, in contrast to standard care; and 2. an evaluation of the implementation tools using a standardised tool and qualitative approaches to understand the barriers and facilitators of implementation in the different sites.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Webber, PhD, University of York
- Investigators
- Micheal Barber, PhD, Study director, University of York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945994
- Sponsor's protocol ID
- 225304
- Status last verified
- May 2019
- First submitted
- 1 May 2018
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25441461Webber 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.
PubMed 28286914
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connecting People Implementation Study
- ClinicalTrials.gov ID
- NCT03945994
- Acronym / sponsor ID
- 225304
- Keywords
- Improve Social Capital, Improve mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of YorkUniversity, hospital or other
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 29 Jul 2018 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate if the Connecting People (CP) Programme can be implemented by social care practitioners with high fidelity in community mental health teams (CMHTs) and improve the resourcefulness of social networks of people with mental health problems.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This study will use multiple methods to answer our research questions. It will consist of: 1. a natural experiment in the form of a non-randomised wait-list controlled pre-post study to evaluate the outcomes of the CP programme, when implemented in CMHTs, in contrast to standard care; and 2. an evaluation of the implementation tools using a standardised tool and qualitative approaches to understand the barriers and facilitators of implementation in the different sites.
| Arm | Type | Receives |
|---|---|---|
| Connecting People Control Group | No intervention | –CMHTs (Community Mental Health Teams) will continue to support people with mental health problems using their standard care. |
| Connecting People Intervention Group | Experimental | Other: Connecting People InterventionCMHTs will receive training on how to implement Connecting People programme. They will receive implementation toolkit to improve their practice in contrast to standard care. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with mental health problems under CMHTs
Key exclusion criteria (2 listed)
- Children
- Adults with mental health problems who are not under CMHTs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Connecting People InterventionImprove the resourcefulness of social networks of people with mental health problems | Other | Connecting People Intervention Group |
Primary outcome
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.
4 secondary outcomes
Goal Attainment Scaling (GAS)
Time frame: 6 months
Questionnaire about the process of recovery (QPR)
Time frame: 6 months
EQ-5D-5L
Time frame: 6 months
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Background: PubMed 25441461Webber 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.
- Background: PubMed 28286914Webber 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Micheal Barber, PhD study director
University of York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connecting People Intervention in people with Social Isolation and Mental Health Wellness 1, run by University of York at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resource Generator-UK (RG-UK) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03945994, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.