Background
Methods
Study design and participants
-
Control group: received routine community mental health care under the Care Programme Approach (treatment as usual / TAU)
-
Intervention group: received enhanced community care intervention that uses interactive SMS communication tools in addition to TAU.
Intervention development, study setting, and recruitment procedure
Inclusion criteria
-
Established diagnosis of Severe Mental Illness (Schizophrenia, Schizoaffective Disorder, Bipolar Disorder)
-
Duration of illness ≥ one year
-
Currently receiving care within the framework of the Care Programme Approach (be on CPA and have a care coordinator assigned to them or receive secondary mental care service in a depot clinic with regular reviews)
-
Basic command of English
Exclusion criteria
-
Lack of capacity (as assessed pre consent giving by patient’s clinicians)
-
Organic psychosis
-
Diagnosis of Learning Disability
-
Currently an inpatient receiving acute care in hospital
Intervention
Wellbeing Score | Automatic response to wellbeing score submission |
5 or 6 | Thank you. You’re doing really well. Take note of what you’re doing to help yourself. Flo |
3 or 4 | Thank you. Good to hear you’re coping well. Keep it up, Flo |
2 | Thank you. Sorry to hear things are difficult for you. You might want to look at your crisis plan to help yourself manage. Flo |
0 or 1 | Thank you. Sorry to hear you’re not feeling well. You might want to call the crisis line for advice on [local phone number given] or contact your care coordinator. |
Help Code | Automatic response to submitted request for help |
Mental health MH | Thanks for letting us know you’re having difficulties with your mental health. You can call the crisis line for advice if you need it: [local phone number given] |
Physical health PH | Thanks for letting us know you’re having difficulties with your physical health. It may be best to book an appointment with your GP or attend A&E |
Safety SF | Thanks for letting us know that you don’t feel safe. You can call the crisis line for advice on [local phone number given] or in an emergency call 999 |
Medication MED | Thanks for letting us know that you’re having problems with medication. You can call your GP or ask for an appointment with your psychiatrist to discuss this |
Side effects SE | Thanks for letting us know that you’re having side effects. You can call your GP or ask for an appointment with your psychiatrist if you need to discuss this |
Social contact SC | Thanks for letting us know that you’re having problems with social contact. Someone you trust might support you at this time if you talk it through with them |
Finance FI | Thanks for letting us know that you’re having finance problems. You could try asking for advice from community links on [local phone number given] |
HousingHO | Thanks for letting us know that you’re having housing problems. You could try asking for advice from [local area] Council on [local phone number] |
Asylum (seeking) AS | Thanks for letting us know that you’re having Asylum problems. You could try calling RAMP for advice on [local phone number] |
Employment EP | Thanks for letting us know that you’re having employment problems. You could try asking for advice from Workplace on [local phone number] |
Randomisation
Sample size
Assessment of the feasibility of the RCT
Ethics approval and consent to participate
Statistical analysis
Qualitative study
Results
Participant flow and data
Assessment of the feasibility of the RCT
Baseline participant characteristics
‘Florence’ + TAU | TAU | t-test | |
---|---|---|---|
(N = 37) | (N = 28) | (Df = 62/63) | |
Gender female, n (%) | 19 (51) | 15 (54) | – |
Age, mean years (sd) | 36.2 (11.4) | 33.9 (10.9) | n.s. |
Duration of illness, mean years (sd) | 16.3 (11.3) | 12.1 (9.2) | n.s. |
Age leaving education mean age (sd) | 24.4 (18.7) | 28.1 (25.3) | n.s. |
Number of previous hospitalisations, mean number (sd) | 2.6 (2.5) | 2.3 (2.6) | n.s |
Utilisation of the intervention elements
Quantitative outcome data analysis
‘Florence & TAU’ | TAU | Difference (95% CI) | |||||
---|---|---|---|---|---|---|---|
N | Mean | s.d. | N | Mean | s.d. | ||
DIALOG PROM mean score 8 items | |||||||
- at baseline | 30 | 4.6 | 0.8 | 24 | 4.3 | 1.4 | |
- post-treatment | 30 | 4.8 | 1.1 | 24 | 4.6 | 1.2 | −0.27 (−0.51 to −0.02) * |
DIALOG PREM mean score 3 items | |||||||
- at baseline | 31 | 5.6 | 0.9 | 25 | 5.1 | 1.4 | |
- post-treatment | 31 | 5.7 | 1.0 | 25 | 5.3 | 1.0 | −0.14 (−0.49 to 0.20) n.s. |
General Self Efficacy Scale (GSE) | |||||||
- at baseline | 30 | 2.8 | 0.7 | 23 | 2.7 | 0.8 | |
- post-treatment | 30 | 2.7 | 0.7 | 23 | 2.8 | 0.6 | 0.16 (−0.17 to 0.20) n.s. |
Mental Health Confidence Scale | |||||||
- at baseline | 29 | 65.4 | 15.4 | 24 | 61.8 | 19.5 | |
- post treatment | 29 | 62.4 | 17.2 | 24 | 66.5 | 15.5 | −0.85 (−4.97 to 3.23) n.s. |
Medication Adherence Scale (MARS) | |||||||
- at baseline | 31 | 7.7 | 2.1 | 25 | 7.6 | 2.7 | |
- post-treatment | 31 | 7.6 | 2.3 | 25 | 7.7 | 2.1 | −0.14 (−0.79 to 0.50) n.s. |
Qualitative interview data (findings from thematic analysis)
Theme 1: The impact of the ‘Florence’ intervention in community mental health care | ||
Subtheme | Quotes from Service Users | Quotes from clinicians |
1.1: ‘Florence’ facilitating service user-clinician communication | “Florence worked well, like someone checking in, and getting the text message back giving advice or saying you’re doing well was helpful. I was looking forward to the message, like a friend.” [Flo, SU, 009] | “Perfect intervention to communicate their well-being or otherwise to their CCO regularly”. [Flo, CC, 007]. |
1.2: The value of ‘Florence’ medication adherence reminders | “I just like it cause it’s so helpful. Particularly if you’re having a bad day as I would forget meds, mainly the evening ones when feeling low so having the reminders was helpful.” [Flo, SU, 025]. “Brilliant. A few times where I was busy, it would remind me to take my medication” [Flo, SU, 025] “It changed a lot because before, a few times I used to forget to take the medications but now it prompts me to take the medications at the right time so there’s no complications.” [Flo, SU, 050] | “Would be really good for clients when they are coming out of hospital for at least a week or maybe a month to help compliance with medication. Especially for people who have regular admissions after non-compliance. I also think it would be helpful for GP surgeries when medications are first prescribed to help for compliance and monitoring”. [Flo, CC, 063] |
1.3: Florence supporting service users and clinicians to focus on feelings | “It’s very nice that the system also asks how I’m doing every day on a scale of 0–6 so it makes me think about how I’m doing all the time. It’s like mindfulness, it helps me to be aware of how I’m doing and it like helps me to be mindful” [Flo, SU, 050] | “… she’s been using it and found it very helpful to track her mood. I’ve been checking in regularly and it’s helped me to be aware of how she’s doing”. [Flo, CC, 021] |
Theme 2: The acceptability of the Florence intervention amongst servicer users and community mental health professionals | ||
Subtheme | Quotes from Service Users | Quotes from clinicians |
2.1: Satisfaction with Florence | “No, I think it was all good, overall, I don’t have any complaints. With the ‘Florence’ system I don’t think there’s anything that could be improved, I think it’s perfect.” [Flo, SU, 062] “Makes you feel less isolated and that you’re being monitored when not feeling well […] I feel well supported by the team and [NHS] Trust but not my family. The Trust could use FLO to help with support and guidance which would be useful. “[Flo, SU, 009]. | “Positive she was happy” [Flo, CC, 47] |
2.2: Usability of Florence | “The questions were good, straight forward, you just reply with the number that you’re feeling. It was very easy to use” [Flo, SU, 050] “I liked the graph which I think was helpful for Y and she showed it to me sometimes too. The replies of the messages was always positive and I appreciated them most days, they made me smile.” [Flo, SU, 021] “… 10 people with the same diagnosis as me will have 10 different ways of experiencing the illness. So I like that it’s specific to me, it makes me feel more in control. I like that you can change it to your specific needs.” [Flo, SU, 063] | “Flagging up when a service user is not doing well is helpful” [Flo, CC, 025] |
Theme 3: Recommendations for the development of the Florence intervention | ||
Subtheme | Quotes from Service Users | Quotes from clinicians |
3.1: Personalisation of Florence | “… 10 people with the same diagnosis as me will have 10 different ways of experiencing the illness. So I like that it’s specific to me, it makes me feel more in control. I like that you can change it to your specific needs.” [Flo, SU, 063] “It would be good to be able to adjust the frequency so by continuing on the same score until I submit a different score.” [Flo, SU, 031]] | ‘Individualising of text messages for each patient, appointment reminders’ [TAU, CC 66] |
3.2. Practical considerations implementing ‘Florence’ | “A prompt for clinicians to discuss the intervention with patients would be helpful.” [Flo, Con, 007] |
Theme 1: the impact of the ‘Florence’ intervention in community mental health care
“Probably constant communication, a good care coordinator who understands me for when I feel like I’m going off the rails. I can email them, and they respond well. So, email and understanding from care coordinator.” [Flo, SU, 021].
“[Name] has been able to individuate from [their] mother, by taking more responsibility for [their] own care, and this in turn has led to their relationship being more some symbiotic; mutually supportive.” [Flo, CC, 009].
“The message, well 3, “thank you, I’m glad you’re coping well is very nice”. It’s tailored to your needs.” [Flo, SU, 028].
“It also helped them to think about how they were doing from day-to-day in themselves which in turn helped them further develop their reflective capacity and therefore recovery.” [Flo, CC, 009].
Theme 2: the acceptability of the Florence intervention amongst servicer users and community mental health professionals
“yes, people expressed they would like to be asked about their mood and perhaps use the ‘Florence’ similarly to a mood diary. It seems useful for people who are actively looking to engage with their mental health.” [TAU, CC, 066].
“They should use this on a larger scale, more frequency of texts.” [Flo, SU, 009].
“The first time I got a call from [name of care-coordinator] when I scored really low and she called me I was quite surprised because I didn’t know that they got the feedback.” [Flo, SU, 046].
“Flagging up when a service user is not doing well is helpful in Flo” [CC, 025].
Theme 3: recommendations for the development of the Florence intervention
‘10 in the morning it’s too early and some people’s days haven’t started’.
“It would be good to be able to text back something else, like words. I know there were a list of words that I could have text back, but I really want to text back what I’m feeling. [ …] Every number I know corresponds to how I was feeling. 6 was I’m on top of the world and 0 meant I’m going to go and jump off a bridge, but what does 3 mean …? ” [Flo, SU, 063].
“Service users to have more responsibility and power on sharing their information with clinicians, therefore no automatic response, but a choice of whether to share the last weeks or days score with care coordinator. This may increase service user autonomy.” [Flo, CC 25].