There has been a growing interest in the use of telehealth interventions in the UK healthcare system (NHS England, 2015), as a possible way of increasing access to care, helping individuals to manage their own health issues, and reducing the need for face-to-face consultations with healthcare professionals.
Telehealth interventions include telephone-, internet-, and app-based services and support. The evidence base for the benefits of telehealth interventions so far has been relatively inconsistent and difficult to draw firm conclusions from (Flodgren et al., 2015; Wootton, 2012).
A new paper recently published in Lancet Psychiatry, led by Professor Chris Salisbury (2016), describes a randomised controlled trial (RCT) of a specific telehealth intervention (The Healthlines Service) for depression. The Healthlines Service intervention was developed by the authors of this paper, drawing on their evidence-based, conceptual model for the effective use of telehealth interventions to improve the management of chronic health disorders, the TElehealth in CHronic disease (TECH) model. Details about the Healthlines Service intervention and the TECH model can be found in the paper’s appendices, and readers interested in more detail can watch this (30 minute long) screencast of the system.
Participants were recruited from 43 general practices around Bristol, Sheffield, and Southampton. Potentially eligible patients from the practices were identified through searches of the computerised general practice patient records. Information about the study was then posted to a random sample of potentially eligible patients.
Patients who expressed an interest in the study and had a score of at least 10 on the Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001), were then screened by the research team over the telephone to confirm their eligibility. To be included in the trial, participants also had to be aged 18 or over, have a confirmed diagnosis of depression as assessed using a diagnostic interview, and have access to a telephone, the internet, and email.
Participants in the trial were randomly allocated to receive either the Healthlines Service intervention (plus usual care) or usual care alone.
The Healthlines intervention
- The Healthlines Service intervention consisted of an initial assessment and goal-setting telephone call, followed by 6 further telephone calls (approximately equally spaced over a 4-month period), to participants by trained health advisers
- Participants also had access to the Healthlines Service web portal, which included a link to a computerised cognitive behavioural therapy (cCBT) programme called the Living Life to the Full Interactive programme (LLTTFi; Williams et al., 2013)
- The programme consists of 6 self-directed sessions to be completed approximately every 2 weeks. Participants in the trial could complete the programme in either online or book form
- The web portal also provided a link to Big White Wall, which includes a clinically moderated online forum.
The health advisers were not clinically qualified but had had previous experience working for NHS Direct, a telehealth service, and had received three weeks of training specifically relevant to the intervention. The health advisers used scripts generated by the Healthlines Service interactive software to direct participants to relevant online information and programmes, and to support participants in addressing health-related goals and in using the online- or book-based LLTTFi programme. The health advisers also covered a range of modules in their telephone calls, including monitoring depression symptoms, antidepressant treatment and adherence, exercise, and alcohol use.
The primary outcome measured was ‘response to treatment’, defined as the proportion of participants who had a PHQ-9 score of less than 10 and/or a reduction in their PHQ-9 score of at least 5 points, at 4 months after randomisation.
Secondary outcomes measured included:
- PHQ-9 scores at 8 and 12 months after randomisation
- Levels of anxiety
- Quality of life
- Satisfaction with treatment received and with amount of support received
- Antidepressant medication adherence
307 participants were allocated to the intervention group and 302 to the usual care (control) group at the start of the trial. At the 4-month follow-up timepoint, primary outcome data were obtained for 255 participants (83%) in the intervention group and 270 participants (89%) in the control group. 516 participants (85%) were retained in the trial until the 12-month follow-up timepoint.
Findings relating to the primary outcome:
- 27% of the 255 participants in the intervention group and 19% of the 270 participants in the control group had responded to treatment at 4 months after randomisation
- The proportion of participants who had responded to treatment increased in both groups at the 8- and 12-month follow-up timepoints, and the difference between the groups in terms of response to treatment narrowed with time
Findings relating to secondary outcomes:
- Participants in the intervention group had significantly lower levels of anxiety than participants in the control group at 12 months after randomisation
- Participants in the intervention group showed significantly improved self-monitoring and insight, skill and technique acquisition, and health literacy, compared to participants in the control group, at the 12-month follow-up timepoint
- Participants in the intervention group were significantly more satisfied with treatment and with the amount of support received, compared to participants in the control group, at 12 months after randomisation
- No significant differences between the groups were found for quality of life or antidepressant medication adherence at the 12-month follow-up timepoint
Findings related to intervention use:
- In the intervention group, considerable variation was found in terms of participants’ use of the intervention
- Analysis suggested that adherence to the intervention was associated with enhanced effectiveness of the intervention
- For the 295 participants with available data, the median number of telephone encounters was 5 (out of a maximum of 10)
- For the 204 participants who logged onto the LLTTFi website, the median number of modules completed of the cCBT programme was 2 (out of 7)
- No participants posted on the Big White Wall forum
Strengths and limitations
The strengths of this study include its large, well-powered sample, and the high proportion of participants retained in the trial over the 12-month follow-up period.
While a random sample of potentially eligible patients were initially contacted about the study to enhance the generalisability of the findings, Bruce (2016) has pointed out in the accompanying comment piece, in line with the authors, that in fact “factors affecting non-participation . . . could restrict generalisability” (p. 2). This is because out of the random sample of 16,570 potentially eligible patients who were initially posted information about the study, only 2,375 expressed an interest in taking part in the study. Thus, this causes us to question the representativeness of these 2,375 participants of the general population. What were their motivations for taking part in the study? How did they differ from those who did not express interest in taking part?
Delivery of the Healthlines Service intervention was paused for two months when NHS Direct was closed down and transferred to Solent NHS Trust, which affected continuity of the intervention for some participants. Indeed, as the authors acknowledge, a high proportion of participants did not have the maximum number of telephone encounters with the health advisers. Specifically, only 28% of participants in the intervention group received at least 9 of the 10 telephone calls. There could be a multitude of reasons behind this, including the closure of NHS Direct and participants choosing not to take part in the intervention any longer. It would have been useful to have perhaps had a qualitative research arm of the trial to explore participants’ reasons for dropping out of the intervention, to examine the acceptability of the intervention to recipients and inform delivery going forward.
Conclusions and implications
Overall, the findings of this study:
Show the promise of technology to improve the reach and effectiveness of chronic disease management while potentially reducing the burden on GPs (Bruce, 2016, p. 1).
Potential strengths of the Healthlines Service intervention include the possible speed and ease with which it could be implemented across the country, and its potential to reach a large amount of patients.
Yet, in Salisbury et al.’s (2016) study, the mean score on the PHQ-9 remained high (above 10) for both groups of participants at all timepoints in the trial. The authors suggest that this could indicate the ‘treatment-resistant’ nature of participants’ depression. However, I wonder whether this could also indicate that in fact neither this intervention nor usual care (presumably defined as GP appointments and antidepressants) may be powerful enough to have a meaningful impact on severe depression. Or perhaps, generally, participants were unable to use the intervention enough to enable it to have a profound impact on their depressive symptoms.
Indeed, symptoms of depression include feelings of hopelessness, helplessness, having no motivation or interest in things, and lack of energy (NHS Choices, 2014). It is difficult to see how this could not be problematic when, for example, a cCBT programme relies on patients completing self-directed sessions, even with the fortnightly health adviser telephone calls. Perhaps future trials of telehealth interventions for depression could also include a face-to-face psychotherapy treatment arm for comparison purposes.
Salisbury C, O’Cathain A, Edwards L, Thomas C, Gaunt D, Hollinghurst S, … Montgomery AA. (2016) Effectiveness of an integrated telehealth service for patients with depression: A pragmatic randomised controlled trial of a complex intervention. Lancet Psychiatry 2016, DOI: http://dx.doi.org/10.1016/S2215-0366(16)00083-3
Bruce ML. (2016) Comment: New strategies to improve both effectiveness and access to care. Lancet Psychiatry 2016, DOI: http://dx.doi.org/10.1016/S2215-0366(16)30039-6
NHS England (2015). Technology Enabled Care Services (TECS). Retrieved from http://www.england.nhs.uk/ourwork/qual-clin-lead/tecs/
Wootton R. (2012). Twenty years of telemedicine in chronic disease management – An evidence synthesis. Journal of Telemedicine and Telecare, 18, 211–220.
Flodgren G, Rachas A, Farmer AJ, Inzitari M, Shepperd S. (2015) Interactive telemedicine: Effects on professional practice and health care outcomes. Cochrane Database of Systematic Reviews 2015, Issue 9. Art. No.: CD002098. DOI: 10.1002/14651858.CD002098.pub2
Kroenke K, Spitzer R, Williams JW. (2001) The PHQ-9: Validity of a brief depression severity measure. Journal of General Internal Medicine, 16, 606–613.
Williams C, Wilson P, Morrison J, McMahon A, Andrew W, Allan L, … Tansey L. (2013) Guided self-help cognitive behavioural therapy for depression in primary care: A randomised controlled trial. PLoS One, 8, e52735.