Treatment access, and subsequent success, among young people with severe, complex mental health problems are often complicated by the presence of adjunctive social disability in this population. On average, people with social disability spend fewer than thirty weekly hours engaged in structured activity. Here, structured activity refers to paid or voluntary employment, education, caring, sports, and structured leisure. Consequent to this social withdrawal, sufficient engagement with standard interventions is more difficult and therefore less effective.

While some existing interventions do specifically target social disability in youth with severe and complex mental illness, these services are limited in both their potency and accessibility: they are only made accessible to young people with a “confirmed or imminent first episode of psychosis” and have no significant effects one-year post-treatment (Hodgekins et al., 2015). By restricting young persons’ access to socio-vocational support upon the onset of symptoms, socially disabling behaviours are allowed opportunity to transition to mental health problems of greater “diagnostic severity”.

The PRODIGY RCT (randomised controlled trial) led by Clio Berry (Berry et al, 2022) sought to determine whether the addition of social recovery therapy (SRT) that explicitly targets social disability in young people with emerging severe mental illness could enhance the effectiveness of standard psychological interventions. This RCT was conducted with young people with mental health difficulties that had not experienced an episode of psychosis, thus addressing a previously neglected population in research.

The trial set out to test the following predictions:

• Social Recovery Therapy (SRT) in addition to Enhanced Standard Care (ESC) would result in significantly greater improvements in social disability (operationalised as hours per week in structured activity), compared to ESC alone,

• The addition of SRT to ESC would result in greater improvements in other mental health outcomes, including psychotic, mood, and general symptoms, in both the short and long term.

Methods

This single-blind RCT included 270 young people aged 16-25 years with social disability and severe, complex mental health difficulties to test the effectiveness of social recovery therapy (SRT) and enhanced standard care (ESC) in the treatment of social disability at both the acute level and in the long term.

Participants were randomly allocated to receive either combined SRT and ESC or ESC alone. Young people were recruited from various mental health and vocational services, those eligible were then stratified by age, location, severity of social disability, and whether at-risk mental state (ARMS) criteria were met. Moreover, outcome assessors (i.e., research assistants) were blinded to the allocation sequence at both baseline and follow-up assessments.

Following baseline assessment and randomisation, participants in both groups received enhanced standard care. Standard care involved following optimal evidence-based treatment according to NICE guidelines. Participants in the intervention group received Social Recovery Therapy (SRT) in addition to ESC, which incorporated elements of cognitive behavioural therapy, multisystemic therapy, and assertive outreach techniques to address negative self-beliefs and ultimately increase time spent in structured activity.

Secondary outcome measures included levels of attenuated psychotic symptoms, negative symptoms, and general psychopathology. Outcome assessments were taken at 9 months post-randomisation and the primary endpoint of the study was a second assessment period 15 months post-randomisation. Limited long-term assessments took place 24 months post-randomisation. While substantial dropouts occurred at each assessment period, these were largely accounted for and addressed with intent-to-treat analysis (ITT).

Results

Overall findings

In both trial arms, participants showed significant improvements in time spent in structured activity from baseline to follow-up assessments (averaging at an 11-hour increase). Participants across groups also reported significantly reduced levels of depression and anxiety, reflected by a 50% reduction in diagnosable depression and social phobia.

Social disability outcomes

As a primary outcome measure, this study looked at changes in structured activity (hours/week), at 15 months post-randomisation. 87% of the initial 270 participants (n = 235) provided data for this primary ITT analysis. Participants in the combined SRT and ESC group did not show significantly greater increases in time spent in structured activity relative to control participants. These differences remained non-significant at 24-month follow-up.

Secondary mental health outcomes

Findings from general linear models did not show significant superiority of combined SRT and ESC over ESC in improving symptoms of psychosis, negative symptoms, or general mental health at any assessment point.

Treatment adherence and participant perception

Patterns of attrition revealed a bias toward greater dropout among participants receiving ESC alone, compared to those receiving combined SRT and ESC, across all assessment periods.

A qualitative process evaluation revealed that participants viewed SRT as a “challenging but beneficial” tool for pursuing “social recovery goals” and forming positive therapeutic relationships. When comparing SRT with standard care, participants showed a clear preference for adjunctive SRT, and described ESC as “too limited”.

Cost-effectiveness of SRT

Outcomes measured from a health economic standpoint revealed that SRT was not a cost-effective intervention. Regression analyses estimating incremental treatment costs relative to gains showed that the cost of SRT (ranging from £2,708.32– 5,112.86) outweighed treatment gains, as estimated using quality-adjusted life-year (QALY) scores.

Conclusions

The authors conclude that:

We found no evidence of the superiority of SRT as an adjunct to ESC in the primary outcome of weekly hours in structured activity at the primary 15-month end-point or at 9 or 24 months post-randomisation. We found no evidence that SRT was superior to ESC in secondary or other outcomes at any time point. SRT was not estimated to be cost-effective.

Strengths and limitations

This was a sufficiently powered RCT involving a large and representative sample of young people with severe mental health problems, thus addressing a population that has been largely neglected in research.

However, the high drop-out rates across both groups in the trial (at 24 months, 47 out of 138 people in the SRT arm, 81 out of 132 people in the ESC arm) make it difficult to conclude much from these results.

Stratifiers like age and location helped support the randomisation process and form a representative sample, but a lack of gender balance led to the overrepresentation of male participants in the intervention group, which may have inadvertently biased outcomes. Nonetheless, by blinding outcome assessors to intervention allocations across several outcome assessments, this RCT provides some insight into ESC versus SRT.

The addition of a qualitative process evaluation in this trial provided crucial insight into young people’s experience of treatment. Participants’ perceptions offer nuance when determining the effectiveness of an intervention and may explain the bias toward greater disengagement and attrition in the control group.

Implications for practice

Null findings from this RCT add important value to research concerning comprehensive evidence-based standard care and its effectiveness. The knowledge that treatment outcomes see no additional gains by providing SRT informs clinical practice in the real world while shaping the direction of future investigation. Based on findings from this RCT, future studies should endeavour to identify the factors associated with social recovery and those associated with clinical recovery in ESC. Additionally, findings from the qualitative evaluation process highlight the need for further investigations on social recovery therapy, particularly concerning the factors that support treatment adherence and facilitate good therapeutic relationships; these factors can then be integrated into standard care services to improve treatment access for this often-neglected population.

Furthermore, this RCT opens up new research avenues concerning young people with severe and complex mental health problems. The potential gains made in social and clinical recovery imply that “active and comprehensive” standard care may be effective for young people with severe and complex problems, despite previous evidence highlighting difficulties with accessing and benefiting from interventions (Cross et al., 2018). Participants’ preference for adjunctive SRT compared to standard care alone implies that, while it does not influence treatment outcomes directly, clinicians may benefit from providing specialised SRT to young people struggling with treatment compliance and adherence. Therefore, SRT’s additive effects on the perceived quality of treatment deserve further investigation and should not be overlooked.

Statement of interests

No conflict of interest to report.

Links

Primary paper

Berry, C., Hodgekins, J., French, P., Clarke, T., Shepstone, L., Barton, G., Banerjee, R., Byrne, R., Fraser, R., Grant, K., Greenwood, K., Notley, C., Parker, S., Wilson, J., Yung, A. R., & Fowler, D. (2022). Clinical and cost-effectiveness of social recovery therapy for the prevention and treatment of long-term social disability among young people with emerging severe mental illness (prodigy): Randomised controlled trial. The British Journal of Psychiatry, 220(3), 154–162.

Other references

Cross, S. P., Scott, J. L., Hermens, D. F., & Hickie, I. B. (2018). Variability in clinical outcomes for youths treated for subthreshold severe mental disorders at an early intervention service. Psychiatric Services, 69(5), 555–561.

Hodgekins, J., French, P., Birchwood, M., Mugford, M., Christopher, R., Marshall, M., Everard, L., Lester, H., Jones, P., Amos, T., Singh, S., Sharma, V., Morrison, A. P., & Fowler, D. (2015). Comparing time use in individuals at different stages of psychosis and a non-clinical comparison group. Schizophrenia Research, 161(2-3), 188–193.

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