Health and Social Care Delivery Research (Dec 2024)
Interpersonal counselling for adolescent depression delivered by youth mental health workers without core professional training: the ICALM feasibility RCT
Abstract
Background As milder cases of adolescent depression do not meet treatment thresholds for specialist mental health services, young people often receive support from non-qualified professionals in third-sector/voluntary agencies. Early psychological interventions to meet growing demand with limited resources are crucial. Objectives The study aimed to explore the effectiveness and cost effectiveness of interpersonal counselling for adolescents by (1) assessing the feasibility and acceptability of trial procedures; (2) exploring the delivery of, and differences between, interpersonal counselling for adolescents and treatment as usual; (3) evaluating the extent of contamination of the control arm and if it should be mitigated against in a future trial; and (4) investigating whether the interval estimate of benefit of interpersonal counselling for adolescents over treatment as usual in depression post treatment includes a clinically significant effect. Design This was a feasibility randomised controlled trial. Non-qualified professionals from non-specialist mental health services received interpersonal counselling for adolescent training. Participants were randomised to receive either interpersonal counselling for adolescents plus treatment as usual or treatment as usual only. Assessments occurred at baseline and were followed up at weeks 5, 10 and 23. A health economics component was included to inform the design of the economic evaluation in a future study. A process evaluation examined implementation of the intervention across settings, acceptability and contamination. Interviews, observations and focus groups were analysed using thematic analysis. Session recordings were analysed using conversation analysis. Setting The trial was conducted in 13 non-speicialist mental health services across Norfolk and Suffolk. Participants Help-seeking adolescents aged 12–18 years with mild depression as the primary difficulty were eligible to participate. Comorbid presentations were not an exclusion criterion. Of a target of 60, 16 participants were randomised, and 2 participants withdrew following study suspensions related to COVID-19. Of the remaining 14 participants, 7 received an intervention, with 3 receiving interpersonal counselling for adolescents and 4 receiving treatment as usual. The rest either disengaged, withdrew or were signposted. Interventions Participants were randomised to receive either interpersonal counselling for adolescents plus treatment as usual or treatment as usual only. Main outcome measures The primary outcome was the Revised Children’s Anxiety and Depression Scale, although the proposed study was not designed to assess efficacy. The primary output of the feasibility trial was to design a subsequent full-scale trial. Results Feasibility outcomes did not meet the estimated progression criteria. Despite efforts to increase referrals, the 80% recruitment rate was not achieved. Interpersonal counselling for adolescents' attendance rates at 10 weeks were less than the 70% progression criteria estimation, impacting intervention feasibility. Retention was high, with 85.7% of participants reaching 23-week follow-up. The health economic measures appeared to perform well and were completed. Implementation and theoretical fidelity of interpersonal counselling for adolescents were analysed from four participant recordings. Adherence to the principles of interpersonal counselling for adolescents was identified, with 100% satisfactory fidelity and no indication of contamination in the control arm. The two interventions were clinically non-significant due to the study being underpowered. Limitations The feasibility of the randomised controlled trial was impacted by COVID-19. Services had to change standard practices, disrupting trial procedures. Challenges were identified when implementing a randomised controlled trial in non-specialist services. Conclusions Findings indicate a randomised controlled trial of interpersonal counselling for adolescents in non-specialist services is not feasible, yet the data collection and outcome measures were suitable. COVID-19 challenges, sites’ lack of familiarity with research procedures and the research team’s unfamiliarity with how different early intervention services operate led to challenges. High staff shortages, turnover and inconsistent training could have been considered. This study demonstrated the difficulties in conducting a randomised controlled trial in this service setting. Further work is needed to improve the feasibility of conducting such trials before they are attempted in future. Trial registration This trial is registered as ISRCTN82180413. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 17/112/16) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 48. See the NIHR Funding and Awards website for further award information. Plain language summary Why was the study needed? Mild depression is common in young people and, if not treated, can lead to major depression. Evidence shows that offering young people with mild depression a talking therapy called interpersonal counselling could reduce distress. However, most young people with mild depression consult family services, where staff do not have training in interpersonal counselling. What were we trying to find out? We wanted to find out if it would be possible to carry out a big study to test interpersonal counselling for young people with mild depression, which can be delivered by non-mental health professionals following a 2-day training workshop. What did we do? We invited young people with mild depression to take part in the study. We provided training in interpersonal counselling to staff from 13 different services. Individuals were selected at random to either continue their usual care or trial interpersonal counselling. The aim was to recruit 60 young people to make the study valid; however, we were only able to recruit 16. We collected information using questionnaires, interviews and session recordings. What did we find out? Most participants found interpersonal counselling helpful. We found evidence that it might lead to better quality of life and reduced need for health care over time. Due to COVID-19, staff shortages, staff concerns that participants may not receive interpersonal counselling and participants’ changing needs, we were not able to recruit enough participants to fully answer our questions, meaning we cannot rely on the findings of the study. This study did not support a future study of interpersonal counselling in the current settings. However, we have included what we learnt from our challenges, which might help researchers plan similar studies in future. Scientific summary Background Depression is a common mental health condition among young people, with estimated prevalence rates for major depressive disorder (MDD) in adolescents ranging from 11% to 20%. Despite high MDD prevalence in this age group, research highlights even higher mild/subthreshold depression rates. Untreated mild depression in adolescence is of major concern, often leading to a range of adversities in adulthood. As milder cases of adolescent depression do not meet treatment thresholds for specialist mental health services, young people often receive support from non-qualified mental health professionals in third-sector/voluntary agencies. Increasing rates of mild depression create an urgent need to find suitable early psychological interventions to address mild depression in non-specialist sectors and meet growing demand with limited resources. Interpersonal counselling for adolescents (IPC-A) is an adapted form of interpersonal counselling (IPC) designed to meet the needs of young people. IPC was adapted from interpersonal psychotherapy (IPT), which is a National Institute for Health and Care Excellence-recommended first-line treatment for adolescents with moderate to severe depression. However, IPT must be delivered by a qualified mental health professional, which means it is unlikely to be a feasible treatment option outside of specialist Child and Adolescent Mental Health Services. IPC has a shorter treatment duration; it is designed for clients with mild depression; and it can be delivered by non-mental health professionals after participation in a brief (2-day) training course. IPC has been found to be an effective treatment for adults with mild to moderate depression. The adapted intervention for adolescents was recently developed and piloted in a single-arm study by members of the research team. IPC-A was delivered by staff without prior psychotherapy training and was found to be well accepted by staff and young people, but its effectiveness as a treatment for adolescent depression has yet to be tested. The intervention was designed to be delivered over three to six (30- to 60-minute) sessions, depending on the participant's needs, by staff without core professional training. Practitioners delivering the intervention received training and supervision to promote adherence to the treatment manual. Aims The aims of this feasibility study were to (1) assess the feasibility and acceptability of trial procedures, (2) explore the delivery of IPC-A and treatment as usual (TAU) and how and why intervention delivery varies across differing service contexts, (3) evaluate the extent of contamination of the control arm and if it should be mitigated against in a future trial and (4) investigate if the interval estimate of benefit of IPC over TAU in depression scores post treatment includes a clinically significant effect. Methods The feasibility randomised control trial involved 13 sites across two counties in England. Young people (age 12–18) who were seeking help for low mood (as their primary presenting difficulty) of a level of illness where they would normally receive treatment from the service were eligible to participate. Participants were randomised in a 1 : 1 ratio using a stochastic minimisation algorithm to minimise imbalance between groups in baseline symptom severity, gender and study site to receive either IPC-A or TAU. Participants were assessed pre randomisation (baseline) and at 5, 10 and 23 weeks. Mixed-methods process data were collected to understand how the intervention was implemented across settings, explore acceptability and monitor contamination. Progression criteria The primary intended output of the research was the design of a subsequent trial. The following criteria were set out at the beginning of the study to make recommendations regarding the suitability of the proposed design for the full-scale trial: (1) recruitment rate is at least 80% of target, (2) at least 70% of those randomised to receive the intervention attended at least three therapy sessions within the 10-week treatment window, (3) follow-up assessments are completed by at least 80% of participants at 10 weeks and 70% of participants at 23 weeks, (4) at least 80% of IPC treatment sessions reviewed meet treatment fidelity criteria, (5) contamination of the control arm can be sufficiently limited for individual randomisation to be justified and (6) the mean Revised Children’s Anxiety and Depression Scale (RCADS) depression scores of the IPC-A and TAU groups at 10 weeks are indicative of a clinically significant difference in depression (3 points). Results The feasibility trial was disrupted by the COVID-19 pandemic, and recruitment was suspended from March 2020 to July 2020 due to the first lockdown of the COVID-19 pandemic, with recruitment recommencing in September 2020. In total, 32 referrals were received, with 16 eligible participants being recruited and randomised. Prior to suspension, the study had recruited two participants. These participants discontinued follow-up data collection with the research practitioner due to study suspension but continued with therapy (either IPC-A or TAU). For those who were recruited after suspension (n = 14), the overall rate of recruitment was slower than anticipated: on average, 1.7 per month (18 months) versus a target recruitment rate of five participants per month (12 months). In response to COVID-19 and changing team responsibilities, it became necessary to recruit further teams alongside the original sites. However, alterations to the referral pathways did not increase the number of referrals made to the study. The recruitment rate of 80% of target set out in the progression criteria was not achieved. Out of the 14 randomised participants, only 7 received an intervention (IPC-A or TAU), with 3 out of 6 participants receiving IPC-A and 4 out of 6 receiving TAU. The remaining seven participants either disengaged from therapy or were signposted due to risk. Of the six participants randomised to the IPC-A arm who had come to the end of the 10-week treatment window, three (50%) attended three or more treatment sessions, which was less than the target of 70% set out in the progression criteria. Participant retention was high, with 85.7% of participants reaching 23-week follow-up. The retention of staff delivering IPC-A was fairly low. Of the 19 staff trained for IPC-A at the beginning of the study, only 8/19 remained in the study, with 4/8 being allocated a client. From those practitioners allocated a client on IPC-A, only two delivered the intervention. For the two practitioners who offered IPC-A but did not deliver the intervention, one client did not engage with the service nor attended IPC-A sessions, and the second was signposted due to complexity and risk and need for a more appropriate intervention. Only four participants (three IPC-A and one TAU) consented to their session recordings being analysed for the process evaluation. Therefore, all recordings were rated and analysed to assess implementation and theoretical fidelity. From the four recordings reviewed, clear systematic use of the principles of IPC-A was identified; therefore, 100% of these sessions met the treatment fidelity criteria. There was no evidence of contamination effects from IPC-A training for TAU therapists for the recordings that were provided. There was no clinically significant difference between the two interventions due to the study being underpowered. Health economic information was collected to inform a future trial. The Child Health Utility Index 9D (CHU-9D) and Client Service Receipt Inventory (CSRI) had high rates of completion and appeared to perform well. The CHU-9D showed possible improvement over time, suggesting it may be able to detect differences. The CSRI showed reduced healthcare use over time and would be a potential candidate for use in a future trial of ICALM, although it may benefit from simplification. The small recruitment rate means the potential cost of IPC-A remains unclear. Furthermore, high staff turnover means the benefits may be lost if IPC-A-trained staff leave their roles. A future trial may be feasible if challenges around staffing could be mitigated. Conclusions The findings of this feasibility study and the process evaluation indicate that conducting a randomised clinical trial of IPC-A in non-specialist services is not feasible in the current climate. It remains unknown if IPC-A is a useful therapeutic addition to universal and mild to moderate services for children and young people which should be recommended. Trial registration This trial is registered as ISRCTN82180413. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 17/112/16) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 48. See the NIHR Funding and Awards website for further award information.
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