Main findings
Despite considerable efforts and resources and a systematic approach to identifying and addressing barriers to recruitment and retention, recruitment of young people with depression and repeated self-harm from self-harm and wider services was not feasible to an RCT of remotely delivered problem-solving treatment. During the internal pilot study, three out of four pre-set criteria for feasibility were not met; these were low recruitment, low retention in follow-up and low retention in the remotely delivered PSCBT intervention. In addition, three (14%) participants had to be withdrawn for safety reasons. Therefore the study was not continued. Three adult participants were recruited in the last month of recruitment through a third sector organisation indicating that recruitment of young people with depression and self-harm, more than 96 h after the last self-harm episode, might be possible in the community. Qualitative interviews (see Tables 3, 4 and 5) with participating and non-participating young adults also indicated the possibility of such recruitment but staff interviews suggested that such an approach might not be as effective for adolescents.
Mixed quantitative and qualitative methods showed that most barriers to recruitment and retention during both the intervention and study follow-up periods appeared to be intimately connected with the nature and practice of mental health assessment in self-harm services. These barriers included lack of agency of participants. Clinicians reported that many people who attend emergency rooms do so reluctantly at the insistence of family and friends for medical rather than psychological help. Therefore although they initially agreed to participate, they may not have felt committed to this - hence, only half of those who initially agreed to participate were eventually recruited to the study.
Additional barriers to recruitment and retention were the clinical identification of participants with more severe depression, and the emotionally charged atmosphere in which self-harm clinicians carry out assessments. According to previous NICE Guidelines for self-harm [34], people who self-harmed were usually admitted overnight to hospital for next day mental health assessment once the patient was medically fit, no longer intoxicated with alcohol or drugs and less acutely distressed. Pressures on bed use in acute hospitals coupled with rising rates of self-harm presentations mean that such practice now rarely occurs [35]. However, self-harm services are still expected to provide comprehensive risk and biopsychosocial assessments, identifying ongoing mental health and social problems, soon after self-harm presentation to the accident and emergency department [1]. Under these circumstances, clinicians reported that people who self-harm are difficult to assess in terms of their ongoing mental health (including depression) and social problems because they are often still intoxicated by alcohol, drugs or the substance(s) they had taken as an overdose and/or in a heightened state of emotional distress. The high emotional distress experienced around the time of self-harm was highlighted by clinicians as an important reason for not discussing the study with potential participants - clinicians were primarily focussed on defusing emotional distress and did not want the additional burden of explaining a research study to potential participants.
In this context, depression was difficult to diagnose and depression symptoms were usually conceptualised as being secondary to life stress, emotional dysregulation or personality disorder. Depressive disorder was diagnosed rarely by clinicians working in these services; they made the diagnosis of depression on the basis of pervasiveness and lack of clear relationship with life stress. However, pervasiveness of low mood and lack of reactivity of mood are typical of melancholia and other severe forms of depression [36]. Most of those recruited had severe depression according to the BDI-II when assessed by the research team 2 weeks later. They also had moderately severe hopelessness, anxiety and social impairment. However, in contrast to the views of clinicians, they did not report traits of impulsivity in relation to negative emotion, as is more typical of people with borderline personality disorder or emotional dysregulation. The UPPS urgency scores at baseline in this study were below those for a control group and people with borderline personality disorder [37]. Furthermore, it is a matter of concern that several participants deteriorated rapidly with further psychosocial crises to a level that required withdrawal from the study.
The severity of depression at a time of psychosocial crisis was also a major barrier to the retention of participants in the PSCBT intervention and follow-up as was fear of negative reactions of others [38, 39]. Participants in this RCT were more depressed than in previous successfully conducted RCTs of PSCBT in self-harm where retention rates in both treatment and follow-up were considerably higher [21, 31]. In these RCTs, initial assessment of the severity of depression was conducted by the research team rather than clinicians working in self-harm services. However, one problem with such an approach is that front-line clinicians in these services may not be able to apply the results of such research because they do not recognise less severe depressive disorder.
Methodological issues
Strengths of the study included the use of pre-set criteria for the feasibility and acceptability of the RCT and the intervention to mitigate the possibility of non-completion of the trial, the collection of detailed accounts of efforts made to recruit and retain participants without burdening the services from which participants were recruited, and detailed consideration of barriers and drivers to recruitment during the internal pilot. Despite these, we could not improve referral rates to the study. A further strength was the use of qualitative interviews comparing and contrasting the experiences of clinicians in these services as well as eliciting perspectives of participants and non-participants, supplemented by feedback from a service user group of young people with a history of depression and self-harm (see Tables 3, 4 and 5).
As well as the clear recruitment and retention difficulties, another limitation of the study design is that we do not have information on participants who might have been eligible for the study but were not referred to it. Therefore we have to infer that if depression was conceptualised differently by clinicians, we could have had many more participants who met the study inclusion criteria, based on previous observational studies of the prevalence of depression in people who self-harm [2, 4]. Our data do not indicate how people with milder levels of depression with repeat self-harm could be identified and whether such people have higher levels of impulsivity, as clinicians suggested.
We did not test the intervention in a case series study design before conducting the RCT for two main reasons. First, we worked with, and recruited some participants from, a third sector organisation providing interventions and support to people who have self-harmed. This organisation was already providing remotely delivered CBT to people with a history of self-harm, many of whom also had depression. However, in contrast to this study, the intervention was offered when the participant felt ready to engage rather than shortly after the index self-harm presentation. Second, by carrying out the internal pilot in the way that we did and collecting as much information as we did, we have gained a much better idea of the barriers and facilitators to conducing an RCT than a case series design (without attempts to recruit at scale and understanding the impact of randomisation) would have offered.
In terms of the optimal timing of the clinician approach for participation in the study, there were contrasting views amongst clinicians, study participants and non-participants, and service user group members (see Tables 3, 4 and 5). Some felt that it was too soon and that it would have been preferable to wait until potential participants felt more ready to engage. However, others were concerned that there was only a brief window of opportunity for recruitment following the self-harm presentation, before loss to follow-up. Given that the risk of repeat self-harm and suicide is increased in the period immediately following a self-harm episode, there is a tension between offering help at an early stage or waiting until the person feels more ready to engage. This is likely to vary considerably according to individual preferences and circumstances.
The study age-range (16–30 years) was selected for several reasons. First, up to 60% of self-harm presentations occur in this age range [40]. Second, to determine if the results could be generalised to both adolescents and young adults. Third, to reflect an increasing recent shift in service developments in the UK towards combined mental health services for young people and young adults to overcome barriers to transitions between traditional child and adult services. Fourth and most importantly, this age range is familiar with technology and utilise internet based video-calling (on mobile phones or computer). However, although digital and mobile phone interventions show promise in terms of recruitment of people with depression and anxiety who might not otherwise receive psychological interventions, there were additional barriers for young people with severe depression and recent self-harm. Participants did not necessarily have or could afford consistent mobile phone or internet access. Some reported concerns about data privacy if living with people who were over-controlling or abusive. Poor connectivity of the internet posed an additional barrier in emotionally distressed or poorly motivated participants.
Previous successful RCTs have recruited by simplifying the recruitment process for front-line self-harm assessment staff by using a Zelen design whereby participants are consented only to one form of treatment and data follow-up [41] or participants are recruited independently at follow-up [11]. The former approach is controversial and can lead to imbalances in recruitment if one therapeutic approach in a Zelen design is more popular than the other. The latter study also struggled to recruit participants although it achieved its aims for feasibility.
Alternative study designs might have involved clinicians identifying potential participants on the basis of recent self-harm and the research team assessing for depression and its severity at a later stage or possibly embedding a team of full-time researchers (covering 7 days per week) in each self-harm service to enhance recruitment but the latter would be prohibitively expensive. However, the e-DASH study was commissioned to determine the acceptability and feasibility of an RCT of the effectiveness of an intervention that could be delivered in that same format within NHS services. If the intervention had been found to be effective in real-world clinical settings, it could then potentially have been implemented into routine clinical practice i.e. requiring assessing clinicians to distinguish depression severity without the input of a researcher.
Implications
Further research is now needed on the validity and clinical utility of routine biopsychosocial assessment soon after a self-harm episode or suicide attempt. It is unclear whether psychosocial assessment, admission to hospital or any other intervention reduces repeat self-harm or suicide rates after self-harm [42]. Our data suggest that people who have self-harmed and have severe or pervasive depression symptoms which precede the crisis leading to the self-harm presentation require further structured psychosocial assessment when they are not emotionally distressed or intoxicated, and this may require admission overnight to facilitate this [1]. Only two of the nine participating services reported using standardised assessments of depression, anxiety, hopelessness and suicide risk. Although previous research with people who have self-harmed indicates that many would like further contact in the period immediately after self-harm [38], only a quarter of adolescents can be reached by health services after self-harm [43]. Only with a considerable amount of effort could we reach 50% of referred participants.
Future research on PSCBT for people with depression and self-harm should consider offering a choice of face-to-face, mobile phone or internet-delivered treatment at a time when participants feel most ready to engage. Such participants might be recruited in the community through primary care and third sector organisations.
