Does Interpersonal Psychotherapy improve clinical care for adolescents with depression attending a rural child and adolescent mental health service? Study protocol for a cluster randomised feasibility trial

The immediate and long-term individual, interpersonal and societal costs of depression are substantial [1]. Up to one in five people will have suffered the effects of major depression before the age of 18 years [2]. Despite limited research regarding depression amongst rural adolescents, we know that rural young men are at particularly high risk of suicide compared to their metropolitan peers [3]. Depression during adolescence typically complicates progression through the essential developmental tasks of that time leading to secondary difficulties [4, 5]. To address such problems, effective and accessible treatment is needed. When detected, however, treatment provided for depression is often inconsistent with evidence-based treatment guidelines [6]. Whether or not such treatment discrepancy is problematic for adolescent outcomes remains unclear.

Questions remain regarding the most effective community treatment for adolescents with depression. Antidepressant medication continues to be associated with controversy regarding its efficacy and safety in use with adolescents [7]. Structured psychological interventions, particularly Cognitive Behaviour Therapy (CBT) and Interpersonal Psychotherapy (IPT), have demonstrated efficacy for the treatment of adolescent depression [8, 9]. These psychotherapies are also used as treatments alongside medication, or in the maintenance of post depressive episodes.

Efficacy studies, requiring strict treatment and control conditions, typically exclude clients with complex clinical presentations. In reality, adolescents with depression frequently present with comorbid mental or substance-use disorders [10]. Effectiveness trials are needed to investigate the feasibility and value of implementing structured psychological interventions in community practice.

The available evidence suggests IPT is an efficacious treatment for depression [11] which can be easily learned by Australian mental health professionals [12] and other novice therapists [13, 14]. IPT is based on the formulation that relationships are inherently inter-related with emotional wellbeing. The therapy aims to decrease depressive symptomatology and improve the relational functioning of clients. The treatment focuses on a key interpersonal problem area identified for the individual (e.g. grief, interpersonal role disputes, interpersonal role transitions). IPT is manual-based and time-limited and can be administered effectively with or without medication [15].

From a systematic review of IPT efficacy in the treatment of depressive spectrum disorders between 1974 and 2002, a meta-analysis of 13 studies found IPT superior in efficacy to placebo for mean improvement in depressive symptoms (weighted mean difference [WMD] = -3.57; 95% confidence interval [CI] -5.98, -1.16) and lower short-term drop out rate (relative risk [RR] = 0.59; 95% CI 0.36, 0.99). IPT was similar in efficacy to medication and did not increase when combined with medication. IPT performed significantly better than CBT for mean difference improvement (WMD = -2.16; 95% CI -4.16, -0.15) though not for total remission [16].

Interpersonal Psychotherapy for Adolescents (IPT-A) has evolved from the adult version (IPT), making adaptations for the developmental issues of adolescents. Amongst adolescents with depression, IPT-A has been demonstrated to be superior to Treatment as Usual (TAU) in an effectiveness study of five school-based mental health clinics in New York [17]. In a trial with Puerto Rican adolescents, remission of depressive symptoms was achieved by 82% of adolescents receiving IPT-A and 59% receiving CBT. Compared to the waiting list control, those in an IPT-A group showed increased self-esteem and social adaptation [18]. IPT-A has also demonstrated effectiveness in the treatment of moderate to severe depression in adolescents by well-supervised novice IPT-A therapists [13].

IPT appears a promising intervention to trial for the treatment of adolescents with depression attending a rural Child and Adolescent Mental Health Services (CAMHS). CAMHS aims to treat adolescents presenting with severe, usually comorbid, mental health difficulties. In rural areas this is complicated by limited availability of mental health specialists. IPT appears particularly valuable in this context given its appeal to clinicians and easy delivery by a broad range of mental health professionals. The TAU of adolescent depression in CAMHS is, on contrast, poorly defined and of unknown quality or effectiveness.

The current project explores the impact of implementing IPT in a rural CAMHS and the feasibility of comparing IPT and TAU in practice. Given that implementation and evaluation of interventions in health services is typically complex, a qualitative process evaluation will be incorporated to explore the contextual factors associated with the implementation [19].

The objectives of the clinical research are:

1. to investigate the impact on clinical care of implementing IPT for the treatment of adolescent depression within a rural CAMHS compared with TAU.

2. to evaluate the issues associated with implementing a cluster randomised clinical trial in CAMHS (i.e. feasibility, acceptability, sustainability).

This protocol is the result of collaboration between a rural CAMHS and Monash University. It developed from an interest within CAMHS of implementing and evaluating a focused evidence-based practice clinic. The key interests of CAMHS and academic collaborators are on the evaluation of practice and recording the process issues associated with implementation of a clinical trial in CAMHS. The study aims to inform development of a larger scale definitive clinical trial.

The challenges of linking research and practice in health services are well documented. With the increased pressure on services to deliver and document evidence-based practice, the issues concerning integration of evidence and practice are increasingly important. This study seeks to look at these process issues arising in a rural CAMHS embarking on a clinical trial.

A key aim of the project trial is to assess the feasibility of conducting effectiveness trials of short-term psychological interventions in a rural CAMHS. To assess issues of feasibility and to aid interpretation of trial results, a combination of qualitative and quantitative methodologies will be applied. The facilitated discussion groups with clinicians, and interviews with adolescent and parent/guardian participants, plus a research diary, aim to capture the process issues as they arise and any related complexities and solutions uncovered during the trial. These findings are considered important to assist further mental health services researchers in the design of similar future ventures. They are also important in a political environment of increasing evidence-based practice pressure. Documentation of the implementation obstacles and facilitators can practically inform discussions, expectations and decisions in this area.

To fit in with the CAMHS realities, a cluster randomisation design was chosen over client randomisation. The consideration of client randomisation raised concerns for both clinicians and researchers. It was not feasible to do client randomisation given the scarcity of clinicians based at each of the four rural sites. At any given time a clinician from the allocated treatment stream may not be available at that site to work with the adolescent. For example, one site may have only one participating clinician and others only one for each treatment stream. Cluster randomisation provided the solution to this dilemma. It has the advantage of allowing usual-care allocation of clients and would provide an estimate of the ICC which would assist sample size planning in a larger-scale subsequent trial, if judged to be feasible and valuable.

Given the uncertainties existing regarding the safety and efficacy of psychopharmacological treatment of adolescents [7], it is important that effective psychological interventions are readily available for the treatment of adolescent depression. IPT appears a useful intervention for this purpose, given that it is described as easily learned and applied by a range of mental health professionals [13, 14].

The study of TAU, however, is also an important component of the study. First, there has been little study of what TAU specifically entails in a multidisciplinary rural mental health service. Clarification of the content of this is important if we are to understand or evaluate it or compare it to alternative forms of treatment. Second, the effectiveness of TAU is unknown. If TAU proves as effective in practice as identified evidence-based practices then questions about the value of implementation efforts regarding the latter may be raised. Definitive answers about effectiveness of TAU compared to IPT in practice will, however, require large sample sizes and replication of results with different studies, a challenging endeavor within community practice.

The real-world context of this study means that it faces important limitations. First, key variables cannot be controlled in this environment. The methodology is impacted by such factors as clinician turn-over, mixed attitudes to involvement in research, questions of treatment fidelity, challenges of data collection, amongst others. The decision was made, therefore, to describe the variables rather than attempt to control.

A cluster randomisation design was utilized to avoid the inevitable implementation failures that would occur randomising individual participants to particular treatment streams. Randomisation of individuals would not be possible when, for example, the relevant clinician at that site was unavailable to take another case. Instead it was decided that cases would be allocated by the team. This lack of allocation blinding and randomisation of participants is likely to introduce bias to the allocation of cases. Nevertheless, the cluster randomisation design is likely to detect and account for the variability between groups. The limitations found during this research will have important findings. They will illustrate sources of complexity in seeking to marry evidence and practice in child and mental health services.

The transferability of efficacious treatments into practice is an important issue for clinical researchers and clinicians. It is a complex area of implementation challenges. This article describes the methodological responses to challenges foreseen in conducting a clinical feasibility trial concurrently being conducted within a rural CAMHS. This study protocol illustrates a collaborative clinical research design of potential value to researchers interested in innovative and realistic treatment trials in this area.