Efficacy of the unified protocol for the treatment of emotional disorders in the Spanish public mental health system using a group format: study protocol for a multicenter, randomized, non-inferiority controlled trial

Emotional disorders (EDs; i.e., depressive and anxiety disorders) have become the most prevalent psychiatric disorders globally [1]. The 12-month prevalence of anxiety and depressive disorders affect 14% and 7.8% (6.9% by major depression) of the population, respectively [2], and comordibity may be as high as 50% [3]. Lifetime prevalence rates in primary care settings in Spain reveal that mood and anxiety disorders, as defined in the DSM-IV-TR) [4], are the most prevalent psychiatric problems as well, with 35.8% and 25.6%, respectively [5].

As a result of their high prevalence in the population, EDs have become a global health problem due to their associated costs. For instance, a study conducted in 36 countries estimated that the annual treatment cost of depressive disorders and anxiety problems amounted to $91 billion and $56 billion, respectively [6]. It has been calculated that more than 12 billion days of productivity loss are attributable to depression and anxiety disorders every year, which results in $925 billion in productivity losses. In Spain, when direct and indirect costs are included, mood and anxiety disorders (again, according to DMS-IV-TR categories), are estimated to cost approximately $10.76 billion and $10.36 billion, respectively [7]. The high prevalence and important burden of EDs indicate that there is an urgent need to enhance the effectiveness of treatments for EDs in public mental health systems.

The Unified Protocol (UP) for the Treatment of Emotional Disorders [8, 9] is a recently developed form of cognitive behavioral therapy (CBT).The UP can be applied to a variety of disorders simultaneously and it can be easily performed in a group format. The UP was created on the basis of the identification of common psychopathological vulnerability factors in EDs [1, 10].In the UP, traditional CBT techniques (i.e., cognitive restructuring) are combined with more novel psychological skills (i.e., increasing awareness) to treat emotion regulation deficits, which are argued to be the underlying common factors in all EDs [11]. The UP is a structured, manual-based treatment [8, 9] which facilitates group delivery when patients present different EDs [11]. This, together with the fact that the UP can be applied simultaneously to individuals with different EDs, might help reduce existent waiting lists and current costs of individual treatment.

So far, studies exploring the effectiveness of the UP in a group format have led to promising findings [12‐15].Overall, results suggest that the UP obtains medium-to-large effect sizes on numerous outcomes, including depression, anxiety, positive and negative affect, quality of life, overall adjustment, and avoidance of negative sensations, for both anxiety and mood disorders [12‐14]. These studies have also revealed that between half and two thirds of patients ceased to meet diagnostic criteria after the treatment and one investigation, conducted by our team, revealed that changes remained stable 12 months after treatment completion [13]. Despite the previous results are encouraging, conclusions should be interpreted with caution as sample sizes have been small (11 participants in two studies and 47 patients in one investigation). Methodologically-sound, randomized, controlled trials are needed in order to replicate the aforementioned findings and to elucidate whether the UP in group format is indeed an effective treatment option for EDs in public settings.

The present non-inferiority, randomized, controlled trial will compare the efficacy of the UP in group format against traditional individual CBT treatment in a sample of patients with EDs. Ultimately, our goal is to explore whether the UP in group format can be an effective psychological intervention for EDs in the Spanish National Health System, that is, one that generates long-lasting changes in symptoms. To ensure the generalizability of results, our goal is tested in various public mental health centers in Spain.

The current study is a non-inferiority, multicenter, randomized, controlled clinical trial with two treatment groups: UP in group format and traditional CBT in individual format (treatment as usual, TAU). A conservative, non-inferiority design was selected because, to the best of our knowledge, this is the first randomized controlled trial to compare the UP in a group format against individual CBT in public mental health settings.

In the present investigation, all consecutive patients with EDs attending any of the collaborating centers (see “Sample and recruitment” section) are asked to participate. Once inclusion criteria are met (see “Inclusion and exclusion criteria” section), each patient is randomly assigned to one of the two experimental groups: TAU or UP (see “Procedure” section). The study includes 5 assessment points (baseline, post-treatment, and three follow-ups at 3, 6, and 12 months after treatment completion). The flow chart of study design is shown in Fig. 1. Also, a schedule of enrolment, interventions, and assessments is reported following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines (Fig. 2). Note that, despite treatment occurs at different frequencies between conditions (approximately once a month in the TAU condition and weekly in the UP group), assessment points are the same for both groups.

EDs have become a matter of public concern due to their high prevalence and associated costs [6, 7, 44]. The UP has emerged as a promising form of CBT to be used across diagnostic categories both in individual and group format [8, 9]. Therefore, the study of a therapeutic approach that can be administered to several patients with different disorders simultaneously, as in the present study, may have important clinical implications for countries.

The use of the UP in group format in public mental health settings may have some advantages over traditional individual CBT: 1) it may allow clinicians to use the same treatment for a variety of psychological disorders [8, 9, 12]; 2) it might help reduce existing waiting lists as between 6 and 8 patients can be treated simultaneously, which would probably reduce the duration of suffering in unattended patients; 3) in contexts similar to the Spanish public system, where individual CBT is the norm and therapy sessions occur at long intervals (i.e., once a month) due to waiting lists, a UP-based treatment program in group format can help increase the frequency of sessions because more patients are treated simultaneously, which may facilitate a more rapid detection of patients’ problems during treatment; 4) finally, group therapy is known to report benefits for the patient that are not obtained with individual treatment, such as reducing isolation, facilitating social support, and learning from others’ experiences [45, 46], which might enhance its efficiency. The present RCT taps into the aforementioned aspects of treatment satisfaction and effectiveness.

Our study has also some limitations. First, some people who ask for treatment in the public mental health system prefer individual treatment, which could be a barrier when randomly assigned to a group format (i.e., dropout or decreased satisfaction and efficacy of the UP). To control for this, we will explore the effect of format preference and format assignment on treatment adherence and effectiveness. Additionally, as conditions differ in terms of type of therapy (CBT vs. UP) and format (individual vs. group), it will be difficult to ascertain what was responsible for the results. Despite the present study only seeks to find whether the UP in a group format can be an alternative to the traditional psychological treatment in public settings in Spain (i.e., individual CBT), results should be interpreted with caution and no conclusions can be drawn on whether results are due to differences in the type of therapy, its format, or both. In line with the previous, it is important to note that the usual treatment was not stabilized across clinicians at centers (i.e., duration of sessions and treatment) precisely to ensure that the newly tested treatment, namely the UP in a group format, was compared against the usual treatment in Public Mental Health Settings in Spain. It is also important to note that, due the multicenter nature of the study, interventions are conducted by different clinicians, so implementation could differ across centers. In order to minimize this effect, a certified UP Researcher/Trainer, J.O., has been in charge of the full treatment for the first two groups at all collaborating centers. All clinicians will act as co-therapists of one group at their working center. Also, when they start treatment they will receive a videoconference supervision before every session by J.O. Despite this is done to promote fidelity to the protocol, it is important to note that assessment of fidelity is not performed by an independent rater, so true fidelity cannot be ensured. Finally, another shortcoming is that interviewers using the ADIS are not blind to treatment arm. This was not possible due to legal reasons (data collection at participating hospitals had to be done by a psychologist/psychiatrist working at the center). Due to time restrictions of psychiatrists, this was done by psychologists, who were also in charge of treatment. Despite this limitation, it is important to note that the ADIS is an objective, structured interview, and that on each assessment two interviews are independently made by two different psychologists, which should reduce the likelihood of biases.

Despite the aforementioned shortcomings, the present study may have important clinical implications as it is the first randomized, controlled clinical trial to test the effectiveness of a transdiagnostic intervention in group format for the treatment of EDs in public settings in Spain. Results will reveal whether the use of the UP in group format may serve to reduce existent waiting lists without decreasing the effectiveness of interventions (non-inferior to TAU).This would have important implications for patients, as it would possibly allow treatments to be more intensive (i.e., on a weekly basis instead of monthly) thanks to the simultaneous treatment of an increased number of patients.