TITLE: Cost-effectiveness evaluation of the individual vs. group transdiagnostic psychological treatment for emotional disorders in Primary Care (PsicAP-COSTS)
AUTHORS: Angel Aguilera-Martin, Mario Gálvez-Lara, Fátima Cuadrado, Eliana Moreno, Francisco García-Torres, Carolina Pérez-Dueñas, Araceli Sánchez-Raya, José F. Venceslá, Jorge Corpas, Francisco Jurado, Juan A. Moriana

[DESCRIPTION]
<div class = "text-blocks"><div class = "text-block"><span>The </span><span style = "font-weight:bold;">aim </span><span>of this multicenter, single-blinded, randomized controlled trial is to compare, in cost-effectiveness terms, a brief transdiagnostic, cognitive-behavioural therapy in two different modes, individual and group, with the pharmacological treatment usually administered in Primary Care.</span></div><div class = "text-block">Participants between 18 and 65 years old and with, according to pretreatment evaluation, mild or moderate emotional disorders will be randomly allocated to the three experimental groups. After treatment phase and 6 and 12 months later they will be assessed again.</div><div class = "text-block"><span>Funder: </span><a href="https://www.ciencia.gob.es/portal/site/MICINN/aei" style = "text-decoration:underline;color:blue;cursor:pointer;"><span style = ":;">Agencia Estatal de Investigación</span></a><span>.</span></div><div class = "text-block"><span>Ethics approval: </span><a href="http://www.sspa.juntadeandalucia.es/servicioandaluzdesalud/hrs3/index.php?id=comite_etica_investigacion" style = "text-decoration:underline;color:blue;cursor:pointer;"><span style = ":;">Comité de Ética de la Investigación de Córdoba</span></a><span>.</span></div><div class = "text-block">ClinicalTrials.gov: NCT04847310.</div></div>

[STEPS]
?. [RECRUITMENT AND FIRST ASSESSMENT]
The recruitment will be accomplished in three different primary care settings of the province of Cordoba: the "Carlos Castilla del Pino" Health Centre, the "Levante Sur Dr. Manuel Barragán Solís" Health Centre, and the Community Mental Health Unit of Montilla. General practitioners (GPs) will invite the patients in whom they suspect a diagnosis of emotional disorder (ED) to participate in the study. Participants will be informed and asked for the written consent, and an assessor-investigator (the blinded party) will administer the instruments (see Materials).Participants will be only adult (18-65 year-old) men and women who have mild or moderate EDs (i.e. depressive, anxiety and/or somatoform disorders) according to the PHQ subscales: the PHQ-4 for the screening, and the PHQ-9, the GAD-7, the PHQ-PD, and the PHQ-15 to determine the kind of disorder and the severity level. Those who do not have an ED and/or do have a severe mental illness, will be returned to their GPs. Participants with a recent, severe suicide attempt, or with a high level of impairment (according to the SDI) will be excluded as well.The sample size needed would be 150.Start date of the recruitment: May 2021.
?. [INTERVENTION]
Participants will be allocated, by a non-assessor investigator with a computer-generated randomization, to the three experimental groups:Group psychotherapyBrief transdiagnostic, cognitive-behavioural therapy focused on the emotion regulation strategies that maintain the emotional symptoms. It is an adaptation of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (Barlow et al., 2011) and the "Improving Access to Psychological Therapies (IAPT)" program (Clark, 2011). It consists on seven 90-minute sessions, provided by a non-assessor clinical psychologist in 12-16 weeks, with 8-10 participants per group (more information in Cano-Vindel et al., 2016):Sessions 1 and 2 (weeks 1 and 2): Psychoeducation and relaxation tecniques.Sessions 3 and 4 (weeks 3 and 5): Cogntive restructuring and emotion regulation training.Sessions 5 and 6 (weeks 7 and 9): Behaviour modification tecniques.Session 7 (week 12): Review and relapse prevention.Individual psychotherapyAn adaptation to individual format of the group intervention. From 2 to 8 sessions of 30-60 minutes. Provided by a non-assessor clinical psychologist.Treatment as usual (TAU)Brief transdiagnostic, cognitive-behavioural therapy focused on the emotion regulation strategies that maintain the emotional symptoms. It is an adaptation of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (Barlow et al., 2011) and the "Improving Access to Psychological Therapies (IAPT)" program (Clark, 2011). It consists on seven 90-minute sessions, provided by a non-assessor clinical psychologist in 12-16 weeks, with 8-10 participants per group (more information in Cano-Vindel et al., 2016):Sessions 1 and 2 (weeks 1 and 2): Psychoeducation and relaxation tecniques.Sessions 3 and 4 (weeks 3 and 5): Cogntive restructuring and emotion regulation training.Sessions 5 and 6 (weeks 7 and 9): Behaviour modification tecniques.Session 7 (week 12): Review and relapse prevention.Individual psychotherapyAn adaptation to individual format of the group intervention. From 2 to 8 sessions of 30-60 minutes. Provided by a non-assessor clinical psychologist.Treatment as usual (TAU)An adaptation to individual format of the group intervention. From 2 to 8 sessions of 30-60 minutes. Provided by a non-assessor clinical psychologist.Mainly pharmacological treatment prescribed by the GP. If they recommended psychotherapy as part of the TAU, the participant would be excluded to avoid bias.ReferencesBarlow, D. H., Farchione, T. J., Fairholme, C. P., Ellard, K. K., Boisseau, C. L., Allen, L. B., & Ehrenreich-May, J. (2011). Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. Oxford: Oxford University Press.Cano-Vindel, A., Muñoz-Navarro, R., Wood, C. M., Limonero, J. T., Medrano, L. A., Ruiz-Rodríguez, P., Gracia-Gracia, I., Dongil-Collado, E., Iruarrizaga, I., Chacón, F., & Santolaya, F. (2016). Transdiagnostic Cognitive Behavioral Therapy Versus Treatment as Usual in Adult Patients With Emotional Disorders in the Primary Care Setting (PsicAP Study): Protocol for a Randomized Controlled Trial. JMIR Research Protocols, 5(4), e246. https://doi.org/10.2196/resprot.6351Clark, D. M. (2011). Implementing NICE guidelines for the psychological treatment of depression and anxiety disorders: the IAPT experience. International Review of Psychiatry, 23(4), 318-327. https://doi.org/10.3109/09540261.2011.606803
?. [SECOND ASSESSMENT AND FOLLOW-UPS]
Instruments will be administered again after each intervention is finished. They will be administered again 6 and 12 months later in order to assess if the potential changes remain over time.
?. [ANALYSES]
STATISTICAL ANALYSESData will be analyzed both intention-to-treat and per protocol approaches. After homogeneity intra and intergroups has been checked, changes over time (baseline, postintervention, and follow-ups) in primary and secondary outcomes will be analyzed through linear mixed models. Likewise, effect size (Cohen's d) will be calculated, as well as its accuracy taking into account the number of sessions received. Additionally, it will be estimated the percentage of patients in each group who experience a 50% decrease in the number of clinical symptoms and scores by one standard deviation, as well as the percentage of cases with a probable ED before and after receiving treatment (according to cut-off criteria). Therapeutic success criteria will be the obtaining of postintervention means significantly lower (p ≤ .05) and medium/large effect sizes significantly greater than the control's, specially in the ED scores. Furthermore, groups will be compared regarding impairment, quality of life, satisfaction with the treatment, and cost-effectiveness and cost-utility results.COST-EFECTIVENESS ANALYSESData will be collected through medical records and assessments 3 months before the inclusion, immediately before and after the intervention, and 6 and 12 months later. Direct costs will be calculated by adding the costs due to drugs use (antidepressants, anxiolytics, hypnotics, and sedatives), checkups and other health services, and health personnel. Since group psychotherapy has not a specific tariff, it will be considered as a GP consultation without medical tests (as GPs and clinical psychologists have similar salaries in Spain). Indirect costs will be calculated by multiplying the days of sick leave from work by the daily minimum salary at the moment. It will be also taken into account if it is necessary a replacement worker. Total costs will be obtained by adding the previous ones.Cost-effectiveness analysis will be accomplished by calculating the incremental cost-effectiveness ratios (ICER). Furthermore, the EQ-5D-5L will be used to calculate the intervention utility as quality-adjusted life years (QALYs), and these to obtain the incremental cost-utility ratios (ICUR). The bootstrapping method will be used in order to obtain more accurate ICUR. Lost data will be analyzed through Student's t and χ2 tests regarding ED severity level, sex and age. Finally a sensitivity analysis will be done to test the cost-effectiveness results.
Hypothesis 1: The individual treatment will be generally more effective than the group one.Hypothesis 2: The group therapy will be more effective than the individual with mild disorders and it will get better results in terms of cost-effectiveness.Hypothesis 3: The usual pharmacological treatment will get the worst cost-effectiveness results.Hypothesis 4: The same results will be found across the follow-up assessments.