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

Antonio Cano-Vindel; Roger Muñoz-Navarro; Cristina Mae Wood; Joaquín T Limonero; Leonardo Adrián Medrano; Paloma Ruiz-Rodríguez; Irene Gracia-Gracia; Esperanza Dongil-Collado; Iciar Iruarrizaga; Fernando Chacón; Francisco Santolaya

doi:10.2196/resprot.6351

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 Res Protoc. 2016 Dec 23;5(4):e246. doi: 10.2196/resprot.6351.

Authors

Antonio Cano-Vindel^{1

2}, Roger Muñoz-Navarro^{1

3}, Cristina Mae Wood^{1

2}, Joaquín T Limonero^{1

4}, Leonardo Adrián Medrano^{1

5}, Paloma Ruiz-Rodríguez^{1

6}, Irene Gracia-Gracia¹, Esperanza Dongil-Collado^{1

7}, Iciar Iruarrizaga^{1

8}, Fernando Chacón^{1

2

9}, Francisco Santolaya^{1

9

10}

Affiliations

¹ PsicAP Research Group, Complutense University of Madrid, Madrid, Spain.
² Faculty of Psychology, Complutense University of Madrid, Madrid, Spain.
³ Faculty of Psychology, University of Valencia, Valencia, Spain.
⁴ Faculty of Psychology, Autonomous University of Barcelona, Barcelona, Spain.
⁵ Faculty of Psychology, Universidad Siglo 21, Córdoba, Argentina.
⁶ Fuenlabrada Primary Care Center, Health Service of Madrid, Madrid, Spain.
⁷ Faculty of Psychology, Catholic University of Valencia, Valencia, Spain.
⁸ Faculty of Social Work, Complutense University of Madrid, Madrid, Spain.
⁹ Spanish Association of Psychologists, Madrid, Spain.
¹⁰ Malva-Rosa Mental Health Service, Valencia, Spain.

Abstract

Background: Demand for primary care (PC) services in Spain exceeds available resources. Part of this strong demand is due to the high prevalence of emotional disorders (EDs)-anxiety, depression, and somatic symptom disorders-and related comorbidities such as pain or chronic illnesses. EDs are often under- or misdiagnosed by general practitioners (GPs) and, consequently, treatment is frequently inadequate.

Objective: We aim to compare the short- and long-term effectiveness of group-delivered transdiagnostic cognitive behavioral therapy (TD-CBT) versus treatment as usual (TAU) in the treatment of EDs in the PC setting in Spain. We also aim to compare the effect of these treatments on disability, quality of life, cognitive-emotional factors, and treatment satisfaction.

Methods: Here we present the study design of a two-arm, single-blind, randomized controlled trial (N=1126) to compare TAU to TD-CBT for EDs. TAU will consist primarily of pharmacological treatment and practical advice from the GP while TD-CBT will be administered in seven 90-minute group sessions held over a period ranging from 12 to 14 weeks. Psychological assessments are carried out at baseline (ie, pretreatment); posttreatment; and at 3-, 6-, and 12-month follow-up. The study is conducted in approximately 26 PC centers from the National Health System in Spain.

Results: This study was initiated in December 2013 and will remain open to new participants until recruitment and follow-up has been completed. We expect all posttreatment evaluations to be completed by December 2017, and follow-up will end in December 2018.

Conclusions: We expect the TD-CBT group to have better results compared to TAU on all posttreatment measures and that this improvement will be maintained during follow-up. This project could serve as a model for use in other areas or services of the National Health System in Spain and even in other countries.

Clinicaltrial: International Standard Randomized Controlled Trial Number (ISRCTN): 58437086; http://www.isrctn.com/ISRCTN58437086 (Archived by WebCite at http://www.webcitation.org/6mbYjQSn3).

Keywords: anxiety; cognitive behavioral therapy; common mental health disorders; depression; emotional disorders; medically unexplained symptoms; primary care; quality of life; somatization; transdiagnostic therapy; treatment as usual.

©Antonio Cano-Vindel, Roger Muñoz-Navarro, Cristina Mae Wood, Joaquín T. Limonero, Leonardo Adrián Medrano, Paloma Ruiz-Rodríguez, Irene Gracia-Gracia, Esperanza Dongil-Collado, Iciar Iruarrizaga, Fernando Chacón, Francisco Santolaya. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 23.12.2016.