Cognitive behavioral intervention via a smartphone app for non-professional caregivers with depressive symptoms: study protocol for a randomized controlled trial

Fernando L Vázquez, Ángela Torres, Olga Díaz, Mario Páramo, Patricia Otero, Vanessa Blanco, Lara López, Fernando L Vázquez, Ángela Torres, Olga Díaz, Mario Páramo, Patricia Otero, Vanessa Blanco, Lara López

Abstract

Background: Although major depression is a frequent disorder in non-professional caregivers and there are effective psychological interventions to prevent it, caregivers have difficulty accessing them. Interventions for depression applied through an app could improve accessibility; yet, to date, adherence to such interventions has been low. The objectives of this study are to (1) evaluate the efficacy of a cognitive behavioral depression prevention intervention administered through a smartphone app with and without telephone conference calls, (2) analyze the mediators of the change in the incidence of depression and depressive symptoms, and (3) assess adherence and satisfaction with the interventions.

Methods: A randomized controlled clinical trial will be conducted. Caregivers with elevated symptoms will be randomly assigned to a cognitive behavioral intervention administered by a smartphone app (CBIA) group, a CBIA plus telephone conference calls (TCCs) group (CBIA + TCC), or an attention control group. Each condition will consist of approximately 58 participants. Both interventions will be administered in five modules through a smartphone app and the CBIA + TCC group will receive additional TCCs in group format (four sessions of 30 min each). Trained blind assessors will conduct pre-treatment, post-treatment and follow-up assessments at 1, 3, 6, and 12 months.

Discussion: This study will provide evidence of the efficacy of a cognitive behavioral intervention to prevent depression in caregivers with elevated depressive symptoms administered through a smartphone app and the impact of feedback applied through conference calls to increase program adherence and efficacy. If the results were favorable, it would mean that we have developed a more effective, accessible, and clinically useful preventive depression intervention than the currently available ones for many present and future caregivers.

Trial registration: ClinicalTrials.gov: NCT03110991 . Registered 5 April 2017.

Keywords: Adherence to the intervention; App; Depression; Non-professional caregivers; Prevention; Smartphone; Study protocol.

Conflict of interest statement

Ethics approval and consent to participate

The human rights and the dignity of the study participants will be protected in accordance with the Declaration of Helsinki. The study procedures have been approved by the Bioethics Committee of the University of Santiago de Compostela (Spain). The confidentiality of all participants will be guaranteed. Participants will have to give their informed consent, and the informed consent form has been approved by the Bioethics Committee of the University of Santiago de Compostela (Spain). Any significant protocol modification will require a formal amendment to the protocol, which will have to be approved by the Bioethics Committee prior to its implementation. The study protocol is in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines (see SPIRIT checklist as Additional file 1).

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
SPIRIT Figure. Phases of the randomized controlled trial. Note: * During the intervention and at post-treatment

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