Cognitive-behavioral Intervention Via a Smartphone App for Depressive Symptoms in Caregivers

Not Applicable

Completed

• Conditions: Depression

• Registration Number: NCT03110991
• Lead Sponsor: University of Santiago de Compostela

Brief Summary

Major depression is a common disorder among non-professional caregivers, and it can be disabling and costly. Although there are effective psychological interventions to prevent depression, most of them involve in-person treatment. New technologies have the potential to overcome the barriers this format presents, which limit accessibility to such interventions. The main objective of this project is to evaluate the effectiveness of a cognitive-behavioral intervention in the prevention of depression, administered through a smartphone application (App), both with and without telephone contact through multiconferencing. Secondary objectives are: (a) test the moderating or mediating effect of the variables in the theoretical model underlying the intervention; (b) analyze the variables that are predictors of intervention outcomes; (c) analyze the acceptability and satisfaction with interventions. A randomized controlled trial will be perform. Caregivers with clinically significant depressive symptoms who do not meet the diagnostic criteria for depressive episode will be included. Recruitment of 174 participants is planned, with random allocation to one of the three conditions (58 participants per intervention): (a) a cognitive-behavioral intervention administered via a smartphone App (CCIA); (b) a cognitive-behavioral intervention administered via a smartphone App + telephone contact via conference call (CCIA+CC); (c) attention control group (ACG). Both interventions will be administered in 5 modules via an App for Smartphones and one group additionally will receive telephone contact via conference call in group format during 4 sessions of 30 minutes. These phone sessions will be recorded to assess the therapists adherence to the intervention protocols. All participants will be evaluated at pre and posttreatment, and 1-, 3-, 6- and 12-month follow-up by trained interviewers who will be blind to the aims of the study, the interventions employed, and the group to which any given participant belongs. Incidence of depression will be examined as the primary measure, with secondary measures being depressive symptoms, symptoms related to the model (pleasant activities, negative thoughts and social contacts) and the acceptability of and satisfaction with the intervention.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-12
• Study Start: 2017-10-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

Inclusion Criteria

• Serves as an informal caregiver for dependent family member
• Dependence is recognized by the Xunta de Galicia
• Commitment to participate in all assessments
• A CES-D score ≥ 16
• Not suffering from a depressive episode
• Provides informed consent
• Has a Smartphone

Exclusion Criteria

• Having received psychological or pharmacological treatment in the previous two months
• To present other conditions that may act as confounders (e.g., symptoms due to substance use)
• Presenting serious psychological or medical disorders that require immediate intervention (e.g., suicidal ideation) or prevent study implementation (e.g., significant cognitive impairment)
• The dependent has a serious or terminal prognosis for the next 14 months
• Planning a change of address or institutionalization of the family member for the next 14 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline Major depressive episode to post-treatment (6 weeks), and follow-ups at 1, 3, 6 and 12 months	Pre- and post-intervention (6 weeks) with follow-ups at 1, 3, 6, and 12 months	The presence of a major depressive episode will be assessed with the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-5, DSM-5® -Clinician Version (SCID-5-CV; First, Williams, Karg, \& Spitzer, 2015). This is a semi-structured interview that provides DSM-5 diagnosis and must be administered by a specialized professional. It includes diagnostic assessment of depressive disorder, bipolar disorder, schizophrenia and other psychotic disorders, substance use disorders, anxiety disorders, obsessive-compulsive disorder, posttraumatic stress disorders, attention deficit and hyperactivity disorder, adaptative disorders, and it allows screening for 17 additional disorders. For this study the module corresponding to major depressive episode was use. The interrater reliability (Kappa) ranges from .70 y 1.00.

Secondary Outcome Measures

Name	Time	Method
Change from baseline depressive symptomatology to post-treatment (6 weeks), and follow-ups at 1, 3, 6 and 12 months	Pre- and post-intervention (6 weeks) with follow-ups at 1, 3, 6, and 12 months	Depressive symptoms as measured by the Center for Epidemiological Studies Depression Scale \[CES-D\] (Radloff,1977; Spanish version of Vazquez, Blanco, \& Lopez, 2007). This 20-item scale is self-administered and assesses depressive symptoms. The person evaluates each item based on how often they have experienced it in the last week using a Likert scale with four response options ranging from 0 (rarely or none of the time) to 3 (most of the time).The total score ranges from 0 to 60, and higher scores correspond to greater depressive symptomatology. Internal consistency (Cronbach's alpha) of the scale ranges from .85 and .90, with .89 for the Spanish version (Vazquez et al.,2007 and 2014).

Trial Locations

Locations (1)

Research Group on Mental Health and Psychopatology; 🇪🇸 Santiago de Compostela, A Coruña, Spain