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

University of Santiago de Compostela

Status: Completed

Conditions: Depression

Treatments: Behavioral: Multicomponent Cognitive Behavioral Intervention administered via a smartphone App+ telephone contact via conference call (CCIA+CC); Behavioral: Multicomponent Cognitive Behavioral Intervention administered via a smartphone App (CCIA)

Study type: Interventional

Funder types: Other

Identifiers

NCT03110991

PSI2016-79041-P

Details and patient eligibility

About

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.

Enrollment: 179 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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179 participants in 3 patient groups

Cognitive-behavioral intervention via App

Experimental group

Description:

The participants of the two experimental groups will receive a cognitive-behavioral intervention for depression prevention via a smartphone App, adapted from an indicated depression prevention program for caregivers in face-to-face group format developed by our research team, based on the model by Lewinsohn, Hoberman, Teri, \& Hautzinger (1985), which has proven to be efficacious in the prevention of the onset of new major depressive episodes and the decrease of depressive symptoms both short- and long-term (Vázquez et a., 2014, 2016). In both groups the intervention administered via App will consist of 5 modules.

Treatment:

Behavioral: Multicomponent Cognitive Behavioral Intervention administered via a smartphone App (CCIA)

Cognitive-behavioral intervention via App + multiconference

Experimental group

Description:

Additionally, this experimental group will receive phone group conference calls during four 30 minute-sessions.

Treatment:

Behavioral: Multicomponent Cognitive Behavioral Intervention administered via a smartphone App+ telephone contact via conference call (CCIA+CC)

Usual care

No Intervention group

Description:

Individuals assigned to this group will receive no intervention or material, but they will have unrestricted access to any routine medical or psychological care that they might want to seek to treat depressive symptoms.The use of such treatments will be recorded.