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

NCT ID: NCT03110991

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cognitive-behavioral intervention via App

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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Cognitive-behavioral intervention via App + multiconference

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

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Usual care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type BEHAVIORAL

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

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministerio de Economía y Competitividad, Spain

OTHER_GOV

Sponsor Role collaborator

Ministry of Work and Welfare - Xunta de Galicia

OTHER_GOV

Sponsor Role collaborator

University of Santiago de Compostela

OTHER

Sponsor Role lead

Responsible Party

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Fernando Lino Vázquez González

Tenured Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fernando L. Vázquez González, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Tenured Professor

Locations

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Research Group on Mental Health and Psychopatology

Santiago de Compostela, A Coruña, Spain

Site Status

Countries

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Spain

References

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Attkisson CC; Greenfield TK. The UCSF Client Satisfaction Scales: I. The Client Satisfaction Questionnaire-8. In Maruish ME, editor, The use of psychological testing for treatment planning and outcomes assessment. 3rd ed. Volume 3. Mahwah, NJ: Lawrence Erlbaum Associates; 2004. p. 799-811.

Reference Type BACKGROUND

First MB, Williams, JBW, Karg RS, Spitzer RL. Structured Clinical Interview for DSM-5 Disorders, Clinician Version (SCID-5-CV). Arlington, VA: American Psychiatric Association; 2015.

Reference Type BACKGROUND

Hollon SD; Kendall PC. Cognitive self-statements in depression: development of an Automatic Thought Questionnaire. Cognitive Ther Res 1980; 4: 383-395.

Reference Type BACKGROUND

Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.

Reference Type BACKGROUND
PMID: 10245370 (View on PubMed)

Lewinsohn PM, Hoberman H, Teri L, Hautzinger M. An integrative theory of depression. In Reiss S, Bootzin RR, editors, Theoretical issues in behaviour therapy. New York: Academic Press; 1985, p. 313-359.

Reference Type BACKGROUND

Radloff LS. A CES-D scale: a self-report depression scale for research in thegeneral population. Appl Psychl Meas 1977; 1: 385-401.

Reference Type BACKGROUND

Vazquez FL, Blanco V, Lopez M. An adaptation of the Center for Epidemiologic Studies Depression Scale for use in non-psychiatric Spanish populations. Psychiatry Res. 2007 Jan 15;149(1-3):247-52. doi: 10.1016/j.psychres.2006.03.004. Epub 2006 Dec 1.

Reference Type BACKGROUND
PMID: 17141880 (View on PubMed)

Vázquez FL; Hermida E; Torres A; Otero P; Blanco V; Díaz O. Eficacia de una intervención preventiva cognitivo conductual en cuidadoras con síntomas depresivos elevados. Behav Psychol 2014; 22: 77-94.

Reference Type BACKGROUND

Vazquez FL, Torres A, Blanco V, Otero P, Diaz O, Ferraces MJ. Long-term Follow-up of a Randomized Clinical Trial Assessing the Efficacy of a Brief Cognitive-Behavioral Depression Prevention Intervention for Caregivers with Elevated Depressive Symptoms. Am J Geriatr Psychiatry. 2016 Jun;24(6):421-32. doi: 10.1016/j.jagp.2016.02.050. Epub 2016 Feb 27.

Reference Type BACKGROUND
PMID: 27067068 (View on PubMed)

Vázquez FL, Torres A, Otero P. CSQ-8 Castilian (TMS.047). Available in: http://www.CSQscales.com; 2009.

Reference Type BACKGROUND

Vazquez FL, Torres A, Diaz O, Paramo M, Otero P, Blanco V, Lopez L. Cognitive behavioral intervention via a smartphone app for non-professional caregivers with depressive symptoms: study protocol for a randomized controlled trial. Trials. 2018 Jul 31;19(1):414. doi: 10.1186/s13063-018-2793-2.

Reference Type DERIVED
PMID: 30064466 (View on PubMed)

Other Identifiers

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PSI2016-79041-P

Identifier Type: -

Identifier Source: org_study_id