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

NCT03110991 | Completed

• 1 other identifier: PSI2016-79041-P
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression; Depressive symptoms; Prevention; Non-professional caregivers; App

Outcome Measures

Primary Outcomes (1)

• Change from baseline Major depressive episode to post-treatment (6 weeks), and 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.

  Pre- and post-intervention (6 weeks) with follow-ups at 1, 3, 6, and 12 months

Secondary Outcomes (1)

• 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

Other Outcomes (7)

• Socio-demographic characteristics

  Pre-intervention

• Change from baseline Automatic negative thoughts to post-treatment (6 weeks)

  Pre- and post-intervention (6 weeks)

• Change from baseline Pleasant activities to post-treatment (6 weeks)

  Pre- and post-intervention (6 weeks)

Study Arms (3)

Cognitive-behavioral intervention via App

EXPERIMENTAL

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.

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

Cognitive-behavioral intervention via App + multiconference

EXPERIMENTAL

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

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

Usual care

NO INTERVENTION

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.

Interventions

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

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

Cognitive-behavioral intervention via App

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+ telephone contact via conference call (CCIA+CC)

Cognitive-behavioral intervention via App + multiconference

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Santiago de Compostela: lead
• Ministerio de Economía y Competitividad, Spain: collaborator
• Ministry of Work and Welfare - Xunta de Galicia: collaborator

Study Sites (1)

Research Group on Mental Health and Psychopatology

Santiago de Compostela, A Coruña, 15782, Spain

Location

Related Publications (11)

• 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.

  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.

  BACKGROUND

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

  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.

  PMID: 10245370 BACKGROUND

• 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.

  BACKGROUND

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

  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.

  PMID: 17141880 BACKGROUND

• 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.

  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.

  PMID: 27067068 BACKGROUND

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

  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.

  PMID: 30064466 DERIVED

MeSH Terms

Conditions

Depression; Alzheimer Disease

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Fernando L. Vázquez González, Ph.D.

  Tenured Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tenured Professor

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 12, 2017
• Study Start: October 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)