Clinical trial NCT03110991: Cognitive-behavioral Intervention Via a Smartphone App for Depressive Symptoms in Caregivers
Official title: A Randomized Controlled Trial on the Efficacy of a Cognitive-behavioral Intervention Via a Smartphone App for Caregivers With Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Depressive symptoms
Prevention
Non-professional caregivers
App
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
name: Ministry of Work and Welfare - Xunta de Galicia
First posted: 2017-04-12
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline Major depressive episode to post-treatment (6 weeks), and follow-ups at 1, 3, 6 and 12 months
timeFrame: Pre- and post-intervention (6 weeks) with follow-ups at 1, 3, 6, and 12 months
Secondary outcomes:
measure: Change from baseline depressive symptomatology to post-treatment (6 weeks), and follow-ups at 1, 3, 6 and 12 months
timeFrame: Pre- and post-intervention (6 weeks) with follow-ups at 1, 3, 6, and 12 months
Other outcomes:
measure: Socio-demographic characteristics
timeFrame: Pre-intervention
measure: Change from baseline Automatic negative thoughts to post-treatment (6 weeks)
timeFrame: Pre- and post-intervention (6 weeks)
measure: Change from baseline Pleasant activities to post-treatment (6 weeks)
timeFrame: Pre- and post-intervention (6 weeks)
measure: Change from baseline Social contacts to post-treatment (6 weeks)
timeFrame: Pre- and post-intervention (6 weeks)
measure: Number of dropouts
timeFrame: During the intervention sessions (5 weeks)
measure: Treatment adherence
timeFrame: During the intervention sessions (5 weeks)
measure: Satisfaction with the service received
timeFrame: Post-intervention (6 weeks)
Locations:
city: Santiago de Compostela
country: Spain
facility: Research Group on Mental Health and Psychopatology
state: A Coruña
Study officials:
affiliation: Tenured Professor
name: Fernando L. Vázquez González, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Hollon SD; Kendall PC. Cognitive self-statements in depression: development of an Automatic Thought Questionnaire. Cognitive Ther Res 1980; 4: 383-395.
citation: 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.
citation: 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.
citation: Radloff LS. A CES-D scale: a self-report depression scale for research in thegeneral population. Appl Psychl Meas 1977; 1: 385-401.
citation: 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.
citation: 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.
citation: 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.
citation: Vázquez FL, Torres A, Otero P. CSQ-8 Castilian (TMS.047). Available in: http://www.CSQscales.com; 2009.
citation: 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.