Cognitive-behavioral Intervention Via a Smartphone App for Depressive Symptoms in Caregivers (App Depression)
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|ClinicalTrials.gov Identifier: NCT03110991|
Recruitment Status : Active, not recruiting
First Posted : April 12, 2017
Last Update Posted : October 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Multicomponent Cognitive Behavioral Intervention administered via a smartphone App (CCIA) Behavioral: Multicomponent Cognitive Behavioral Intervention administered via a smartphone App+ telephone contact via conference call (CCIA+CC)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||174 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized Controlled Trial on the Efficacy of a Cognitive-behavioral Intervention Via a Smartphone App for Caregivers With Depressive Symptoms|
|Actual Study Start Date :||October 1, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: 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.
Behavioral: Multicomponent Cognitive Behavioral Intervention administered via a smartphone App (CCIA)
Multicomponent Cognitive Behavioral Intervention administered via a smartphone App (CCIA)
Experimental: Cognitive-behavioral intervention via App + multiconference
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)
Multicomponent Cognitive Behavioral Intervention administered via a smartphone App+ telephone contact via conference call (CCIA+CC)
No Intervention: 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.
- Change from baseline Major depressive episode to post-treatment (6 weeks), and follow-ups at 1, 3, 6 and 12 months [ Time Frame: 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.
- Change from baseline depressive symptomatology to post-treatment (6 weeks), and follow-ups at 1, 3, 6 and 12 months [ Time Frame: 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).
- Socio-demographic characteristics [ Time Frame: Pre-intervention ]Sociodemographic characteristics were collected via the Care Characteristics and Status of Caregiver questionnaire. This questionnaire was developed in a previous study (Vázquez et al., 2014, 2016), and assesses the sociodemographic characteristics (sex, age, marital status, social class, family monthly income per household, level of education, main occupation and area of residence), and the care situation (number of persons cared for, relationship with the persona cared for, age and sex of the person cared for, disease of the person cared for, time of care, and hours a day of care) of non professional caregivers.
- Change from baseline Automatic negative thoughts to post-treatment (6 weeks) [ Time Frame: Pre- and post-intervention (6 weeks) ]The occurrence of automatic negative thoughts will be assessed through the 30-item Automatic Negative Thoughts Questionnaire (ATQ-N, Hollon and Kendall, 1980). The subject must indicate the frequency for which a number of thoughts have suddenly arisen in their mind over the last week on a five-point scale from 1 (never) to 5 (always). Scores range between 30 and 150, and there is a direct relationship between the score and the frequencies of certain types of thoughts, with a higher score indicating more negative thoughts experienced by the subject. The internal consistency for the ATQ-N subscale is .96.
- Change from baseline Pleasant activities to post-treatment (6 weeks) [ Time Frame: Pre- and post-intervention (6 weeks) ]The pleasant activities will be assessed via the List of Pleasant Activities for Caregivers (LAA). It includes 40 activities to evaluate the pleasant activities that the caregivers have performed during the last week. It consists of a pleasant activities list, where the participants indicate whether or not a certain activity is pleasant to them, if they performed it during the last week, and the number of times it was carried out (developed and used in a previous study; Vázquez et al., 2016). In the previous study it showed an internal consistency of .89.
- Change from baseline Social contacts to post-treatment (6 weeks) [ Time Frame: Pre- and post-intervention (6 weeks) ]To evaluate the participants' weekly social contacts we will use the Register of Social Networking (developed and used in the previous study by Vazquez et al., 2016) that asks the participants to report the number of people they had daily contact with.
- Number of dropouts [ Time Frame: During the intervention sessions (5 weeks) ]We will construct a registry of the number of dropouts from each group to assess their response to the interventions over the duration of the study.
- Treatment adherence [ Time Frame: During the intervention sessions (5 weeks) ]Treatment adherence will be assessed by recording the number of meetings each caregiver attends and whether they complete homework assignments.
- Satisfaction with the service received [ Time Frame: Post-intervention (6 weeks) ]Participant satisfaction with the service received will be evaluated upon intervention completion. We will use the Client Satisfaction Questionnaire ([CSQ-8]; Larsen, Attkisson, Hargreaves, & Nguyen, 1979; Spanish version Vazquez, Torres, & Otero, 2009). It is an 8-item scale with 4 possible answers and a final ranking score ranging from 8 to 32, where a higher score implies greater satisfaction with the service received. It is a widely used tool with an internal consistency between .83 and .93 (Attkisson & Greenfield, 2004).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110991
|Research Group on Mental Health and Psychopatology|
|Santiago de Compostela, A Coruña, Spain, 15782|
|Principal Investigator:||Fernando L. Vázquez González, Ph.D.||Tenured Professor|