Brief Telephone Psychological Intervention for Depressive Symptoms in Caregivers (RCDS)
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|ClinicalTrials.gov Identifier: NCT02292394|
Recruitment Status : Completed
First Posted : November 17, 2014
Last Update Posted : May 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Multicomponent Cognitive Behavioral Telephone Intervention Behavioral: Telephone Intervention Pleasant Activities||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Study of Randomized Controlled Dismantling of a Brief Telephone Psychological Intervention Applied to Informal Caregivers With Depressive Symptoms|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Multicomponent Cognitive Behavioral Telephone Intervention
In this study, we will apply a telephone intervention that is a modified version of a brief prevention intervention for depressed caregivers that previously was applied in person in a group format during five 90-minute sessions (Vazquez et al., 2014). During the intervention, participants will be trained in various behavioral and cognitive abilities such as increasing pleasant activities, self-reinforcement, relaxation techniques, assertive communication, strategies to increase social contacts and social skills, and strategies to increase positive thoughts and decrease depressive ones.
Behavioral: Multicomponent Cognitive Behavioral Telephone Intervention
Experimental: Telephone Intervention Pleasant Activities
This intervention is also a modified version of a protocol described by Vazquez et al. (2014). However, in this case, we will specifically focus on the behavioral activation components of the multicomponent cognitive-behavioral telephone intervention. This intervention will also be structured in groups and administered by phone in five 90-minute sessions.
Behavioral: Telephone Intervention Pleasant Activities
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 Axis I Disorders from the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV Clinical Version (Structured Clinical Interview for DSM-IV, Clinician Version [SCID-CV]; First, Spitzer, Gibbon and Williams, 1997/1999). This is a semi-structured interview that provides a DSM-IV diagnosis and must be administered by a clinician. It consists of six modules of diagnostic interviews: mood episodes, psychotic symptoms, psychotic disorders, mood disorders, substance use disorders, anxiety disorders, and other disorders. The SCID-CV has good test-retest reliability and adequate reliability for psychiatric patients (kappa index = 0.61)
- 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, White, and 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 ]Socio-demographic characteristics were collected via the Care Characteristics and Status of Caregiver questionnaire that was developed in a previous study (Vazquez et al., 2014). The data of caregivers (sex, age, marital status, number of children, social class, family monthly income per household, level of education, main occupation, province and area of residence), the care situation, health of the caregiver, and contact information (landline home phone)
- 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 Behavioral activation to post-treatment (6 weeks) [ Time Frame: Pre- and post-intervention (6 weeks) ]To assess behavioral activation, we will use the Environmental Reward Observation Scale (EROS, Armento and Hopko, 2007; Spanish version Barraca and Pérez-Álvarez, 2010). It is a self-administered 10-item scale that assesses the degree of positive reinforcement contingent on the response received from the media. Each item is evaluated based on the degree to which the individual believes applies to them, according to a Likert scale with four response options ranging from 1 (strongly disagree) to 4 (strongly agree), with higher scores indicating a greater degree of positive reinforcement. The total score ranges from 10 to 40. The Spanish version of EROS is reliable (Cronbach's alpha = .86) and valid (high correlations with the BDI-II, BADS, STAI-S/R, AAQ, significant differences between participants and non-clinical subjects).
- 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., 2014) that asks the participants to report the number of people they had daily contact with.
- Change from baseline Self-efficacy to post-treatment (6 weeks) [ Time Frame: Pre- and post-intervention (6 weeks) ]Self-efficacy will be evaluated with the 10-item version of the General Self-Efficacy Scale (GSES, Jerusalem and Schwarzer, 1992; Spanish version Baessler and Schwarzer, 1996). This self-administered 10-item scale was designed to assess the feeling of personal competence to deal with difficult life situations. Each item is evaluated based on the degree to which the subject believes that the statement about their ability to solve problems is true on a Likert 4-point scale ranging from 1 (false) to 4 (true). Higher scores indicate a greater expectation of self-efficacy. Internal consistency for the Spanish version, estimated by Cronbach's alpha was .81.
- Dropout and treatment adherence [ Time Frame: During the intervention sessions (5 weeks) ]We will construct a registry of dropouts from each group to assess their response to the interventions over the duration of the study. In addition, 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, and Nguyen, 1979; Spanish version Vazquez, Torres, and 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 and 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): NCT02292394
|Depressive Disorders Unit. School of Psychology. University of Santiago de Compostela.|
|Santiago de Compostela, Galicia/A Coruña, Spain, 15782|
|Principal Investigator:||Fernando L. Vázquez González, Associate Professor||University of Santiago de Compostela|