Brief Telephone Psychological Intervention for Depressive Symptoms in Caregivers

Study Overview
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Brief Summary
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Caring for dependent persons can give rise to depression in non-professional caregivers, placing a burden on health care services and threatening the quality of the care dispensed to the dependent. Unfortunately, the ability of these patients to attend therapy sessions is often limited precisely by their role as caregivers. Preventive measures that are accessible to caregivers are thus called for. The primary aim of this project is to evaluate the efficacy of telephonic administration of a brief indicated preventive psychological intervention for depression that in previous work proved effective when administered in person in group sessions. With a view to optimizing resource usage by maximizing interventional efficacy, the secondary aim is to determine the contribution to overall efficacy of that part of the intervention that consists in increasing pleasant activities. To these ends, some 180 informed, consenting caregivers satisfying appropriate criteria for inclusion in the study will be randomized to one of three interventions (≈ 60 participants per intervention): the full cognitive-behavioural programme; a program focused only on the component of pleasant activities; or a usual care condition. Both programmes will be administered in five 90 minute sessions by audio tele-conference. All sessions will be recorded for verification of adherence to the intervention protocols. Participants will be re-evaluated at the end of their intervention (when participant satisfaction with the cognitive-behavioural programmes will also be assessed) and also 1, 3, 6 and 12 months later; all evaluations will be performed 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. Analyses of these evaluations will compare the short- and long-term efficacies of the three groups. Factors that mediate participant improvement or predict results will also be investigated, and the cost-effectiveness of the interventions will be estimated.The central hypothesis of the proposed study is that a multicomponent cognitive-behavioral telephone intervention and a protocol assessing participation in pleasant activities will both significantly reduce the incidence of depression and depressive symptoms compared to a control group with usual care immediately after treatment and at 1-, 3-, 6-, and 12-month follow-up visits.

Official Title
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A Study of Randomized Controlled Dismantling of a Brief Telephone Psychological Intervention Applied to Informal Caregivers With Depressive Symptoms

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Multicomponent Cognitive Behavioral Telephone Intervention
* Behavioral: Telephone Intervention Pleasant Activities


Participation Criteria
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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 telephone Exclusion Criteria: Having received psychological or pharmacological treatment in the previous 2 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, severe hearing 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multicomponent Cognitive Behavioral Telephone Intervention<br>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<br> <br> |
| Experimental: Telephone Intervention Pleasant Activities<br>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<br> <br> |
| No Intervention: Usual care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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) | Pre- and post-intervention (6 weeks) with follow-ups at 1, 3, 6, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline depressive symptomatology to post-treatment (6 weeks), and 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). | Pre- and post-intervention (6 weeks) with follow-ups at 1, 3, 6, and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Depressive symptoms, Prevention, Caregivers, Telephone intervention