Clinical trial NCT02292394: Brief Telephone Psychological Intervention for Depressive Symptoms in Caregivers
Official title: A Study of Randomized Controlled Dismantling of a Brief Telephone Psychological Intervention Applied to Informal Caregivers With Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Depressive symptoms
Prevention
Caregivers
Telephone intervention
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: 2014-11-17
Enrollment: 180
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: 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.


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 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

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 Behavioral activation 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: Change from baseline Self-efficacy to post-treatment (6 weeks)
timeFrame: Pre- and post-intervention (6 weeks)
measure: Dropout and 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: Depressive Disorders Unit. School of Psychology. University of Santiago de Compostela.
state: Galicia/A Coruña
Study officials:
affiliation: University of Santiago de Compostela
name: Fernando L. Vázquez González, Associate Professor
role: PRINCIPAL_INVESTIGATOR
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