Brief Telephone Psychological Intervention for Depressive Symptoms in Caregivers

NCT ID: NCT02292394

Last Updated: 2016-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-12-31

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Multicomponent Cognitive Behavioral Telephone Intervention

Intervention Type: BEHAVIORAL

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.

Group Type: EXPERIMENTAL

Telephone Intervention Pleasant Activities

Intervention Type: BEHAVIORAL

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multicomponent Cognitive Behavioral Telephone Intervention

Intervention Type: BEHAVIORAL

Telephone Intervention Pleasant Activities

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministerio de Economía y Competitividad, Spain

OTHER_GOV

Sponsor Role: collaborator

Ministry of Work and Welfare - Xunta de Galicia

OTHER_GOV

Sponsor Role: collaborator

University of Santiago de Compostela

OTHER

Sponsor Role: lead

Responsible Party

Fernando Lino Vázquez González

Associate Professor [Tenured Professor]

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fernando L. Vázquez González, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

University of Santiago de Compostela

Locations

Depressive Disorders Unit. School of Psychology. University of Santiago de Compostela.

Santiago de Compostela, Galicia/A Coruña, Spain

Countries

Spain

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: DERIVED

PMID: 26597295 (View on PubMed)

Other Identifiers

PSI2012-37396

Identifier Type: -

Identifier Source: org_study_id