Brief Telephone Psychological Intervention for Depressive Symptoms in Caregivers — RCDS  

Depression Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression

• NCT number: NCT02292394
• Study type: Interventional
• Source: University of Santiago de Compostela
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Completion date: December 2015