Self-help Guided by Lay Providers for Anxiety in Older Adults

NCT03768544 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-10-04

No results posted yet for this study

Summary

Few older adults receive treatment for Generalized Anxiety Disorder (GAD) despite a high prevalence in this population and significant associated health care costs. Although older adults generally prefer psychotherapy to medication for help with anxiety, face-to-face psychotherapy is difficult to access for many of them. Psychological guided self-help (GSH), which patients use by themselves at home under the supervision of a licensed mental health provider (e.g., psychologist), has been shown to be effective. However, the capacity of our health care system to respond adequately to the mental health needs of seniors has been questioned and cost-effective solutions are required. Because the therapist's role in GSH is limited to supporting the patient, it is conceivable that this role could be assumed by trained and supervised lay providers (LP) instead of licensed providers. If this approach is effective, it could help provide many older adults with much needed mental health treatment at a lower cost. The main objective of this project is to evaluate the effectiveness of GSH guided by LP for GAD in older adults. Participants will be assigned randomly to an experimental group, which will receive treatment immediately, or to a control group whose treatment will be delayed. Data will be obtained through clinician evaluations and self-assessment questionnaires. They will include socio-demographic characteristics, symptoms of GAD, variables related to anxiety, such as depression and sleep difficulties, and participants' perception of treatment. For the experimental group, data collection will take place at four different times: before treatment begins, after treatment ends, and at 6 and 12 months after the end of treatment. Control group participants will be assessed on three occasions: before and after the waiting period and after receiving treatment. The efficacy of GSH will be established by comparing the change in the two groups on the main variables. We will also identify the characteristics of patients associated with improvement during treatment and document their perception of treatment.

Conditions

  • Generalized Anxiety Disorder

Interventions

BEHAVIORAL

Self-help guided by a lay provider

Self-help based on the principles of cognitive-behavioral therapy and guided by a lay provider. Treatment lasts 15 weeks, is based on a participant's manual, and consists of relaxation, differentiation of the main types of worries, learning to tolerate uncertainty, questioning false beliefs about worries, problem solving, cognitive exposure, and planning pleasant activities. Weekly telephone sessions with the lay provider serve to provide support.

BEHAVIORAL

Waiting list where participants wait for delayed treatment

Participants have a 15-week wait period during which they receive a 15-minute telephone call from the local professional research assistant on three occasions separated by four-week intervals. The purpose of these calls is to encourage the participant to persevere until the start of treatment and to identify potential negative effects that could be associated with the waiting period. Participants receive self-help guided by a lay provider after the waiting period.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • CIUSSS du Centre-Sud-de-l'Île-Montréal

    collaborator UNKNOWN
  • Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke

    collaborator OTHER
  • Integrated University Health and Social Services Center of the Capitale-Nationale

    collaborator OTHER
  • Laval University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-11
Primary Completion
2023-02-24
Completion
2023-02-24

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03768544 on ClinicalTrials.gov