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

NCT03768544 | Completed

• 1 other identifier: SIRUL 118715
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

generalized anxiety disorder; older adult; psychological treatment; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Change in Penn State Worry Questionnaire

  16 items rated on a scale ranging from 1 to 5. A higher total score indicates a greater tendency to worry.

  Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

• Change in GAD-7

  7 items answered on a scale ranging from 0 to 3. A higher total score suggests greater severity.

  Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

Secondary Outcomes (10)

• Change in Intolerance to Uncertainty Inventory

  Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

• Change in Negative Problem Orientation Questionnaire

  Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

• Change in Cognitive Avoidance Questionnaire

  Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

• Change in Why Worry Questionnaire

  Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

• Change in Geriatric Anxiety Inventory

  Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

Other Outcomes (3)

• Evaluation of treatment by participants

  Post treatment (15 weeks)

• Questionnaire of behavioral manifestations linked to anxiety

  Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

• Nine items relating to COVID-19

  Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

Study Arms (2)

Self-help guided by a lay provider

EXPERIMENTAL

Behavioral: Self-help guided by a lay provider

Waiting list where participants wait for delayed treatment

OTHER

Behavioral: Self-help guided by a lay provider; Behavioral: Waiting list where participants wait for delayed treatment

Interventions

Self-help guided by a lay provider BEHAVIORAL

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.

Self-help guided by a lay provider; Waiting list where participants wait for delayed treatment

Waiting list where participants wait for delayed treatment BEHAVIORAL

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.

Waiting list where participants wait for delayed treatment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• meet at least criteria for subthreshold GAD at screening based on items of the Worry and Anxiety Questionnaire
• meet DSM-5 criteria for primary threshold or subthreshold GAD
• be able to read and speak French and to use the telephone without difficulty
• if an anxiety medication is used, commit to maintaining the type of medication or dose during eight weeks prior to treatment and during the protocol.

You may not qualify if:

• a disabling physical disorder that is not adequately controlled (e.g., acute heart disease, recent stroke)
• the presence of a substance use disorder
• presenting a bipolar disorder or symptoms of a psychotic disorder
• having significant cognitive impairment (score of less than 22 on the Telephone version of the Mini-Mental State Examination)
• currently receiving or having received psychotherapy for anxiety over the last six months.

Sponsors & Collaborators

• Laval University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• CIUSSS du Centre-Sud-de-l'Île-Montréal: collaborator
• Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke: collaborator
• Integrated University Health and Social Services Center of the Capitale-Nationale: collaborator

Study Sites (3)

Centre de recherche de l'Institut universitaire de gériatrie de Montréal

Montreal, Quebec, H3W 1W4, Canada

Location

École de psychologie, Université Laval

Québec, Quebec, G1V 0A6, Canada

Location

Département de psychologie, Université de Sherbrooke

Sherbrooke, Quebec, J1K 2R1, Canada

Location

Related Publications (1)

• Landreville P, Gosselin P, Grenier S, Carmichael PH. Self-help guided by trained lay providers for generalized anxiety disorder in older adults: study protocol for a randomized controlled trial. BMC Geriatr. 2021 May 22;21(1):324. doi: 10.1186/s12877-021-02221-x.

  PMID: 34022795 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Treatment Delay

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Time-to-Treatment; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: December 7, 2018
• Study Start: March 11, 2019
• Primary Completion: February 24, 2023
• Study Completion: February 24, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)