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

October 2, 2023 updated by: Philippe Landreville, Laval University

Generalized Anxiety Disorder in Older Adults : Efficacy of a Self-help Treatment Guided by Trained Lay Providers

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Few older adults with Generalized Anxiety Disorder (GAD) receive treatment although it is one of the most prevalent anxiety disorders in this population and involves significant health care costs. Studies show that older adults generally prefer psychotherapy and find it more acceptable than medication for help with anxiety. Unfortunately, face-to-face psychotherapy is difficult to access for many of them. Guided self-help (GSH) is an alternative to psychotherapy which requires that the patient take home a standardized psychological treatment and work through it more or less independently. The role of the therapist is primarily of supportive nature and the amount of contact between the patient and therapist is minimized. There is evidence that GSH based on the principles of cognitive-behavioral therapy (GSH-CBT) and guided by a licensed mental health provider is effective for treating GAD in older adults. However, the capacity of our health care system to respond adequately to the mental health needs of older adults has been questioned and cost-effective solutions are required to meet the needs of a rapidly aging population. Because the therapist's role in GSH-CBT 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. LP are generally providers with no post-graduate training in a specialized mental health program. The main goal of the study is to evaluate the efficacy of GSH-CBT guided by LP for GAD in older adults. Secondary goals are to identify the characteristics of patients associated with improvement during treatment and to document perception of treatment by patients and LP. We will conduct a multisite randomized controlled trial comparing an experimental group receiving GSH-CBT guided by LP to a wait-list control group. LP training will include readings, didactic training, and role plays. LP will be supervised throughout the project by licensed psychologists. Treatment will last 15 weeks and be based on a participant's manual. Weekly telephone sessions with LP (30 minutes maximum) will be limited to providing support. Data will be obtained through clinician evaluations and self-assessment questionnaires. They will include symptoms of GAD and variables related to anxiety, such as depression. For the experimental group, measurements will take place at pre- and post-treatment and at 6 and 12 months post-treatment. For the control group, three evaluations are planned: two pre-treatment evaluations (before and after the waiting period) and after receiving treatment (post-treatment). The efficacy of GSH-CBT will be established by comparing the change in the two groups on the main variables. This project will provide evidence on the effectiveness of a novel approach to treat GAD in older adults. If effective, it may be implemented on a larger scale and provide many older adults with much needed mental health treatment through an expanded workforce.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H3W 1W4
        • Centre de recherche de l'institut Universitaire de Gériatrie de Montreal
      • Québec, Quebec, Canada, G1V 0A6
        • École de psychologie, Université Laval
      • Sherbrooke, Quebec, Canada, J1K 2R1
        • Département de psychologie, Université de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 60 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Self-help guided by a lay provider
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.
Other: Waiting list where participants wait for delayed treatment
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Penn State Worry Questionnaire
Time Frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
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
Time Frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Intolerance to Uncertainty Inventory
Time Frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
27 items rated on a scale ranging from 1 to 5. A higher total score suggests higher intolerance to uncertainty.
Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Change in Negative Problem Orientation Questionnaire
Time Frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
12 items rated on a scale ranging from 1 to 5. A higher total score suggests more negative attitudes toward problems.
Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Change in Cognitive Avoidance Questionnaire
Time Frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
25 items rated on a scale ranging from 1 to 5. A higher total score suggests more likely use of cognitive avoidance.
Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Change in Why Worry Questionnaire
Time Frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
25 items rated on a scale ranging from 1 to 5. A higher total score suggests a greater belief that worrying is useful.
Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Change in Geriatric Anxiety Inventory
Time Frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
20 items rated as "agree" or "disagree". Minimum score = 0; Maximum score = 20. A higher total score is indicative of greater severity of symptoms.
Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Change in Geriatric Depression Scale
Time Frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
30 items rated as "yes" or "no". Minimum score = 0; Maximum score = 30.A higher total score is indicative of greater severity of symptoms.
Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Change in Insomnia Severity Index
Time Frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
7 items rated on a scale ranging from 1 to 4. A higher total score suggests more severe insomnia.
Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Change in Sheehan Disability Scale
Time Frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Three self-rated items of family, work, and social impairment rated on a scale ranging from 0 to 10.
Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Change in Mini-Mental State Examination, telephone version
Time Frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Items on orientation to time and place, registration, attention, recall, and language. Scores vary between 0 and 26 with higher scores indicating better cognitive functioning.
Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Change in GAD diagnosis
Time Frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
The Anxiety and Related Disorders Interview Schedule for DSM-5 is a validated structured interview used to confirm the presence or absence of anxiety disorders and associated psychiatric diagnoses.
Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of treatment by participants
Time Frame: Post treatment (15 weeks)
Measures participant's perception of treatment. 19 statements covering various aspects of treatment (modules, readings, exercises, telephone sessions, workload, organization and duration of treatment, and its usefulness). Each statement is evaluated on a four-point scale ranging from "strongly agree" to "absolutely disagree". A fifth possible answer, 'does not apply', is also provided.
Post treatment (15 weeks)
Questionnaire of behavioral manifestations linked to anxiety
Time Frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Twenty-four items evaluating six behaviors related to generalized anxiety, namely reassurance seeking, avoidance, control, procrastination, overplanning and checking. Items are rated on a five point Likert scale
Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Nine items relating to COVID-19
Time Frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
These items were added to describe the reality of the participants while considering the effects of the pandemic on their anxiety. Five questions are framed as "yes or no" with an open-ended description of their answer choice whereas four items are rated on a five-point Likert scale.
Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laval University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)
Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
Integrated University Health and Social Services Center of the Capitale-Nationale
CIUSSS du Centre-Sud-de-l'Île-Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 24, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 24, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SIRUL 118715

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings