Generalized Anxiety DisorderNCT03768544
Self-help Guided by Lay Providers for Anxiety in Older Adults
A study testing Self-help guided by a lay provider and Waiting list where participants wait for delayed treatment in people with Generalized Anxiety Disorder, run by Laval University at 3 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Self-help guided by a lay provider and Waiting list where participants wait for delayed treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesCanada
- Study dates
- 11 Mar 2019to 24 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Centre de recherche de l'Institut universitaire de gériatrie de Montréal
Montreal, Quebec, H3W 1W4
École de psychologie, Université Laval
Québec, Quebec, G1V 0A6
Département de psychologie, Université de Sherbrooke
Sherbrooke, Quebec, J1K 2R1
About this study
Official title: 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.
Read the 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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Self-help guided by a lay provider, Waiting list where participants wait for delayed treatment
- Keywords
- generalized anxiety disorder, older adult, psychological treatment, randomized controlled trial
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-help guided by a lay providerBehavioural
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.
Waiting list where participants wait for delayed treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-help guided by a lay provider | Experimental | Not described Receives: Behavioral: Self-help guided by a lay provider |
| Waiting list where participants wait for delayed treatment | Other | Not described Receives: Behavioral: Self-help guided by a lay provider; Behavioral: Waiting list where participants wait for delayed treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Secondary outcomes (10)
Change in Intolerance to Uncertainty Inventory
27 items rated on a scale ranging from 1 to 5. A higher total score suggests higher intolerance to uncertainty.
Measured: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Change in Negative Problem Orientation Questionnaire
12 items rated on a scale ranging from 1 to 5. A higher total score suggests more negative attitudes toward problems.
Measured: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Change in Cognitive Avoidance Questionnaire
25 items rated on a scale ranging from 1 to 5. A higher total score suggests more likely use of cognitive avoidance.
Measured: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Change in Why Worry Questionnaire
25 items rated on a scale ranging from 1 to 5. A higher total score suggests a greater belief that worrying is useful.
Measured: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Change in Geriatric Anxiety Inventory
20 items rated as "agree" or "disagree". Minimum score = 0; Maximum score = 20. A higher total score is indicative of greater severity of symptoms.
Measured: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Change in Geriatric Depression Scale
30 items rated as "yes" or "no". Minimum score = 0; Maximum score = 30.A higher total score is indicative of greater severity of symptoms.
Measured: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Change in Insomnia Severity Index
7 items rated on a scale ranging from 1 to 4. A higher total score suggests more severe insomnia.
Measured: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Change in Sheehan Disability Scale
Three self-rated items of family, work, and social impairment rated on a scale ranging from 0 to 10.
Measured: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Change in Mini-Mental State Examination, telephone version
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.
Measured: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Change in GAD diagnosis
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.
Measured: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start11 Mar 2019
- Primary completion24 Feb 2023
- Study completion24 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), CIUSSS du Centre-Sud-de-l'Île-Montréal, Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke, Integrated University Health and Social Services Center of the Capitale-Nationale
- Responsible party
- Principal investigator, Philippe Landreville, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768544
- Sponsor's protocol ID
- SIRUL 118715
- Status last verified
- Oct 2023
- First submitted
- 21 Nov 2018
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34022795
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generalized Anxiety Disorder in Older Adults : Efficacy of a Self-help Treatment Guided by Trained Lay Providers
- ClinicalTrials.gov ID
- NCT03768544
- Acronym / sponsor ID
- SIRUL 118715
- Conditions
- Generalized Anxiety Disorder
- Keywords
- generalized anxiety disorder, older adult, psychological treatment, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), CIUSSS du Centre-Sud-de-l'Île-Montréal, Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke, Integrated University Health and Social Services Center of the Capitale-Nationale
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 24 Feb 2023 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-help guided by a lay providerSelf-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. | Behavioural | Self-help guided by a lay provider, Waiting list where participants wait for delayed treatment |
| Waiting list where participants wait for delayed treatmentParticipants 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. | Behavioural | Waiting list where participants wait for delayed treatment |
Primary outcome
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.
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.
10 secondary outcomes
Change in Intolerance to Uncertainty Inventory
Time frame: 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.
Change in Cognitive Avoidance Questionnaire
Time frame: 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.
Change in Geriatric Anxiety Inventory
Time frame: 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.
Change in Insomnia Severity Index
Time frame: 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.
Change in Mini-Mental State Examination, telephone version
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Derived from this study: PubMed 34022795Landreville 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-help guided by a lay provider and Waiting list where participants wait for delayed treatment in people with Generalized Anxiety Disorder, run by Laval University at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Penn State Worry Questionnaire (time frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03768544, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.