Clinical trial NCT03768544: Self-help Guided by Lay Providers for Anxiety in Older Adults
Official title: Generalized Anxiety Disorder in Older Adults : Efficacy of a Self-help Treatment Guided by Trained Lay Providers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: generalized anxiety disorder
older adult
psychological treatment
randomized controlled trial
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: CIUSSS du Centre-Sud-de-l'Île-Montréal
name: Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
name: Integrated University Health and Social Services Center of the Capitale-Nationale
First posted: 2018-12-07
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Penn State Worry Questionnaire
timeFrame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
measure: Change in GAD-7
timeFrame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Secondary outcomes:
measure: Change in Intolerance to Uncertainty Inventory
timeFrame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
measure: Change in Negative Problem Orientation Questionnaire
timeFrame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
measure: Change in Cognitive Avoidance Questionnaire
timeFrame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
measure: Change in Why Worry Questionnaire
timeFrame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
measure: Change in Geriatric Anxiety Inventory
timeFrame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
measure: Change in Geriatric Depression Scale
timeFrame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
measure: Change in Insomnia Severity Index
timeFrame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
measure: Change in Sheehan Disability Scale
timeFrame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
measure: Change in Mini-Mental State Examination, telephone version
timeFrame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
measure: Change in GAD diagnosis
timeFrame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Other outcomes:
measure: Evaluation of treatment by participants
timeFrame: Post treatment (15 weeks)
measure: Questionnaire of behavioral manifestations linked to anxiety
timeFrame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
measure: Nine items relating to COVID-19
timeFrame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
Locations:
city: Montréal
country: Canada
facility: Centre de recherche de l'Institut universitaire de gériatrie de Montréal
state: Quebec
city: Québec
country: Canada
facility: École de psychologie, Université Laval
state: Quebec
city: Sherbrooke
country: Canada
facility: Département de psychologie, Université de Sherbrooke
state: Quebec
Study officials:
References:
citation: 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.