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

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ClinicalTrials.gov Identifier: NCT03768544
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : August 13, 2019
Sponsor:
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
Information provided by (Responsible Party):
Philippe Landreville, Laval University

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.

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Behavioral: Self-help guided by a lay provider Behavioral: Waiting list where participants wait for delayed treatment Not Applicable

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 (CBT-GSH) 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 CBT-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. 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 CBT-GSH 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 CBT-GSH guided by LP (n=45) to a wait-list control group (n=45). 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Generalized Anxiety Disorder in Older Adults : Efficacy of a Self-help Treatment Guided by Trained Lay Providers
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Other Outcome Measures:
  1. Change in Anxiety Literacy Questionnaire. [ Time Frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up. ]
    Measures knowledge about anxiety. 22 items answered with one of three options - true, false or don't know. Minimum score = 0; maximum score = 22. Higher scores indicate higher mental health literacy of anxiety.

  2. Change in Short version of Sarason's Social Support Questionnaire [ Time Frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up. ]
    Each of the 6 items describes a specific situation for which individuals providing support are listed and perceived support is rated on a 6-point likert scale from "very dissatisfied" to "very satisfied".

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768544


Contacts
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Contact: Mélanie Fournel, M.Sc. (514) 340-3540 ext 4788 melanie.fournel@criugm.qc.ca
Contact: Philippe Landreville, Ph.D. (418) 656-2131 ext 3024 philippe.landreville@psy.ulaval.ca

Locations
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Canada, Quebec
Centre de recherche de l'Institut universitaire de gériatrie de Montréal Recruiting
Montréal, Quebec, Canada, H3W 1W4
Contact: Mélanie Fournel, M.Sc.    (514) 340-3540 ext 4788    melanie.fournel@criugm.qc.ca   
Contact: Sébastien Grenier, Ph.D.    (514) 340-3540 ext 4782    sebastien.grenier@umontreal.ca   
École de psychologie, Université Laval Recruiting
Québec, Quebec, Canada, G1V 0A6
Contact: Catherine Filion, M.A.    418-656-2131 ext 408115    catherine.filion.3@ulaval.ca   
Contact: Philippe Landreville, Ph.D.    418-656-2131 ext 403024    philippe.landreville@psy.ulaval.ca   
Département de psychologie, Université de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1K 2R1
Contact: Patrick Gosselin, Ph.D.    (514) 340-3540 ext 4788    Patrick.Gosselin@USherbrooke.ca   
Sponsors and Collaborators
Laval University
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

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Responsible Party: Philippe Landreville, Full professor, Laval University
ClinicalTrials.gov Identifier: NCT03768544     History of Changes
Other Study ID Numbers: SIRUL 118715
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Philippe Landreville, Laval University:
generalized anxiety disorder
older adult
psychological treatment
randomized controlled trial

Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders