<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03768544</url>
  </required_header>
  <id_info>
    <org_study_id>SIRUL 118715</org_study_id>
    <nct_id>NCT03768544</nct_id>
  </id_info>
  <brief_title>Self-help Guided by Lay Providers for Anxiety in Older Adults</brief_title>
  <official_title>Generalized Anxiety Disorder in Older Adults : Efficacy of a Self-help Treatment Guided by Trained Lay Providers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CIUSSS du Centre-Sud-de-l'Île-Montréal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Integrated University Health and Social Services Center of the Capitale-Nationale</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Laval University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Few older adults receive treatment for Generalized Anxiety Disorder (GAD) despite a high&#xD;
      prevalence in this population and significant associated health care costs. Although older&#xD;
      adults generally prefer psychotherapy to medication for help with anxiety, face-to-face&#xD;
      psychotherapy is difficult to access for many of them. Psychological guided self-help (GSH),&#xD;
      which patients use by themselves at home under the supervision of a licensed mental health&#xD;
      provider (e.g., psychologist), has been shown to be effective. However, the capacity of our&#xD;
      health care system to respond adequately to the mental health needs of seniors has been&#xD;
      questioned and cost-effective solutions are required. Because the therapist's role in GSH is&#xD;
      limited to supporting the patient, it is conceivable that this role could be assumed by&#xD;
      trained and supervised lay providers (LP) instead of licensed providers. If this approach is&#xD;
      effective, it could help provide many older adults with much needed mental health treatment&#xD;
      at a lower cost. The main objective of this project is to evaluate the effectiveness of GSH&#xD;
      guided by LP for GAD in older adults. Participants will be assigned randomly to an&#xD;
      experimental group, which will receive treatment immediately, or to a control group whose&#xD;
      treatment will be delayed. Data will be obtained through clinician evaluations and&#xD;
      self-assessment questionnaires. They will include socio-demographic characteristics, symptoms&#xD;
      of GAD, variables related to anxiety, such as depression and sleep difficulties, and&#xD;
      participants' perception of treatment. For the experimental group, data collection will take&#xD;
      place at four different times: before treatment begins, after treatment ends, and at 6 and 12&#xD;
      months after the end of treatment. Control group participants will be assessed on three&#xD;
      occasions: before and after the waiting period and after receiving treatment. The efficacy of&#xD;
      GSH will be established by comparing the change in the two groups on the main variables. We&#xD;
      will also identify the characteristics of patients associated with improvement during&#xD;
      treatment and document their perception of treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Few older adults with Generalized Anxiety Disorder (GAD) receive treatment although it is one&#xD;
      of the most prevalent anxiety disorders in this population and involves significant health&#xD;
      care costs. Studies show that older adults generally prefer psychotherapy and find it more&#xD;
      acceptable than medication for help with anxiety. Unfortunately, face-to-face psychotherapy&#xD;
      is difficult to access for many of them. Guided self-help (GSH) is an alternative to&#xD;
      psychotherapy which requires that the patient take home a standardized psychological&#xD;
      treatment and work through it more or less independently. The role of the therapist is&#xD;
      primarily of supportive nature and the amount of contact between the patient and therapist is&#xD;
      minimized. There is evidence that GSH based on the principles of cognitive-behavioral therapy&#xD;
      (GSH-CBT) and guided by a licensed mental health provider is effective for treating GAD in&#xD;
      older adults. However, the capacity of our health care system to respond adequately to the&#xD;
      mental health needs of older adults has been questioned and cost-effective solutions are&#xD;
      required to meet the needs of a rapidly aging population. Because the therapist's role in&#xD;
      GSH-CBT is limited to supporting the patient, it is conceivable that this role could be&#xD;
      assumed by trained and supervised lay providers (LP) instead of licensed providers. LP are&#xD;
      generally providers with no post-graduate training in a specialized mental health program.&#xD;
      The main goal of the study is to evaluate the efficacy of GSH-CBT guided by LP for GAD in&#xD;
      older adults. Secondary goals are to identify the characteristics of patients associated with&#xD;
      improvement during treatment and to document perception of treatment by patients and LP. We&#xD;
      will conduct a multisite randomized controlled trial comparing an experimental group&#xD;
      receiving GSH-CBT guided by LP to a wait-list control group. LP training will include&#xD;
      readings, didactic training, and role plays. LP will be supervised throughout the project by&#xD;
      licensed psychologists. Treatment will last 15 weeks and be based on a participant's manual.&#xD;
      Weekly telephone sessions with LP (30 minutes maximum) will be limited to providing support.&#xD;
      Data will be obtained through clinician evaluations and self-assessment questionnaires. They&#xD;
      will include symptoms of GAD and variables related to anxiety, such as depression. For the&#xD;
      experimental group, measurements will take place at pre- and post-treatment and at 6 and 12&#xD;
      months post-treatment. For the control group, three evaluations are planned: two&#xD;
      pre-treatment evaluations (before and after the waiting period) and after receiving treatment&#xD;
      (post-treatment). The efficacy of GSH-CBT will be established by comparing the change in the&#xD;
      two groups on the main variables. This project will provide evidence on the effectiveness of&#xD;
      a novel approach to treat GAD in older adults. If effective, it may be implemented on a&#xD;
      larger scale and provide many older adults with much needed mental health treatment through&#xD;
      an expanded workforce.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 11, 2019</start_date>
  <completion_date type="Anticipated">March 2023</completion_date>
  <primary_completion_date type="Anticipated">March 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Penn State Worry Questionnaire</measure>
    <time_frame>Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.</time_frame>
    <description>16 items rated on a scale ranging from 1 to 5. A higher total score indicates a greater tendency to worry.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in GAD-7</measure>
    <time_frame>Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.</time_frame>
    <description>7 items answered on a scale ranging from 0 to 3. A higher total score suggests greater severity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Intolerance to Uncertainty Inventory</measure>
    <time_frame>Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.</time_frame>
    <description>27 items rated on a scale ranging from 1 to 5. A higher total score suggests higher intolerance to uncertainty.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Negative Problem Orientation Questionnaire</measure>
    <time_frame>Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.</time_frame>
    <description>12 items rated on a scale ranging from 1 to 5. A higher total score suggests more negative attitudes toward problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cognitive Avoidance Questionnaire</measure>
    <time_frame>Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.</time_frame>
    <description>25 items rated on a scale ranging from 1 to 5. A higher total score suggests more likely use of cognitive avoidance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Why Worry Questionnaire</measure>
    <time_frame>Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.</time_frame>
    <description>25 items rated on a scale ranging from 1 to 5. A higher total score suggests a greater belief that worrying is useful.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Geriatric Anxiety Inventory</measure>
    <time_frame>Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.</time_frame>
    <description>20 items rated as &quot;agree&quot; or &quot;disagree&quot;. Minimum score = 0; Maximum score = 20. A higher total score is indicative of greater severity of symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Geriatric Depression Scale</measure>
    <time_frame>Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.</time_frame>
    <description>30 items rated as &quot;yes&quot; or &quot;no&quot;. Minimum score = 0; Maximum score = 30.A higher total score is indicative of greater severity of symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Insomnia Severity Index</measure>
    <time_frame>Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.</time_frame>
    <description>7 items rated on a scale ranging from 1 to 4. A higher total score suggests more severe insomnia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sheehan Disability Scale</measure>
    <time_frame>Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.</time_frame>
    <description>Three self-rated items of family, work, and social impairment rated on a scale ranging from 0 to 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mini-Mental State Examination, telephone version</measure>
    <time_frame>Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in GAD diagnosis</measure>
    <time_frame>Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Evaluation of treatment by participants</measure>
    <time_frame>Post treatment (15 weeks)</time_frame>
    <description>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 &quot;strongly agree&quot; to &quot;absolutely disagree&quot;. A fifth possible answer, 'does not apply', is also provided.</description>
  </other_outcome>
  <other_outcome>
    <measure>Questionnaire of behavioral manifestations linked to anxiety</measure>
    <time_frame>Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Nine items relating to COVID-19</measure>
    <time_frame>Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.</time_frame>
    <description>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 &quot;yes or no&quot; with an open-ended description of their answer choice whereas four items are rated on a five-point Likert scale.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Generalized Anxiety Disorder</condition>
  <arm_group>
    <arm_group_label>Self-help guided by a lay provider</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting list where participants wait for delayed treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-help guided by a lay provider</intervention_name>
    <description>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.</description>
    <arm_group_label>Self-help guided by a lay provider</arm_group_label>
    <arm_group_label>Waiting list where participants wait for delayed treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Waiting list where participants wait for delayed treatment</intervention_name>
    <description>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.</description>
    <arm_group_label>Waiting list where participants wait for delayed treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  60 years of age or older&#xD;
&#xD;
          -  meet at least criteria for subthreshold GAD at screening based on items of the Worry&#xD;
             and Anxiety Questionnaire&#xD;
&#xD;
          -  meet DSM-5 criteria for primary threshold or subthreshold GAD&#xD;
&#xD;
          -  be able to read and speak French and to use the telephone without difficulty&#xD;
&#xD;
          -  if an anxiety medication is used, commit to maintaining the type of medication or dose&#xD;
             during eight weeks prior to treatment and during the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a disabling physical disorder that is not adequately controlled (e.g., acute heart&#xD;
             disease, recent stroke)&#xD;
&#xD;
          -  the presence of a substance use disorder&#xD;
&#xD;
          -  presenting a bipolar disorder or symptoms of a psychotic disorder&#xD;
&#xD;
          -  having significant cognitive impairment (score of less than 22 on the Telephone&#xD;
             version of the Mini-Mental State Examination)&#xD;
&#xD;
          -  currently receiving or having received psychotherapy for anxiety over the last six&#xD;
             months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre de recherche de l'Institut universitaire de gériatrie de Montréal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3W 1W4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>École de psychologie, Université Laval</name>
      <address>
        <city>Québec</city>
        <state>Quebec</state>
        <zip>G1V 0A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Département de psychologie, Université de Sherbrooke</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1K 2R1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>January 3, 2022</last_update_submitted>
  <last_update_submitted_qc>January 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Laval University</investigator_affiliation>
    <investigator_full_name>Philippe Landreville</investigator_full_name>
    <investigator_title>Full professor</investigator_title>
  </responsible_party>
  <keyword>generalized anxiety disorder</keyword>
  <keyword>older adult</keyword>
  <keyword>psychological treatment</keyword>
  <keyword>randomized controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03768544
org study id: SIRUL 118715
nct id: NCT03768544
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Penn State Worry Questionnaire
time frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
description: 16 items rated on a scale ranging from 1 to 5. A higher total score indicates a greater tendency to worry.
measure: Change in GAD-7
time frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
description: 7 items answered on a scale ranging from 0 to 3. A higher total score suggests greater severity.
measure: Change in Intolerance to Uncertainty Inventory
time frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
description: 27 items rated on a scale ranging from 1 to 5. A higher total score suggests higher intolerance to uncertainty.
measure: Change in Negative Problem Orientation Questionnaire
time frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
description: 12 items rated on a scale ranging from 1 to 5. A higher total score suggests more negative attitudes toward problems.
measure: Change in Cognitive Avoidance Questionnaire
time frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
description: 25 items rated on a scale ranging from 1 to 5. A higher total score suggests more likely use of cognitive avoidance.
measure: Change in Why Worry Questionnaire
time frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
description: 25 items rated on a scale ranging from 1 to 5. A higher total score suggests a greater belief that worrying is useful.
measure: Change in Geriatric Anxiety Inventory
time frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
description: 20 items rated as "agree" or "disagree". Minimum score = 0; Maximum score = 20. A higher total score is indicative of greater severity of symptoms.
measure: Change in Geriatric Depression Scale
time frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
description: 30 items rated as "yes" or "no". Minimum score = 0; Maximum score = 30.A higher total score is indicative of greater severity of symptoms.
measure: Change in Insomnia Severity Index
time frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
description: 7 items rated on a scale ranging from 1 to 4. A higher total score suggests more severe insomnia.
measure: Change in Sheehan Disability Scale
time frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
description: Three self-rated items of family, work, and social impairment rated on a scale ranging from 0 to 10.
measure: Change in Mini-Mental State Examination, telephone version
time frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
description: 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.
measure: Change in GAD diagnosis
time frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
description: 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.
measure: Evaluation of treatment by participants
time frame: Post treatment (15 weeks)
description: 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.
measure: Questionnaire of behavioral manifestations linked to anxiety
time frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
description: 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
measure: Nine items relating to COVID-19
time frame: Baseline, post treatment (15 weeks), 6 months and 12 months follow-up.
description: 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.
arm group label: Self-help guided by a lay provider
arm group type: Experimental
arm group label: Waiting list where participants wait for delayed treatment
arm group type: Other
intervention type: Behavioral
intervention name: Self-help guided by a lay provider
description: 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.
arm group label: Self-help guided by a lay provider
arm group label: Waiting list where participants wait for delayed treatment
intervention type: Behavioral
intervention name: Waiting list where participants wait for delayed treatment
description: 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.
arm group label: Waiting list where participants wait for delayed treatment
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Laval University
investigator full name: Philippe Landreville
investigator title: Full professor
mesh term: Anxiety Disorders
sharing ipd: No