<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/NCT04458870</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-300005230</org_study_id>
    <nct_id>NCT04458870</nct_id>
  </id_info>
  <brief_title>Acceptance and Commitment Therapy for Family Caregivers of People With Dementia</brief_title>
  <official_title>Internet-based Acceptance and Commitment Therapy for Family Caregivers of People With Dementia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</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>
      The pilot project aims to investigate the feasibility and the preliminary efficacy of a&#xD;
      guided online acceptance and commitment therapy (ACT) intervention for distressed family&#xD;
      caregivers of people with dementia. A one-group pretest-posttest design (n=15) will be used&#xD;
      to investigate the potential effects of the 10 weekly online ACT intervention session on&#xD;
      caregivers' outcomes at posttest (10 weeks).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project will employ one-group pretest-posttest design to investigate the potential&#xD;
      impact of a guided online ACT intervention on improving quality of life and psychological&#xD;
      health in distressed family caregivers of people with dementia. After the baseline&#xD;
      evaluation, eligible caregivers will receive 10 weekly ACT sessions, individually delivered&#xD;
      by a licensed professional counselor online. Each session lasts for one hour. Primary outcome&#xD;
      measures will be psychological distress measured by the Depression, Anxiety and Stress Scale&#xD;
      (DASS)- 21 and care-related quality of life measured by the Care-related Quality of Life&#xD;
      instrument (CarerQol). A one-time interview at the completion of the 10 weekly sessions will&#xD;
      be conducted to explore caregivers' experiences in the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">November 9, 2020</completion_date>
  <primary_completion_date type="Actual">November 9, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depression, Anxiety and Stress Scale - 21</measure>
    <time_frame>Change from baseline to 10 weeks</time_frame>
    <description>The Depression, Anxiety and Stress Scale (DASS)- 21 is a 21-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and stress. Higher scores represent greater symptomatology.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Care-related Quality of Life instrument</measure>
    <time_frame>Change from baseline to 10 weeks</time_frame>
    <description>Care-related Quality of Life instrument (CarerQol) assesses the impact of providing informal care on caregivers and combines a 7-item subjective burden measure (CarerQol-7D) with well-being (CarerQol-VAS). Higher scores indicate higher levels of quality of life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Zarit Burden Interview</measure>
    <time_frame>Change from baseline to 10 weeks</time_frame>
    <description>The Zarit Burden Interview (ZBI) is a 12-item self-report questionnaire assessing caregiver. Higher scores indicate higher levels of burden.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Coping Orientation to Problems Experienced</measure>
    <time_frame>Change from baseline to 10 weeks</time_frame>
    <description>Brief COPE (Coping Orientation to Problems Experienced) is a 28-item self-report questionnaire measuring coping strategies in response to stressors. Three composite subscales include problem-focused, emotion-focused, and dysfunctional coping strategies. Higher scores on a subscale indicates more frequent use of the relevant coping strategies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Engagement in Meaningful Activities Survey</measure>
    <time_frame>Change from baseline to 10 weeks</time_frame>
    <description>The Engagement in Meaningful Activities Survey (EMAS) is a 12-item self-assessment instrument that measures a person's subjective experience of the meaningfulness of everyday activities. Higher scores indicate greater levels of engagement in meaningful activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Experiential Avoidance in Caregiving Questionnaire</measure>
    <time_frame>Change from baseline to 10 weeks</time_frame>
    <description>The Experiential Avoidance in Caregiving Questionnaire (EACQ) is a 15-item self-report questionnaire measuring experiential avoidance in caregivers. Higher scores indicate greater levels of experiential avoidance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptance and Action Questionnaire-II</measure>
    <time_frame>Change from baseline to 10 weeks</time_frame>
    <description>The Action and Acceptance Questionnaire (AAQ)-II is a 7-item self-report questionnaire measuring psychological flexibility. Higher scores indicate poor psychological flexibility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Fusion Questionnaire</measure>
    <time_frame>Change from baseline to 10 weeks</time_frame>
    <description>The Cognitive Fusion Questionnaire (CFQ)-7 is a 7-item self-report questionnaire measuring cognitive fusion. Higher scores indicate greater levels of cognitive fusion.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cortisol levels by collecting fingernails</measure>
    <time_frame>Change from baseline to 10 weeks</time_frame>
    <description>A biological measure of stress will be assessed through analysis of cortisol levels in caregivers' nail samples.</description>
  </other_outcome>
  <other_outcome>
    <measure>System Usability Scale</measure>
    <time_frame>at 10 weeks</time_frame>
    <description>The System Usability Scale (SUS) is a 10-item self-report questionnaire measuring usability of a program/intervention. Higher scores indicate greater levels of perceived usability of the intervention.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Psychological Distress</condition>
  <arm_group>
    <arm_group_label>Acceptance and Commitment Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Acceptance and Commitment Therapy</intervention_name>
    <description>Participants will receive 10 weekly individual acceptance and commitment therapy by a trained coach through zoom video-conferencing.</description>
    <arm_group_label>Acceptance and Commitment Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. community-dwelling adults (age 18 or over) who are currently taking primary&#xD;
             responsibility for the care of a relative with dementia living in the community&#xD;
&#xD;
          2. devoting at least 1 hour daily to the care of the relative with dementia&#xD;
&#xD;
          3. having cared for a relative with dementia for at least 3 months&#xD;
&#xD;
          4. suffering at least mild symptoms of psychological distress measured by the DASS-21&#xD;
             (scores ≥ 5 on Depression Subscale of DASS-21, scores ≥ 4 on Anxiety Subscale, or&#xD;
             scores ≥ 8 on Stress Subscale)&#xD;
&#xD;
          5. having a computer/smartphone with internet access capable of doing web browsing and&#xD;
             video-conferencing&#xD;
&#xD;
          6. being able to provide informed consent by understanding the nature of study&#xD;
             participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. having cognitive, physical, or sensory deficits, or language barriers (non-English&#xD;
             communicator) that impede study participation&#xD;
&#xD;
          2. receiving a psychological therapy currently&#xD;
&#xD;
          3. having psychiatric hospitalizations or diagnoses of mental illness in the previous 2&#xD;
             years&#xD;
&#xD;
          4. taking antipsychotic or anticonvulsant medication at the time of recruitment&#xD;
&#xD;
          5. considering or planning to place family members of dementia in a nursing home within 6&#xD;
             months&#xD;
&#xD;
          6. having the possibility of study dropouts due to other medical conditions of family&#xD;
             members with dementia (e.g., conditions that may impede study participation due to&#xD;
             frequent hospitalization or death).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Areum Han, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>December 8, 2020</last_update_submitted>
  <last_update_submitted_qc>December 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Areum Han</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Caregivers</keyword>
  <keyword>Dementia</keyword>
  <keyword>Alzheimer's Disease</keyword>
  <keyword>Burden</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Acceptance and Commitment Therapy</keyword>
  <keyword>Mindfulness</keyword>
  <keyword>Psychological health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</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/NCT04458870
org study id: IRB-300005230
nct id: NCT04458870
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The pilot project aims to investigate the feasibility and the preliminary efficacy of a
      guided online acceptance and commitment therapy (ACT) intervention for distressed family
      caregivers of people with dementia. A one-group pretest-posttest design (n=15) will be used
      to investigate the potential effects of the 10 weekly online ACT intervention session on
      caregivers' outcomes at posttest (10 weeks).
This project will employ one-group pretest-posttest design to investigate the potential
      impact of a guided online ACT intervention on improving quality of life and psychological
      health in distressed family caregivers of people with dementia. After the baseline
      evaluation, eligible caregivers will receive 10 weekly ACT sessions, individually delivered
      by a licensed professional counselor online. Each session lasts for one hour. Primary outcome
      measures will be psychological distress measured by the Depression, Anxiety and Stress Scale
      (DASS)- 21 and care-related quality of life measured by the Care-related Quality of Life
      instrument (CarerQol). A one-time interview at the completion of the 10 weekly sessions will
      be conducted to explore caregivers' experiences in the intervention.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Depression, Anxiety and Stress Scale - 21
time frame: Change from baseline to 10 weeks
description: The Depression, Anxiety and Stress Scale (DASS)- 21 is a 21-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and stress. Higher scores represent greater symptomatology.
measure: Care-related Quality of Life instrument
time frame: Change from baseline to 10 weeks
description: Care-related Quality of Life instrument (CarerQol) assesses the impact of providing informal care on caregivers and combines a 7-item subjective burden measure (CarerQol-7D) with well-being (CarerQol-VAS). Higher scores indicate higher levels of quality of life.
measure: Zarit Burden Interview
time frame: Change from baseline to 10 weeks
description: The Zarit Burden Interview (ZBI) is a 12-item self-report questionnaire assessing caregiver. Higher scores indicate higher levels of burden.
measure: Brief Coping Orientation to Problems Experienced
time frame: Change from baseline to 10 weeks
description: Brief COPE (Coping Orientation to Problems Experienced) is a 28-item self-report questionnaire measuring coping strategies in response to stressors. Three composite subscales include problem-focused, emotion-focused, and dysfunctional coping strategies. Higher scores on a subscale indicates more frequent use of the relevant coping strategies.
measure: Engagement in Meaningful Activities Survey
time frame: Change from baseline to 10 weeks
description: The Engagement in Meaningful Activities Survey (EMAS) is a 12-item self-assessment instrument that measures a person's subjective experience of the meaningfulness of everyday activities. Higher scores indicate greater levels of engagement in meaningful activities.
measure: Experiential Avoidance in Caregiving Questionnaire
time frame: Change from baseline to 10 weeks
description: The Experiential Avoidance in Caregiving Questionnaire (EACQ) is a 15-item self-report questionnaire measuring experiential avoidance in caregivers. Higher scores indicate greater levels of experiential avoidance.
measure: Acceptance and Action Questionnaire-II
time frame: Change from baseline to 10 weeks
description: The Action and Acceptance Questionnaire (AAQ)-II is a 7-item self-report questionnaire measuring psychological flexibility. Higher scores indicate poor psychological flexibility.
measure: Cognitive Fusion Questionnaire
time frame: Change from baseline to 10 weeks
description: The Cognitive Fusion Questionnaire (CFQ)-7 is a 7-item self-report questionnaire measuring cognitive fusion. Higher scores indicate greater levels of cognitive fusion.
measure: Cortisol levels by collecting fingernails
time frame: Change from baseline to 10 weeks
description: A biological measure of stress will be assessed through analysis of cortisol levels in caregivers' nail samples.
measure: System Usability Scale
time frame: at 10 weeks
description: The System Usability Scale (SUS) is a 10-item self-report questionnaire measuring usability of a program/intervention. Higher scores indicate greater levels of perceived usability of the intervention.
arm group label: Acceptance and Commitment Therapy
arm group type: Experimental
intervention type: Behavioral
intervention name: Acceptance and Commitment Therapy
description: Participants will receive 10 weekly individual acceptance and commitment therapy by a trained coach through zoom video-conferencing.
arm group label: Acceptance and Commitment Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Areum Han, PhD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Areum Han
investigator title: Assistant Professor
mesh term: Dementia
sharing ipd: No