<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/NCT03839329</url>
  </required_header>
  <id_info>
    <org_study_id>201902715</org_study_id>
    <nct_id>NCT03839329</nct_id>
  </id_info>
  <brief_title>Group Acceptance and Commitment Training (ACT) With Healthy Older Adults</brief_title>
  <official_title>Well-being in ACTion: Examining the Impact of Acceptance and Commitment Training in Community-Dwelling Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Anne Roche, MA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Iowa</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 current study aims to explore the impact of a two-session group Acceptance and Commitment&#xD;
      Therapy (ACT) intervention compared to an assessment-only control on psychological outcomes&#xD;
      in healthy older adults. The proposed study has two main objectives.&#xD;
&#xD;
        1. Examine the impact the intervention on targeted ACT processes over time&#xD;
&#xD;
        2. Examine the impact of the intervention on aspects of eudaimonic well-being over time&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Older adults are a growing segment of our population, and this period of life presents a&#xD;
      variety of physical, emotional, environmental, and cognitive changes, even for healthy&#xD;
      individuals. The current study aims to explore the impact of a two-session group Acceptance&#xD;
      and Commitment Therapy (ACT) intervention compared to an assessment-only control on&#xD;
      psychological outcomes in healthy, community-dwelling older adults.&#xD;
&#xD;
      Participants will be randomly assigned (stratified by sex) to the ACT group condition or to&#xD;
      an assessment-only control group. After randomization, those in the assessment-only control&#xD;
      group will be asked to complete four assessments via mail (baseline, one-month, three-month,&#xD;
      and six-month). The intervention group will participate in a brief group ACT intervention&#xD;
      occurring over two sessions (90 minutes each, approximately one week apart). Intervention&#xD;
      participants will also complete assessments at baseline and at one-month, three-months, and&#xD;
      six-months post-intervention.&#xD;
&#xD;
      The specific aims and hypotheses of the current study are:&#xD;
&#xD;
      Specific Aim #1: To examine longitudinal between-group differences in targeted ACT processes&#xD;
      including psychological flexibility (openness to experience, behavioral awareness, and valued&#xD;
      action) and satisfaction with social roles and activities from baseline to follow-up. We&#xD;
      hypothesize that there will be significant time by group interaction, such that psychological&#xD;
      flexibility and satisfaction with social roles and activities will increase significantly&#xD;
      more in the intervention group relative to the assessment-only control group.&#xD;
&#xD;
      Specific Aim #2: To examine longitudinal between-group differences in eudaimonic well-being&#xD;
      (purpose in life and personal growth) from baseline to follow-up. We hypothesize that there&#xD;
      will be significant time by group interactions, such that purpose in life and personal growth&#xD;
      will increase significantly more in the intervention group relative to the assessment-only&#xD;
      control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 17, 2019</start_date>
  <completion_date type="Actual">September 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2020</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>
    <intervention_model_description>Participants will be randomized (stratified by sex) to either the ACT workshop group or to the assessment-only control group. Participants in the ACT group will complete two 90-minute group workshops (scheduled approximately one week apart) and will complete a baseline, 1-month, 3-month, and 6-month follow-up assessment. Participants in the time-matched assessment only-group will complete assessments at baseline, 1-month, 3-month, and 6-month follow-up.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in change over time between conditions on The Comprehensive Assessment of Acceptance and Commitment Therapy processes (CompACT)</measure>
    <time_frame>baseline, 1-month, 3-month, and 6-month post-intervention follow-up</time_frame>
    <description>The CompACT is a self-report measure of psychological flexibility. Total scores on the measure range from 0-138 with higher scores indicative of greater psychological flexibility.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences in change over time between conditions on the Patient-Reported Outcomes Measurement Information System's (PROMIS) 8-item Satisfaction with Social Roles and Activities scale</measure>
    <time_frame>baseline, 1-month, 3-month, and 6-month post-intervention follow-up</time_frame>
    <description>The PROMIS 8-item Satisfaction with Social Roles and Activities scale is a self-report measure. Total scores on the measure are converted to T scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in change over time between conditions on the Ryff's Scales of Psychological Well-Being 14-item Purpose in Life Scale</measure>
    <time_frame>baseline, 1-month, 3-month, and 6-month post-intervention follow-up</time_frame>
    <description>Ryff's Scales of Psychological Well-Being 14-item Purpose in Life Scale is a self-report measure. Total scores range from 14-84, with higher scores indicative of greater purpose in life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in change over time between conditions on the Ryff's Scales of Psychological Well-Being 14-item Personal Growth Scale</measure>
    <time_frame>baseline, 1-month, 3-month, and 6-month post-intervention follow-up</time_frame>
    <description>Ryff's Scales of Psychological Well-Being 14-item Personal Growth Scale is a self-report measure. Total scores range from 14-84, with higher scores indicative of greater personal growth.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Aging</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>ACT Group Condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The ACT group condition will receive two 90-minute group Acceptance and Commitment Training (ACT) workshops (scheduled approximately one week apart) and will complete assessments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Assessment-Only Condition</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The Assessment-only condition will not receive any intervention and will only complete assessments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Acceptance and Commitment Training</intervention_name>
    <description>Acceptance and Commitment Therapy is an acceptance- and mindfulness-based psychotherapy that aims to foster psychological flexibility.</description>
    <arm_group_label>ACT Group Condition</arm_group_label>
    <other_name>Acceptance and Commitment Therapy</other_name>
    <other_name>ACT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy, community-dwelling older adult (age 65-99)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  significant primary psychiatric disease&#xD;
&#xD;
          -  medications that have the potential to affect cognitive functioning&#xD;
&#xD;
          -  neurological events&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne I Roche, MA</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>November 11, 2020</last_update_submitted>
  <last_update_submitted_qc>November 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Anne Roche, MA</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Older Adult</keyword>
  <keyword>Psychological Well-being</keyword>
  <keyword>Acceptance and Commitment Therapy</keyword>
  <keyword>Brief interventions</keyword>
  <keyword>Psychological flexibility</keyword>
  <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/NCT03839329
org study id: 201902715
nct id: NCT03839329
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current study aims to explore the impact of a two-session group Acceptance and Commitment
      Therapy (ACT) intervention compared to an assessment-only control on psychological outcomes
      in healthy older adults. The proposed study has two main objectives.

        1. Examine the impact the intervention on targeted ACT processes over time

        2. Examine the impact of the intervention on aspects of eudaimonic well-being over time
Older adults are a growing segment of our population, and this period of life presents a
      variety of physical, emotional, environmental, and cognitive changes, even for healthy
      individuals. The current study aims to explore the impact of a two-session group Acceptance
      and Commitment Therapy (ACT) intervention compared to an assessment-only control on
      psychological outcomes in healthy, community-dwelling older adults.

      Participants will be randomly assigned (stratified by sex) to the ACT group condition or to
      an assessment-only control group. After randomization, those in the assessment-only control
      group will be asked to complete four assessments via mail (baseline, one-month, three-month,
      and six-month). The intervention group will participate in a brief group ACT intervention
      occurring over two sessions (90 minutes each, approximately one week apart). Intervention
      participants will also complete assessments at baseline and at one-month, three-months, and
      six-months post-intervention.

      The specific aims and hypotheses of the current study are:

      Specific Aim #1: To examine longitudinal between-group differences in targeted ACT processes
      including psychological flexibility (openness to experience, behavioral awareness, and valued
      action) and satisfaction with social roles and activities from baseline to follow-up. We
      hypothesize that there will be significant time by group interaction, such that psychological
      flexibility and satisfaction with social roles and activities will increase significantly
      more in the intervention group relative to the assessment-only control group.

      Specific Aim #2: To examine longitudinal between-group differences in eudaimonic well-being
      (purpose in life and personal growth) from baseline to follow-up. We hypothesize that there
      will be significant time by group interactions, such that purpose in life and personal growth
      will increase significantly more in the intervention group relative to the assessment-only
      control group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomized (stratified by sex) to either the ACT workshop group or to the assessment-only control group. Participants in the ACT group will complete two 90-minute group workshops (scheduled approximately one week apart) and will complete a baseline, 1-month, 3-month, and 6-month follow-up assessment. Participants in the time-matched assessment only-group will complete assessments at baseline, 1-month, 3-month, and 6-month follow-up.
primary purpose: Treatment
masking: None (Open Label)
measure: Differences in change over time between conditions on The Comprehensive Assessment of Acceptance and Commitment Therapy processes (CompACT)
time frame: baseline, 1-month, 3-month, and 6-month post-intervention follow-up
description: The CompACT is a self-report measure of psychological flexibility. Total scores on the measure range from 0-138 with higher scores indicative of greater psychological flexibility.
measure: Differences in change over time between conditions on the Patient-Reported Outcomes Measurement Information System's (PROMIS) 8-item Satisfaction with Social Roles and Activities scale
time frame: baseline, 1-month, 3-month, and 6-month post-intervention follow-up
description: The PROMIS 8-item Satisfaction with Social Roles and Activities scale is a self-report measure. Total scores on the measure are converted to T scores.
measure: Differences in change over time between conditions on the Ryff's Scales of Psychological Well-Being 14-item Purpose in Life Scale
time frame: baseline, 1-month, 3-month, and 6-month post-intervention follow-up
description: Ryff's Scales of Psychological Well-Being 14-item Purpose in Life Scale is a self-report measure. Total scores range from 14-84, with higher scores indicative of greater purpose in life.
measure: Differences in change over time between conditions on the Ryff's Scales of Psychological Well-Being 14-item Personal Growth Scale
time frame: baseline, 1-month, 3-month, and 6-month post-intervention follow-up
description: Ryff's Scales of Psychological Well-Being 14-item Personal Growth Scale is a self-report measure. Total scores range from 14-84, with higher scores indicative of greater personal growth.
arm group label: ACT Group Condition
arm group type: Experimental
description: The ACT group condition will receive two 90-minute group Acceptance and Commitment Training (ACT) workshops (scheduled approximately one week apart) and will complete assessments.
arm group label: Assessment-Only Condition
arm group type: No Intervention
description: The Assessment-only condition will not receive any intervention and will only complete assessments.
intervention type: Behavioral
intervention name: Acceptance and Commitment Training
description: Acceptance and Commitment Therapy is an acceptance- and mindfulness-based psychotherapy that aims to foster psychological flexibility.
arm group label: ACT Group Condition
other name: Acceptance and Commitment Therapy
other name: ACT
criteria: 
gender: All
minimum age: 65 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anne I Roche, MA
role: Principal Investigator
affiliation: University of Iowa
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Iowa
investigator full name: Anne Roche, MA
investigator title: Principal Investigator
sharing ipd: No