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Group Acceptance and Commitment Training (ACT) With Healthy Older Adults

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ClinicalTrials.gov Identifier: NCT03839329
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Anne Roche, MA, University of Iowa

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Aging Quality of Life Behavioral: Acceptance and Commitment Training Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Well-being in ACTion: Examining the Impact of Acceptance and Commitment Training in Community-Dwelling Older Adults
Estimated Study Start Date : April 15, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Experimental: ACT Group Condition
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.
Behavioral: Acceptance and Commitment Training
Acceptance and Commitment Therapy is an acceptance- and mindfulness-based psychotherapy that aims to foster psychological flexibility.
Other Names:
  • Acceptance and Commitment Therapy
  • ACT

No Intervention: Assessment-Only Condition
The Assessment-only condition will not receive any intervention and will only complete assessments.



Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. 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 ]
    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.



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Ages Eligible for Study:   65 Years to 99 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy, community-dwelling older adult (age 65-99)

Exclusion Criteria:

  • significant primary psychiatric disease
  • medications that have the potential to affect cognitive functioning
  • neurological events

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): NCT03839329


Contacts
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Contact: Anne I Roche, MA (1) 319-384-6050 anne-roche@uiowa.edu
Contact: Natalie Denburg, PhD (1) 319-356-4704 natalie-denburg@uiowa.edu

Locations
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United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Anne Roche, MA    319-384-6050    anne-roche@uiowa.edu   
Sponsors and Collaborators
Anne Roche, MA
Investigators
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Principal Investigator: Anne I Roche, MA University of Iowa

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Responsible Party: Anne Roche, MA, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT03839329     History of Changes
Other Study ID Numbers: 201902715
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 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 Anne Roche, MA, University of Iowa:
Older Adult
Psychological Well-being
Acceptance and Commitment Therapy
Brief interventions
Psychological flexibility