- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03839329
Group Acceptance and Commitment Training (ACT) With Healthy Older Adults
Well-being in ACTion: Examining the Impact of Acceptance and Commitment Training in Community-Dwelling Older Adults
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.
- Examine the impact the intervention on targeted ACT processes over time
- Examine the impact of the intervention on aspects of eudaimonic well-being over time
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- University of Iowa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Acceptance and Commitment Therapy is an acceptance- and mindfulness-based psychotherapy that aims to foster psychological flexibility.
Other Names:
|
|
No Intervention: Assessment-Only Condition
The Assessment-only condition will not receive any intervention and will only complete assessments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline, 1-month, 3-month, and 6-month post-intervention follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline, 1-month, 3-month, and 6-month post-intervention follow-up
|
|
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.
|
baseline, 1-month, 3-month, and 6-month post-intervention follow-up
|
|
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.
|
baseline, 1-month, 3-month, and 6-month post-intervention follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne I Roche, MA, University of Iowa
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 201902715
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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