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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03839329
Other study ID # 201902715
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 17, 2019
Est. completion date September 1, 2020

Study information

Verified date November 2020
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date September 1, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Acceptance and Commitment Training
Acceptance and Commitment Therapy is an acceptance- and mindfulness-based psychotherapy that aims to foster psychological flexibility.

Locations

Country Name City State
United States University of Iowa Iowa City Iowa

Sponsors (1)

Lead Sponsor Collaborator
Anne Roche, MA

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Differences in change over time between conditions on The Comprehensive Assessment of Acceptance and Commitment Therapy processes (CompACT) 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 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 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
Secondary Differences in change over time between conditions on the Ryff's Scales of Psychological Well-Being 14-item Purpose in Life Scale 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
Secondary Differences in change over time between conditions on the Ryff's Scales of Psychological Well-Being 14-item Personal Growth Scale 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
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