NCT03839329

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. 1.Examine the impact the intervention on targeted ACT processes over time
  2. 2.Examine the impact of the intervention on aspects of eudaimonic well-being over time

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 17, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

1.4 years

First QC Date

February 8, 2019

Last Update Submit

November 11, 2020

Conditions

Keywords

Older AdultPsychological Well-beingAcceptance and Commitment TherapyBrief interventionsPsychological flexibility

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

    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

    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

    baseline, 1-month, 3-month, and 6-month post-intervention follow-up

Study Arms (2)

ACT Group Condition

EXPERIMENTAL

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

Assessment-Only Condition

NO INTERVENTION

The Assessment-only condition will not receive any intervention and will only complete assessments.

Interventions

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

Also known as: Acceptance and Commitment Therapy, ACT
ACT Group Condition

Eligibility Criteria

Age65 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Anne I Roche, MA

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 8, 2019

First Posted

February 15, 2019

Study Start

April 17, 2019

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations