AgingNCT03839329
Group Acceptance and Commitment Training (ACT) With Healthy Older Adults
A study testing Acceptance and Commitment Training in people with Aging and Quality of Life, run by Anne Roche, MA at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Quality of Life
- What is being tested?
- Acceptance and Commitment Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2019to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 99 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- healthy, community-dwelling older adult (age 65-99)
Who cannot join
- significant primary psychiatric disease
- medications that have the potential to affect cognitive functioning
- neurological events
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Aging, Quality of Life
- Being tested
- Acceptance and Commitment Training
- Keywords
- Older Adult, Psychological Well-being, Acceptance and Commitment Therapy, Brief interventions, Psychological flexibility
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TrainingBehavioural
Also called Acceptance and Commitment Therapy, ACT
Acceptance and Commitment Therapy is an acceptance- and mindfulness-based psychotherapy that aims to foster psychological flexibility.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Acceptance and Commitment Training |
| Assessment-Only Condition | No intervention | The Assessment-only condition will not receive any intervention and will only complete assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: baseline, 1-month, 3-month, and 6-month post-intervention follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start17 Apr 2019
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anne Roche, MA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anne Roche, MA, University of Iowa
- Investigators
- Anne I Roche, MA, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839329
- Sponsor's protocol ID
- 201902715
- Status last verified
- Nov 2020
- First submitted
- 8 Feb 2019
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Well-being in ACTion: Examining the Impact of Acceptance and Commitment Training in Community-Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT03839329
- Acronym / sponsor ID
- 201902715
- Conditions
- Aging, Quality of Life
- Keywords
- Older Adult, Psychological Well-being, Acceptance and Commitment Therapy, Brief interventions, Psychological flexibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Anne Roche, MAUniversity, hospital or other
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ACT Group Condition | Experimental | Behavioral: Acceptance and Commitment TrainingThe ACT group condition will receive two 90-minute group Acceptance and Commitment Training (ACT) workshops (scheduled approximately one week apart) and will complete assessments. |
| Assessment-Only Condition | No intervention | –The Assessment-only condition will not receive any intervention and will only complete assessments. |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- healthy, community-dwelling older adult (age 65-99)
Key exclusion criteria (3 listed)
- significant primary psychiatric disease
- medications that have the potential to affect cognitive functioning
- neurological events
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TrainingAlso: Acceptance and Commitment Therapy, ACTAcceptance and Commitment Therapy is an acceptance- and mindfulness-based psychotherapy that aims to foster psychological flexibility. | Behavioural | ACT Group Condition |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne I Roche, MA principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Training in people with Aging and Quality of Life, run by Anne Roche, MA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.