Anxiety DisordersPhase 1/2NCT01693874
Mindfulness-based Stress Reduction and Cognitive Function in Stress and Aging
A Phase 1/2 study testing MBSR in people with Anxiety Disorders and Depression, run by Washington University School of Medicine at 2 sites in United States.
Trial summary
The investigators are developing and then testing whether Mindfulness-Based Stress Reduction, a group-based instruction for increasing mindfulness, reduces anxiety and depressive symptoms and improves cognitive functioning in older adults. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anxiety Disorders, Depression
- What is being tested?
- MBSR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2011to Jun 2014
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- aged 65+
- current depressive and/or anxiety symptoms
- current depressive and/or anxiety disorder
- able to participate in behavioral study
Who cannot join
- unable to participate in study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California San Diego
San Diego, California, 92122
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
The investigators are developing and then testing whether Mindfulness-Based Stress Reduction, a group-based instruction for increasing mindfulness, reduces anxiety and depressive symptoms and improves cognitive functioning in older adults.
- Conditions
- Anxiety Disorders, Depression
- Being tested
- MBSR, control (health education)
- Keywords
- anxiety, depression, cognition, MBSR, mindfulness, stress, elderly
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSRBehavioural
Mindfulness-Based Stress Reduction
control (health education)Behavioural
health education
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Stress Reduction | Experimental | All participants in this arm receive Mindfulness Based Stress Reduction (MBSR). Receives: Behavioral: MBSR |
| control | Active comparator | All participants in this arm receive an attention control Receives: Behavioral: control (health education) |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive functioning
neuropsychological battery examining memory, executive functioning, and attention
Measured: approximately 2 months of study intervention
Secondary outcomes (3)
mind-wandering
computerized task(s) of mind-wandering
Measured: 2 months of intervention
mindfulness
self-report plus ecological momentary assessment measurements of mindfulness (process variable).
Measured: 2 months of intervention
anxiety and depressive symptoms
scales of self-report anxiety and depressive symptoms from NIH PROMIS, and worry severity (Penn State Worry Questionnaire Abbreviated). also we will examine ecological momentary assessment measurements of anxiety and depressive symptoms.
Measured: 2 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startOct 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of California, San Diego
- Responsible party
- Principal investigator, Eric Lenze, Washington University School of Medicine
- Investigators
- Eric Lenze, MD, Principal investigator, Washington University School of MedicineJulie Wetherell, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693874
- Sponsor's protocol ID
- AT007064
- Status last verified
- Jul 2014
- First submitted
- 29 Mar 2012
- Last updated
- 23 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kornfield SL, Nicol GE, Lenze EJ, Yingling M, Loebach Wetherell J. Mindfulness-Based Stress Reduction in Older Individuals: Who Benefits the Most? Adv Mind Body Med. 2022 Winter;36(1):4-12.
PubMed 35476747Haddad R, Lenze EJ, Nicol G, Miller JP, Yingling M, Wetherell JL. Does patient expectancy account for the cognitive and clinical benefits of mindfulness training in older adults? Int J Geriatr Psychiatry. 2020 Jun;35(6):626-632. doi: 10.1002/gps.5279. Epub 2020 Mar 20.
PubMed 32017250Wetherell JL, Hershey T, Hickman S, Tate SR, Dixon D, Bower ES, Lenze EJ. Mindfulness-Based Stress Reduction for Older Adults With Stress Disorders and Neurocognitive Difficulties: A Randomized Controlled Trial. J Clin Psychiatry. 2017 Jul;78(7):e734-e743. doi: 10.4088/JCP.16m10947.
PubMed 28686822
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Stress Reduction and Cognitive Function in Stress and Aging
- ClinicalTrials.gov ID
- NCT01693874
- Acronym / sponsor ID
- AT007064
- Conditions
- Anxiety Disorders, Depression
- Keywords
- anxiety, depression, cognition, MBSR, mindfulness, stress, elderly
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of California, San Diego
- Study start
- Oct 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Sep 2012 (estimated)
- 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 investigators are developing and then testing whether Mindfulness-Based Stress Reduction, a group-based instruction for increasing mindfulness, reduces anxiety and depressive symptoms and improves cognitive functioning in older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Stress Reduction | Experimental | Behavioral: MBSRAll participants in this arm receive Mindfulness Based Stress Reduction (MBSR). |
| control | Active comparator | Behavioral: control (health education)All participants in this arm receive an attention control |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- aged 65+
- current depressive and/or anxiety symptoms
- current depressive and/or anxiety disorder
- able to participate in behavioral study
Key exclusion criteria (1 listed)
- unable to participate in study
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 |
|---|---|---|
| MBSRMindfulness-Based Stress Reduction | Behavioural | Mindfulness Based Stress Reduction |
| control (health education)health education | Behavioural | control |
Primary outcome
cognitive functioning
Time frame: approximately 2 months of study intervention
neuropsychological battery examining memory, executive functioning, and attention
3 secondary outcomes
mind-wandering
Time frame: 2 months of intervention
mindfulness
Time frame: 2 months of intervention
anxiety and depressive symptoms
Time frame: 2 months of intervention
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 23 Jul 2014.
- Derived from this study: PubMed 35476747Kornfield SL, Nicol GE, Lenze EJ, Yingling M, Loebach Wetherell J. Mindfulness-Based Stress Reduction in Older Individuals: Who Benefits the Most? Adv Mind Body Med. 2022 Winter;36(1):4-12.
- Derived from this study: PubMed 32017250Haddad R, Lenze EJ, Nicol G, Miller JP, Yingling M, Wetherell JL. Does patient expectancy account for the cognitive and clinical benefits of mindfulness training in older adults? Int J Geriatr Psychiatry. 2020 Jun;35(6):626-632. doi: 10.1002/gps.5279. Epub 2020 Mar 20.
- Derived from this study: PubMed 28686822Wetherell JL, Hershey T, Hickman S, Tate SR, Dixon D, Bower ES, Lenze EJ. Mindfulness-Based Stress Reduction for Older Adults With Stress Disorders and Neurocognitive Difficulties: A Randomized Controlled Trial. J Clin Psychiatry. 2017 Jul;78(7):e734-e743. doi: 10.4088/JCP.16m10947.
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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.
Eric Lenze, MD principal investigator
Washington University School of Medicine
Julie Wetherell, PhD principal investigator
University of California, San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MBSR in people with Anxiety Disorders and Depression, run by Washington University School of Medicine at 2 sites 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 4 inclusion and 1 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 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
cognitive functioning (time frame: approximately 2 months of study intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01693874, which also lists 3 linked publications.
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 23 Jul 2014.