Old Age; DebilityNCT04165005
Mindfulness-based Short Intervention for Seniors - Decentering Effects on Cognitive Functions and Psychological Distress
A study testing decentering and guided imagery in people with Old Age; Debility and Psychological Distress, run by Ben-Gurion University of the Negev at 1 site in Israel.
Trial summary
The present study examined the effect of a short Mindfulness-based intervention emphasizing a 'decentering' component on elderly seniors. Methods: 30 community seniors (Mage= 74.7) performed either 'decentering' intervention, guided imagery intervention, or control care as usual. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Old Age; Debility, Psychological Distress, Cognitive Change
- What is being tested?
- decentering and guided imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2017to 1 Aug 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age 65 and above
- membership in the study's specific enrollment community centers
- scoring 24 and above in the Mini-Mental State Examination (MMSE).
Who cannot join
- age under 65
- not being a member in the study's specific enrollment community centers
- scoring under 24 in the Mini-Mental State Examination (MMSE).
Trial locations and contacts
1 site in 1 country.
About this study
The present study examined the effect of a short Mindfulness-based intervention emphasizing a 'decentering' component on elderly seniors. Methods: 30 community seniors (Mage= 74.7) performed either 'decentering' intervention, guided imagery intervention, or control care as usual. The 8-week interventions included weekly 20-minute sessions and daily 10-minute home practice. Participants underwent a cognitive and emotional assessment before and after the interventions, which included filling out questionnaires and performing the Simon task. Trial registration: The study follows the principles of the Declaration of Helsinki, approved by the committee in Beer-Yaacov Hospital, Israel (number 579) on 24 Oct. 2017.
- Conditions
- Old Age; Debility, Psychological Distress, Cognitive Change
- Being tested
- decentering, guided imagery
- Keywords
- elderly, MBSR, cognitive functions, psychological status
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decenteringBehavioural
examined a mindfulness-based intervention focused on a decentering component, that is suitable for elders, aimed to influence on cognitive measures and psychological distress.
guided imageryBehavioural
relaxing guided imagery including breathing exercises.
| Study group | Role | What they receive |
|---|---|---|
| decentering group | Experimental | MBSR focused on a "decentering" component (i.e. individuals observe their feelings and thoughts as ephemeral events, with no reactivity, alongside with acceptance). Receives: Behavioral: decentering |
| guided imagery group | Experimental | a group practicing in guided imagery sessions. Receives: Behavioral: guided imagery |
| control group | No intervention | usual care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simon task- change from baseline to after intervention
a cognitive task, assessing control processes under speeded conditions, measured by response time and accuracy rate. shorter response time and higher accuracy rate indicate better performance.
Measured: at baseline and through intervention's completion, 10 weeks.
Secondary outcomes (5)
FFMQ- change from baseline to after intervention
The Five-Fact Mindfulness Questionnaire, a manipulation check of mindfulness, ranging from 1 to 5, with higher score indicating higher mindfulness level
Measured: at baseline and through intervention's completion, 10 weeks.
PWB questionnaire- change from baseline to after intervention
The Psychological Well-Being Questionnaire, ranging from 1 to 6, with higher score indicating higher well-being level
Measured: at baseline and through intervention's completion, 10 weeks.
MMSE- change from baseline to after intervention
the Mini-Mental State examination: a cognitive function measure for elders, used to determine participation eligibility. the animation score ranges between 0 to 30, with higher score indicating better cognitive functioning
Measured: at baseline and through intervention's completion, 10 weeks.
PHQ-9- change from baseline to after intervention
The Patient Health Questionnaire - a depression levels measure, ranging from 0 to 3, with higher score indicating higher depression level
Measured: at baseline and through intervention's completion, 10 weeks.
BDI-II- change from baseline to after intervention
The Beck Depression Inventory-II- a depression levels measure, ranging from 1 to 4, with higher score indicating higher depression level
Measured: at baseline and through intervention's completion, 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start1 Nov 2017
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Old Age; DebilityStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ben-Gurion University of the Negev
- Sponsor type
- University, hospital or other
- Collaborators
- Ruppin Acdemic Center
- Responsible party
- Principal investigator, Ophir Leshets, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165005
- Sponsor's protocol ID
- 597
- Status last verified
- Nov 2019
- First submitted
- 1 Nov 2019
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aisenberg-Shafran D, Shturm L. The effects of mindfulness meditation versus CBT for anxiety on emotional distress and attitudes toward seeking mental health treatment: a semi-randomized trial. Sci Rep. 2022 Nov 16;12(1):19711. doi: 10.1038/s41598-022-24256-9.
PubMed 36385638
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Short Intervention for Seniors - Decentering Effects on Cognitive Functions and Psychological Distress
- ClinicalTrials.gov ID
- NCT04165005
- Acronym / sponsor ID
- 597
- Conditions
- Old Age; Debility, Psychological Distress, Cognitive Change
- Keywords
- elderly, MBSR, cognitive functions, psychological status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ben-Gurion University of the NegevUniversity, hospital or other
- Collaborators
- Ruppin Acdemic Center
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 15 Nov 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 present study examined the effect of a short Mindfulness-based intervention emphasizing a 'decentering' component on elderly seniors. Methods: 30 community seniors (Mage= 74.7) performed either 'decentering' intervention, guided imagery intervention, or control care as usual. The 8-week interventions included weekly 20-minute sessions and daily 10-minute home practice. Participants underwent a cognitive and emotional assessment before and after the interventions, which included filling out questionnaires and performing the Simon task. Trial registration: The study follows the principles of the Declaration of Helsinki, approved by the committee in Beer-Yaacov Hospital, Israel (number 579) on 24 Oct. 2017.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| decentering group | Experimental | Behavioral: decenteringMBSR focused on a "decentering" component (i.e. individuals observe their feelings and thoughts as ephemeral events, with no reactivity, alongside with acceptance). |
| guided imagery group | Experimental | Behavioral: guided imagerya group practicing in guided imagery sessions. |
| control group | No intervention | –usual care group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- age 65 and above
- membership in the study's specific enrollment community centers
- scoring 24 and above in the Mini-Mental State Examination (MMSE).
Key exclusion criteria (3 listed)
- age under 65
- not being a member in the study's specific enrollment community centers
- scoring under 24 in the Mini-Mental State Examination (MMSE).
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 |
|---|---|---|
| decenteringexamined a mindfulness-based intervention focused on a decentering component, that is suitable for elders, aimed to influence on cognitive measures and psychological distress. | Behavioural | decentering group |
| guided imageryrelaxing guided imagery including breathing exercises. | Behavioural | guided imagery group |
Primary outcome
Simon task- change from baseline to after intervention
Time frame: at baseline and through intervention's completion, 10 weeks.
a cognitive task, assessing control processes under speeded conditions, measured by response time and accuracy rate. shorter response time and higher accuracy rate indicate better performance.
5 secondary outcomes
FFMQ- change from baseline to after intervention
Time frame: at baseline and through intervention's completion, 10 weeks.
PWB questionnaire- change from baseline to after intervention
Time frame: at baseline and through intervention's completion, 10 weeks.
MMSE- change from baseline to after intervention
Time frame: at baseline and through intervention's completion, 10 weeks.
PHQ-9- change from baseline to after intervention
Time frame: at baseline and through intervention's completion, 10 weeks.
BDI-II- change from baseline to after intervention
Time frame: at baseline and through intervention's completion, 10 weeks.
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 15 Nov 2019.
- Derived from this study: PubMed 36385638Aisenberg-Shafran D, Shturm L. The effects of mindfulness meditation versus CBT for anxiety on emotional distress and attitudes toward seeking mental health treatment: a semi-randomized trial. Sci Rep. 2022 Nov 16;12(1):19711. doi: 10.1038/s41598-022-24256-9.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing decentering and guided imagery in people with Old Age; Debility and Psychological Distress, run by Ben-Gurion University of the Negev at 1 site in Israel.
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 3 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 15 Nov 2019. 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 Israel. 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?
Simon task- change from baseline to after intervention (time frame: at baseline and through intervention's completion, 10 weeks.). 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 NCT04165005, which also lists 1 linked publication.
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 15 Nov 2019.