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CompletedNCT04165005Updated Nov 15, 2019

Mindfulness-based Short Intervention for Seniors - Decentering Effects on Cognitive Functions and Psychological Distress

An interventional study of decentering and guided imagery in Old Age; Debility, Psychological Distress and Cognitive Change, sponsored by Ben-Gurion University of the Negev. Completed at 1 site in Israel. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-15.

Sponsored by Ben-Gurion University of the Negev · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Nov 2017, registered Nov 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
65 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Old Age; Debility
  • Psychological Distress
  • Cognitive Change

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Keywords

  • elderly
  • MBSR
  • cognitive functions
  • psychological status
03

In context

Frailty

1,229 studies on the registry are indexed under Frailty; 433 are open to participants now.

This study's enrollment of 30 is below the median of 80 across 704 interventional studies indexed under Frailty.

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Lead sponsor

Ben-Gurion University of the Negev is the lead sponsor of 20 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age 65 and above
  • membership in the study's specific enrollment community centers
  • scoring 24 and above in the Mini-Mental State Examination (MMSE).

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    decentering group

    MBSR focused on a "decentering" component (i.e. individuals observe their feelings and thoughts as ephemeral events, with no reactivity, alongside with acceptance).

    Behavioral: decentering

  • Experimental
    guided imagery group

    a group practicing in guided imagery sessions.

    Behavioral: guided imagery

  • No intervention
    control group

    usual care group

Interventions

  • Behavioraldecentering

    examined a mindfulness-based intervention focused on a decentering component, that is suitable for elders, aimed to influence on cognitive measures and psychological distress.

  • Behavioralguided imagery

    relaxing guided imagery including breathing exercises.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: at baseline and through intervention's completion, 10 weeks.

Secondary outcomes

  1. 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

    Time frame: at baseline and through intervention's completion, 10 weeks.

  2. 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

    Time frame: at baseline and through intervention's completion, 10 weeks.

  3. 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

    Time frame: at baseline and through intervention's completion, 10 weeks.

  4. 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

    Time frame: at baseline and through intervention's completion, 10 weeks.

  5. 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

    Time frame: at baseline and through intervention's completion, 10 weeks.

07

Study locations

1 site
  • Ruppin Academic Center
    Emek-Hefer, Emek-Hefer 4025000, Israel
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04165005
Lead sponsor
Ben-Gurion University of the Negev
Collaborators
Ruppin Acdemic Center
Responsible party
Ophir Leshets (MA student, MA in the clinical-gerontological program, Ruppin Academic Center, Ben-Gurion University of the Negev) — Principal investigator
First posted
Nov 15, 2019
Start date
Nov 1, 2017
Primary completion
Aug 1, 2018
Completion
Aug 1, 2018
Last update
Nov 15, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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