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

Primary Purpose

Old Age; Debility, Psychological Distress, Cognitive Change

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
decentering
guided imagery
Sponsored by
Ben-Gurion University of the Negev
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Old Age; Debility focused on measuring elderly, MBSR, cognitive functions, psychological status

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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:

  • 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).

Sites / Locations

  • Ruppin Academic Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

decentering group

guided imagery group

control group

Arm Description

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

a group practicing in guided imagery sessions.

usual care group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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
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
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

Full Information

First Posted
November 1, 2019
Last Updated
November 13, 2019
Sponsor
Ben-Gurion University of the Negev
Collaborators
Ruppin Acdemic Center
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1. Study Identification

Unique Protocol Identification Number
NCT04165005
Brief Title
Mindfulness-based Short Intervention for Seniors - Decentering Effects on Cognitive Functions and Psychological Distress
Official Title
Mindfulness-based Short Intervention for Seniors - Decentering Effects on Cognitive Functions and Psychological Distress
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ben-Gurion University of the Negev
Collaborators
Ruppin Acdemic Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Old Age; Debility, Psychological Distress, Cognitive Change
Keywords
elderly, MBSR, cognitive functions, psychological status

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
decentering group
Arm Type
Experimental
Arm Description
MBSR focused on a "decentering" component (i.e. individuals observe their feelings and thoughts as ephemeral events, with no reactivity, alongside with acceptance).
Arm Title
guided imagery group
Arm Type
Experimental
Arm Description
a group practicing in guided imagery sessions.
Arm Title
control group
Arm Type
No Intervention
Arm Description
usual care group
Intervention Type
Behavioral
Intervention Name(s)
decentering
Intervention Description
examined a mindfulness-based intervention focused on a decentering component, that is suitable for elders, aimed to influence on cognitive measures and psychological distress.
Intervention Type
Behavioral
Intervention Name(s)
guided imagery
Intervention Description
relaxing guided imagery including breathing exercises.
Primary Outcome Measure Information:
Title
Simon task- change from baseline to after intervention
Description
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 Outcome Measure Information:
Title
FFMQ- change from baseline to after intervention
Description
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.
Title
PWB questionnaire- change from baseline to after intervention
Description
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.
Title
MMSE- change from baseline to after intervention
Description
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.
Title
PHQ-9- change from baseline to after intervention
Description
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.
Title
BDI-II- change from baseline to after intervention
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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).
Facility Information:
Facility Name
Ruppin Academic Center
City
Emek-Hefer
ZIP/Postal Code
4025000
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36385638
Citation
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.
Results Reference
derived

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

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