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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04165005
Other study ID # 597
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2017
Est. completion date August 1, 2018

Study information

Verified date November 2019
Source Ben-Gurion University of the Negev
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 1, 2018
Est. primary completion date August 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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).

Study Design


Intervention

Behavioral:
decentering
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 imagery
relaxing guided imagery including breathing exercises.

Locations

Country Name City State
Israel Ruppin Academic Center Emek-Hefer

Sponsors (2)

Lead Sponsor Collaborator
Ben-Gurion University of the Negev Ruppin Acdemic Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. at baseline and through intervention's completion, 10 weeks.
Secondary 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 at baseline and through intervention's completion, 10 weeks.
Secondary 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 at baseline and through intervention's completion, 10 weeks.
Secondary 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 at baseline and through intervention's completion, 10 weeks.
Secondary 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 at baseline and through intervention's completion, 10 weeks.
Secondary 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 at baseline and through intervention's completion, 10 weeks.
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