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

Psychological Distress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04165005
• Other study ID #: 597
• Status: Completed
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Cognitive Change
• Old Age; Debility
• Psychological Distress

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.