NCT04165005

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
Last Updated

November 15, 2019

Status Verified

November 1, 2019

Enrollment Period

9 months

First QC Date

November 1, 2019

Last Update Submit

November 13, 2019

Conditions

Old Age; DebilityPsychological DistressCognitive Change

Keywords

elderlyMBSRcognitive functionspsychological status

Outcome Measures

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.

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

Secondary Outcomes (5)

  • FFMQ- change from baseline to after intervention

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

  • PWB questionnaire- change from baseline to after intervention

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

  • MMSE- change from baseline to after intervention

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

  • PHQ-9- change from baseline to after intervention

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

  • BDI-II- change from baseline to after intervention

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

Study Arms (3)

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).

Behavioral: decentering

guided imagery group

EXPERIMENTAL

a group practicing in guided imagery sessions.

Behavioral: guided imagery

control group

NO INTERVENTION

usual care group

Interventions

decenteringBEHAVIORAL

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

decentering group
guided imageryBEHAVIORAL

relaxing guided imagery including breathing exercises.

guided imagery group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruppin Academic Center

Emek-Hefer, Emek-Hefer, 4025000, Israel

Location

Related Publications (1)

  • 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.

    PMID: 36385638DERIVED

MeSH Terms

Conditions

Frailty

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MA student, MA in the clinical-gerontological program, Ruppin Academic Center

Study Record Dates

First Submitted

November 1, 2019

First Posted

November 15, 2019

Study Start

November 1, 2017

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

November 15, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)