NCT05920057

Brief Summary

Emotional dysregulation is considered a phenotypic finding that has a purported impact on older adults' peace of mind. In this venue, employing constructive emotional management intervention is one of the breakthroughs that has been empirically targeted to restore positive emotional states and strengthen mental clarity in the geriatric population. Aim: to determine the effect of constructive emotional management interventions on emotional regulation difficulties and peace of mind among older adults. Design: The present study adopted a quasi-experimental methodological approach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

1 month

First QC Date

June 16, 2023

Last Update Submit

June 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mini-Mental State Examination Scale (MMES)

    3 month

Secondary Outcomes (1)

  • II) Geriatric Depression Scale- Short Form (GDS-SF)

    3 month

Other Outcomes (2)

  • III) Brief Version of the Difficulties in Emotion Regulation Scale: The DERS-16

    3 month

  • IV) The Peace of Mind Scale: PoM

    3 month

Study Arms (2)

interventional group

EXPERIMENTAL

senior citizens aged 60 and more were randomly assigned into two equal groups at and placed in the study group, which received the constructive emotional management interventions

Behavioral: constructive emotional management interventions

control group

NO INTERVENTION

the control group, which received the elderly clubs' regular services

Interventions

The Constructive emotional management interventions sessions were conducted in the activity rooms of the elderly clubs where the researchers met the participants. Participants completed a baseline evaluation of the outcome measures of the researched variables after being found to be eligible for the current study and indicating their willingness to participate willingly. After explaining the study's objectives to participants, the researchers themselves delivered the Constructive Emotional Management Interventions program, which had been vetted by experts in the field.

interventional group

Eligibility Criteria

Age60 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Did not have depression, according to the Geriatric Depression Scale Short Form (GDS SF), which has a 0 to 4 score range.
  • \. Difficulties with emotional regulation: a score of 17 or higher on the Brief Version of the Difficulties in Emotion Regulation Scale: The DERS-16.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Nursing

Alexandria, 21523, Egypt

Location

Faculty of Nursing

Alexandria, Egypt

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

June 16, 2023

First Posted

June 27, 2023

Study Start

January 22, 2023

Primary Completion

February 28, 2023

Study Completion

March 30, 2023

Last Updated

June 27, 2023

Record last verified: 2023-06

Locations