NCT06180694

Brief Summary

This research will be carried out with the aim of determining the effect of reminiscence therapy applied to individuals with dementia on cognitive functions, anxiety, depression and activities of daily living. The research will be conducted with a pre-test post-test single group, quasi-experimental research design.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 22, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

August 19, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

December 13, 2023

Last Update Submit

April 14, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change from Baseline in Cognitive Status on the Standardized Mini Mental Test (SMMT) at Week 8

    SMMT, which allows assessing cognitive status, is the most frequently used and easily applied test in dementia screening. The scale is evaluated out of 30 points in total. For SMMT, scores of 23/24 are considered the cutoff score for dementia, but traditionally scores between 24 and 30 are considered normal. A score below 24 indicates cognitive impairment, between 18 and 23 points is considered mild dementia, between 13 and 17 points is considered moderate dementia, and below 12 points is considered severe dementia. Change = (Week 8 Score-Baseline Score)

    Baseline and week 8

  • Change from Baseline in Anxiety Symptoms on Geriatric Anxiety Scale (GAS)

    GAS,developed for the elderly, is a 30-item scale that has somatic, cognitive and affective subscales and monitors anxiety symptoms. The total score on the scale varies between 0-75. A high score indicates a high level of anxiety.Change = (Week 8 Score-Baseline Score)

    Baseline and week 8

  • Change from Baseline in Depressive Symptoms on Geriatric Depression Scale Short Form (GDS-SF)

    GDS-SF, is a scale consisting of 15 questions that questions the emotional state of elderly individuals. The cut-off point of the scale is 7 points and above. Scores between 0 and 4 indicate no depressive symptoms, scores between 5 and 8 indicate mild depressive symptoms, scores between 9 and 11 indicate moderate depressive symptoms, and scores of 12 and above indicate severe depressive symptoms. Change = (Week 8 Score-Baseline Score)

    Baseline and week 8

  • Change from Baseline in Patient's Dependency on Basic Self-Care Behaviors on Katz's Activities of Daily Living Index (KADLI)

    KADLI, evaluates the patient's dependence on basic self-care behaviors that are required to live and are expected to do every day. The scale evaluates the degree of dependency in basic daily living activity parameters, including information on bathing, dressing, toileting, transfer, continence and nutrition. Scoring of the index ranges from 0 to 6, and a patient with a score of 6 is considered independent, and a patient with a score of 0 is considered fully dependent. Change = (Week 8 Score-Baseline Score)

    Baseline and week 8

Study Arms (1)

Reminiscence group

EXPERIMENTAL

Reminiscence therapies will be applied to individuals with dementia

Other: Reminiscence therapy

Interventions

Reminiscence therapies will be applied to individuals with dementia in 45-minute sessions once a week for 8 weeks.

Reminiscence group

Eligibility Criteria

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

You may qualify if:

  • Being diagnosed with mild to moderate dementia according to DSM-5 criteria (whether individuals have an official diagnosis of neurocognitive disorder according to DSM-5 criteria and their medical diagnosis will be verified from the health records at the institution),
  • Getting a score between 13-23 for the educated (literate) and 10-23 for the uneducated (illiterate) on the mini mental state examination,
  • Being 65 years of age or older,
  • Being able to communicate,
  • No vision or hearing problems,
  • Consent to participate in the research.

You may not qualify if:

  • Getting a score below 13 and above 23 for the educated (literate) and below 10 and above 23 for the uneducated (illiterate) from the mini mental state examination,
  • Having an acute illness that prevents participation in intervention sessions,
  • Having serious sensory and physical limitations that prevent participation,
  • Having severe neuropsychiatric symptoms (agitation, psychosis, apathy, uncontrolled delirium, etc.),
  • Having a traumatic life history,
  • Having recently participated in a similar program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Merve Çayır Yılmaz

Amasya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Merve çayır yılmaz, asst. prof.

    Amasya University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2023

First Posted

December 22, 2023

Study Start

August 19, 2024

Primary Completion

October 20, 2024

Study Completion

November 20, 2024

Last Updated

April 17, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations