NCT07550335

Brief Summary

Depression is common among older adults and is often associated with declines in physical and oral health. Non-pharmacological, community-based interventions are needed to support both mental and physical well-being. This study examines the effects of a program combining group-based reading activities and oral exercises in community-dwelling older adults. Participants are randomly assigned to either an intervention group, which receives the six-week program, or a control group receiving general oral health education. The study evaluates whether the intervention can improve physical and oral function, enhance psychological resilience (grit), and reduce depressive symptoms.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Apr 2026

Status
not yet recruiting

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 Progress3%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

April 19, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

April 23, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

April 19, 2026

Last Update Submit

April 19, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Depressive Symptoms

    Depressive symptoms measured using the Geriatric Depression Scale (GDS), with higher scores indicating more severe depressive symptoms.

    At baseline and immediately after the 6-week intervention period

Secondary Outcomes (3)

  • Oral Frailty

    At baseline and immediately after the 6-week intervention period

  • Sarcopenia Risk

    At baseline and immediately after the 6-week intervention period

  • Grit

    At baseline and immediately after the 6-week intervention period

Study Arms (2)

Intervention Group

EXPERIMENTAL
Behavioral: Reading and Oral Exercise Program

Control Group

NO INTERVENTION

Interventions

Participants in the intervention group receive a combined program of group-based reading activities and oral exercises. The program is delivered in a focus group format and includes guided reading discussions to promote emotional expression and reflection, along with structured oral exercises to enhance oral muscle function. The intervention is conducted over a 6-week period, with sessions held once every two weeks for a total of three sessions.

Intervention Group

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community-dwelling adults aged 55 years and older.
  • Able to communicate in Mandarin or Taiwanese and capable of understanding study instructions and participating in group discussions.
  • Able to complete study questionnaires independently or with assistance from research staff.

You may not qualify if:

  • Individuals with severe cognitive impairment that precludes understanding study procedures or participation in group discussions.
  • Individuals with a current diagnosis of severe psychiatric disorders (e.g., schizophrenia, acute phase of bipolar disorder) that would make participation in group activities inappropriate.
  • Individuals who have participated in similar psychological or bibliotherapy-based interventions within the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionSarcopenia

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2026

First Posted

April 24, 2026

Study Start

April 23, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

April 24, 2026

Record last verified: 2026-04