Clinical trial NCT06709027: The Construction and Application of a Mobile Health Management Program for Elderly Depression Based on the Patterns of Cognitive Function Changes
Official title: The Construction and Application of a Mobile Health Management Program for Elderly Depression Based on the Patterns of Cognitive Function Changes
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Patients With Depression in the Elderly
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study employs a parallel assignment design where participants are randomly assigned to either the experimental group receiving Mobile Health Management Intervention or the control group receiving a standard treatment. The study is single-blind, meaning participants are unaware of which group they belong to, thus minimizing potential bias. Data will be collected at regular intervals to evaluate the efficacy and safety of the intervention.
Primary purpose: TREATMENT

Brief summary: Based on the changing law of cognitive function, combined with the behavior change wheel theory and the health behavior process orientation model, we constructed a mobile health management program for geriatric depression. The aim is to explore the effect of this intervention program on the health behavior of elderly patients with depression; and to verify the effect of the intervention program on improving the primary outcome and other secondary outcomes of elderly patients with depression, with a view to providing a scientific basis for the management of depression in the elderly and promoting the optimization of personalized intervention strategies.

Detailed description: Based on the changing law of cognitive function, combined with the behavior change wheel theory and the health behavior process orientation model, we constructed a mobile health management program for geriatric depression. The aim is to explore the effect of this intervention program on the health behavior of elderly patients with depression; and to verify the effect of the intervention program on improving the primary outcome and other secondary outcomes of elderly patients with depression, with a view to providing a scientific basis for the management of depression in the elderly and promoting the optimization of personalized intervention strategies.

Eligibility criteria: Inclusion Criteria:

* ① Meet the clinical diagnosis of geriatric depression and DSM-5 diagnostic criteria; ② Age ≥ 60 years old, clear consciousness; ③ Be able to communicate in Mandarin, with a certain degree of comprehension and expression; ④ Possess a smart phone and have the ability to operate it in a basic way; ⑤ Voluntarily participate in this study and sign an informed consent form

Exclusion Criteria:

* ①previous or current cognitive impairment and other severe mental illnesses that prevent cooperation with the study;②comorbidities such as severe cardiac, hepatic, or renal impairment

Primary outcomes:
measure: cognitive function
timeFrame: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)
Secondary outcomes:
measure: depressive symptoms
timeFrame: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)
measure: Behavioral Inhibition /Behavioral Activation
timeFrame: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)
measure: patients' quality of life
timeFrame: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)
measure: sleep quality
timeFrame: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)
measure: psychological needs
timeFrame: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medial University
state: Fujian
Study officials:
References: