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Enrolling by Invitation

NCT Number: NCT06709027

The Construction and Application of a Mobile Health Management Program for Elderly Depression Based on the Patterns of Cognitive Function Changes

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fujian Medial University

Fuzhou, Fujian, 350100, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention Group (Mobile Health Management Intervention)

Device

Participants in this group will receive a mobile health management intervention over a period of 12 weeks. This intervention includes the use of a mobile application designed for health management, psychological support, and monitoring,et al, with the aim of improving the mental health status of elderly patients with depression.

Primary outcomes

  1. cognitive function

    Time frame: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)

    Using Montreal Cognitive Assessment( MoCA) to assess patients' cognitive function

Secondary outcomes

  1. depressive symptoms

    Time frame: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)

    sing the Geriatric Depression Scale (GDS-15) to assess patients' depressive symptoms.

  2. Behavioral Inhibition /Behavioral Activation

    Time frame: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)

    Using the Behavioral Inhibition System/Behavioral Activation System Scale (BIS/BAS) to assess patients' behavior.

  3. patients' quality of life

    Time frame: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)

    Using the WHO QOL-BREF to assess patients' quality of life.

  4. sleep quality

    Time frame: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)

    Using the Pittsburgh Sleep Quality Index (PSQI) to assess patients' sleep quality.

  5. psychological needs

    Time frame: From baseline (T0) to 6 weeks post-intervention (T1) and 12 weeks post-intervention (T2)

    Using the Basic Psychological Needs Scale (BPNS) to assess patients' psychological needs.

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.