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Construction and evaluation of the effectiveness of a stimulus control intervention program guided by the Theory of Planned Behavior for assisting community-based older adults with mild cognitive impairment and insomnia

Construction and evaluation of the effectiveness of a stimulus control intervention program guided by the Theory of Planned Behavior for assisting community-based older adults with mild cognitive impairment and insomnia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100686
Enrollment
Unknown
Registered
2025-04-14
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild cognitive impairment

Interventions

Intervention group:The intervention group received a stimulus control intervention that consisted of two components: stimulus control therapy and sleep and cognition-related health education.
Control group:The control group received only the same sleep and cognition-related health education as the intervention group.

Sponsors

Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria for Part I Qualitative Research: 1. Age>=60 years; 2. Residence in the community for =6 months; 3. Meets the diagnostic criteria for both MCI and insomnia; 4. Possesses basic communication and comprehension skills. Inclusion criteria for Part III Randomized Controlled Trial: 1. aged >=60 years; 2. lived in that community for =6 months; 3. met the diagnostic criteria for both MCI and insomnia; 4. was able to cooperate in completing scale assessments; 5. was able to use WeChat; 6. was able to receive stimulus-controlled treatment guided by the Theory of Planned Behavior and booster; 7. did not live alone.

Exclusion criteria

Exclusion criteria: Exclusion Criteria for Part I Qualitative Research: 1. People with speech communication, hearing, and vision disorders; 2. People with cognitive dysfunction due to other medications, such as antiepileptic drugs; 3. People who suffer from serious psychiatric disorders, such as schizophrenia, or who are addicted to drugs or alcohol, and who are not able to understand and cooperate in completing the interview; 4. People who suffer from other neurological disorders that can cause brain dysfunction, or serious physical illnesses that can interfere with daily life Diseases; 5. Any form of sleep disorder other than insomnia, such as sleep apnea, restless legs syndrome, etc.; 6. Acute illness or trauma, and other significant life events in the last six months. Exclusion Criteria for Part III Randomized Controlled Trial: 1. People with hearing, vision and speech communication disorders; 2. People with cognitive dysfunction due to taking other medications, such as antiepileptic drugs; 3. Comorbid serious psychiatric disorders, such as schizophrenia, etc.; 4. People who have been taking sleeping pills, antidepressant or anti-anxiety medications regularly for the last one month; 5. People who have a history of pesticide, gas, or alcohol intoxication or who have a drug or alcohol dependence; 6. the existence of other neurological diseases that can cause brain dysfunction or serious physical diseases that affect daily life; 7. the existence of any form of sleep disorder other than insomnia, such as sleep apnea, restless legs syndrome, etc.; 8. the occurrence of acute illness or trauma in the last half a year, as well as other important life events; 9. engaged in the night, early morning work and work at heights and other workers who have high requirements for arousal; 10. Those who are currently receiving other forms of insomnia intervention.

Design outcomes

Primary

MeasureTime frame
Insomnia Severity Index;The Montreal Cognitive Assessment;

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index;Glasgow Sleep Effort Scale;Mini-Mental state examination;Geriatric Depression Scale-15;Self-Rating Anxiety Scale;General Self-efficacy Scale;

Countries

China

Contacts

Public ContactJunyu Zhao/ Yuhe Zhang

Fujian Medical University

zyh113085105@163.com+86 158 9338 2124

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026