Clinical trial NCT06658158: Effects of Cognitive Correction and Stimulus Control in Chronic Insomnia Patients
Official title: Effects of Cognitive Correction and Stimulus Control in Chronic Insomnia Patients With Sleep Cognitive Distortions and Maladaptive Sleep Patterns
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Insomnia
Keywords: chronic insomnia
cognitive correction
stimulus control
sleep hygiene education
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to validate the effect of cognitive correction and stimulus control on correcting sleep cognitive distortions and improving maladaptive sleep behaviors.

Detailed description: Cognitive correction aims to identify and change patients' erroneous beliefs and attitudes about sleep, which may include exaggerated sleep needs, excessive worry about the consequences of insomnia, and unrealistic expectations about bedtime. Stimulus control, on the other hand, focuses on modifying patients' behaviors in bed, linking the bed with a rapid onset of sleep, and reducing the negative association between the bed and insomnia.

Eligibility criteria: Inclusion Criteria:

1. Meets the diagnostic criteria for insomnia disorder according to DSM-5;
2. PSQI total score \> 5;
3. Age ≥ 18 years, with at least a junior high school education;
4. Sleep cognitive distortions assessed using the DBAS-16;
5. "Maladaptive Sleep Behavior Questionnaire - 8 items" used to assess "maladaptive sleep behaviors";
6. Willing to participate in the study and sign an informed consent form.

Exclusion Criteria:

1. Presence of severe physical illness or serious mental disorders, or at risk for suicide;
2. Clinically diagnosed or suspected sleep-related breathing disorders, restless legs syndrome, and circadian rhythm sleep-wake disorders; shift workers;
3. Pregnant or lactating women;
4. Currently undergoing any form of psychological therapy.

Primary outcomes:
measure: The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks.
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: The change of PSQI total scores from baseline to 3 months, 6 months, and 12 months.
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of sleep efficiency from baseline to 6 weeks, 3 months, 6 months, and 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Snaith-Hamilton Pleasure Scale (SHAPS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Short Form 36 (SF-36) total scores from baseline to 6 weeks, 3 months, 6 months, 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months.
measure: The change of Patient Health Questionnaire-4 (PHQ-4) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Patient Health Questionnaire-15 (PHQ-15) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of 5-item Perceived Deficits Questionnaire-Depression (PDQ-D-5) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
References: