Clinical trial NCT06658171: Effects of Relaxation Training and Stimulus Control in Chronic Insomnia Patients
Official title: Effects of Relaxation Training and Stimulus Control in Chronic Insomnia Patients With Hyperarousal and Maladaptive Sleep Patterns
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Insomnia
Keywords: chronic insomnia
sleep restriction
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: The study aims to validate the effect of relaxation training and stimulus control on reducing hyperarousal states and improving maladaptive sleep behaviors.

Detailed description: Relaxation training typically includes techniques such as breathing exercises, muscle relaxation, and mindfulness meditation to help patients reduce levels of physical and psychological tension, promote relaxation, and create favorable conditions for sleep onset. Stimulus control aims to break the negative association between the bed and insomnia, and rebuild a positive association between the bed and sleep.

Eligibility criteria: Inclusion Criteria:

1. Meet the diagnostic criteria for insomnia disorder according to DSM-5.
2. Pittsburgh Sleep Quality Index (PSQI) total score \> 5.
3. Age ≥ 18 years, with at least a middle school education level.
4. Anxiety symptoms meeting HAMA ≥ 14.
5. "Self-developed 8-item questionnaire on maladaptive sleep behaviors" used to assess "maladaptive sleep behaviors."
6. Voluntarily participate in this study and sign an informed consent form.

Exclusion Criteria:

1. Individuals with severe physical illnesses or severe mental disorders, at risk of suicide.
2. Clinically diagnosed or suspected sleep-related breathing disorders, restless leg syndrome, and sleep-wake rhythm disorders, as well as shift workers.
3. Pregnant or lactating women.
4. Currently undergoing any 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, and 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: