Effect of WBT for CI With Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8+
SponsorXuanwu Hospital, Beijing
About this trial
This randomized controlled trial aims to explore the therapeutic effects of Well-Being Therapy (WBT) on patients with Chronic Insomnia accompanied by depressive symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with Insomnia Disorder according to DSM-5 criteria, with a duration of at least 3 months.
Pittsburgh Sleep Quality Index (PSQI) total score > 5.
Age 8 years or older.
Educational level of at least junior high school.
Disqualifiers
Presence of severe physical illnesses or major psychiatric disorders, or at risk of suicide.
Diagnosed or suspected of having sleep breathing disorders, restless legs syndrome, circadian rhythm sleep disorders, or engaged in shift work.
Pregnant or breastfeeding women.
Currently undergoing any psychological therapy.
Trial design
Design model
Parallel
Treatments tested in this trial
Well-Being Therapy
BehavioralParticipants will undergo Well-Being Therapy (WBT) sessions once daily for 50 minutes over a period of six weeks. The core elements of WBT include prompting participants to identify instances of well-being, contextualize these experiences using a structured diary, and recognize as well as restructure thoughts, beliefs, and behaviors that prematurely disrupt well-being. Additionally, the specific components of the six dimensions of the Psychological Well-Being (PWB) scale-autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance-are systematically integrated into different therapy sessions
Sleep Hygiene Education
BehavioralParticipants will receive Sleep Hygiene Education (SHE) alone for 6 weeks. SHE involves education on maintaining consistent sleep schedules, creating a sleep-conducive environment, reducing stimulant use (e.g., caffeine, alcohol), and promoting healthy daily routines to improve sleep quality.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: WBT-CIExperimental treatment 1 intervention
Group B: SHE-CIActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at 6 Weeks
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire designed to evaluate sleep quality over a one-month period. It consists of 19 items grouped into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored on a scale of 0 to 3, and the total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame
Baseline and Week 6Secondary outcomes
1
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Scores at 3, 6, and 12 Months
As mentioned in the previous text.
Time frame
Baseline, 3 months, 6 months, and 12 months2
Change from Baseline in Hamilton Depression Scale-17 (HAMD-17) Scores
The Hamilton Depression Scale-17 (HAMD-17) is a clinician-administered tool designed to assess the severity of depressive symptoms over the past week. It consists of 17 items that evaluate various aspects of depression, such as mood, guilt, insomnia, anxiety, and physical symptoms. Each item is scored on a scale, and the total score reflects the severity of depression. The scoring criteria are as follows: 0-7: Normal (not depressed) 8-13: Mild depression 14-18: Moderate depression 19-22: Severe depression 23 or above: Very severe depression.
Time frame
Baseline, Week 6, 3 months, 6 months, and 12 months3
Change from Baseline in Beck Depression Inventory-II (BDI-II) Scores
The Beck Depression Inventory-II (BDI-II) is a self-report questionnaire designed to assess the severity of depressive symptoms. It consists of 21 items, each scored on a scale from 0 to 3, with a total score ranging from 0 to 63. The scoring interpretation is as follows: 0-13: Minimal depression 14-19: Mild depression 20-28: Moderate depression 29-63: Severe depression
Time frame
Baseline, Week 6, 3 months, 6 months, and 12 months4
Change from Baseline in Beck Anxiety Inventory (BAI) Scores
The scale contains 21 items and uses a 4-point scale method, with a total score of 15-25 as mild anxiety, 26-35 as moderate anxiety, and 36 or more as severe anxiety
Time frame
Baseline, Week 6, 3 months, 6 months, and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov