Ai Youmian (Love Better Sleep) for People Living With HIV

Not Applicable

Completed

• Conditions: HIV Infections; Sleep
• Interventions: Behavioral: 8-week interpersonal and social rhythm intervention; Other: Usual care

• Registration Number: NCT05576844
• Lead Sponsor: Central South University

Brief Summary

People living with HIV (PLWH) frequently report sleep disturbances. The social rhythm theory, which proposes that stressful life events can interfere with sleep by disrupting the stability of daily routines, provides new insights into identifying predictors of sleep disturbances and improving sleep in PLWH. This study is a randomized controlled trial. PLWH with poor self-reported sleep quality (Pittsburgh sleep quality index\>7) was randomly divided into a control group or an intervention group. The control group receives the usual care, that is, daily disease management and routine drug guidance (set as waitlist). The intervention group received a sleep promotion intervention program based on social rhythm theory, along with daily disease management and routine drug guidance. The intervention period was 8 weeks, once a week, and the duration of each intervention was about 40-60 minutes. The sleep-related outcome indicators were measured before the intervention (T0), immediately after the intervention (T1), and 3 months after the intervention (T2), and the participants' social rhythm, daytime sleepiness, sleep belief and attitude, depression, etc. were evaluated to verify the effects of the intervention. At the same time, participants who insisted on completing all intervention modules were selected from the intervention group after the end of the whole study. Self-designed satisfaction questionnaires and semi-structured interviews were used to understand the participants' experience and feedback on the intervention program. In addition, the investigator asked the reasons for the withdrawal of participants who withdrew from the study through an interview during the outcome period.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-28
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2022-10
• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-08
• Study First Posted: 2022-10-13
• Last Update Submitted: 2022-10-15
• Last Update Posted: 2022-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

1. Confirmed HIV infection,
2. Aged 18 years or above,
3. Total score of Pittsburgh sleep quality index > 7,
4. Possess basic literacy,
5. Voluntary participation in the study.

Exclusion Criteria

1. Self reported previous diagnoses of severe sleep disorder disorders such as obstructive sleep apnea, restless legs syndrome, periodic limb movement of sleep, nocturnal urinary frequency or diurnal phase shift disorder,
2. Initiation of antiretroviral therapy within the past 30 days or change in antiretroviral therapy regimen within the past 30 days,
3. Current treatment with psychotropic medication, or use of any medication with sedative or excitatory effects,
4. Working in jobs that require night shifts that may affect the circadian rhythm and no consideration of changing jobs in the recent month,
5. Currently participating in other research projects.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interpersonal and social rhythm intervention	8-week interpersonal and social rhythm intervention	-
Controlled group	Usual care	-

Primary Outcome Measures

Name	Time	Method
change of sleep quality	Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)	Pittsburgh sleep quality index (PSQI) was used. The scale consists of 18 items divided into 7 dimensions. Each dimension is scored from 0 to 3. The total PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality.

Secondary Outcome Measures

Name	Time	Method
change of social rhythm	Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)	The Brief Social Rhythm Scale was used. The scale consists of 10 items to assess the regularity of daily activities during the week. The regularity of each activity is rated on a 6-point Likert type scale. The total BSRS score ranges from 10 to 60, with higher total scores reflecting greater irregularity of the daily activities.
change of sleepiness	Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)	The Epworth Sleepiness Scale was used. It contains 8 questions, each scoring 0-3 with increasing number signifying higher chance of "dozing" while engaged in specific activities of daily life.
change of sleep beliefs and attitudes	Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)	The Dysfunctional Beliefs and Attitudes about Sleep was used. The scale consists of 16 items. The scoring range for each item was from 1 to 5 and the sum of scores of all 16 items ranged from 16 to 80. The lower total score indicates the more erroneous beliefs a participant has.
change of depression symptoms	Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)	The self-rating depression scale was used. The scale included 20 items and each item was scored on a 4-point Likert scale to examine the frequency of the occurrence of assessed depression symptoms over the previous week. The total raw score ranged from 20 to 80, with higher scores indicating higher levels of depression symptoms.
change of social support	Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)	Perceived Social Support Scale was used. The 12-item scale uses a 7-point Likert scale, with total scores ranging from 12 to 84, with higher scores indicating higher levels of perceived social support.
change of interpersonal competence	Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)	Interpersonal Competence Questionnaire was used. The scale included 40 items and each item was scored on a 5-point Likert scale. The total score ranged from 40 to 200, with higher scores indicating higher levels of interpersonal competence.
change of coping styles	Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)	Simplified Coping Style Questionnaire was used. The 20-item scale includes 2 dimensions, positive coping (12 items) and negative coping (8 items). Each item is scored on a 4-point Likert scale, with higher scores indicating greater positive/negative coping styles. The mean scores for the positive and negative items were the final scores for positive and negative coping, respectively.

Trial Locations

Locations (1)

The First Hospital of Changsha; 🇨🇳 Changsha, Hunan, China