Clinical trial NCT05576844: Ai Youmian (Love Better Sleep) for People Living With HIV
Official title: Developing and Validating a Sleep Promotion Intervention Program for People Living With HIV Based on Social Rhythm Theory
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
HIV Infections
Keywords: social rhythm
sleep quality
people living with HIV
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: change of sleep quality
timeFrame: Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)
Secondary outcomes:
measure: change of social rhythm
timeFrame: Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)
measure: change of sleepiness
timeFrame: Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)
measure: change of sleep beliefs and attitudes
timeFrame: Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)
measure: change of coping styles
timeFrame: Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)
measure: change of social support
timeFrame: Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)
measure: change of depression symptoms
timeFrame: Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)
measure: change of interpersonal competence
timeFrame: Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)
Other outcomes:
measure: sleep diary
timeFrame: Participants in the intervention group were required to record a sleep diary after getting up on a daily basis during the 8-week intervention, which was used to guide adjustment of the weekly intervention strategy.
Locations:
city: Changsha
country: China
facility: The First Hospital of Changsha
state: Hunan
Study officials:
affiliation: Central South University
name: Jingjing MENG
role: PRINCIPAL_INVESTIGATOR
References:
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