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

Central South University

Status: Completed

Conditions: HIV Infections; Sleep

Treatments: Other: Usual care; Behavioral: 8-week interpersonal and social rhythm intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05576844

CX20210113 (Other Grant/Funding Number)

2021zzts0334

Details and patient eligibility

About

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.

Enrollment: 113 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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113 participants in 2 patient groups

Interpersonal and social rhythm intervention

Experimental group

Treatment:

Behavioral: 8-week interpersonal and social rhythm intervention

Controlled group

Active Comparator group

Treatment:

Other: Usual care