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

NCT ID: NCT05576844

Last Updated: 2022-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-28
• Study Completion Date: 2022-08-31

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.

Conditions

Sleep; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Interpersonal and social rhythm intervention

Group Type: EXPERIMENTAL

8-week interpersonal and social rhythm intervention

Intervention Type: BEHAVIORAL

The development of the intervention strategies are based on social rhythm theory, interpersonal and social rhythm therapy, and previous research results, and the intervention aims to improve sleep by stabilizing participants' social rhythm and increasing the amount of interpersonal communication.

Controlled group

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

Control group participants received usual care, including daily disease management and routine drug guidance.

Interventions

8-week interpersonal and social rhythm intervention

The development of the intervention strategies are based on social rhythm theory, interpersonal and social rhythm therapy, and previous research results, and the intervention aims to improve sleep by stabilizing participants' social rhythm and increasing the amount of interpersonal communication.

Intervention Type: BEHAVIORAL

Usual care

Control group participants received usual care, including daily disease management and routine drug guidance.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central South University

OTHER

Sponsor Role: lead

Responsible Party

Jingjing MENG

PhD candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jingjing MENG

Role: PRINCIPAL_INVESTIGATOR

Central South University

Locations

The First Hospital of Changsha

Changsha, Hunan, China

Countries

China

References

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Reference Type: BACKGROUND

PMID: 26748739 (View on PubMed)

Wu J, Wu H, Lu C, Guo L, Li P. Self-reported sleep disturbances in HIV-infected people: a meta-analysis of prevalence and moderators. Sleep Med. 2015 Aug;16(8):901-7. doi: 10.1016/j.sleep.2015.03.027. Epub 2015 May 18.

Reference Type: BACKGROUND

PMID: 26188954 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 31177727 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 22334812 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 16904251 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 12638693 (View on PubMed)

Other Identifiers

CX20210113

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2021zzts0334

Identifier Type: -

Identifier Source: org_study_id