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

NCT05576844 | Completed

• 2 other identifiers: 2021zzts0334CX20210113
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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

Keywords

social rhythm; sleep quality; people living with HIV

Outcome Measures

Primary Outcomes (1)

• change of sleep quality

  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.

  Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)

Secondary Outcomes (7)

• 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)

• 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)

• 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)

• 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)

• 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)

Other Outcomes (1)

• sleep diary

  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.

Study Arms (2)

Interpersonal and social rhythm intervention

EXPERIMENTAL

Behavioral: 8-week interpersonal and social rhythm intervention

Controlled group

ACTIVE COMPARATOR

Other: Usual care

Interventions

8-week interpersonal and social rhythm intervention 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.

Interpersonal and social rhythm intervention

Usual care OTHER

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

Controlled group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed HIV infection,
• Aged 18 years or above,
• Total score of Pittsburgh sleep quality index \> 7,
• Possess basic literacy,
• Voluntary participation in the study.

You may not qualify if:

• 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,
• Initiation of antiretroviral therapy within the past 30 days or change in antiretroviral therapy regimen within the past 30 days,
• Current treatment with psychotropic medication, or use of any medication with sedative or excitatory effects,
• Working in jobs that require night shifts that may affect the circadian rhythm and no consideration of changing jobs in the recent month,
• Currently participating in other research projects.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

The First Hospital of Changsha

Changsha, Hunan, 410000, China

Location

Related Publications (8)

• 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.

  PMID: 26188954 BACKGROUND

• Ning CX, Chen XX, Lin HJ, Qiao XT, Xu YY, Shen WW, Zhao D, He N, Ding YY. [Characteristics of sleep disorder in HIV positive and HIV negative individuals: a cluster analysis]. Zhonghua Liu Xing Bing Xue Za Zhi. 2019 May 10;40(5):499-504. doi: 10.3760/cma.j.issn.0254-6450.2019.05.002. Chinese.

  PMID: 31177727 BACKGROUND

• Lee KA, Gay C, Portillo CJ, Coggins T, Davis H, Pullinger CR, Aouizerat BE. Types of sleep problems in adults living with HIV/AIDS. J Clin Sleep Med. 2012 Feb 15;8(1):67-75. doi: 10.5664/jcsm.1666.

  PMID: 22334812 BACKGROUND

• Pujasari H, Chung MH. Sleep Disturbance in the Context of HIV: A Concept Analysis. SAGE Open Nurs. 2022 Apr 20;8:23779608221094541. doi: 10.1177/23779608221094541. eCollection 2022 Jan-Dec.

  PMID: 35493547 BACKGROUND

• Voss JG, Barroso J, Wang T. A Critical Review of Symptom Management Nursing Science on HIV-Related Fatigue and Sleep Disturbance. Int J Environ Res Public Health. 2021 Oct 12;18(20):10685. doi: 10.3390/ijerph182010685.

  PMID: 34682431 BACKGROUND

• Grandin LD, Alloy LB, Abramson LY. The social zeitgeber theory, circadian rhythms, and mood disorders: review and evaluation. Clin Psychol Rev. 2006 Oct;26(6):679-94. doi: 10.1016/j.cpr.2006.07.001. Epub 2006 Aug 10.

  PMID: 16904251 BACKGROUND

• Monk TH, Reynolds CF 3rd, Buysse DJ, DeGrazia JM, Kupfer DJ. The relationship between lifestyle regularity and subjective sleep quality. Chronobiol Int. 2003 Jan;20(1):97-107. doi: 10.1081/cbi-120017812.

  PMID: 12638693 BACKGROUND

• Haynes PL, Kelly M, Warner L, Quan SF, Krakow B, Bootzin RR. Cognitive Behavioral Social Rhythm Group Therapy for Veterans with posttraumatic stress disorder, depression, and sleep disturbance: Results from an open trial. J Affect Disord. 2016 Mar 1;192:234-43. doi: 10.1016/j.jad.2015.12.012. Epub 2015 Dec 24.

  PMID: 26748739 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Jingjing MENG

  Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 13, 2022
• Study Start: September 28, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)