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SleepNCT05576844

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

A study testing 8-week interpersonal and social rhythm intervention in people with Sleep and HIV Infections, run by Central South University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sleep, HIV Infections
What is being tested?
8-week interpersonal and social rhythm intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
113 participants
Where
1 siteChina
Study dates
28 Sep 2021to 31 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Hospital of Changsha

    Changsha, Hunan, 410000

Other trials in China

About this study

Official title: Developing and Validating a Sleep Promotion Intervention Program for People Living With HIV Based on Social Rhythm Theory

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.

Being tested
8-week interpersonal and social rhythm intervention, Usual care
Keywords
social rhythm, sleep quality, people living with HIV
Medical subject headings
HIV Infections, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 8-week interpersonal and social rhythm interventionBehavioural

    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.

  • Usual careOther

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

Study groups in NCT05576844
Study groupRoleWhat they receive
Interpersonal and social rhythm interventionExperimentalNot described
Receives: Behavioral: 8-week interpersonal and social rhythm intervention
Controlled groupActive comparatorNot described
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. change of social rhythm

    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.

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

  2. change of sleepiness

    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.

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

  3. change of sleep beliefs and attitudes

    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.

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

  4. change of coping styles

    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.

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

  5. change of social support

    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.

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

  6. change of depression symptoms

    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.

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

  7. change of interpersonal competence

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2022
  2. Study start28 Sep 2021
  3. Primary completion31 Aug 2022
  4. Study completion31 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05576844
Sponsor's protocol ID
2021zzts0334
Other IDs
CX20210113
Status last verified
Oct 2022
First submitted
7 Oct 2022
Last updated
18 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The participants in this study were all HIV/AIDS patients. Due to sexual and HIV-related stigma and discrimination, HIV/AIDS patients are reluctant to inform others of their infection status. At recruitment, participants were also informed that the data were anonymous and presented in a total sample format to help alleviate their reluctance and concerns about privacy breaches.

Publications

  • 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.

    PubMed 26188954

  • 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.

    PubMed 31177727

  • 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.

    PubMed 22334812

  • 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.

    PubMed 35493547

  • 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.

    PubMed 34682431

  • 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.

    PubMed 16904251

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

    PubMed 12638693

  • 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.

    PubMed 26748739

Questions about this trial

What is this clinical trial studying?

A study testing 8-week interpersonal and social rhythm intervention in people with Sleep and HIV Infections, run by Central South University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change of sleep quality (time frame: Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05576844, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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