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

Primary Purpose

Sleep, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
8-week interpersonal and social rhythm intervention
Usual care
Sponsored by
Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep focused on measuring social rhythm, sleep quality, people living with HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The First Hospital of Changsha

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interpersonal and social rhythm intervention

Controlled group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 7, 2022
Last Updated
October 15, 2022
Sponsor
Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT05576844
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, HIV Infections
Keywords
social rhythm, sleep quality, people living with HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interpersonal and social rhythm intervention
Arm Type
Experimental
Arm Title
Controlled group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
8-week interpersonal and social rhythm intervention
Intervention Description
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
Other
Intervention Name(s)
Usual care
Intervention Description
Control group participants received usual care, including daily disease management and routine drug guidance.
Primary Outcome Measure Information:
Title
change of sleep quality
Description
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.
Time Frame
Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)
Secondary Outcome Measure Information:
Title
change of social rhythm
Description
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.
Time Frame
Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)
Title
change of sleepiness
Description
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.
Time Frame
Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)
Title
change of sleep beliefs and attitudes
Description
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.
Time Frame
Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)
Title
change of coping styles
Description
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.
Time Frame
Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)
Title
change of social support
Description
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.
Time Frame
Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)
Title
change of depression symptoms
Description
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.
Time Frame
Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)
Title
change of interpersonal competence
Description
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.
Time Frame
Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)
Other Pre-specified Outcome Measures:
Title
sleep diary
Description
Bedtime, sleep latency, times of waking up during the night, self-rated sleep quality, time of getting up in the morning, etc
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed HIV infection, Aged 18 years or above, Total score of Pittsburgh sleep quality index > 7, Possess basic literacy, Voluntary participation in the study. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jingjing MENG
Organizational Affiliation
Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Hospital of Changsha
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
26188954
Citation
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.
Results Reference
background
PubMed Identifier
31177727
Citation
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.
Results Reference
background
PubMed Identifier
22334812
Citation
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.
Results Reference
background
PubMed Identifier
35493547
Citation
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.
Results Reference
background
PubMed Identifier
34682431
Citation
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.
Results Reference
background
PubMed Identifier
16904251
Citation
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.
Results Reference
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PubMed Identifier
12638693
Citation
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.
Results Reference
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PubMed Identifier
26748739
Citation
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.
Results Reference
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Ai Youmian (Love Better Sleep) for People Living With HIV

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