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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05576844
• Other study ID #: 2021zzts0334
• Secondary ID: CX20210113
• Status: Completed
• Phase: N/A
• Start date: September 28, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: October 2022
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Sleep

Intervention

Behavioral:
• 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.

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

Locations

Country	Name	City	State
China	The First Hospital of Changsha	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

References & Publications (8)

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. Epub 2006 Aug 10. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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). pii: 10685. doi: 10.3390/ijerph182010685. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	sleep diary	Bedtime, sleep latency, times of waking up during the night, self-rated sleep quality, time of getting up in the morning, etc	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.
Primary	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	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.	Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)
Secondary	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.	Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)
Secondary	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.	Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)
Secondary	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.	Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)
Secondary	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.	Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)
Secondary	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.	Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)
Secondary	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.	Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2)