Developing and Validating a Sleep Promotion Intervention Program for People Living With HIV Based on Social Rhythm Theory
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 113
- Locations
- 1
- Primary Endpoint
- change of sleep quality
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Interpersonal and social rhythm intervention
Intervention: 8-week interpersonal and social rhythm intervention (Behavioral)
Controlled group
Intervention: Usual care (Other)
Outcomes
Primary Outcomes
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)
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 Outcomes
- change 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))
- 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 social support(Outcomes was evaluated before the intervention (T0), after the 8-week intervention (T1), and 3 months follow-up after the intervention (T2))
- change 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))
- 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))
Investigators
Jingjing MENG
PhD candidate
Central South University