An interventional study of Telenursing-based sleep coaching in Insomnia and HIV Infections, sponsored by Universitas Indonesia. Not yet recruiting at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Universitas Indonesia · Not applicable, Interventional, and Supportive care
Insomnia is common among people living with HIV and is linked to fatigue and lower quality of life. Cognitive behavioural therapy for insomnia (CBT-I) is the recommended first-line treatment, but access is limited in Indonesia. This study develops a nurse-led sleep coaching programme based on CBT-I principles and delivered online (telenursing), and tests whether the programme and the study procedures are feasible. Fifty adults living with HIV who have insomnia symptoms will complete two baseline assessments four weeks apart, four weekly online coaching sessions and a follow-up assessment four weeks after the last session. The study measures recruitment, retention, attendance, adherence, data completeness, fidelity, usability and safety, and describes changes in sleep, fatigue, pain, anxiety and depression.
The study has three phases. In Phase 1, exploratory interviews explore the perceptions and needs of people living with HIV regarding telenursing-based sleep coaching, and people living with HIV, HIV counsellors and the research team then co-design the content, format and delivery of the programme in online workshops. In Phase 2, about 10 participants pilot the programme, and usability and acceptability are assessed with the System Usability Scale and interviews. This registration covers Phase 3, a single-arm feasibility study with a double baseline. Participants complete baseline 1 (T1), baseline 2 four weeks later with no intervention in between (T2), four weekly online sessions covering sleep education and sleep hygiene, cognitive restructuring and relaxation, stimulus control and sleep restriction, and maintenance, and a follow-up assessment four weeks after the last session (T3). The change between T1 and T2 describes the course of symptoms without intervention. Feasibility outcomes are compared with prespecified traffic light progression criteria to decide whether to proceed to a definitive trial. About 15 to 20 participants take part in qualitative interviews at follow-up.
1,925 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 612 are open to participants now.
This study's planned enrollment of 50 is below the median of 72 across 1,689 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Universitas Indonesia is the lead sponsor of 27 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Four weekly online sessions of 1 to 2 hours, delivered by nurse coaches and trained HIV counsellors, after a four-week period without intervention.
Behavioral: Telenursing-based sleep coaching
A nurse-led programme based on CBT-I principles, delivered by video call through a secure telenursing platform. Week 1: sleep education and sleep hygiene. Week 2: cognitive restructuring and relaxation. Week 3: stimulus control and sleep restriction. Week 4: maintenance and relapse prevention. Participants set weekly behavioural goals with their coach, keep a sleep diary and receive reminders between sessions. Content and format are finalised through co-design and a pilot.
Also known as: Sleep coaching, Telenursing CBT-I
Recruitment rate
Number of participants enrolled, expressed as a percentage of the target sample of 50.
Time frame: 3 months from the start of recruitment
Retention to the second baseline
Percentage of enrolled participants who complete the second baseline assessment.
Time frame: Week 4
Retention to follow-up
Percentage of enrolled participants who complete the follow-up assessment.
Time frame: Week 11
Session attendance
Percentage of participants who attend at least 3 of the 4 coaching sessions.
Time frame: Weeks 4 to 7
Sleep diary completion
Percentage of participants who complete at least 5 of 7 sleep diary days at each assessment.
Time frame: Weeks 0, 4 and 11
Questionnaire completion
Percentage of questionnaires with complete data at each assessment.
Time frame: Weeks 0, 4 and 11
Intervention fidelity
Percentage of core session components delivered, recorded on coach fidelity checklists.
Time frame: Weeks 4 to 7
Usability of the telenursing platform
System Usability Scale total score. Range 0 to 100; higher scores indicate better usability.
Time frame: Week 11
Number of participants with adverse events
Number of participants with at least one adverse event, including events possibly related to the intervention.
Time frame: Weeks 4 to 11
Insomnia severity
Insomnia Severity Index total score. Range 0 to 28; higher scores indicate more severe insomnia.
Time frame: Weeks 0, 4 and 11
Sleep quality
Pittsburgh Sleep Quality Index global score. Range 0 to 21; higher scores indicate poorer sleep quality.
Time frame: Weeks 0, 4 and 11
Sleep onset latency
Mean time to fall asleep in minutes, from 7 days of the Consensus Sleep Diary.
Time frame: Weeks 0, 4 and 11
Wake after sleep onset
Mean time awake after first falling asleep in minutes, from 7 days of the Consensus Sleep Diary.
Time frame: Weeks 0, 4 and 11
Total sleep time
Mean total sleep time in minutes, from 7 days of the Consensus Sleep Diary.
Time frame: Weeks 0, 4 and 11
Sleep efficiency
Mean sleep efficiency (total sleep time divided by time in bed, as a percentage), from 7 days of the Consensus Sleep Diary.
Time frame: Weeks 0, 4 and 11
Fatigue
FACIT-Fatigue subscale score. Range 0 to 52; higher scores indicate less fatigue.
Time frame: Weeks 0, 4 and 11
Pain intensity
Numeric Pain Rating Scale score. Range 0 to 10; higher scores indicate more severe pain.
Time frame: Weeks 0, 4 and 11
Anxiety
Hospital Anxiety and Depression Scale anxiety subscale score. Range 0 to 21; higher scores indicate more anxiety.
Time frame: Weeks 0, 4 and 11
Depression
Hospital Anxiety and Depression Scale depression subscale score. Range 0 to 21; higher scores indicate more depression.
Time frame: Weeks 0, 4 and 11
Plan to share: Yes — De-identified individual participant data underlying the published results will be shared.
Supporting information: Study protocol
Time frame: After publication of the main findings.
Access criteria: Reasonable request to the corresponding author, subject to approval by the Ethics Review Committee, Faculty of Nursing, Universitas Indonesia.
No publications or documents are linked to this record.
Start is estimated for Apr 2027; primary completion for Sep 2027, 5 months later.
Of 825 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's planned 5 months is below that.
Counting every sponsor, half of 883 studies reached it within 19 months; a quarter within 7 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Universitas Indonesia