Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 15 to 39 years at the time of enrollment 2. Confirmed diagnosis of cancer of any type 3. At least 6 months post-treatment at the time of enrollment 4. Able to read and write in either English or Hindi 5.Have consented to participate 6. Insomnia Severity Index score of more than or equal to 12 and two or more domains impaired on RU SATED framework.
Exclusion criteria
Exclusion criteria: 1. prior attempts to treat insomnia using cognitive behavioural therapy for insomnia. 2. History of mood disorders or schizophrenia. 3. History of a seizure disorder diagnosis or seizure in the past 12 months 4. Intention to adjust use of sedative, hypnotic, or over-the-counter medications that can affect sleep during the study period 5. Diagnosed, untreated sleep apnea or other sleep disorder 6. Employment involving irregular sleep patterns such as shift work or frequent long-distance travel across time zones 7. Refusal to modify or reduce excessive alcohol use likely to interfere with sleep
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the intervention study is feasibility, defined as the proportion of enrolled participants who successfully complete all three intervention sessions. The intervention will be considered feasible if 70 percent or more of enrolled participants complete all three sessions. A completion rate below 50 percent will be considered unacceptableTimepoint: 3 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Acceptability will be assessed using context adapted client satisfaction questionnaire administered at the end of the intervention capturing participants appraisal of the intervention content, format, digital delivery, and perceived usefulness.Timepoint: 3 weeks;Longitudinal change in Insomnia Severity Index scores at baseline, 3 months, and 6 months.Timepoint: 3 weeks, 3 months, 6 months;Longitudinal change in PSQI global scores and RU SATED composite scores at baseline, 3 months, and 6 monthsTimepoint: 3 weeks, 3 months and 6 months;Longitudinal change in DASS-21 subscale scores at baseline, 3 months, and 6 months.Timepoint: 3 weeks, 3 months and 6 months;Change in actigraphy-derived Total Sleep Time, Sleep Efficiency, Sleep Onset Latency, and Wake After Sleep Onset .Timepoint: across the three-week intervention period | — |
Countries
India
Contacts
AIIMS New Delhi