Trial reportJMIR mHealth and uHealth2025
Assessment of an App-Based Sleep Program to Improve Sleep Outcomes in a Clinical Insomnia Population: Randomized Controlled Trial.
Trial report in JMIR mHealth and uHealth, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05872672 (Assessment of a Behavioral Sleep Program Using Subjective and Objective Measures of Sleep Quality in a Population With Sleep Disturbances), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Assessment of a Behavioral Sleep Program Using Subjective and Objective Measures of Sleep Quality in a Population With Sleep Disturbances
Who cites it
6 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Non-pharmacological therapies for sleep and occupational stress regulation among nightshift nurses: a systematic review and Bayesian network meta-analysis based on randomized controlled trials.Frontiers in public health · 2026Pooled it
- Effectiveness of unguided digital cognitive behavioral therapy for insomnia on depressive symptoms: a systematic review and meta-analysis of randomized controlled trials.Frontiers in psychiatry · 2025Pooled it
- A digital mindfulness intervention improves sleep efficiency and heart rate variability in healthy adults.Scientific reports · 2026Trial
- Efficacy of a Self-Guided Transdiagnostic Intervention for Adults With Anxiety and Depression: Randomized Controlled Trial.JMIR mHealth and uHealth · 2025Trial
- Adjunctive electroacupuncture to facilitate discontinuation of non-benzodiazepine hypnotics in chronic insomnia: a randomized controlled trial protocol.Frontiers in neurology · 2026Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInsomnia is the most commonly reported sleep disturbance and significantly impacts mental health and quality of life. Traditional treatments for insomnia include pharmacological interventions or cognitive behavioral therapy for insomnia (CBT-I), but these options may not be accessible to everyone who needs treatment.
objectiveThis study aims to assess the effectiveness of the app-based Headspace Sleep Program in adults with clinical insomnia on sleep disturbance and mental health outcomes, compared with a waitlist control group.
methodsThis randomized controlled trial included 132 adults with clinical insomnia who were assigned to either the Headspace Sleep Program (an 18-session self-guided, in-app program utilizing CBT-I techniques augmented by mindfulness) or a waitlist control group. Sleep disturbance outcomes were assessed by changes in insomnia symptoms (measured using the Insomnia Severity Index) and sleep efficiency (measured via sleep diary and actigraphy). Mental health outcomes included perceived stress (measured by the 10-item Perceived Stress Scale), depressive symptoms (measured by the 8-item Patient Health Questionnaire), sleep quality (measured by the Pittsburgh Sleep Quality Index), anxiety symptoms (measured by the 7-item Generalized Anxiety Disorder Scale), and mindfulness (measured by the Mindful Attention Awareness Scale). Changes from baseline to postintervention and follow-up were assessed for each outcome.
resultsParticipants had a mean (SD) age of 37.2 (10.6) years, with 69 out of 132 (52.3%) identifying as female. Those randomized to the Headspace Sleep Program group experienced significantly greater improvements in insomnia symptoms from baseline to postintervention and follow-up compared with participants in the waitlist control group (P<.001, η²p=0.107). Improvements from baseline to postintervention and follow-up were also observed in the Headspace Sleep Program group for sleep efficiency, as measured by both sleep diary (P=.01, η²p=.03) and actigraphy outcomes (P=.01, η²p=.03). Participants in the Headspace Sleep Program group showed greater improvements in insomnia remission rates (8/66, 12%, at postintervention and 9/66, 14%, at follow-up) and treatment response (11/66, 17%, at postintervention and 15/66, 23%, at follow-up) compared with the control group (remission rate 2/66, 3%, at postintervention and 0/66, 0%, at follow-up; treatment response 3/66, 5%, at postintervention and 1/66, 2%, at follow-up). The results suggest significant improvements in depressive symptoms (P=.01, η²p=.04), anxiety symptoms (P=.02, η²p=.02), and mindfulness (P=.01, η²p=.03) in the Headspace Sleep Program group.
conclusionsThe Headspace Sleep Program is an effective intervention for improving sleep disturbances in adults with clinical insomnia.
trial registrationClinicalTrials.gov NCT05872672; https://clinicaltrials.gov/ct2/show/NCT05872672.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.