Conceptualizing Acceptance and Knowledge as Process Variables in Internet-Delivered and Therapist-Supported Cognitive Behavioral Therapy and Acceptance and Commitment Therapy in Primary Care for Insomnia: Pilot Feasibility and Process-Oriented Randomized Controlled Trial

Clinical Snapshot

Key Findings

• P Value: P=.01 for iACT within-group change; P=.10 for iCBT within-group change

• Effect Size: Not reported

• Primary Outcome: Insomnia Severity Index showed significant within-group improvement for iACT (P=.01) but not iCBT (P=.10)

• Nnt Or Sensitivity: Cannot be calculated due to insufficient data

• Confidence Interval: Not reported

Clinical Application

Limited by high attrition rates; requires significant refinement before clinical implementation Highly relevant to Australian primary care; could integrate with existing digital health initiatives and Medicare-funded psychological services Adults with insomnia in primary care settings seeking digital health interventions

Abstract

BACKGROUND: Internet-based interventions for insomnia show promise, but understanding the process variables, such as knowledge acquisition and psychological acceptance, is crucial for enhancing digital adherence and clinical effectiveness. OBJECTIVE: This study aimed to evaluate the feasibility, adherence, and preliminary clinical signals of 2 therapist-assisted interventions-internet-delivered cognitive behavioral therapy (iCBT) and internet-delivered acceptance and commitment therapy (iACT)-for insomnia in a primary care setting. METHODS: This was a pilot randomized controlled trial. Adults seeking help for insomnia (n=18) were recruited via primary care and randomized to either a 5-module iCBT or iACT program delivered via a secure digital platform with weekly therapist feedback. Blinding of participants and therapists was not possible due to the nature of the interventions. Primary outcomes included the Insomnia Severity Index; secondary outcomes included the 9-item Patient Health Questionnaire, 7-item Generalized Anxiety Disorder, and WHO Disability Assessment Schedule. A novel sleep knowledge test was used as a process variable. The data were analyzed using split-plot analyses of variance (intention-to-treat or last observation carried forward and complete case analysis) and nonparametric Friedman and Kruskal-Wallis tests. RESULTS: A total of 18 participants were randomized (iCBT: n=9; iACT: n=9). High attrition was observed, with only 33.3% (n=3) of iCBT and 55.6% (n=5) of iACT participants completing all modules. The iACT group demonstrated a significant within-group reduction in insomnia severity (P=.01, Friedman test), whereas iCBT results were nonsignificant (P=.10, Friedman test). No significant between-group differences were found for any clinical or process variables. Participants rated both treatments as credible (Credibility/Expectancy Questionnaire scores remained stable), though qualitative feedback indicated a need for more flexible, less burdensome content. CONCLUSIONS: This pilot study demonstrates that while internet-delivered insomnia treatments are feasible and credible in primary care, high attrition remains a significant barrier. Preliminary signals suggest that iACT may be a viable alternative to iCBT, potentially offering better adherence. Larger, fully powered pilot randomized controlled trials (estimated N=404) with refined recruitment and automated retention strategies are required to determine definitive comparative efficacy and the mediating role of sleep knowledge and acceptance.

References

1. 1.Larsson, A. C., Jernelöv, S., Kaldo, V., Blom, K., & Weineland, S. (2026). Conceptualizing Acceptance and Knowledge as Process Variables in Internet-Delivered and Therapist-Supported Cognitive Behavioral Therapy and Acceptance and Commitment Therapy in Primary Care for Insomnia: Pilot Feasibility and Process-Oriented Randomized Controlled Trial. JMIR Formative Research. https://doi.org/10.2196/81285