Digital Cognitive Behavioral Therapy-Based Treatment for Insomnia, Nightmares, and Posttraumatic Stress Disorder Symptoms in Survivors of Wildfires: Pilot Randomized Feasibility Trial.

Symptoms of insomnia, nightmares, and trauma are highly prevalent. However, there are significant barriers to accessing evidence-based treatments for these conditions, leading to poor mental health outcomes. This pilot trial evaluated the feasibility of a 4-week, digital self-paced intervention combining cognitive behavioral therapy for insomnia and exposure, relaxation, and rescripting therapy for nightmares in survivors of wildfires from Australia, Canada, and the United States. Study participants were recruited between May 2023 and December 2023 through social media platforms, workshops, conferences, and radio interviews. Participants had to meet at least one of the following criteria: a score of ≥8 on the Insomnia Severity Index, a score of ≥3 on the Nightmare Disorder Index, or a score of ≥31 on the PTSD Checklist for DSM-5. In total, 30 survivors of wildfires were allocated to either the treatment group (n=16, 53%) or the waitlist control group (n=14, 47%) in a sequential manner. Participants' ages ranged from 18 to 79 years, with a mean age of 52.50 (SD 16.26) years. The cohort consisted of 63% (19/30) female and 37% (11/30) male participants. Participants also completed self-report secondary outcome measures, including the Generalized Anxiety Disorder-7, the Patient Health Questionnaire-9, and the Pittsburgh Sleep Quality Index, via the HealthZone digital platform. Assessments were conducted at baseline, the posttreatment time point, and the 3-month follow-up, with the waitlist group undergoing an additional assessment at the pretreatment time point, after 4 weeks of waiting and before crossing over to treatment. This study used intention-to-treat analysis as a primary analysis and per-protocol analysis as a secondary analysis. Mixed-effects linear regression models and difference-in-differences analyses were used to assess the intervention's effects. The intention-to-treat analysis revealed significant improvements over time (main effect of time), with a 1.64-point reduction (P=.001) on the Nightmare Disorder Index and 10.64-point reduction (P=.009) on the PTSD Checklist for DSM-5 at the postintervention time point. No significant changes were observed in insomnia symptoms. On the secondary measures, there was an interaction effect of condition × time, with a 2.22-point reduction (P<.001) on the Pittsburgh Sleep Quality Index, and a main effect of time, with a 6.48-point reduction (P<.001) on the Patient Health Questionnaire-9. No changes were detected on the Generalized Anxiety Disorder-7. The per-protocol analysis yielded comparable results for both the primary and secondary measures. The findings of this pilot trial demonstrated a reduction in nightmares and trauma symptoms. Future research studies should aim at evaluating the intervention in a more definitive trial with a larger sample size. Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12623000415606; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385054.

Isaac F ，Klein B ，Nguyen H ，Watson S ，Kennedy GA ... -  《-》

Treating sleep disturbances in refugees and asylum seekers: results from a randomized controlled pilot trial evaluating the STARS group intervention.

Dumser B ，Müller CL ，Ehring T ，Werner GG ，Koch T ... -  《-》

Sleep Treatment Education Program for Cancer Survivors: Protocol for an Efficacy Trial.

Cancer survivors are at increased risk for chronic insomnia, even years after treatment completion. As insomnia is associated with a variety of long-term health consequences, access to insomnia treatment is critically important for the survivor population. Cognitive behavioral therapy for insomnia (CBTI) is the recommended first-line treatment for insomnia but remains largely unavailable to survivors. Treatment barriers include geographic limitations, a shortage of trained providers, and demanding treatment regimens. Designed with these limitations in mind, the Sleep Treatment Education Program (STEP-1) delivers components of CBTI in a low-intensity educational intervention delivered online. This is a phase II pilot randomized controlled trial. The primary aims are to test the efficacy of STEP-1 to improve (1) insomnia symptoms and (2) mood in cancer survivors compared to a control condition. The secondary aims will (1) explore participant factors associated with clinically significant response, (2) evaluate acceptability of the control intervention, (3) explore feasibility of delivering individualized coaching sessions for participants who do not have a significant response to STEP-1, and (4) describe participants' satisfaction with STEP-1 and suggestions for improvement. This 2-arm randomized controlled trial enrolled 70 off-treatment cancer survivors aged 40-89 years with clinically significant insomnia. Participants are randomized to receive either the STEP-1 intervention or control condition (relaxation education); interventions are delivered in one-on-one, synchronous, virtual videoconference sessions by trained interventionists. The STEP-1 intervention presents educational information on the development of insomnia after cancer and offers suggestions for improving insomnia symptoms based on the CBTI elements of sleep hygiene, stimulus control, and cognitive restructuring. With the interventionist, participants review the suggestions and develop a personalized sleep action plan for implementation. The relaxation education session provides information on the potential benefits of relaxation and how to independently access online relaxation exercises. The Insomnia Severity Index is used to measure insomnia symptoms, and the Profile of Mood States Short Form is used to measure mood at baseline and 4 and 8 weeks after intervention. The primary end point is change in the Insomnia Severity Index score at 8 weeks, and the secondary end point is change in mood symptoms (Profile of Mood States Short Form) at 8 weeks. This trial was funded in July 2022. Enrollment and data collection began in February 2023 and concluded in October 2024, with 70 participants enrolled. The analysis will begin in fall 2024, and the results are expected in winter 2025. Trial results will determine if STEP-1 effects go beyond those that could be attributed to placebo and other nonspecific treatment factors. Should results support the efficacy of STEP-1 to improve mood and insomnia symptoms, we anticipate developing efficacy and implementation trials of STEP-1 in larger and more diverse samples. ClinicalTrials.gov NCT05519982; https://clinicaltrials.gov/study/NCT05519982. DERR1-10.2196/60762.

Bice BL ，Michaud AL ，McCormick KG ，Miklos EM ，Descombes ID ，Medeiros-Nancarrow C ，Zhou ES ，Recklitis CJ ... -  《-》

Cognitive Behavioral Therapy for Insomnia in Pain Management for Nonspecific Chronic Spinal Pain: A Randomized Clinical Trial.

Malfliet A ，De Baets L ，Bilterys T ，Van Looveren E ，Mairesse O ，Cagnie B ，Meeus M ，Moens M ，Goubert D ，Munneke W ，Daneels L ，Ickmans K ，Kamper S ，Nijs J ... -  《JAMA Network Open》

Internet-Guided Cognitive Behavioral Therapy for Insomnia Among Patients With Traumatic Brain Injury: A Randomized Clinical Trial.

Malarkey ME ，Fu AJ ，Mannan N ，Shaw OM ，Haight TJ ，Cota MR ，Jahed NC ，Werner JK ，Brody DL ... -  《JAMA Network Open》