bluuebunny/crossref_metadata_2025_split huggingface dataset:
0514 Efficacy of a Forehead-Cooling Device for Treating Insomnia in Veterans
Authors: Nofzinger E 
Published: May 2020

Abstract

Introduction
In 2 independent studies, we explored whether a forehead-cooling device was effective in improving insomnia in veterans.

Methods
Both studies were uncontrolled and exploratory in nature. The first study involved 20 veterans who expressed interest in using the forehead-cooling device and received 4 weeks treatment. The second study involved 19 veterans who were recruited via media to participate in a 4-week study and were compensated for their participation. All participants completed questionnaires before and after treatment.

Results
In the retrospective analysis, veterans had improvements over baseline in insomnia severity index (M ± SD =17.6 ± 4.7 pre- vs 6.9 ± 3.5 post-treatment, t(19) = -9.4, p&lt;0.00001), in sleep latency (M ± SD = 61.7 ± 49.1 minutes pre- vs 25.0 ± 20.8 minutes post-treatment, t(19) = -4.6, p&lt;0.001) and in minutes awake after sleep onset (M ± SD =78.7 ± 57.8 minutes pre- vs 29.9 ± 18.3 minutes post-treatment, t(19) = -4.0, p&lt;0.001). In the prospective study, veterans had improvements in insomnia severity index over baseline (M ± SD = 20.7 +3.8 pre- vs 9.5 ± 7.5 post-treatment, t(18) = 5.8, p&lt;0.00001), depression severity on the PHQ-9 (M ± SD = 21.5 ±6.1 pre- vs 14.2 ± 5.1 post-treatment, t(18) =4.1, p&lt;0.001) and anxiety severity on the GAD 7 (M ± SD = 9.8 ±7.1 pre- vs. 6.2 ± 5.4 post-treatment, t(18) = -3.1, p&lt;0.01).

Conclusion
Use of a forehead-cooling device improved insomnia in veterans. These findings were replicated in an independent prospective trial. Reductions in depressive and anxiety symptoms from baseline were also noted in the prospective study. These promising preliminary data suggest the need for further large scale randomized controlled trials to establish the efficacy of forehead-cooling on insomnia in veterans.

Support
Ebb Pharmaceuticals, Pittsburgh, PA 15222
0528 Insomnia as a Mechanism for Improvement in Alcohol Problems Among Young Adults
Authors: Miller M , Freeman L B , Park C J , Hall N , Sahota P K , McCrae C S 
Published: May 2020

Abstract

Introduction
More than half of heavy-drinking young adults report symptoms of insomnia, which have been associated with alcohol-related problems. This study examined improvement in insomnia (via Cognitive Behavioral Therapy for Insomnia; CBT-I) as a mechanism for improvement in alcohol-related problems.

Methods
Fifty-six heavy-drinking young adults with insomnia (ages 18-30y) were randomized to CBT-I (n=28) or single-session sleep hygiene control (SH; n=28). Of those, 43 (77%) completed post-treatment (24 SH, 19 CBT-I) and 48 (86%) completed 1-month follow-up (25 SH, 23 CBT-I). Multiple imputation was used to estimate missing data. Treatment outcomes were assessed using multilevel models. Mediation was tested using bootstrapped confidence intervals for indirect effects in the PROCESS macro.

Results
CBT-I participants reported greater decreases in insomnia severity than those in the sleep hygiene group [group X time interaction, F(2,59)=11.29, p&lt;.001], both post-treatment and at 1-month follow-up. Both groups decreased significantly in diary-assessed sleep quality [time, F(2,55)=40.30, p&lt;.001], with a marginally significant interaction in favor of the CBT-I group [F(2,55)=2.69, p=.08]. There were no significant group by time interactions in the prediction of actigraphy-assessed sleep variables, although again, there was a marginally significant interaction in the prediction of actigraphy-assessed sleep efficiency [F(2,66)=2.75, p=.07]. Both groups reported significant decreases in drinking quantity over time [time, F(2,58=13.88, p&lt;.001]. However, CBT-I participants reported greater decreases in alcohol-related consequences than those in the sleep hygiene group [F(2,67)=4.13, p=.02]. In the mediation model, CBT-I did not have a direct effect on change in alcohol-related consequences (B=1.49, SE=1.06, 95%CI=-0.65, 3.62); however, it influenced change in 1-month alcohol-related consequences indirectly through its influence on post-treatment insomnia symptoms (B=-1.09, SE=0.57, 95%CI=-2.30, -0.05).

Conclusion
CBT-I is effective in treating insomnia among heavy-drinking young adults and may be associated with reductions in alcohol-related problems due to its impact on insomnia symptoms.

Support
This work was supported by funding from the University of Missouri System Research Board Office (PI Miller). Mary Beth Miller’s contribution to this project was also supported by the National Institute on Alcohol Abuse and Alcoholism [grant number K23AA026895].
0532 Cognitive Behavioral Therapy Delivered Via Telemedicine vs. Face-to-Face: Results from a Randomized Controlled Non-Inferiority Trial
Authors: Arnedt J , Conroy D , Mooney A , DuBuc K , Balstad S , Pace D , Yang A , Furgal A , Sen A , Eisenberg D 
Published: May 2020

Abstract

Introduction
Telemedicine is increasingly an option for delivery of healthcare services, but its efficacy and acceptability for delivering CBT for insomnia has not been adequately tested. In a randomized controlled non-inferiority trial, we compared face-to-face and telemedicine delivery (via the AASM SleepTM platform) of CBT for insomnia for improving sleep and daytime functioning at post-treatment and 12-week follow-up.

Methods
Sixty-five adults with chronic insomnia (46 women, mean age 47.2 ± 16.3 years) were recruited primarily from insomnia clinics and screened for disqualifying sleep, medical, and mental health disorders. Eligible participants were randomized to 6 sessions of CBT for insomnia delivered face-to-face (n=32) or via AASM SleepTM (n=33). Participants completed self-report measures of insomnia (Insomnia Severity Index, ISI) and daytime functioning (fatigue, depression, anxiety, and overall functioning) at pre-treatment, post-treatment, and 12-week follow-up. The ISI was the primary non-inferiority outcome.

Results
Telemedicine was non-inferior to face-to-face delivery of CBT for insomnia, based on a non-inferiority margin of 4 points on the ISI (β = -0.07, 95% CI -2.28 to 2.14). Compared to pre-treatment, ISI scores improved significantly at post-treatment (β = -9.02, 95% CI -10.56 to -7.47) and at 12-week follow-up (β = -9.34, 95% CI -10.89 to -7.79). Similarly, daytime functioning measures improved from pre- to post-treatment, with sustained improvements at 12-week follow-up. Scores on the fatigue scale were lower in the telemedicine group at both post-treatment (F=4.64, df=1,119, p&lt;.03) and follow-up (F=5.79, df=1,119, p&lt;.02).

Conclusion
Insomnia and daytime functioning improve similarly whether CBT for insomnia is delivered via telemedicine or face-to-face. Telemedicine delivery of CBT for insomnia should be implemented more systematically to improve access to this evidence-based treatment.

Support
American Sleep Medicine Foundation Grant # 168-SR-17 (JT Arnedt, PhD)
0533 Age and Education Level are Associated with Dropout from Cognitive-Behavioral Therapy for Insomnia in Participants with Co-Occurring Depression: A Report from the TRIAD Study
Authors: Dietch J R , Manber R , Buysse D J , Edinger J D , Krystal A 
Published: May 2020

Abstract

Introduction
Early termination (i.e., dropout) from cognitive-behavioral therapy for insomnia (CBT-I) likely attenuates benefits and may reduce motivation for future treatment. The aim of the current study was to identify characteristics of participants who dropped out of CBT-I in an RCT of combined treatment for depression and insomnia.

Methods
Participants were 148 adults with comorbid insomnia and depression diagnoses (73% female; M age = 46.6[SD = 12.6]) who were randomly assigned to receive depression pharmacotherapy plus 7 weekly sessions of CBT-I (n = 73) or a credible control therapy for insomnia (n = 75). Receiver operating characteristic curve (ROC) analyses were performed to determine which participant characteristics (i.e., demographics, baseline depression and sleep variables) predicted dropout at session 4 (i.e., minimum dose) and session 7 (i.e., full course of CBT-I).

Results
Early termination (prior to session 4) rate was 28% and ROC analyses indicated participants aged 36 or less were more likely to drop out than those older than 36 (49% vs. 22%). The model did not identify additional predictors for either of the two age categories. Overall termination (prior to session 7) rate was 45% and ROC analyses indicated participants aged 46 or less were more likely to drop out than those older than 46 (61% vs. 34%). The model further found that among participants aged 46 or less, those with less than 14y education were at greater risk for dropout than those with greater than 14y education (79% vs. 46%). No other demographic, depression, or sleep variables were significant predictors of dropout.

Conclusion
Age was associated with elevated rate of dropout from CBT-I among individuals with co-occurring depression and insomnia. It appears that the combination of younger age and lower education level is particularly detrimental to treatment engagement. Better understanding of factors that contribute to dropout from CBT-I in this vulnerable group can guide development of retention strategies.

Support
MH078924, MH078961, MH079256
0540 Insomnia Symptom Trajectories During and Following Combined Treatment for Insomnia and Depression: A Report from the Triad Study
Authors: Atwood M E , Dietch J R , Buysse D J , Edinger J D , Krystal A , Manber R 
Published: May 2020

Abstract

Introduction
Cognitive behavioral therapy for insomnia (CBT-I) reduces insomnia severity among individuals with insomnia and major depressive disorder (MDD). Understanding the long-term trajectories of insomnia symptom severity has the potential to inform optimization of CBT-I in this population. The objectives of this study were to examine trajectories of change in insomnia severity over a 16-week treatment phase and 2-year naturalistic follow-up, and explore correlates of symptom trajectories.

Methods
148 adults (age 46.6±12.6, 73.0% female) with insomnia and MDD were randomly assigned to receive depression pharmacotherapy plus seven sessions of either CBT-I or control insomnia therapy. Depression and insomnia severity were assessed via the Hamilton Depression Rating Scale and Insomnia Severity Index at baseline, bi-weekly during treatment, and every 4 months over follow-up. Sleep effort and beliefs about sleep were assessed at baseline, midtreatment, and posttreatment.

Results
Latent class linear mixed modeling revealed four insomnia response trajectories: 1) Early Sustained-Responders (16%) showed marked improvement early in treatment, sustained over follow-up; 2) Gradual-Responders (36.7%) achieved substantial symptom reduction by posttreatment, sustained over follow-up; 3) Initial-Responders (25.3%) had substantial symptom reduction during treatment but increased in severity over follow-up; and 4) Partial-Responders (20.7%) achieved minimal improvement over treatment, and maintained moderate symptom severity over follow-up. Chi-square analyses revealed that classes did not differ significantly on sex, ethnicity, employment, relationship status, or treatment received (all ps &gt; .05). One-way ANOVAs with Tukey’s HSD, showed that Partial-Responders consistently endorsed higher depressive symptom severity, sleep effort, and unhelpful beliefs about sleep at baseline, throughout treatment, and follow-up (ps &lt; .05). Early Sustained-Responders endorsed lower sleep effort by midtreatment (ps &lt; .01).

Conclusion
Results suggest four temporal patterns of treatment response and identified clinical correlates. Future work will be needed to determine if addressing sleep effort early in the course of treatment might enhance sustained insomnia outcome.

Support
MH078924, MH078961, MH079256
0546 Sleep Science at Home - Delivering Sleep Assessment and Digital CBT-i at Scale
Authors: Arnal P J , Thorey V , Debellemaniere E , Mordret E , Llamosi A , Chouraki A 
Published: May 2020

Abstract

Introduction
Cognitive-behavioral therapy for insomnia (CBT-I) is the current first-line treatment for insomnia disorder, recommended by the AASM and SRS. Digital versions of CBT-I have been developed and validated to address the need for implementation at scale but still suffer from poor accessibility and compliance. Therefore, the aim of this open-label, Real-World Study (RWS) was to assess the engagement and efficacy of a next-generation CBT-i 6-weeks program.

Methods
1304 subjects were included in the analysis between Dec 23rd, 2018 and December, 14th 2019. The main inclusion criteria were having an Insomnia Severity Index ISI ≥ 15 and completion of one week of Dreem program. The variables have been measured by the Dreem headband (DH) for objective variables, and on subjects’ answers to questionnaires for subjective ones.

Results
The retention during this RWS was 70.4 % (Pre: n = 1304 and Week 4: n = 935). The program led to a clinically significant decrease of 7.42 points on the ISI (p &lt; 0.001). The obj-WASO was reduced by 35% (n = 359, p &lt; 0.001), obj-Awakenings were reduced by 37% (n = 359 p &lt; 0.001), obj-SE was increased by 2.56 points (n = 305, p &lt; 0.001) and obj-SOL was reduced by 22% (n = 359, p &lt; 0.001). The subj-SOL was reduced by 41% (n = 176, p &lt; 0.001), subj-SE was increased by 8.9 points (n =168, p &lt; 0.001), subj-SD was increased by 16% (baseline: 307.50 ± 88.86 min; post 357.07 ± 91.24 min, subj-SD (n = 174, p &lt; 0.001).

Conclusion
The results of this RWS suggest this insomnia program has a high engagement compared to other digital CBT-I programs and is as effective as traditional in-person CBT-I. This new generation of Insomnia therapy combining hardware, software and therapist serves as an efficient and engaging treatment implementable at scale.

Support
This study has been supported by Dreem sas.