Effectiveness of Internet-Delivered Computerized Cognitive Behavioral Therapy for Patients With Insomnia Who Remain Symptomatic Following Pharmacotherapy: Randomized Controlled Exploratory Trial.

In reality, pharmacotherapy still remains the most common treatment for insomnia. This study aimed to examine the effectiveness of our internet-delivered computerized cognitive behavioral therapy (ICBT) program as an adjunct to usual care (UC) compared with UC alone in patients with insomnia who remain symptomatic following hypnotics. We recruited 23 patients with insomnia who remained symptomatic following pharmacologic treatment including benzodiazepines, and we conducted an exploratory randomized controlled trial. The primary outcome was the Pittsburgh Sleep Quality Index (PSQI) at week 6 of the treatment. Secondary outcomes were sleep onset latency, total sleep time, sleep efficiency, number of awakenings, refreshment and soundness of sleep, anxiety by Hospital Anxiety and Depression Scale, depression measured by the Center for Epidemiologic Studies Depression Scale, and quality of life (QOL) measured by the EuroQol-5D. All parameters were measured at weeks 0 (baseline), 6 (postintervention), and 12 (follow-up). The adjusted mean reduction (-6.11) in PSQI at week 6 from baseline in the ICBT plus UC group was significantly (P<.001) larger than the adjusted mean reduction (0.40) in the UC alone group. Significant differences were also found in favor of ICBT plus UC for PSQI, sleep onset latency, sleep efficiency, number of awakenings, and depression at all assessment points. Refreshment, soundness of sleep, anxiety, and QOL improved by week 6 in ICBT plus UC compared with UC alone. There were no reports of adverse events in either group during the study. These results indicated that our 6-week ICBT program is an effective treatment adjunct to UC for improving insomnia and related symptoms even after unsuccessful pharmacotherapy. University Hospital Medical Information Network Clinical Trials Registry: UMIN000021509; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023545 (Archived by WebCite at http://www.webcitation. org/75tCmwnYt).

Sato D ，Yoshinaga N ，Nagai E ，Nagai K ，Shimizu E ... -  《JOURNAL OF MEDICAL INTERNET RESEARCH》

Randomised controlled trial on the effect of internet-delivered computerised cognitive-behavioural therapy on patients with insomnia who remain symptomatic following hypnotics: a study protocol.

Insomnia has severe consequences for health. Primary care physicians in Japan commonly provide hypnotics, which is far from optimal. The recommended treatment for insomnia is cognitive-behavioural therapy (CBT). Access to trained therapists, however, is limited. Rather than face-to-face CBT, several researchers have studied internet-delivered computerised CBT (ICBT). This paper describes the study protocol for a randomised controlled trial (RCT) to evaluate effectiveness and feasibility of our newly developed five-step ICBT as an adjunct to usual care (UC) compared with UC alone for patients with insomnia who remain symptomatic following hypnotics. This proposed exploratory RCT comprises two parallel groups (ICBT+UC and UC alone) consisting of 15 participants each (n=30) diagnosed with insomnia who remain symptomatic after pharmacotherapy. We aim to evaluate the effectiveness of six intervention weeks. The primary outcome of insomnia severity will be the Pittsburgh Sleep Quality Index (PSQI) at week 6. Secondary outcomes include sleep onset latency, total sleep time, sleep efficiency extracted from PSQI, current feeling of refreshment and perceived soundness of sleep measured using visual analogue scale, number of awakenings, anxiety by Hospital Anxiety and Depression Scale, depression by Center for Epidemiologic Studies Depression Scale and quality of life by Euro Qol-5D. All measures will be assessed at weeks 0 (baseline), 6 (postintervention) and 12 (follow-up), and intention-to-treat analysis will be applied. The statistical analysis plan has been developed considering design of field materials. This study will be conducted at the academic outpatient clinic of Chiba University Hospital, Japan. Ethics approval was granted by the Institutional Review Board of Chiba University Hospital. All participants will be required to provide written informed consent. The trial will be implemented and reported in accordance with Consolidated Standards of Reporting Trials recommendations. UMIN000021509; Pre-results.

Sato D ，Yoshinaga N ，Nagai E ，Hanaoka H ，Sato Y ，Shimizu E ... -  《BMJ Open》

Effectiveness of Unguided Internet-Based Cognitive Behavioral Therapy and the Three Good Things Exercise for Insomnia: 3-Arm Randomized Controlled Trial.

The treatment of insomnia with sleep medication causes problems such as long-term use, dependence, and significant economic losses, including medical expenses. Evidence-based lifestyle guidance is required to improve insomnia symptoms not only in person but also in easy-to-use web-based formats. This study aims to clarify whether unguided internet-based cognitive behavioral therapy (ICBT) or the Three Good Things (TGT) exercise, both administered as self-help internet interventions without email support, could improve insomnia symptoms compared with a waiting list control (WLC) group. A 4-week program was implemented, and participants were randomly allocated to 1 of the 3 groups. The primary outcome measure was the Pittsburgh Sleep Questionnaire (PSQI) score at 4 weeks compared with baseline. Of the 21,394 individuals invited to participate, 312 (1.46%) met the eligibility criteria and were randomly assigned to 1 of the 3 groups. Of these 312 individuals, 270 (86.5%; ICBT 79/270, 29.3%; TGT 88/270, 32.6%; and WLC 103/270, 38.1%) completed a postintervention survey at 4 and 8 weeks. The adjusted mean changes of the primary outcome measure (PSQI) in the ICBT (-1.56, 95% CI -2.52 to -0.59; P<.001) and TGT (-1.15, 95% CI -2.08 to -0.23; P=.002) groups at 4 weeks from baseline showed a significant improvement compared with the WLC group. The adjusted mean changes in the secondary outcome measures of sleep onset latency, total sleep time, Athens Insomnia Scale score, and Patient Health Questionnaire-9 score at 4 weeks from baseline, as well as in the PSQI at 8 weeks from baseline, showed significant improvement for ICBT. Moreover, total sleep time, Athens Insomnia Scale, and Patient Health Questionnaire-9 scores at 4 weeks from baseline showed a significant improvement in the TGT group compared with the WLC group. A total of 4 weeks of unguided ICBT and TGT exercises improved insomnia. University Hospital Medical Information Network Clinical Trial Registry UMIN000034927; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039814.

Sato D ，Sekizawa Y ，Sutoh C ，Hirano Y ，Okawa S ，Hirose M ，Takemura R ，Shimizu E ... -  《JOURNAL OF MEDICAL INTERNET RESEARCH》

Differences in the Effect of Internet-Based Cognitive Behavioral Therapy for Improving Nonclinical Depressive Symptoms Among Workers by Time Preference: Randomized Controlled Trial.

Previous randomized controlled trials (RCTs) have shown a significant intervention effect of internet-based computerized cognitive behavioral therapy (iCBT) on improving nonclinical depressive symptoms among healthy workers and community residents in a primary prevention setting. Time preference is one's relative valuation for having a reward (eg, money) at present than at a later date. Time preference may affect the effectiveness of cognitive behavioral therapy. This RCT aimed to test the difference of intervention effect of an iCBT program on improving nonclinical depressive symptoms between two subgroups classified post-hoc on the basis of time preference among workers in Japan. All workers in one corporate group (approximate n=20,000) were recruited. Participants who fulfilled the inclusion criteria were randomly allocated to either intervention or control groups. Participants in the intervention group completed 6 weekly lessons and homework assignments within the iCBT program. The Beck Depression Inventory-II (BDI-II) and Kessler's Psychological Distress Scale (K6) measures were obtained at baseline and 3-, 6-, and 12-month follow-ups. Two subgroups were defined by the median of time preference score at baseline. Only few (835/20,000, 4.2%) workers completed the baseline survey. Of the 835 participants, 706 who fulfilled the inclusion criteria were randomly allocated to the intervention or control group. Participants who selected irrational time preference options were excluded (21 and 18 participants in the intervention and control groups, respectively). A three-way interaction (group [intervention/control] × time [baseline/follow-up] × time preference [higher/lower]) effect of iCBT was significant for BDI-II (t1147.42=2.33, P=.02) and K6 (t1254.04=2.51, P=.01) at the 3-month follow-up, with a greater effect of the iCBT in the group with higher time preference. No significant three-way interaction was found at the 6- and 12-month follow-ups. The effects of the iCBT were greater for the group with higher time preference at the shorter follow-up, but it was leveled off later. Workers with higher time preference may change their cognition or behavior more quickly, but these changes may not persist. UMIN Clinical Trials Registry UMIN000014146; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi? recptno=R000016466 (Archived by WebCite at http://www.webcitation.org/70o2rNk2V).

Imamura K ，Furukawa TA ，Matsuyama Y ，Shimazu A ，Kuribayashi K ，Kasai K ，Kawakami N ... -  《JOURNAL OF MEDICAL INTERNET RESEARCH》

Internet-Delivered Cognitive Behavioral Therapy for Insomnia Comorbid With Chronic Pain: Randomized Controlled Trial.

Patients with chronic pain often experience insomnia symptoms. Pain initiates, maintains, and exacerbates insomnia symptoms, and vice versa, indicating a complex situation with an additional burden for these patients. Hence, the evaluation of insomnia-related interventions for patients with chronic pain is important. This randomized controlled trial examined the effectiveness of internet-based cognitive behavioral therapy for insomnia (ICBT-i) for reducing insomnia severity and other sleep- and pain-related parameters in patients with chronic pain. Participants were recruited from the Swedish Quality Registry for Pain Rehabilitation. We included 54 patients (mean age 49.3, SD 12.3 years) who were randomly assigned to the ICBT-i condition and 24 to an active control condition (applied relaxation). Both treatment conditions were delivered via the internet. The Insomnia Severity Index (ISI), a sleep diary, and a battery of anxiety, depression, and pain-related parameter measurements were assessed at baseline, after treatment, and at a 6-month follow-up (only ISI, anxiety, depression, and pain-related parameters). For the ISI and sleep diary, we also recorded weekly measurements during the 5-week treatment. Negative effects were also monitored and reported. Results showed a significant immediate interaction effect (time by treatment) on the ISI and other sleep parameters, namely, sleep efficiency, sleep onset latency, early morning awakenings, and wake time after sleep onset. Participants in the applied relaxation group reported no significant immediate improvements, but both groups exhibited a time effect for anxiety and depression at the 6-month follow-up. No significant improvements on pain-related parameters were found. At the 6-month follow-up, both the ICBT-i and applied relaxation groups had similar sleep parameters. For both treatment arms, increased stress was the most frequently reported negative effect. In patients with chronic pain, brief ICBT-i leads to a more rapid decline in insomnia symptoms than does applied relaxation. As these results are unique, further research is needed to investigate the effect of ICBT-i on a larger sample size of people with chronic pain. Using both treatments might lead to an even better outcome in patients with comorbid insomnia and chronic pain. ClinicalTrials.gov NCT03425942; https://clinicaltrials.gov/ct2/show/NCT03425942.

Wiklund T ，Molander P ，Lindner P ，Andersson G ，Gerdle B ，Dragioti E ... -  《JOURNAL OF MEDICAL INTERNET RESEARCH》