Efficacy of a Self-Help Web-Based Recovery Training in Improving Sleep in Workers: Randomized Controlled Trial in the General Working Population.

BACKGROUND: Sleep complaints are among the most prevalent health concerns, especially among workers, which may lead to adverse effects on health and work. Internet-delivered cognitive behavioral therapy for insomnia (iCBT-I) offers the opportunity to deliver effective solutions on a large scale. The efficacy of iCBT-I for clinical samples has been demonstrated in recent meta-analyses, and there is evidence that iCBT-I is effective in the working population with severe sleep complaints. However, to date, there is limited evidence from randomized controlled trials that iCBT-I could also be an effective tool for universal prevention among the general working population regardless of symptom severity. Although increasing evidence suggests that negatively toned cognitive activity may be a key factor for the development and maintenance of insomnia, little is known about how iCBT-I improves sleep by reducing presleep cognitive activity. OBJECTIVE: This study aimed to examine the efficacy of a self-help internet-delivered recovery training, based on principles of iCBT-I tailored to the work-life domain, among the general working population. General and work-related cognitive activities were investigated as potential mediators of the intervention's effect. METHODS: A sample of 177 workers were randomized to receive either the iCBT-I (n=88) or controls (n=89). The intervention is a Web-based training consisting of six 1-week modules. As the training was self-help, participants received nothing but technical support via email. Web-based self-report assessments were scheduled at baseline, at 8 weeks, and at 6 months following randomization. The primary outcome was insomnia severity. Secondary outcomes included measures of mental health and work-related health and cognitive activity. In an exploratory analysis, general and work-related cognitive activities, measured as worry and work-related rumination, were investigated as mediators. RESULTS: Analysis of the linear mixed effects model showed that, relative to controls, participants who received iCBT-I reported significantly lower insomnia severity scores at postintervention (between-group mean difference -4.36; 95% CI -5.59 to - 3.03; Cohen d=0.97) and at 6-month follow-up (between-group difference: -3.64; 95% CI -4.89 to -2.39; Cohen d=0.86). The overall test of group-by-time interaction was significant (P<.001). Significant differences, with small-to-large effect sizes, were also detected for cognitive activity and for mental and work-related health, but not for absenteeism. Mediation analysis demonstrated that work-related rumination (indirect effect: a1b1=-0.80; SE=0.34; 95% boot CI -1.59 to -0.25) and worry (indirect effect: a2b2=-0.37; SE=0.19; 95% boot CI -0.85 to -0.09) mediate the intervention's effect on sleep. CONCLUSIONS: A self-help Web-based recovery training, grounded in the principles of iCBT-I, can be effective in the general working population, both short and long term. Work-related rumination may be a particularly crucial mediator of the intervention's effect, suggesting that tailoring interventions to the workplace, including components to reduce the work-related cognitive activity, might be important when designing recovery interventions for workers. TRIAL REGISTRATION: German Clinical Trials Register DRKS00007142; https://www.drks.de/DRKS00007142.

The Efficacy of Web-Based Cognitive Behavioral Therapy With a Shame-Specific Intervention for Social Anxiety Disorder: Randomized Controlled Trial.

Background: Social anxiety disorder (SAD) is one of the most prevalent psychological disorders and generally co-occurs with elevated shame levels. Previous shame-specific interventions could significantly improve outcomes in social anxiety treatments. Recent review suggests that integrating a more direct shame intervention could potentially increase the effectiveness of cognitive behavioral therapy. Web-based cognitive behavioral therapy (WCBT) has proven efficacy, sustaining benefits for 6 months to 4 years. Previous evidence indicated that shame predicted the reduction of social anxiety and mediated between engagements in exposure and changes in social anxiety during WCBT. Objective: This study aimed to design a shame intervention component through a longitudinal study and conduct a randomized controlled trial to investigate the effectiveness of a shame intervention component in reducing social anxiety symptoms and shame experience in a clinical sample of people with SAD. Methods: The development of a shame intervention component was informed by cognitive behavioral principles and insights from longitudinal data that measured the Experience of Shame Scale (ESS), the Coping Styles Questionnaire, and the Social Interaction Anxiety Scale (SIAS) in 153 participants. The psychoeducation, cognitive construct, and exposure sections were tailored to focus more on shame-related problem-solving and self-blame. A total of 1220 participants were recruited to complete questionnaires, including the ESS, the SIAS, the Social Phobia Scale (SPS), and diagnostic interviews. Following a 2-round screening process, 201 participants with SAD were randomly assigned into a shame WCBT group, a normal WCBT group, and a waiting group. After the 8-week WCBT intervention, the participants were asked to complete posttest evaluations, including the ESS, SIAS and SPS. Results: Participants in the shame WCBT group experienced significant reductions in shame levels after the intervention (ESS: P<.001; ηp2=0.22), and the reduction was greater in the shame intervention group compared to normal WCBT (P<.001; mean deviation -12.50). Participants in both the shame WCBT and normal WCBT groups experienced significant reductions in social anxiety symptoms (SIAS: P<.001; ηp2=0.32; SPS: P<.001; ηp2=0.19) compared to the waiting group after intervention. Furthermore, in the experience of social interaction anxiety (SIAS), the shame WCBT group showed a higher reduction compared to the normal WCBT group (P<.001; mean deviation -9.58). Problem-solving (SE 0.049, 95% CI 0.025-0.217) and self-blame (SE 0.082, 95% CI 0.024-0.339) mediated the effect between ESS and SIAS. Conclusions: This is the first study to design and incorporate a shame intervention component in WCBT and to validate its efficacy via a randomized controlled trial. The shame WCBT group showed a significant reduction in both shame and social anxiety after treatment compared to the normal WCBT and waiting groups. Problem-solving and self-blame mediated the effect of shame on social anxiety. In conclusion, this study supports previous findings that a direct shame-specific intervention component could enhance the efficacy of WCBT.

Nurse-Supported Web-Based Cognitive Behavioral Therapy for Chronic Musculoskeletal Pain: A Randomized Controlled Trial.

BACKGROUND: Web-based cognitive behavioral therapy (CBT) has increased access to effective pain management. Though efficacy of web-based and face-to-face CBT may be comparable, fewer studies have examined whether remote clinical support in addition to web-based CBT can improve pain-related outcomes. OBJECTIVES: The objectives of this study were to determine if the addition of phone-based support to web-based CBT could enhance pain-related outcomes in patients with chronic musculoskeletal pain (CMP). STUDY DESIGN: Randomized controlled clinical trial. SETTING: The internal medicine and rheumatology clinics at Atrium Health Wake Forest Baptist. METHODS: Patients were recruited from a major academic medical center. Sixty patients were randomized to web-based CBT with 6 phone calls (nurse support group, n = 30) vs web-based CBT alone (control group, n = 30). The purpose of the calls was to enhance patients' engagement in the online program. All patients had access to the program from baseline to week 16. Outcome measures were collected at baseline, week 8, and week 16. Adjusting for baseline measurements, analysis of covariance  was used to determine within- and between-group differences. RESULTS: Both nurse support and control groups demonstrated significant within-group improvements in Brief Pain Inventory (BPI) pain interference (-1.3 [-2.0, -0.7, P < 0.05] and -1.7 [-2.3, -1.0, P < 0.05]), BPI pain intensity (-1.2 [-1.7, -0.6, P < 0.05] and -1.3 [-1.8, -0.8, P < 0.05]), Patient-Reported Outcomes Measurement System (PROMIS) pain interference (-5.0 [-6.9, -3.2, P < 0.05] and -5.4 [-7.2, -3.5, P < 0.05]), and PROMIS pain intensity (-1.4 [-2.0, -0.9, P < 0.05] and -1.4 [-1.9, -0.8, P < 0.05]), respectively. However, there were no significant between-group differences amongst the 2 treatment groups in all measures, except PROMIS sleep disturbance that favored the nurse support group (50.5 ± 1.3 vs 54.3 ± 1.3, P < 0.05). LIMITATIONS: Small sample size and lack of treatment fidelity assessment. CONCLUSIONS: Web-based CBT was effective with and without motivational support from nurses. Phone-based support did not enhance pain-related outcomes of web-based CBT. If confirmed in a larger study, web-based CBT without motivational support may be considered as a low-cost treatment intervention for patients with CMP.

Detecting and Treating Psychosocial and Lifestyle-Related Difficulties in Chronic Disease: Development and Treatment Protocol of the E-GOAL eHealth Care Pathway.

Many patients with lifestyle-related chronic diseases find it difficult to adhere to a healthy and active lifestyle, often due to psychosocial difficulties. The aim of the current study was to develop an eHealth care pathway aimed at detecting and treating psychosocial and lifestyle-related difficulties that fits the needs and preferences of individual patients across various lifestyle-related chronic diseases. Each intervention component was developed by (1) developing initial versions based on scientific evidence and/or the Behavior Change Wheel; (2) co-creation: acquiring feedback from patients and health professionals; and (3) refining to address users' needs. In the final eHealth care pathway, patients complete brief online screening questionnaires to detect psychosocial and lifestyle-related difficulties, i.e., increased-risk profiles. Scores are visualized in personal profile charts. Patients with increased-risk profiles receive complementary questionnaires to tailor a 3-month guided web-based cognitive behavioral therapy intervention to their priorities and goals. Progress is assessed with the screening tool. This systematic development process with a theory-based framework and co-creation methods resulted in a personalized eHealth care pathway that aids patients to overcome psychosocial barriers and adopt a healthy lifestyle. Prior to implementation in healthcare, randomized controlled trials will be conducted to evaluate its cost-effectiveness and effectiveness on psychosocial, lifestyle, and health-related outcomes.