Caregiver Experiences With an Internet-Delivered Insomnia Intervention: SHUTi-CARE Trial Primary Qualitative Analysis.

BACKGROUND: Digital health interventions show potential to increase caregivers' access to psychosocial care; however, it is unclear to what extent existing interventions may need to be tailored to meet caregivers' unique needs. PURPOSE: This study aimed to determine whether-and if so, how-an efficacious Internet-delivered insomnia program should be modified for caregivers. The generalizability of these findings beyond the tested program was also examined. METHODS: Higher-intensity family caregivers (N = 100; age M = 52.82 [SD = 13.10], 75% non-Hispanic White, 66% ≥college degree) received access to an Internet-based cognitive-behavioral therapy for insomnia (CBT-I) program. Participants who completed one or more intervention "Cores" provided open-ended feedback on their experience; nonusers (completed no Cores) shared their barriers. RESULTS: Most caregivers who used the program (n = 82, 82%) found it feasible, citing its user-friendly, fully automated online format. Many reported that CBT-I strategies were helpful, although some faced challenges in implementing these strategies due to the unpredictability of their caregiving responsibilities. Opinions were divided on the utility of tailoring the program for caregivers. Nonusers (n = 18, 18%) primarily cited concerns about time burden and lifestyle compatibility as usage barriers. CONCLUSIONS: Delivering fully automated behavioral interventions through the Internet appears suitable for many caregivers. Extensive tailoring may not be required for most caregivers to benefit from an existing online CBT-I program, although additional guidance on integrating CBT-I strategies in the context of challenging sleep schedules and environments may help a subset of caregivers. Future research should explore how such tailoring may enhance digital health intervention uptake and effectiveness for caregivers.

This study examined family caregivers' experiences using an online cognitive-behavioral therapy for insomnia program. The aim was to determine if the program needed changes to better fit caregivers' needs. Researchers gave 100 caregivers with insomnia access to Sleep Healthy Using the Internet (SHUTi), an online insomnia program that had no caregiver-specific tailoring. Of the 82 caregivers who used the program, most found the program easy to use and helpful, although some struggled with behavioral strategies because of their unpredictable caregiving duties. There was no clear consensus among caregivers on whether tailoring would be helpful. The 18 caregivers who did not use the program most commonly said that they did not have enough time to use the program or that they felt it would not work well with their lifestyle. Overall, findings suggest that providing interventions via the Internet is a good fit for many caregivers. Many caregivers benefitted from an online insomnia program without being tailored specifically for caregivers, although some additional guidance on how to follow behavioral strategies may be helpful to some caregivers.

Caregivers' Internet-Delivered Insomnia Intervention Engagement and Benefit: SHUTi-CARE Trial Primary Quantitative Analysis.

BACKGROUND: Delivering insomnia treatment by the Internet holds promise for increasing care access to family caregivers, but their ability to adhere to and benefit from such fully-automated programs has not been rigorously tested. PURPOSE: This fully-powered, single-group trial tested whether characteristics of the caregiving context influence high-intensity caregivers' engagement with and benefit from an empirically validated Internet intervention for insomnia. METHODS: At baseline, caregivers providing unpaid time- and responsibility-intensive care who reported insomnia (N = 100; age M = 52.82 [SD = 13.10], 75% non-Hispanic white, 66% ≥college degree) completed questionnaires about caregiving context and sleep, then 10 prospectively-collected online daily sleep diaries. Caregivers then received access to SHUTi (Sleep Healthy Using the Internet), which has no caregiver-specific content, for 9 weeks, followed by post-assessment (questionnaires, diaries). Engagement was tracked by the SHUTi delivery system. RESULTS: Sixty caregivers completed SHUTi, 22 initiated but did not complete SHUTi, and 18 did not initiate SHUTi. Caregivers were more likely to use SHUTi (than not use SHUTi) when their care recipient (CR) had worse functioning, and were more likely to complete SHUTi when supporting more CR activities of daily living (ADL; ps < .03). Higher caregiver guilt, more CR problem behaviors, and being bedpartners with the CR related to more improved sleep outcomes, whereas supporting more CR instrumental ADL related to less improvement (ps < .05). CONCLUSIONS: Factors associated with greater caregiving burden, including greater CR impairment and caregiving guilt, were generally associated with better engagement and outcomes. Caregivers with substantial burdens can adhere to and benefit from a fully automated insomnia program without caregiver-specific tailoring.

This study examined how family caregivers, who often have trouble sleeping due to their responsibilities, used an online insomnia treatment program. The goal was to determine if certain aspects of caregiving would influence how caregivers engage with or benefit from the program. Researchers surveyed 100 caregivers with insomnia about their caregiving situation and sleep, and caregivers also kept online sleep diaries for 10 days. Afterward, caregivers used an online insomnia program with no caregiver-specific content called Sleep Healthy Using the Internet (SHUTi) for 9 weeks. Caregivers' usage was monitored, and they repeated measures of sleep outcomes and 10 online sleep diaries. Sixty caregivers completed SHUTi, 22 partially completed the program, and 18 did not initiate the program. Caregivers who cared for individuals with more severe functional limitations were more likely to use and complete SHUTi. Additionally, caregivers experiencing more guilt and those who managed more challenging behaviors from the person they cared for tended to report greater improvements in their sleep. This study suggests that caregivers, even those with significant care responsibilities, can use and benefit from an online insomnia treatment program like SHUTi, even when it has not been specifically tailored for caregivers.

Efficacy of an Internet- and Mobile-Based Intervention for Subclinical Anxiety and Depression (ICare Prevent) with Two Guidance Formats: Results from a Three-Armed Randomized Controlled Trial.

INTRODUCTION: Limited research exists on intervention efficacy for comorbid subclinical anxiety and depressive disorders, despite their common co-occurrence. Internet- and mobile-based interventions (IMIs) are promising to reach individuals facing subclinical symptoms. OBJECTIVE: This study aimed to evaluate the efficacy of a transdiagnostic and self-tailored IMI in reducing subclinical anxiety and depressive symptom severity with either individualized (IG-IMI) or automated (AG-IMI) guidance compared to a waitlist control group with care-as-usual access (WLC). METHODS: Participants included 566 adults with subclinical anxiety (GAD-7 ≥ 5) and/or depressive (CES-D ≥16) symptoms, who did not meet criteria for a full-syndrome depressive or anxiety disorder. In a three-arm randomized clinical trial, participants were randomized to a cognitive behavioral 7-session IMI plus booster session with IG-IMI (n = 186) or AG-IMI (n = 189) or WLC (n = 191). Primary outcomes included observer-rated anxiety (HAM-A) and depressive (QIDS) symptom severity 8 weeks after randomization assessed by blinded raters via telephone. Follow-up outcomes at 6 and 12 months are reported. RESULTS: Symptom severity was significantly lower with small to medium effects in IG-IMI (anxiety: d = 0.45, depression: d = 0.43) and AG-IMI (anxiety: d = 0.31, depression: d = 0.32) compared to WLC. No significant differences emerged between guidance formats in primary outcomes. There was a significant effect in HAM-A after 6 months favoring AG-IMI. On average, participants completed 85.38% of IG-IMI and 77.38% of AG-IMI. CONCLUSIONS: A transdiagnostic, self-tailored IMI can reduce subclinical anxiety and depressive symptom severity, but 12-month long-term effects were absent. Automated guidance holds promise for enhancing the scalability of IMIs in broad prevention initiatives.

Investigating Alexithymia as a Moderator of Outcomes in a Randomized Controlled Trial of an Online Intervention for Co-Occurring Depression and Hazardous Alcohol Use: Enquête sur l'alexithymie en tant que modérateur des résultats dans un essai randomisé contrôlé d'une intervention en ligne pour la dépression concomitante et la consommation dangereuse d'alcool.

OBJECTIVE: Alexithymia is characterized by difficulty identifying and/or describing emotions, reduced imaginal processes, and externally oriented thinking. High levels of alexithymia may increase the challenge of supporting individuals with co-occurring depression and hazardous alcohol use. This secondary analysis sought to investigate whether or not alexithymia moderated the outcomes of an online intervention for depression and alcohol use. METHOD: As part of a randomized controlled trial, 988 participants were randomly assigned to receive an intervention dually focused on depression and alcohol use, or an intervention only focused on depression. The pre-specified mediation hypothesis was that changes in drinking at 3 months follow-up would effect the association between the intervention and change in depression at 6 months. This secondary analysis extends the investigation by adding alexithymia as a moderator. RESULTS: The current analysis demonstrated that including alexithymia as a moderator resulted in a conditional direct effect. Specifically, there was an intervention effect where participants who received the combined depression and alcohol intervention had larger improvements in their depression scores at 6 months, but this was only when their alexithymia score at baseline was also high (60.5 or higher). CONCLUSION: These results suggest that treatment planning and intervention effectiveness could be informed and optimized by taking alexithymia severity into consideration. This is especially merited as alexithymia can contribute to the weaker therapeutic alliance, more distress and dysphoria, shorter periods of abstinence, and more severe depression, compounding the complexity of supporting individuals with comorbid conditions. More research is needed to systematically investigate these possible modifying effects. PLAIN LANGUAGE TITLE: Does difficulty identifying/describing emotions or externally-oriented thinking influence the effectiveness of an intervention among people with both depression and hazardous alcohol use?

In a recent study we recruited participants who were concerned with both their alcohol use and low mood. We provided two different online interventions. Half of the participants received an intervention designed for both concerns and half received an intervention that addressed only depression. We hypothesized that receiving the combined intervention for both concerns would result in greater benefits, however, our results indicated no apparent difference. This analysis uses the same data, but investigated the influences of alexithymia on the effectiveness of the interventions. Alexithymia is defined as having difficulty identifying/describing emotions and/or thinking more about external events than internal feelings. It commonly co-occurs with depression and with hazardous alcohol use and can increase the challenge of supporting individuals with these co-occurring concerns. The results of this analysis showed support for our original hypothesis that participants who received the intervention that addressed both their mood and alcohol concerns had lower depression scores 6-months later, but only among individuals who also had alexithymia scores above 60.5. Taking alexithymia severity into consideration during treatment planning may help optimize the effectiveness of interventions. These results show merit for future research to consider alexithymia as a variable that could potentially impact outcomes among individuals with co-occurring depression and hazardous alcohol use.

Internet- and mobile-based anxiety and depression interventions for children and adolescents: efficacy and negative effects - a systematic review and meta-analysis.

Mental disorders, most commonly anxiety disorders and fourth most common depression, are prevalent in children and adolescents. Internet- and mobile-based interventions might represent a scalable approach to improve mental health care, however, evidence so far is inconclusive and systematic reports on negative effects are missing. Four data-bases were searched for randomized controlled trials evaluating internet- and mobile-based interventions (IMIs) targeting anxiety disorders or depression in children and adolescents up to 18 years exhibiting clinically relevant symptoms. Meta-analytic evaluations were conducted in comparison to active and passive control groups, furthermore, pre-defined sub-groups were explored and reported negative effects examined. Pooled estimates showed a moderate positive effect for IMIs targeting anxiety disorders compared to passive control groups (g = -0.69; CI -0.94 to -0.45; k = 8; n = 559; p ≤ 0,001), but not for depression. Pooled estimates compared to active control groups remained non-significant. Subgroup analyses were largely omitted due to an insufficient number of trials or were non-significant. Negative effects were mainly reported as drop-out rates and (non)-response rates, while additional negative effects, such as deterioration rates or the development of additional symptoms, were reported by only one third of included studies. The focus on children and adolescents with clinically relevant symptoms allowed the present findings to complement previous work, however, the limited amount of trials hindered many planned comparisons. The overview of reported negative effects highlighted that negative effects are being neglected in the majority of RCTs. Hence, in the future RCTs should include more information about potential negative effects, at best a combination of quantitative and qualitative information. Open Science Framework (osf.io/ch5nj).

Cost-effectiveness analysis of a psychosocial web-based intervention for adolescents distressed by a visible difference: Results from a randomized controlled trial in Norway.

Adolescents with a visible difference to the face or body (e.g., due to a congenital condition, illness, or injury), may be at risk of elevated psychological distress. Young Person's Face IT (YPF), a web-based psychosocial intervention, has displayed effectiveness, but no previous study has specifically evaluated its cost-effectiveness. The aim of our study was to investigate whether YPF could be a cost-effective alternative for psychosocial support to adolescents distressed by a visible difference, relative to care-as-usual (CAU). Within the context of a randomized controlled trial in Norway, 102 participants (43% boys) were allocated to intervention (n = 55) or waiting list control group (n = 47). Mean age was 13.9 years (SD = 1.71; range 11-18), and all self-identified as experiencing distress related to a visible difference. Participants answered questionnaires including measures of health-related quality of life and social anxiety at baseline and 3-month follow-up. A health economic evaluation using the method of cost-utility analysis was performed, including quality-adjusted life-years (QALYs). Results indicated that the incremental cost-effectiveness of YPF was 63,641 Norwegian kroner per QALYs gained, which is well within the acceptability threshold in the Norwegian healthcare sector. Hence, YPF could potentially be considered a cost-effective intervention for adolescents experiencing distress related to a visible difference, but more research is needed that includes comparisons of YPF to other health- and societal resources and long-term follow-ups. Our study also constitutes an addition to research as, compared to interventions for somatic diseases, there is a lack of studies exploring the cost-effectiveness of psychological interventions.

The Uptake and Effectiveness of a Multidisciplinary Online Program for Managing Chronic Pain before and During the COVID-19 Pandemic.

OBJECTIVES: Societal and health system pressures associated with the coronavirus disease 2019 (COVID-19) pandemic exacerbated the burden of chronic pain and limited access to pain management services for many. Online multidisciplinary pain programs offer an effective and scalable treatment option, but have not been evaluated within the context of COVID-19. This study aimed to investigate the uptake and effectiveness of the Reboot Online chronic pain program before and during the first year of the COVID-19 pandemic. METHODS: Retrospective cohort analyses were conducted on routine service users of the Reboot Online program, comparing those who commenced the program during the COVID-19 pandemic (March 2020-March 2021), to those prior to the pandemic (April 2017-March 2020). Outcomes included the number of course registrations; commencements; completion rates; and measures of pain severity, interference, self-efficacy, pain-related disability, and distress. RESULTS: Data from 2,585 course users were included (n = 1138 pre-COVID-19 and n = 1,447 during-COVID-19). There was a 287% increase in monthly course registrations during COVID-19, relative to previously. Users were younger, and more likely to reside in a metropolitan area during COVID-19, but initial symptom severity was comparable. Course adherence and effectiveness were similar before and during COVID-19, with moderate effect size improvements in clinical outcomes post-treatment (g = 0.23-0.55). DISCUSSION: Uptake of an online chronic pain management program substantially increased during the COVID-19 pandemic. Program adherence and effectiveness were similar pre- and during-COVID. These findings support the effectiveness and scalability of online chronic pain management programs to meet increasing demand.

Web-based treatment for depression in pregnancy: a feasibility study of Mum2BMoodBooster.

BACKGROUND: Depression in pregnancy is prevalent, under-treated, and has serious impacts on the wellbeing of women and on child development. Internet programs can reach women who may not access traditional treatments due to distance, stigma or concern about taking medication. We adapted our online postnatal depression program, MumMoodBooster, for antenatal use. We aimed to trial feasibility, acceptability, and potential efficacy of the new Mum2BMoodBooster intervention with depressed pregnant women. METHODS: Twenty-seven pregnant women with Edinburgh Postnatal Depression Scale score > 11 used the program in a feasibility trial. Twenty-one had current diagnoses of major or minor depression on the Structured Clinical Interview for the DSM-IV. Assessment of symptoms occurred at screening/baseline, post-test (8 weeks post-enrollment), and at follow-up (3 months postpartum) using the Patient Health Questionnaire (PHQ-9) and the Depression Anxiety Stress Scales (DASS-21). RESULTS: In this feasibility trial, depression scores on both the PHQ-9 and the DASS-21, showed significant reductions representing large effects, with average symptom scores reduced by > 50%, and maintained in the 'minimal or no depression' range at 3 month follow-up. Anxiety scores also decreased significantly. Program usage was high with 74% of women visiting all six sessions. Program acceptability ratings were moderate to high. CONCLUSIONS: Findings paralleled the magnitude of symptom reductions seen in randomised trials of the postnatal MumMoodBooster program, suggesting that Mum2BMoodBooster is an effective treatment for depressed pregnant women. Effective internet therapies are likely to become increasingly important as the COVID-19 pandemic continues to make face-to-face access to health care problematic during 'lockdowns'.

Effect of internet-based cognitive behaviour therapy among women with negative birth experiences on mental health and quality of life - a randomized controlled trial.

BACKGROUND: Giving birth is often a positive experience, but 7-44% have negative experiences and about 4% develop posttraumatic stress disorder following childbirth (PTSD FC). This randomized controlled trial (RCT) investigated the effect of internet-based cognitive behaviour therapy (iCBT) for women with negative birth experiences and/or at risk for PTSD FC. METHODS: This was a superiority nonblinded multicentre RCT comparing iCBT combined with treatment as usual (TAU) with TAU only. Data were collected through questionnaires at baseline, at 6 weeks, 14 weeks and 1 year after randomization. The RCT was conducted at four delivery clinics in Sweden and participants were recruited from September 2013 until March 2018. Women who rated their childbirth experience as negative on a Likert scale, and/or had an immediate caesarean section or a haemorrhage of > 2000 ml were eligible. Primary outcomes were symptoms of posttraumatic stress (Traumatic Event Scale, TES) and symptoms of depression (Edinburgh Postnatal Depression Scale, EPDS). Secondary outcomes were satisfaction with life (Satisfaction With Life Scale, SWLS) and coping (Ways of Coping Questionnaire, WCQ). RESULTS: Out of 1810 eligible women, 266 women were randomised to iCBT+TAU (n = 132) or to TAU (n = 134). In the iCBT+TAU group 59 (45%) completed the treatment. ICBT+TAU did not reduce PTSD FC at 6 weeks, at 14 weeks, or at 1 year follow-up compared with TAU, according to the TES. Both the ITT and completer analyses showed significant time and quadratic time effects due to reduction of symptoms in both groups on the TES (re-experience subscale) and on the EPDS, and significant time effect on the self-controlling subscale of the WCQ (which increased over time). There was also a significant main effect of group on the SWLS where the TAU group showed higher initial satisfaction with life. Exploratory subgroup analyses (negative birth experience, immediate caesarean section, or severe haemorrhage) showed significant time effects among participants with negative birth experience on re-experience, arousal symptoms and depressive symptoms. CONCLUSIONS: The ICBT intervention did not show superiority as both groups showed similar beneficial trajectories on several outcomes up to 1 year follow-up. This intervention for women with negative birth experiences and/or at risk for PTSD FC was feasible; however, the study suffered from significant drop out rate. Future studies with more narrow inclusion criteria and possibly a modified intervention are warranted. TRIAL REGISTRATION: ISRCTN39318241. Date for registration 12/01/2017.

Effects of an internet-delivered insomnia intervention for older adults: A secondary analysis on symptoms of depression and anxiety.

OBJECTIVE: To test whether an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) program for older adults attenuates symptoms of depression and anxiety. METHODS: Adults aged ≥ 55 with insomnia were randomized to SHUTi-OASIS (Sleep Healthy Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness; N = 207) or Patient Education (PE; N = 104). Depression and anxiety were assessed (HADS-D and HADS-A, respectively) at baseline, post-assessment, and 6- and 12-month follow-ups. RESULTS: Multilevel modeling of HADS-D showed a condition by time interaction (F[3,779] = 3.23, p = .02): SHUTi-OASIS participants reported lower symptoms than PE at post-assessment. There was no such interaction effect for HADS-A (F[3,779] = 2.12, p = .10). Generalized linear modeling showed no moderation of effects by baseline symptom severity. CONCLUSIONS: Participants randomized to Internet-delivered CBT-I showed stable depression and anxiety across time, while control participants' depressive symptoms briefly increased. CBT-I may help prevent development or worsening of psychological distress among older adults with insomnia. TRIAL REGISTRATION: [Registered at ClinicalTrials.gov; identifier removed for anonymity].

Internet-Based Audiologist-Guided Cognitive Behavioral Therapy for Tinnitus: Randomized Controlled Trial.

BACKGROUND: Tinnitus is a symptom that can be very distressing owing to hearing sounds not related to any external sound source. Managing tinnitus is notoriously difficult, and access to evidence-based care is limited. Cognitive behavioral therapy (CBT) is a tinnitus management strategy with the most evidence of effectiveness but is rarely offered to those distressed by tinnitus. The provision of internet-based CBT for tinnitus overcomes accessibility barriers; however, it is not currently readily available in the United States. OBJECTIVE: The aim of this study is to investigate the efficacy of internet-based CBT compared with that of weekly monitoring for the management of tinnitus in reducing tinnitus distress; reducing tinnitus-related comorbidities, including tinnitus cognitions, insomnia, anxiety, and depression; and assessing the stability of the intervention effects 2 months after the intervention. METHODS: A 2-arm randomized clinical trial comparing audiologist-guided internet-based CBT (n=79) to a weekly monitoring group (n=79) with a 2-month follow-up assessed the efficacy of internet-based CBT. Eligible participants included adults seeking help for tinnitus. Recruitment was conducted on the web using an open-access website. Participants were randomized via 1:1 allocation, but blinding was not possible. The study was undertaken by English or Spanish speakers on the web. The primary outcome was a change in tinnitus distress as measured using the Tinnitus Functional Index. Secondary outcome measures included anxiety, depression, insomnia, tinnitus cognition, hearing-related difficulties, and quality of life. RESULTS: Internet-based CBT led to a greater reduction in tinnitus distress (mean 36.57, SD 22) compared with that in weekly monitoring (mean 46.31, SD 20.63; effect size: Cohen d=0.46, 95% CI 0.14-0.77) using an intention-to-treat analysis. For the secondary outcomes, there was a greater reduction in negative tinnitus cognition and insomnia. The results remained stable over the 2-month follow-up period. No important adverse events were observed. Further, 16% (10/158) of participants withdrew, with low overall compliance rates for questionnaire completion of 72.3% (107/148) at T1, 61% (91/148) at T2, and 42% (62/148) at T3. CONCLUSIONS: This study is the first to evaluate and indicate the efficacy of audiologist-delivered internet-based CBT in reducing tinnitus distress in a US population. It was also the first study to offer internet-based CBT in Spanish to accommodate the large Hispanic population in the United States. The results have been encouraging, and further work is indicated in view of making such an intervention applicable to a wider population. Further work is required to improve compliance and attract more Spanish speakers. TRIAL REGISTRATION: ClinicalTrials.gov NCT04004260; https://clinicaltrials.gov/ct2/show/NCT04004260.

Predictors of Dropout in a Digital Intervention for the Prevention and Treatment of Depression in Patients With Chronic Back Pain: Secondary Analysis of Two Randomized Controlled Trials.

BACKGROUND: Depression is a common comorbid condition in individuals with chronic back pain (CBP), leading to poorer treatment outcomes and increased medical complications. Digital interventions have demonstrated efficacy in the prevention and treatment of depression; however, high dropout rates are a major challenge, particularly in clinical settings. OBJECTIVE: This study aims to identify the predictors of dropout in a digital intervention for the treatment and prevention of depression in patients with comorbid CBP. We assessed which participant characteristics may be associated with dropout and whether intervention usage data could help improve the identification of individuals at risk of dropout early on in treatment. METHODS: Data were collected from 2 large-scale randomized controlled trials in which 253 patients with a diagnosis of CBP and major depressive disorder or subclinical depressive symptoms received a digital intervention for depression. In the first analysis, participants' baseline characteristics were examined as potential predictors of dropout. In the second analysis, we assessed the extent to which dropout could be predicted from a combination of participants' baseline characteristics and intervention usage variables following the completion of the first module. Dropout was defined as completing <6 modules. Analyses were conducted using logistic regression. RESULTS: From participants' baseline characteristics, lower level of education (odds ratio [OR] 3.33, 95% CI 1.51-7.32) and both lower and higher age (a quadratic effect; age: OR 0.62, 95% CI 0.47-0.82, and age2: OR 1.55, 95% CI 1.18-2.04) were significantly associated with a higher risk of dropout. In the analysis that aimed to predict dropout following completion of the first module, lower and higher age (age: OR 0.60, 95% CI 0.42-0.85; age2: OR 1.59, 95% CI 1.13-2.23), medium versus high social support (OR 3.03, 95% CI 1.25-7.33), and a higher number of days to module completion (OR 1.05, 95% CI 1.02-1.08) predicted a higher risk of dropout, whereas a self-reported negative event in the previous week was associated with a lower risk of dropout (OR 0.24, 95% CI 0.08-0.69). A model that combined baseline characteristics and intervention usage data generated the most accurate predictions (area under the receiver operating curve [AUC]=0.72) and was significantly more accurate than models based on baseline characteristics only (AUC=0.70) or intervention usage data only (AUC=0.61). We found no significant influence of pain, disability, or depression severity on dropout. CONCLUSIONS: Dropout can be predicted by participant baseline variables, and the inclusion of intervention usage variables may improve the prediction of dropout early on in treatment. Being able to identify individuals at high risk of dropout from digital health interventions could provide intervention developers and supporting clinicians with the ability to intervene early and prevent dropout from occurring.

Internet-based cognitive behavioural therapy for tinnitus in Spanish: a global feasibility trial.

OBJECTIVE: Internet-based cognitive behavioural therapy (ICBT) for tinnitus is an evidence-based intervention, but only available in a few languages. To increase accessibility, ICBT was translated into Spanish. This study's objective was to determine the feasibility of ICBT for Spanish speakers. DESIGN: A single-group pre-test post-test design was used. Compliance, engagement, acceptance and outcome feasibility were measured. STUDY SAMPLE: Forty-six Spanish speakers with tinnitus were screened. There were 32 participants meeting the eligibility criteria, with a mean age of 47 (±11) years. Of these 91% were Hispanic or Latino with 66% living in Spain and 34% living in South America. RESULTS: Outcome feasibility was established, as a large pre- and post-test within-group effect size of d = 0.90 was found for tinnitus severity. Large pre- and post-test effect sizes were also present for the secondary outcomes of anxiety and depression with a medium effect for insomnia, health-related quality of life, and tinnitus cognitions. Intervention engagement and compliance were not optimal although no participants withdrew. Intervention acceptance rates indicated scope for improvement. CONCLUSIONS: ICBT for Spanish communities appears to be feasible. A randomised controlled trial is required to further investigate the effects and identify ways of improving engagement and attracting Spanish speakers from different countries.

The impact of internet-based cognitive behaviour therapy for perfectionism on different measures of perfectionism: a randomised controlled trial.

The current study investigated the impact of an 8-module internet-based cognitive behaviour therapy for perfectionism (ICBT-P) across a variety of perfectionism subscales. Undergraduate students who identified as having a problem with perfectionism were randomized to receive the intervention (n = 41), and were free to choose the number of treatment modules they completed over a 4-week period, while the control group (N = 48) received access to treatment 8 weeks post-randomisation. Secondary measures included depression, anxiety, stress, body image and self-compassion. Assessments occurred at baseline, 2-, 4- and 8-week time points. A mean of 3.12 (SD = 2.67) modules were completed; 7 participants (17%) completed none and 6 (15%) completed all. Linear mixed modelling (with baseline observation included as a covariate) showed significant Bonferroni-adjusted post-hoc between-group differences for 5 of the 6 perfectionism measures, favouring the intervention group; the most robust between group effect sizes were for the Concern over Mistakes (d = -0.82), High Standards (d = -0.69), and Perfectionistic Standards (d = -0.47) subscales. There were no between-group differences for our secondary measures. ICBT-P was found to be an effective intervention for reducing different components of perfectionism compared to a control group. The relatively low use of modules may have contributed to a lack of effect on secondary measures.Australian New Zealand Clinical Trials Registry (ANZCTR) Trial Number: ACTRN12620000562976.

COVID-19 related differences in the uptake and effects of internet-based cognitive behavioural therapy for symptoms of obsessive-compulsive disorder.

BACKGROUND: The impacts of COVID-19 for people with obsessive-compulsive disorder (OCD) may be considerable. Online cognitive behavioural therapy (iCBT) programmes provide scalable access to psychological interventions, although the effectiveness of iCBT for OCD during COVID-19 has not been evaluated. AIM: This study investigated the uptake and effectiveness of iCBT for OCD (both self- and clinician-guided courses) during the first 8 months of the pandemic in Australia (March to October 2020) and compared outcomes with the previous year. METHOD: 1,343 adults (824/1343 (61.4%) female, mean age 33.54 years, SD = 12.00) commenced iCBT for OCD (1061 during the pandemic and 282 in the year before) and completed measures of OCD (Dimensional Obsessive-Compulsive Scale) and depression (Patient Health Questionaire-9) symptom severity, psychological distress (Kessler-10), and disability (WHO Disability Assessment Schedule) pre- and post-treatment. RESULTS: During COVID-19, there was a 522% increase in monthly course registrations compared with the previous year, with peak uptake observed between April and June 2020 (a 1191% increase compared with April to June 2019). OCD and depression symptom severity were similar for the COVID and pre-COVID groups, although COVID-19 participants were more likely to enrol in self-guided courses (versus clinician-guided). In both pre- and during-COVID groups, the OCD iCBT course was associated with medium effect size reductions in OCD (g = 0.65-0.68) and depression symptom severity (g = 0.56-0.65), medium to large reductions in psychological distress (g = 0.77-0.83) and small reductions in disability (g = 0.35-.50). CONCLUSION: Results demonstrate the considerable uptake of online psychological services for those experiencing symptoms of OCD during COVID-19 and highlight the scalability of effective digital mental health services.

Examining the 4-D Model in Persons Enrolled in the Top DD Internet Intervention.

The 4-dimensional (4-D) model of trauma-related dissociation differentiates between dissociative experiences involving trauma-related altered states of consciousness and symptoms of distress that do not appear to involve alterations in normal waking consciousness across four phenomenological dimensions (i.e., our experience of time, thought, body, and emotions). The current study evaluated hypotheses associated with the 4-D model using analyses of variance and correlation analyses in individuals with a primary diagnosis of a trauma-related dissociative disorder who were participating in the TOP DD internet study involving a combination of in-person psychotherapy and an online psychoeducational program (n = 111). Intrusive memories of traumatic events were more frequently endorsed than flashbacks, but emotional numbing was more frequently endorsed than other forms of affect dysregulation. Negative thoughts and emotion dysregulation were more strongly intercorrelated than were voice hearing and emotional numbing. Distress symptoms were more strongly associated with PTSD symptoms and difficulties in emotion regulation, whereas experiences of depersonalization were more strongly associated with dissociative self-states. Greater reduction in distress symptoms was also seen in comparison with trauma-related altered states of consciousness over the course of the combined psychotherapy and internet-based psychoeducational intervention. Overall, results continue to suggest that measures of distress and dissociative experiences can be distinguished by measures of symptom frequency, co-occurrence, and convergence with other measures of distress vs. dissociation albeit that results varied across the four phenomenological dimensions that were surveyed.

Efficacy of internet-delivered acceptance and commitment therapy for severe health anxiety: results from a randomized, controlled trial.

BACKGROUND: Health anxiety is common, disabling and costly due to patients' extensive use of health care services. Internet-delivered treatment may overcome barriers of accessibility to specialized treatment. We aimed to evaluate the efficacy of internet-delivered acceptance and commitment therapy (iACT). METHODS: A randomized, controlled trial of iACT versus an internet-delivered discussion forum (iFORUM), performed in a Danish university hospital setting. Patients self-referred and underwent video-diagnostic assessment. Eligible patients (≥18 years) with health anxiety were randomized to 12 weeks of intervention. The randomization was blinded for the assessor. The primary outcome was between-group unadjusted mean differences in health anxiety symptoms measured by the Whiteley-7 Index (WI-7, range 0-100) from baseline to 6-month follow-up (6-MFU) using intention to treat and a linear mixed model. The study is registered at clinicaltrials.gov, number NCT02735434. RESULTS: A total of 151 patients self-referred, and 101 patients were randomized to iACT (n = 53) or iFORUM (n = 48). A mean difference in change over time of 19.0 points [95% confidence interval (CI) 10.8-27.2, p < 0.001] was shown on the WI-7, and a large standardized effect size of d = 0.80 (95% CI 0.38-1.23) at 6-MFU. The number needed to treat was 2.8 (95% CI 1.8-6.1, p < 0.001), and twice as many patients in iACT were no longer clinical cases (35% v. 16%; risk ratio 2.17, 95% CI 1.00-4.70, p = 0.050). Adverse events were few and insignificant. CONCLUSIONS: iACT for health anxiety led to sustained effects at 6-MFU. The study contributes to the development of easily accessible treatment options and deserves wider application.

Internet-Based Cognitive Behavioral Therapy for Informal Caregivers: Randomized Controlled Pilot Trial.

BACKGROUND: Caregiving for a family member can result in reduced well-being for the caregiver. Internet-delivered cognitive behavioral therapy (ICBT) may be one way to support this population. This is especially the case for caregivers in countries with limited resources, but high demand for psychological services. OBJECTIVE: In this study we evaluated the effects of a therapist-guided 8-week-long ICBT intervention for informal caregivers. METHODS: In total, 63 participants were recruited online and randomized either to the intervention or to the wait-list control group. The main study outcome was the Caregiver Burden Inventory (CBI). Secondary outcomes included measures of caregiver depression, anxiety, stress, and quality of life. RESULTS: Moderate between-group effect sizes were observed for the CBI measure, in favor of the intervention group, with a Cohen d=-0.70 for the intention-to-treat analysis. Analyses of the subscales of the CBI showed significant reductions on the subscales of Development and Physical Health. Moderate reductions were found for depression and anxiety scores as indicated by the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) scores. Large between-group effects were observed for reduction in stress and increase in quality of life as indicated by the Perceived Stress Scale-14 (PSS-14), The Brunnsviken Brief Quality of Life Scale (BBQ), and The World Health Organization-Five Well-Being Index (WHO-5). In addition, participants experienced little to no difficulty in using the program and were mostly satisfied with the intervention's platform and the choice of content. CONCLUSIONS: This is the first internet intervention study for informal caregivers in Lithuania. The results suggest that therapist-guided ICBT can be effective in reducing caregiver burden, anxiety, depression, stress, and improving quality of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT04052724; https://clinicaltrials.gov/ct2/show/NCT04052724.

Development of a Web-Based Mindfulness Program for People With Multiple Sclerosis: Qualitative Co-Design Study.

BACKGROUND: Mindfulness-based stress reduction is an efficacious treatment for people with chronic health problems; however, it is highly intensive and time-consuming, which is a barrier for service provision. OBJECTIVE: This study aims to develop an internet-delivered adapted version of mindfulness-based stress reduction for people with multiple sclerosis to make the intervention more accessible. METHODS: We co-designed a web-based mindfulness program with end users, that is, people with multiple sclerosis (N=19). Iterative feedback was also collected from a subsample of the initial group of end users (n=11), and the program was reviewed by experts (n=8). RESULTS: We identified three main themes common to people with multiple sclerosis: dealing with uncertainty and fears for the future, grief and loss, and social isolation. These themes were incorporated into narratives throughout the program. People with multiple sclerosis who reviewed the program gave feedback that the program was relatable, feasible, and acceptable. Experts agreed that the program appropriately represented the main tenets of mindfulness. Iterative feedback was used to further refine the program. CONCLUSIONS: The web-based mindfulness program that we developed was viewed positively by both experts and end users. The program reflects common concerns for people with multiple sclerosis and has the potential to meet important unmet psychological needs. A randomized controlled trial was planned to determine the efficacy of the program.

Resource-Based Internet Intervention (Med-Stress) to Improve Well-Being Among Medical Professionals: Randomized Controlled Trial.

BACKGROUND: Medical professionals are exposed to multiple and often excessive demands in their work environment. Low-intensity internet interventions allow them to benefit from psychological support even when institutional help is not available. Focusing on enhancing psychological resources-self-efficacy and perceived social support-makes an intervention relevant for various occupations within the medical profession. Previously, these resources were found to operate both individually or sequentially with self-efficacy either preceding social support (cultivation process) or following it (enabling process). OBJECTIVE: The objective of this randomized controlled trial is to compare the efficacy of 4 variants of Med-Stress, a self-guided internet intervention that aims to improve the multifaceted well-being of medical professionals. METHODS: This study was conducted before the COVID-19 pandemic. Participants (N=1240) were recruited mainly via media campaigns and social media targeted ads. They were assigned to 1 of the following 4 groups: experimental condition reflecting the cultivation process, experimental condition reflecting the enabling process, active comparator enhancing only self-efficacy, and active comparator enhancing only perceived social support. Outcomes included 5 facets of well-being: job stress, job burnout, work engagement, depression, and job-related traumatic stress. Measurements were taken on the web at baseline (time 1), immediately after intervention (time 2), and at a 6-month follow-up (time 3). To analyze the data, linear mixed effects models were used on the intention-to-treat sample. The trial was partially blinded as the information about the duration of the trial, which was different for experimental and control conditions, was public. RESULTS: At time 2, job stress was lower in the condition reflecting the cultivation process than in the one enhancing social support only (d=-0.21), and at time 3, participants in that experimental condition reported the lowest job stress when compared with all 3 remaining study groups (ds between -0.24 and -0.41). For job-related traumatic stress, we found a significant difference between study groups only at time 3: stress was lower in the experimental condition in which self-efficacy was enhanced first than in the active comparator enhancing solely social support (d=-0.24). The same result was found for work engagement (d=-0.20), which means that it was lower in exactly the same condition that was found beneficial for stress relief. There were no differences between study conditions for burnout and depression neither at time 2 nor at time 3. There was a high dropout in the study (1023/1240, 82.50% at posttest), reflecting the pragmatic nature of this trial. CONCLUSIONS: The Med-Stress internet intervention improves some components of well-being-most notably job stress-when activities are completed in a specific sequence. The decrease in work engagement could support the notion of dark side of this phenomenon, but further research is needed. TRIAL REGISTRATION: ClinicalTrials.gov NCT03475290; https://clinicaltrials.gov/ct2/show/NCT03475290. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-019-3401-9.