Effect of Sleep Disturbance Symptoms on Treatment Outcome in Blended Cognitive Behavioral Therapy for Depression (E-COMPARED Study): Secondary Analysis.

BACKGROUND: Sleep disturbance symptoms are common in major depressive disorder (MDD) and have been found to hamper the treatment effect of conventional face-to-face psychological treatments such as cognitive behavioral therapy. To increase the dissemination of evidence-based treatment, blended cognitive behavioral therapy (bCBT) consisting of web-based and face-to-face treatment is on the rise for patients with MDD. To date, no study has examined whether sleep disturbance symptoms have an impact on bCBT treatment outcomes and whether it affects bCBT and treatment-as-usual (TAU) equally. OBJECTIVE: The objectives of this study are to investigate whether baseline sleep disturbance symptoms have an impact on treatment outcomes independent of treatment modality and whether sleep disturbance symptoms impact bCBT and TAU in routine care equally. METHODS: The study was based on data from the E-COMPARED (European Comparative Effectiveness Research on Blended Depression Treatment Versus Treatment-as-Usual) study, a 2-arm, multisite, parallel randomized controlled, noninferiority trial. A total of 943 outpatients with MDD were randomized to either bCBT (476/943, 50.5%) or TAU consisting of routine clinical MDD treatment (467/943, 49.5%). The primary outcome of this study was the change in depression symptom severity at the 12-month follow-up. The secondary outcomes were the change in depression symptom severity at the 3- and 6-month follow-up and MDD diagnoses at the 12-month follow-up, assessed using the Patient Health Questionnaire-9 and Mini-International Neuropsychiatric Interview, respectively. Mixed effects models were used to examine the association of sleep disturbance symptoms with treatment outcome and treatment modality over time. RESULTS: Of the 943 patients recruited for the study, 558 (59.2%) completed the 12-month follow-up assessment. In the total sample, baseline sleep disturbance symptoms did not significantly affect change in depressive symptom severity at the 12-month follow-up (ß=.16, 95% CI -0.04 to 0.36). However, baseline sleep disturbance symptoms were negatively associated with treatment outcome for bCBT (ß=.49, 95% CI 0.22-0.76) but not for TAU (ß=-.23, 95% CI -0.50 to 0.05) at the 12-month follow-up, even when adjusting for baseline depression symptom severity. The same result was seen for the effect of sleep disturbance symptoms on the presence of depression measured with Mini-International Neuropsychiatric Interview at the 12-month follow-up. However, for both treatment formats, baseline sleep disturbance symptoms were not associated with depression symptom severity at either the 3- (ß=.06, 95% CI -0.11 to 0.23) or 6-month (ß=.09, 95% CI -0.10 to 0.28) follow-up. CONCLUSIONS: Baseline sleep disturbance symptoms may have a negative impact on long-term treatment outcomes in bCBT for MDD. This effect was not observed for TAU. These findings suggest that special attention to sleep disturbance symptoms might be warranted when MDD is treated with bCBT. Future studies should investigate the effect of implementing modules specifically targeting sleep disturbance symptoms in bCBT for MDD to improve long-term prognosis.

Effectiveness of internet-based guided self-help for binge-eating disorder and characteristics of completers versus noncompleters.

OBJECTIVE: Binge-eating disorder (BED) is characterized by recurrent episodes of binge eating, accompanied by a lack of control and feelings of shame. Online intervention is a promising, accessible treatment approach for BED. In the current study, we compared completers with noncompleters in a 10-session guided internet-based treatment program (iBED) based on cognitive behavioral therapy. METHODS: Adults (N = 75) with mild to moderate BED participated in iBED with weekly written support from psychologists. Participants were compared on the Eating Disorder Examination Questionnaire (EDE-Q), diagnostic criteria for BED (BED-Q), major depression inventory (MDI), quality of life (EQ-5D-5L), body mass index (BMI) and sociodemographic variables. RESULTS: Minor differences were observed between completers and noncompleters on depression. No differences were found in BED-symptoms, BMI, and sociodemographic variables. Participants who completed treatment showed large reductions in eating disorder pathology. DISCUSSION: More research is needed to determine risk factors for attrition or treatment outcome in internet-based interventions for BED. It is suggested that iBED is an efficient intervention for BED. However, more studies of internet-interventions are needed.

STUDY PROTOCOL: EXPOSURE IN VIRTUAL REALITY FOR SOCIAL ANXIETY DISORDER - a randomized controlled superiority trial comparing cognitive behavioral therapy with virtual reality based exposure to cognitive behavioral therapy with in vivo exposure.

BACKGROUND: Social Anxiety Disorder (SAD) is characterized by an intense fear of negative judgement by others. Cognitive Behavioral Therapy (CBT) is recommended for treatment, but a substantial part of individuals with SAD either do not seek treatment or drop-out. CBT with Virtual Reality (VR)-based exposure has several advantages compared to traditional exposure methods, mainly due to increased control of situational elements. The aim of the current study is to develop a CBT program containing VR-based exposure. The intervention is targeted to adult patients suffering from SAD and treatment effect will be assessed by changes in SAD symptoms. METHODS: This article describes the study protocol of a Randomized Controlled Trial with three arms: 1) CBT with VR exposure based on 360° videos 2) CBT with in vivo exposure and 3) VR relaxation therapy. There will be 30 participants in each arm with a crossover at the end of the treatment period during which the participants in the third group will be randomly re-allocated to one of the two former groups. The treatment program consists of 10 weekly individual sessions with a psychologist, and a six month follow-up consisting of a questionnaire. The primary outcome measure is reduction in SAD symptoms which will be assessed with the Social Interaction Anxiety Scale (SIAS). DISCUSSION: There are currently no published studies on CBT with VR exposure based on 360° videos for SAD treatment. Furthermore, the current study will be the first Danish SAD treatment program that includes VR technology. TRIAL REGISTRATION: clinicaltrials.gov (NCT03973541) June 3rd 2019.

Days between sessions predict attrition in text-based internet intervention of Binge Eating Disorder.

Background: The number of days between treatment sessions is often overlooked as a predictor of attrition in psychotherapy. In text-based Internet interventions, days between sessions may be a simple yet powerful predictor of attrition. Objective: We hypothesized that a larger number of days between sessions increased the likelihood of attrition among participants with Binge Eating Disorder (BED) in a 12-session Internet-based cognitive behavioral therapy (iCBT) program. Participants could work on the sessions whenever convenient for them and received written support from a psychologist. Material and methods: We compared 201 adult participants with mild to moderate BED (85 non-completers and 116 completers) on the number of days between sessions to predict attrition rates. Results: Mixed model binomial logistic regression showed that non-completers spent significantly more days between sessions across the first four treatment sessions (1-4) when controlling for age, gender, and intake measures of BMI, BED, overall health status (EQ VAS), and depression symptoms (MDI) (OR = 1.042, p < .001). Age (OR = 0.976, p < .001) and EQ VAS (OR = 0.984, p < .001) were also significant. The risk of attrition increased by 4.2 % for each additional day participants spent completing a session.A receiver operating characteristic (ROC) curve analysis showed that classification accuracy increased across sessions from 61.1 % in session 1 and 65.7 % in session 2 to 68.8 % in session 3 and 73.2 % in session 4. The optimal cut-off point in session 4 was 17.5 days, which detected 60.4 % of non-completers (sensitivity) and 78.4 % of completers (specificity).An exploratory repeated measures of ANOVA of days between sessions showed a significant within-subjects effect, where both non-completers and completers spent more days between sessions as they progressed from sessions 1 through 4 (F = 20.54, df = 3, p < .001). There was no interaction effect, suggesting that the increase in slope did not differ between non-completers and completers. Conclusions: Participants spending more days between sessions are at increased risk of dropping out of treatment. This may have important implications for identifying measures to reduce attrition, e.g., intensifying interventions through automated reminders or therapist messages. Our findings may have important transdiagnostic implications for text-based Internet interventions. Further studies should investigate the predictive value of days between sessions in other diagnoses.

Therapist perceptions of the implementation of a new screening procedure using the ItFits-toolkit in an iCBT routine care clinic: A mixed-methods study using the consolidated framework for implementation research.

Introduction: This study investigates the implementation of a new, more automated screening procedure using the ItFits-toolkit in the online clinic, Internet Psychiatry (iPsych) (www.internetpsykiatrien.dk), delivering guided iCBT for mild to moderate anxiety and depressive disorders. The study focuses on how the therapists experienced the process. Methods: Qualitative data were collected from semi-structured individual interviews with seven therapists from iPsych. The interviews were conducted using an interview guide with questions based on the Consolidated Framework for Implementation Research (CFIR). Quantitative data on the perceived level of normalization were collected from iPsych therapists, administrative staff, and off-site professionals in contact with the target demographic at 10-time points throughout the implementation. Results: The therapists experienced an improvement in the intake procedure. They reported having more relevant information about the patients to be used during the assessment and the treatment; they liked the new design better; there was a better alignment of expectations between patients and therapists; the patient group was generally a better fit for treatment after implementation; and more of the assessed patients were included in the program. The quantitative data support the interview data and describe a process of normalization that increases over time. Discussion: The ItFits-toolkit appears to have been an effective mediator of the implementation process. The therapists were aided in the process of change, resulting in an enhanced ability to target the patients who can benefit from the treatment program, less expenditure of time on the wrong population, and more satisfied therapists.

Patient and therapist experiences of using a smartphone application monitoring anxiety symptoms.

PURPOSE: A smartphone application (app) from the company Monsenso was developed to monitor anxiety symptoms in the treatment of anxiety disorders as an alternative to paper registrations. The aim of the study was to explore patient and therapist experiences of using the app in conjunction with standard treatment for anxiety disorder in a developmental and implementation phase. METHOD: The study design was qualitative. Semi-structured interviews were conducted with three therapists and seven patients from an outpatient clinic. The interviews were analysed using thematic analysis. FINDINGS: Three main themes emerged for both patients and therapists. The patient themes were usability (it was easier to use the app and remember daily mood registrations), insight in own disorder (awareness of symptom progress), and support to use the app (support from the therapist was wanted). The therapist themes were therapeutic quality (app registrations made it easier to prepare sessions), the role of the therapist (enthusiasm and technical assistance affected the patient), and implementation challenges (time allocation is important). CONCLUSION: The anxiety monitoring app is recommended in standard treatment as an alternative to paper registrations. However, a successful development and implementation process include ready available technical support, time allocation, and therapist effort and enthusiasm.

Behind the athletic body: a clinical interview study of identification of eating disorder symptoms and diagnoses in elite athletes.

Eating disorders are more prevalent in athletes than in the general population and may have severe consequences for sports performance and health. Identifying symptoms can be difficult in athletes because restrictive eating and slim body images are often idealised in a sports setting. The Eating Disorders Examination Questionnaire (EDE-Q) and the SCOFF (Sick, Control, One stone, Fat and Food) questionnaire (SCOFF) are widely used generic instruments to identify symptoms of eating disorders. This study aimed to investigate the instruments' validity and explore eating disorder symptoms in a sample of athletes. A sample of 28 athletes (25 females) competing at a national level was interviewed based on the diagnostic criteria for eating disorders. We interviewed 18 athletes with a high score on EDE-Q and 10 with a low score. All interviews were transcribed and analysed from a general inductive approach. We identified 20 athletes with an eating disorder diagnosis, while 8 had no diagnosis. EDE-Q found 90% of the cases, while SCOFF found 94%. EDE-Q found no false-positive cases, while SCOFF found one. The qualitative results showed that most athletes reported eating concerns, restrictive eating, eating control (counting calories), weight concerns, body dissatisfaction (feeling fat and non-athletic), excessive exercise and health problems (eg, pain, fatigue). In conclusion, EDE-Q and SCOFF seem valid instruments to screen athletes' samples but may fail to find 6%-10% cases with eating disorders. Despite athletic bodies and normal body mass index, many athletes report severe eating problems and dissatisfaction with weight and body appearance. Implementation of regular screening may identify these symptoms at an early stage.

An analysis of patient motivation for seeking online treatment for binge eating disorder-A mixed methods study combining systematic text condensation with sentiment analysis.

Objective: Online treatment for binge eating disorder (BED) is an easily available option for treatment compared to most standard treatment procedures. However, little is known about how motivation types characterize this population and how these impact treatment adherence and effect in an online setting. Therefore, we aimed to investigate a sample of written motivation statements from BED patients, to learn more about how treatment and online treatment in particular, presents in this population. Methods: Using self-determination theory in a mixed methods context, we investigated which types of motivation were prevalent in our sample, how this was connected with patient sentiment, and how these constructs influence treatment and adherence. Results: Contrary to what most current literature suggests, we found that in our sample (n = 148), motivation type was not connected with treatment outcome. We did find a strong association between sentiment scores and motivation types, indicating the model is apt at detecting effects. We found that when comparing an adult and young adult population, they did not differ in motivation type and the treatment was equally effective in young adults and adults. In the sentiment scores there was a difference between sentiment score and adherence in the young adult group, as the more positive the young adults were, the less likely they were to complete the program. Discussion: Because motivation type does not influence online treatment to the same degree as it would in face-to-face treatment it indicates that the typical barriers to treatment may be less crucial in an online setting. This should be considered during intake; as less motivated patients may be able to adhere better to online treatment, because the latter imposes fewer barriers of the kind that only strong motivation can overcome. The fact that motivation type and sentiment score of the written texts are strongly associated, indicate a potential for automated models to detect motivation based on sentiment.

Early development of treatment motivation predicts adherence and symptom reduction in an internet-based guided self-help program for binge eating disorder.

Objective: Lack of motivation is widely acknowledged as a significant factor in treatment discontinuity and poor treatment outcomes in eating disorders. Treatment adherence is lower in internet-based treatment. The current study aimed to assess the relationship between treatment motivation and treatment outcomes in an internet-based therapist-guided intervention for Binge Eating Disorder (BED). Method: Adults (N = 153) with mild to moderate symptoms of BED participated in a 10-session internet-based treatment program. Baseline and between-session scores of "Readiness to change" and "Belief in change" were used to predict treatment completion and eating disorder symptom reduction (EDE-Q Global, BED-Q, and weekly number of binge eating episodes) at post-treatment. Results: Baseline treatment motivation could not predict treatment completion or symptom reduction. Early measures of treatment motivation (regression slope from sessions 1-5) significantly predicted both treatment completion and post-treatment symptom reduction. "Belief in change" was the strongest predictor for completing treatment (OR = 2.18, 95%-CI: 1.06, 4.46) and reducing symptoms (EDE-Q Global: B = -0.53, p = 0.001; number of weekly binge eating episodes: B = 0.81, p < 0.01). Discussion: The results indicated that patients entering online treatment for BED feel highly motivated. However, baseline treatment motivation could not significantly predict treatment completion, which contradicts previous research. The significant predictive ability of early measures of treatment motivation supports the clinical relevance of monitoring the development of early changes to tailor and optimize individual patient care. Further research is needed to examine treatment motivation in regard to internet-based treatment for BED with more validated measures.

Social Anxiety Can Be Triggered by 360-Degree Videos in Virtual Reality: A Pilot Study Exploring Fear of Shopping.

Social anxiety disorder (SAD) involves intense fear of being scrutinized, judged, or embarrassed in public. Virtual reality exposure therapy (VRET) is an exposure tool for SAD. Previous studies have developed computer-generated avatars and virtual environments, but this method is time-consuming and expensive. Preliminary evidence shows that 360-degree virtual reality (VR) videos with real-life situations may be an easy, relatively cheap, and effective alternative. This study aimed to develop VR videos with real-life content from a shopping situation and to evaluate participants' anxiety responses and feelings of presence. Three 360-degree VR videos were filmed in a shopping center. Nine patients with SAD and nine controls matched on gender and age participated in the study. The participants' levels of anxiety during the VR videos were assessed using the Subjective Unit of Discomfort Scale and through semistructured interviews. The SAD patients reported higher levels of presence and significantly increased anxiety levels before, during, and after the videos, whereas controls reported no symptom of anxiety. The patients found the videos authentic and recommended VRET to be integrated into the early stages of treatment before in vivo exposure. Anxiety responses can be triggered in patients with SAD by 360-degree shopping videos. Further studied are needed to investigate the potential of using 360-degree videos for VRET in anxiety disorders.