Effectiveness of a Web-Based Cognitive Behavioral Self-Help Intervention for Binge Eating Disorder: A Randomized Clinical Trial.

Importance: Binge eating disorder (BED) is one of the most frequent eating pathologies and imposes substantial emotional and physical distress, yet insufficient health care resources limit access to specialized treatment. Web-based self-help interventions emerge as a promising solution, offering more accessible care. Objective: To examine the effectiveness of a web-based cognitive behavioral self-help intervention for individuals with BED. Design, Setting, and Participants: This 2-arm, parallel-group randomized clinical trial conducted from January 15, 2021, to August 3, 2022, in Germany and other German-speaking countries enrolled patients aged 18 to 65 years who met the diagnostic criteria for BED (according to the Diagnostic and Statistical Manual of Mental Disorders [Fifth Edition]). Data analysis occurred between January 27 and September 4, 2023, following our statistical analysis plan. Interventions: Participants were randomized to a web-based self-help intervention or a waiting-list control condition. Main Outcomes and Measures: The primary outcome was a change in objective binge eating episodes from baseline to after treatment. Secondary outcomes included global eating pathology, clinical impairment, work capacity, well-being, comorbid psychopathology, self-esteem, and emotion regulation. Results: A total of 1602 patients were screened, of whom 154 (mean [SD] age, 35.93 [10.59] years; 148 female [96.10%]) fulfilled the criteria for BED and were randomized (77 each to the intervention and control groups). The web-based intervention led to significant improvements in binge eating episodes (Cohen d, -0.79 [95% CI, -1.17 to -0.42]; P < .001), global eating psychopathology (Cohen d, -0.71 [95% CI, -1.07 to -0.35]; P < .001), weekly binge eating (Cohen d, -0.49 [95% CI, -0.74 to -0.24]; P < .001), clinical impairment (Cohen d, -0.75 [95% CI, -1.13 to -0.37]; P < .001), well-being (Cohen d, 0.38 [95% CI, 0.01 to 0.75]; P = .047), depression (Cohen d, -0.49 [95% CI, -0.86 to -0.12]; P = .01), anxiety (Cohen d, -0.37 [95% CI, -0.67 to -0.07]; P = .02), self-esteem (Cohen d, 0.36 [95% CI, 0.13 to 0.59]; P = .003), and emotion regulation (difficulties: Cohen d, -0.36 [95% CI, -0.65 to -0.07]; P = .01 and repertoire: Cohen d, 0.52 [95% CI, 0.19 to 0.84]; P = .003). Conclusion and Relevance: In this randomized clinical trial of a web-based self-help intervention for patients with BED, the findings confirmed its effectiveness in reducing binge eating episodes and improving various mental health outcomes, highlighting a scalable solution to bridge the treatment gap for this condition. Trial Registration: ClinicalTrials.gov Identifier: NCT04876183.

Evaluation of a Web-Based Self-Help Intervention for Patients With Generalized Anxiety Disorder: Protocol for a Randomized Controlled Trial.

BACKGROUND: Generalized anxiety disorder (GAD) is a highly prevalent and severely distressing condition that can lead to functional impairments and is considered one of the most difficult anxiety disorders to treat. Following new technological developments, a highly structured cognitive behavioral therapy (CBT) approach that has already shown success in face-to-face psychotherapy can be implemented: internet-delivered CBT (iCBT). There is now evidence for the efficacy of both guided and unguided iCBT interventions for GAD regarding symptom reduction. OBJECTIVE: To establish the usefulness of such interventions, we plan to evaluate the efficacy of a web-based self-help program (Selfapy) for GAD in a relatively large sample. We aim to assess effects beyond symptom reduction, including effects on well-being, functioning, and mental health literacy, as well as the effect on health care burden, while testing the intervention in conditions comparable to routine care. METHODS: Patients (n=156) who have been diagnosed with GAD, are aged between 18 and 65 years, have internet access, and have sufficient German language skills will be recruited for this study. The intervention group (n=78) will receive access to the 12-week self-help web-based program Selfapy. The waitlist control group (n=78) will receive no intervention in the context of the study. However, both groups will be allowed to access further health care services (eg, psychotherapy, medication), reflecting current routine care in Germany. Outcome measures will be assessed at baseline (T1) and 6 weeks (T2) and 12 weeks (T3) after the start of the intervention. The primary outcome will be generalized anxiety symptoms and quality of life at T3. Additional outcomes include depression, work capacity, therapy-related expenses and burdens, health literacy, and negative effects. RESULTS: By May 2023, all participants had finished the trial and the report was being prepared for publication. CONCLUSIONS: Web-based interventions may be an important addition to the German health care system to reduce barriers to treatment access. Further, they may prove cost-effective for the treatment of GAD. TRIAL REGISTRATION: Deutsches Register Klinischer Studien DRKS00023799; https://tinyurl.com/22bds38x. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41440.

[Diagnostic Performance and Validity of the German Version of the BDI-II - A Secondary Analysis with Data from Clinical and Nonclinical Samples]. / Diagnostische Performanz und Validität des deutschsprachigen BDI-II ­ Eine Sekundäranalyse mit Daten aus klinischen und nichtklinischen Stichproben.

OBJECTIVES: Study of the diagnostic performance and validity of the German Beck Depression Inventory (BDI-II) in a large data set from multiple adult samples. METHODS: The BDI-II was assessed together with the SCID-I as external criterion in 638 individuals (385 currently or remitted depressed individuals, 253 controls). The screening performance of the BDI-II was calculated for suggested cut-offs from the BDI-II manual and for optimal cut-offs derived from ROC-analyses. RESULTS: The internal consistency of the BDI-II was high (> 0,90) and it showed plausible associations with construct-related scales. Optimal cut-off scores of 16+ resulted for MDE (Youden's J = 0.838) and of 14+ for DD (J = 0.814). CONCLUSIONS: The German BDI-II is a reliable und valid screening tool for detecting depressive episodes and depressive disorders in the adult population. Depending on prioritized goals different cut-off-values can be used.

Applying a web-based self-help intervention for bulimia nervosa in routine care: Study protocol for a randomized controlled trial.

BACKGROUND: Individuals with bulimia nervosa (BN) experience persistent episodes of binge eating and inappropriate compensatory behavior associated with impaired physical and mental health. Despite the existence of effective treatments, many individuals with BN remain untreated, leading to a high burden and an increased risk of chronicity. Web-based interventions may help facilitate access to evidence-based treatments for BN by reducing barriers to the health care system. METHODS: The present study will investigate the effectiveness of a web-based self-help intervention for BN in a two-armed randomized controlled trial. Individuals diagnosed with BN (N = 152) will be randomly assigned to either (1) an intervention group receiving a 12-week web-based intervention or (2) a waitlist control group with delayed access to the intervention. Further assessments will be scheduled 6 (mid-treatment) and 12 (post-treatment) weeks after baseline. Changes in the number of binge eating episodes and compensatory behaviors will be examined as primary outcomes. Secondary outcomes include global eating pathology, functional impairments, well-being, comorbid psychopathology, self-esteem, and emotion regulation abilities. DISCUSSION: Adding web-based interventions into routine care is a promising approach to overcome the existing treatment gap for patients with BN. Therefore, the current study will test the effectiveness of a web-based intervention for BN under standard clinical care settings. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier: NCT04876196 (registered on May 6th, 2021).

Integrating a web-based intervention into routine care of binge-eating disorder: Study protocol for a randomized controlled trial.

Background: Although binge eating disorder (BED) is the most common eating pathology and carries a high mental and physical burden, access to specialized treatment is limited due to patient-related barriers and insufficient healthcare resources. Integrating web-based self-help programs into clinical care for BED may address this treatment gap by making evidence-based eating disorder interventions more accessible. Methods: A two-armed randomized controlled trial will be conducted to evaluate the effectiveness of a web-based self-help intervention for BED in routine care settings. Patients aged 18-65 years fulfilling the diagnostic criteria for BED (N = 152) will be randomly allocated to (1) an intervention group receiving a 12-week web-based self-help program or (2) a waitlist control group with delayed access to the intervention. The primary outcome will be the number of binge eating episodes. Secondary outcomes include global eating pathology, functional impairments, work capacity, well-being, comorbid psychopathology, self-esteem, and emotion regulation abilities. Measurements will be conducted at baseline (study entrance), 6 weeks after baseline (mid-treatment), and 12 weeks after baseline (post-treatment). To capture outcomes and treatment mechanisms in real-time, traditional self-reports will be combined with weekly symptom monitoring and ecological momentary assessment. Discussion: Evaluating the effectiveness of web-based interventions is essential to overcome the treatment gap for patients with BED. When adequately integrated into standard care, these programs have the potential to alleviate the high burden of BED for individuals, their families, and society. Trial registration: https://clinicaltrials.gov/ct2/show/NCT04876183, Identifier: NCT04876183 (registered on May 6th, 2021).

Modulation of respiration pattern variability and its relation to anxiety symptoms in remitted recurrent depression.

BACKGROUND: Depression is related to default mode network (DMN) connectivity and higher respiration pattern variability (RPV). In addition, DMN connectivity and RPV are interrelated and predict a poorer clinical course of depression. The association of RPV and depression might further be boosted by anxiety levels. Aim of the present study was to investigate whether a mindfulness-based training in emotionally challenged remitted depressed participants (rMDD) leads to reduced DMN connectivity and lower RPV, and if RPV interacts with anxiety levels. METHODS: To challenge participants, sad mood was induced with keywords of personal negative life events in 49 rMDD during fMRI before and after a 4-week mindfulness-based attention training (MBAT) or progressive muscle relaxation. Respiration was measured by means of a built-in respiration belt. RESULTS: After both trainings, rMDD showed no significant changes in DMN connectivity. However, MBAT was effective in reducing the RPV which was related to lower anxiety levels especially in high anxious individuals. CONCLUSIONS: RPV can be influenced by training which may hint to an underlying biological pathway of training effects. Importantly, these effects seem to be associated with anxiety levels. Therefore, respiration focused training might be an important tool assisting the treatment of depression and anxiety.

Mindfulness-based focused attention training versus progressive muscle relaxation in remitted depressed patients: Effects on salivary cortisol and associations with subjective improvements in daily life.

Major Depression is a stress-related disorder characterized by altered hypothalamic-pituitary-adrenal axis function. Mindfulness-based interventions have shown to improve subjective parameters of stress and to reduce relapse rates in depressed patients. However, research on their effects on diurnal patterns of cortisol and associations with subjective outcomes is lacking. The present Ambulatory Assessment study investigated possible changes in daily rhythm cortisol parameters (cortisol awakening response (CAR), daily slope, total cortisol) in currently remitted individuals with recurrent depression who were randomized to a four-week mindfulness-based focused attention training (MBAT, n = 39) or a progressive muscle relaxation training (PMR, n = 39). A second aim was to investigate whether changes in cortisol were linked to improvements in affective and cognitive daily life states. On three weekdays before and after the intervention, seven saliva cortisol samples per day were collected. For analysis, multilevel models were applied. Results revealed no group-specific or general change in CAR and daily slopes from pre- to postintervention. In contrast, total cortisol increased across groups, which was however moderated by group and subjective improvement status. While cortisol increased irrespective of subjective improvement in PMR participants, MBAT participants with larger reductions in negative affect and rumination maintained their initial cortisol levels, whereas those with lower improvement paralleled the PMR group. Thereby, MBAT appeared to buffer an increase in overall cortisol secretion over time, but only in patients showing marked improvements in those affective and cognitive states that constitute core elements for depressive relapses in the vulnerability model of mindfulness-based cognitive therapy.

Respiration pattern variability and related default mode network connectivity are altered in remitted depression.

BACKGROUND: Studies with healthy participants and patients with respiratory diseases suggest a relation between respiration and mood. The aim of the present analyses was to investigate whether emotionally challenged remitted depressed participants show higher respiration pattern variability (RPV) and whether this is related to mood, clinical outcome and increased default mode network connectivity. METHODS: To challenge participants, sad mood was induced with keywords of personal negative life events in individuals with remitted depression [recurrent major depressive disorder (rMDD), n = 30] and matched healthy controls (HCs, n = 30) during functional magnetic resonance imaging. Respiration was measured by means of a built-in respiration belt. Additionally, questionnaires, a daily life assessment of mood and a 3 years follow-up were applied. For replication, we analysed RPV in an independent sample of 53 rMDD who underwent the same fMRI paradigm. RESULTS: During sad mood, rMDD compared with HC showed greater RPV, with higher variability in pause duration and respiration frequency and lower expiration to inspiration ratio. Higher RPV was related to lower daily life mood and predicted higher depression scores as well as relapses during a 3-year follow-up period. Furthermore, in rMDD compared with HC higher main respiration frequency exhibited a more positive association with connectivity of the posterior cingulate cortex and the right parahippocampal gyrus. CONCLUSIONS: The results suggest a relation between RPV, mood and depression on the behavioural and neural level. Based on our findings, we propose interventions focusing on respiration to be a promising additional tool in the treatment of depression.

Cognitive and affective trait and state factors influencing the long-term symptom course in remitted depressed patients.

BACKGROUND: Major depressive disorder (MDD) is characterized by a high risk for relapses and chronic developments. Clinical characteristics such as residual symptoms have been shown to negatively affect the long-term course of MDD. However, it is unclear so far how trait repetitive negative thinking (RNT) as well as cognitive and affective momentary states, the latter experienced during daily-life, affect the long-term course of MDD. METHOD: We followed up 57 remitted depressed (rMDD) individuals six (T2) and 36 (T3) months after baseline. Clinical outcomes were time to relapse, time spent with significant symptoms as a marker of chronicity, and levels of depressive symptoms at T2 and T3. Predictors assessed at baseline included residual symptoms and trait RNT. Furthermore, momentary daily life affect and momentary rumination, and their variation over the day were assessed at baseline using ambulatory assessment (AA). RESULTS: In multiple models, residual symptoms and instability of daily-life affect at baseline independently predicted a faster time to relapse, while chronicity was significantly predicted by trait RNT. Multilevel models revealed that depressive symptom levels during follow-up were predicted by baseline residual symptom levels and by instability of daily-life rumination. Both instability features were linked to a higher number of anamnestic MDD episodes. CONCLUSIONS: Our findings indicate that trait RNT, but also affective and cognitive processes during daily life impact the longer-term course of MDD. Future longitudinal research on the role of respective AA-phenotypes as potential transdiagnostic course-modifiers is warranted.