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  • JMIR Publications Inc.  (28)
  • Berger, Thomas  (28)
  • 1
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    Prevention and Treatment of Social Anxiety Disorder in Adolescents: Protocol for a Randomized Controlled Trial of the Online Guided Self-Help Intervention SOPHIE
    JMIR Publications Inc. ; 2023
    In:  JMIR Research Protocols Vol. 12 ( 2023-6-21), p. e44346-
    Details
    In: JMIR Research Protocols, JMIR Publications Inc., Vol. 12 ( 2023-6-21), p. e44346-
    Abstract: Social anxiety symptoms are highly prevalent among adolescents and are associated with poor quality of life and low psychosocial functioning. If untreated, social anxiety often persists into adulthood and increases the risk for comorbid disorders. Therefore, early interventions for social anxiety to prevent negative long-term consequences are critical. However, adolescents rarely seek help and often avoid face-to-face psychotherapeutic interventions due to the perceived lack of autonomy and anonymity. Thus, online interventions represent a promising opportunity to reach adolescents who have social anxiety but do not seek help yet. Objective This study aims to evaluate the efficacy, moderators, and mediators of an online intervention developed to reduce social anxiety in adolescents. Methods A total of 222 adolescents aged 11-17 years with subclinical social anxiety (N=166) or with a diagnosis of social anxiety disorder (N=56) are randomly assigned to the online intervention or a care-as-usual control group. The 8-week guided online intervention is based on the Cognitive Model of Social Phobia and evidence-based online interventions for social anxiety adapted to the specific needs of adolescents. The care-as-usual group will be given access to the online intervention after the follow-up assessment. Participants are assessed at baseline, at 4 and 8 weeks post intervention, and at 3-month follow-up assessment on the primary outcome, that is, social anxiety, on secondary outcomes (eg, level of functioning, fear and avoidance, general anxiety, depression, quality of life, self-esteem, and negative effects of the intervention), on potential moderators (eg, therapy motivation, therapy expectancy, and satisfaction with the intervention), and potential mediators (eg, therapeutic alliance and adherence to the intervention). Data will be analyzed based on an intention-to-treat approach and both groups (intervention and care-as-usual) will be compared at each assessment time point. Furthermore, potential mechanisms of change and generalization of intervention effects on daily life are assessed using an ecological momentary assessment procedure that includes items on maintaining mechanisms of social anxiety, social context, and affect. Participants are prompted 3 times a day during the first 8 weeks of the study and again for 2 weeks following the follow-up assessment. Results Recruitment is ongoing; initial results are expected in 2024. Conclusions Results are discussed considering the potential of online interventions as a low-threshold prevention and treatment option for adolescents with social anxiety and in light of current advances in dynamic modeling of change processes and mechanisms in early intervention and psychotherapy in adolescents. Trial Registration ClinicalTrials.gov NCT04782102; https://clinicaltrials.gov/ct2/show/NCT04782102 International Registered Report Identifier (IRRID) DERR1-10.2196/44346
    Type of Medium: Online Resource
    ISSN: 1929-0748
    URL: Article
    DOI: 10.2196/44346
    Language: English
    Publisher: JMIR Publications Inc.
    Publication Date: 2023
    detail.hit.zdb_id: 2719222-2
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  • 2
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    Optimizing the Context of Support to Improve Outcomes of Internet-Based Self-help in Individuals With Depressive Symptoms: Protocol for a Randomized Factorial Trial
    JMIR Publications Inc. ; 2021
    In:  JMIR Research Protocols Vol. 10, No. 2 ( 2021-2-2), p. e21207-
    Details
    In: JMIR Research Protocols, JMIR Publications Inc., Vol. 10, No. 2 ( 2021-2-2), p. e21207-
    Abstract: Internet-based self-help interventions for individuals with depressive symptoms, in which the main component is often a web-based self-help program, have been shown to be efficacious in many controlled trials. However, there are also trials on self-help programs showing no significant effect when delivered in routine care, and some studies report high dropout and low adherence rates. Research suggests that these findings do not emerge primarily due to the specific content of a self-help program. It seems more important how a program is embedded in the context of human and automated support before and during the use of a self-help program. Objective This study aims to better understand the effects of 4 supportive contextual factors on outcomes of and adherence to a web-based self-help program for depressive symptoms. In a factorial experiment, 2 of 4 supportive factors, for which there is evidence for their role on outcomes and adherence, are realized during the intervention—personal guidance and automated email reminders. The other 2 factors are realized before the intervention—a diagnostic interview and a preintervention module aimed at increasing the motivation to use the program with motivational interviewing techniques. Methods The study is a full factorial randomized trial. Adults with mild to moderate depressive symptoms (Patient Health Questionnaire–9 score: 5-14) are recruited from the community through the internet and conventional media. All participants receive access to a web-based self-help program based on problem-solving therapy. They are randomized across 4 experimental factors, each reflecting the presence versus absence of a supportive factor (guidance, automated reminders, diagnostic interview, preintervention module) resulting in a 16-condition balanced factorial design. The primary outcome is depressive symptoms at 10 weeks post assessment. Secondary outcomes include adherence to the program, anxiety, stress, health-related quality of life, possible negative effects, and treatment satisfaction. Potential moderators and mediators (eg, treatment expectancy, problem-solving skills, working alliance with the study team) will also be investigated. Results Ethical approval was received on January 20, 2020. The study was initiated in February 2020, and 240 participants have been enrolled in the study as of November 1, 2020. Recruitment for a total of 255 participants is ongoing. Data collection is expected to be completed by May 2021. Conclusions A better understanding of relevant supportive factors in the dissemination of web-based interventions is necessary to improve outcomes of and adherence to web-based self-help programs. This study may inform health care systems and guide decisions to optimize the implementation context of web-based self-help programs for depressive symptoms. Trial Registration ClinicalTrials.gov NCT04318236; https://clinicaltrials.gov/ct2/show/NCT04318236 International Registered Report Identifier (IRRID) DERR1-10.2196/21207
    Type of Medium: Online Resource
    ISSN: 1929-0748
    URL: Article
    DOI: 10.2196/21207
    Language: English
    Publisher: JMIR Publications Inc.
    Publication Date: 2021
    detail.hit.zdb_id: 2719222-2
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  • 3
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    The Association of Therapeutic Alliance With Long-Term Outcome in a Guided Internet Intervention for Depression: Secondary Analysis From a Randomized Control Trial
    JMIR Publications Inc. ; 2020
    In:  Journal of Medical Internet Research Vol. 22, No. 3 ( 2020-3-24), p. e15824-
    Details
    In: Journal of Medical Internet Research, JMIR Publications Inc., Vol. 22, No. 3 ( 2020-3-24), p. e15824-
    Abstract: Therapeutic alliance has been well established as a robust predictor of face-to-face psychotherapy outcomes. Although initial evidence positioned alliance as a relevant predictor of internet intervention success, some conceptual and methodological concerns were raised regarding the methods and instruments used to measure the alliance in internet interventions and its association with outcomes. Objective The aim of this study was to explore the alliance-outcome association in a guided internet intervention using a measure of alliance especially developed for and adapted to guided internet interventions, showing evidence of good psychometric properties. Methods A sample of 223 adult participants with moderate depression received an internet intervention (ie, Deprexis) and email support. They completed the Working Alliance Inventory for Guided Internet Intervention (WAI-I) and a measure of treatment satisfaction at treatment termination and measures of depression severity and well-being at termination and 3- and 9-month follow-ups. For data analysis, we used two-level hierarchical linear modeling that included two subscales of the WAI-I (ie, tasks and goals agreement with the program and bond with the supporting therapist) as predictors of the estimated values of the outcome variables at the end of follow-up and their rate of change during the follow-up period. The same models were also used controlling for the effect of patient satisfaction with treatment. Results We found significant effects of the tasks and goals subscale of the WAI-I on the estimated values of residual depressive symptoms (γ02=−1.74, standard error [SE]=0.40, 95% CI −2.52 to −0.96, t206=−4.37, P 〈 .001) and patient well-being (γ02=3.10, SE=1.14, 95% CI 0.87-5.33, t198=2.72, P=.007) at the end of follow-up. A greater score in this subscale was related to lower levels of residual depressive symptoms and a higher level of well-being. However, there were no significant effects of the tasks and goals subscale on the rate of change in these variables during follow-up (depressive symptoms, P=.48; patient well-being, P=.26). The effects of the bond subscale were also nonsignificant when predicting the estimated values of depressive symptoms and well-being at the end of follow-up and the rate of change during that period (depressive symptoms, P=.08; patient well-being, P=.68). Conclusions The results of this study point out the importance of attuning internet interventions to patients’ expectations and preferences in order to enhance their agreement with the tasks and goals of the treatment. Thus, the results support the notion that responsiveness to a patient’s individual needs is crucial also in internet interventions. Nevertheless, these findings need to be replicated to establish if they can be generalized to different diagnostic groups, internet interventions, and supporting formats.
    Type of Medium: Online Resource
    ISSN: 1438-8871
    URL: Article
    DOI: 10.2196/15824
    Language: English
    Publisher: JMIR Publications Inc.
    Publication Date: 2020
    detail.hit.zdb_id: 2028830-X
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  • 4
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    User Experience and Effects of an Individually Tailored Transdiagnostic Internet-Based and Mobile-Supported Intervention for Anxiety Disorders: Mixed-Methods Study
    JMIR Publications Inc. ; 2020
    In:  Journal of Medical Internet Research Vol. 22, No. 9 ( 2020-9-16), p. e16450-
    Details
    In: Journal of Medical Internet Research, JMIR Publications Inc., Vol. 22, No. 9 ( 2020-9-16), p. e16450-
    Abstract: Internet interventions have been shown to be effective in treating anxiety disorders. Most interventions to date focus on single disorders and disregard potential comorbidities. Objective The aim of this mixed-methods study was to investigate feasibility, user experience, and effects of a newly developed individually tailored transdiagnostic guided internet intervention for anxiety disorders. Methods This study is an uncontrolled, within-group, baseline, postintervention pilot trial with an embedded qualitative and quantitative process and effect evaluation. In total, 49 adults with anxiety disorders (generalized anxiety disorder n=20, social phobia n=19, agoraphobia without panic n=12, panic with agoraphobia n=6, panic without agoraphobia n=4, subclinical depression n=41) received access to the 7-session intervention. We examined motivation and expectations, intervention use, user experience, impact, and modification requests. Qualitative data were assessed using semistructured interviews and analyzed by qualitative content analysis. Quantitative outcomes included symptom severity of anxiety and depression (Hamilton Anxiety Rating Scale [HAM-A], Quick Item Inventory of Depressive Symptomatology clinician rating [QIDS-C] ), diagnostic status in clinical interviews (Mini International Neuropsychiatric Interview [MINI]), and web-based self-reports (Generalized Anxiety Disorder–7 [GAD-7] , Center for Epidemiological Studies Depression Scale [CES-D], Beck Anxiety Inventory [BAI] , Panic and Agoraphobia Scale [PAS], Social Phobia Scale [SP S], Patient Health Questionnaire–9 [PHQ-9] ) at baseline and postassessment. Quantitative data was analyzed by comparing within-group means expressed as Cohen d. Results Anxiety symptom severity (HAM-A d=1.19) and depressive symptoms (QIDS-C d=0.42) improved significantly, and 54% (21/39) no longer were diagnosed as having any anxiety disorder. The main positive effects were the general improvement of disease burden and attentiveness to feelings and risk situations while the main negative effects experienced were lack of change in disease burden and symptom deterioration. The most prevalent reasons for participation were the advantages of online treatment, symptom burden, and openness toward online treatment. Helpful factors included support, psychoeducation and practicing strategies in daily life; the main hindering factors were too little individualization and being overwhelmed by the content and pace. Conclusions The intervention was found to be feasible and results show preliminary data indicating potential efficacy for improving anxiety and depression. The next step should be the evaluation within a randomized controlled trial. Concerning intervention development, it was found that future interventions should emphasize individualization even more in order to further improve the fit to individual characteristics, preferences, and needs.
    Type of Medium: Online Resource
    ISSN: 1438-8871
    URL: Article
    DOI: 10.2196/16450
    Language: English
    Publisher: JMIR Publications Inc.
    Publication Date: 2020
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  • 5
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    Cannabis Use in Adults Who Screen Positive for Attention Deficit/Hyperactivity Disorder: CANreduce 2.0 Randomized Controlled Trial Subgroup Analysis
    JMIR Publications Inc. ; 2022
    In:  Journal of Medical Internet Research Vol. 24, No. 4 ( 2022-4-20), p. e30138-
    Details
    In: Journal of Medical Internet Research, JMIR Publications Inc., Vol. 24, No. 4 ( 2022-4-20), p. e30138-
    Abstract: Prevalence rates for lifetime cannabis use and cannabis use disorder are much higher in people with attention deficit/hyperactivity disorder than in those without. CANreduce 2.0 is an intervention that is generally effective at reducing cannabis use in cannabis misusers. This self-guided web-based intervention (6-week duration) consists of modules grounded in motivational interviewing and cognitive behavioral therapy. Objective We aimed to evaluate whether the CANreduce 2.0 intervention affects cannabis use patterns and symptom severity in adults who screen positive for attention deficit/hyperactivity disorder more than in those who do not. Methods We performed a secondary analysis of data from a previous study with the inclusion criterion of cannabis use at least once weekly over the last 30 days. Adults with and without attention deficit/hyperactivity disorder (based on the Adult Attention deficit/hyperactivity disorder Self-Report screener) who were enrolled to the active intervention arms of CANreduce 2.0 were compared regarding the number of days cannabis was used in the preceding 30 days, the cannabis use disorder identification test score (CUDIT) and the severity of dependence scale score (SDS) at baseline and the 3-month follow-up. Secondary outcomes were Generalized Anxiety Disorder score, Center for Epidemiological Studies Depression scale score, retention, intervention adherence, and safety. Results Both adults with (n=94) and without (n=273) positive attention-deficit/hyperactivity disorder screening reported significantly reduced frequency (reduction in consumption days: with: mean 11.53, SD 9.28, P 〈 .001; without: mean 8.53, SD 9.4, P 〈 .001) and severity of cannabis use (SDS: with: mean 3.57, SD 3.65, P 〈 .001; without: mean 2.47, SD 3.39, P 〈 .001; CUDIT: with: mean 6.38, SD 5.96, P 〈 .001; without: mean 5.33, SD 6.05, P 〈 .001), as well as anxiety (with: mean 4.31, SD 4.71, P 〈 .001; without: mean 1.84, SD 4.22, P 〈 .001) and depression (with: mean 10.25, SD 10.54; without: mean 4.39, SD 10.22, P 〈 .001). Those who screened positive for attention deficit/hyperactivity disorder also reported significantly decreased attention deficit/hyperactivity disorder scores (mean 4.65, SD 4.44, P 〈 .001). There were no significant differences in change in use (P=.08), dependence (P=.95), use disorder (P=.85), attention deficit/hyperactivity disorder status (P=.84), depression (P=.84), or anxiety (P=.26) between baseline and final follow-up, dependent on positive attention-deficit/hyperactivity disorder screening. Attention deficit/hyperactivity disorder symptom severity at baseline was not associated with reduced cannabis use frequency or severity but was linked to greater reductions in depression (Spearman ρ=.33) and anxiety (Spearman ρ=.28). Individuals with positive attention deficit/hyperactivity disorder screening were significantly less likely to fill out the consumption diary (P=.02), but the association between continuous attention deficit/hyperactivity disorder symptom severity and retention (Spearman ρ=−0.10, P=.13) was nonsignificant. There also was no significant intergroup difference in the number of completed modules (with: mean 2.10, SD 2.33; without: mean 2.36, SD 2.36, P=.34), and there was no association with attention deficit/hyperactivity disorder symptom severity (Spearman ρ=−0.09; P=.43). The same was true for the rate of adverse effects (P=.33). Conclusions Cannabis users screening positive for attention deficit/hyperactivity disorder may benefit from CANreduce 2.0 to decrease the frequency and severity of cannabis dependence and attenuate symptoms of depression and attention deficit/hyperactivity disorder-related symptoms. This web-based program’s advantages include its accessibility for remote users and a personalized counselling option that may contribute to increased adherence and motivation to change among program users. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN) 11086185; http://www.isrctn.com/ISRCTN11086185
    Type of Medium: Online Resource
    ISSN: 1438-8871
    URL: Article
    DOI: 10.2196/30138
    Language: English
    Publisher: JMIR Publications Inc.
    Publication Date: 2022
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  • 6
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    Patients’ Experiences of Web- and Mobile-Assisted Group Therapy for Depression and Implications of the Group Setting: Qualitative Follow-Up Study
    JMIR Publications Inc. ; 2018
    In:  JMIR Mental Health Vol. 5, No. 3 ( 2018-07-11), p. e49-
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    In: JMIR Mental Health, JMIR Publications Inc., Vol. 5, No. 3 ( 2018-07-11), p. e49-
    Abstract: Blended group therapy combines group sessions with Web- and mobile-based treatment modules. Consequently, blended group therapy widens the choice within blended interventions at reasonable costs. This is the first qualitative study on blended group therapy. Objective The objective of this study was to investigate the patient-centered feasibility of blended group therapy for major depression, with special emphasis on the fit and dynamic interplay between face-to-face and internet-based elements. Methods A total of 22 patients who had a variety of experiences through participating in one of the two blended group therapy interventions were interviewed following a semistructured interview guide. In-depth interviews were analyzed by three trained psychologists, using thematic analysis and a rule-guided internet-based program (QCAmap). The transcript of the interviews (113,555 words) was reduced to 1081 coded units, with subsequent extraction of 16 themes. Results Web- and mobile-based elements were described as a treatment facilitator and motivator, increasing the salience and consolidation of cognitive behavioral therapy materials, resulting in in- and inter-session alignment to the treatment. Additionally, patients valued the option of intimate Web-based self-disclosure (by lateral patient-therapist communication), and therapists were provided with tools for between-session monitoring and reinforcement of exercising. In this context, group phenomena seemed to back up therapists’ efforts to increase treatment engagement. The dissonance because of noncompliance with Web-based tasks and the constriction of in-session group interaction were considered as possible negative effects. Finally, issues of tailoring and structure seemed to fulfill different preconditions compared with individual therapy. Conclusions Blended group therapy constitutes a structured and proactive approach to work with depression, and the integration of both modalities initiates a beneficial interplay. Results support the patient-centered value of blended group therapy and provide the first insight into blended group therapy’s role in fostering therapeutic treatment factors. However, potential negative effects should be considered carefully.
    Type of Medium: Online Resource
    ISSN: 2368-7959
    URL: Article
    DOI: 10.2196/mental.9613
    Language: English
    Publisher: JMIR Publications Inc.
    Publication Date: 2018
    detail.hit.zdb_id: 2798262-2
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  • 7
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    Effectiveness of an Internet-Based Self-Guided Program to Treat Depression in a Sample of Brazilian Users: Randomized Controlled Trial
    JMIR Publications Inc. ; 2023
    In:  JMIR Formative Research Vol. 7 ( 2023-8-17), p. e46326-
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    In: JMIR Formative Research, JMIR Publications Inc., Vol. 7 ( 2023-8-17), p. e46326-
    Abstract: Depression is undertreated in Brazil. Deprexis is a self-guided internet-based program used to treat depressive symptoms based on empirically supported integrative and cognitive behavioral therapy. Evidence from a meta-analysis supports Deprexis’ efficacy in German-speaking countries and the United States, but no study has been conducted using this program in countries with low literacy rates and large social disparities. Furthermore, few studies have investigated whether internet-based interventions ameliorate the psychological processes that might underlie depressive symptomatology, such as low perceived self-efficacy. Objective The main objective of this study was to replicate in Brazil previously reported effects of Deprexis on depressive symptom reduction. Therefore, the main research question was whether Deprexis is effective in reducing depressive symptoms and the general psychological state in Brazilian users with moderate and severe depression in comparison with a control group that does not receive access to Deprexis. A secondary research question was whether the use of Deprexis affects perceptions of self-efficacy. Methods We interviewed 312 participants recruited over the internet and randomized 189 participants with moderate to severe depression (according to the Patient Health Questionnaire–9 and a semistructured interview) to an intervention condition (treatment as usual plus immediate access to Deprexis for 90 days, n=94) or to a control condition (treatment as usual and delayed access to Deprexis, after 8 weeks, n=95). Results Participants from the immediate access group logged in at Deprexis an average of 14.81 (SD 12.16) times. The intention-to-treat analysis using a linear mixed model showed that participants who received Deprexis improved significantly more than participants assigned to the delayed access control group on the primary depression self-assessment measure (Patient Health Questionnaire–9; Cohen d=0.80; P 〈 .001) and secondary outcomes, such as general psychological state measure (Clinical Outcome in Routine Evaluation–Outcome Measurement; Cohen d=0.82; P 〈 .001) and the perceived self-efficacy measure (Cohen d=0.63; P 〈 .001). The intention-to-treat analyses showed that 21% (20/94) of the participants achieved remission compared with 7% (7/95) in the control group (P 〈 .001). The deterioration rates were lower in the immediate access control group. The dropout rate was high, but no differences in demographic and clinical variables were found. Participants reported a medium to high level of satisfaction with Deprexis. Conclusions These results replicate previous findings by showing that Deprexis can facilitate symptomatic improvement over 3 months in depressed samples of Brazilian users. From a public health perspective, this is important information to expand the reach of internet-based interventions for those who really need them, especially in countries with less access to mental health care. This extends previous research by showing significant effects on perceived self-efficacy. Trial Registration Registro Brasileiro de Ensaios Clíncos (ReBec) RBR-6kk3bx UTN U1111-1212-8998; https://ensaiosclinicos.gov.br/rg/RBR-6kk3bx/ International Registered Report Identifier (IRRID) RR2-10.1590/1516-4446-2019-0582
    Type of Medium: Online Resource
    ISSN: 2561-326X
    URL: Article
    DOI: 10.2196/46326
    Language: English
    Publisher: JMIR Publications Inc.
    Publication Date: 2023
    detail.hit.zdb_id: 2941716-8
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  • 8
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    The Advantages and Disadvantages of Online and Blended Therapy: Survey Study Amongst Licensed Psychotherapists in Austria
    JMIR Publications Inc. ; 2018
    In:  Journal of Medical Internet Research Vol. 20, No. 12 ( 2018-12-18), p. e11007-
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    In: Journal of Medical Internet Research, JMIR Publications Inc., Vol. 20, No. 12 ( 2018-12-18), p. e11007-
    Type of Medium: Online Resource
    ISSN: 1438-8871
    URL: Article
    DOI: 10.2196/11007
    Language: English
    Publisher: JMIR Publications Inc.
    Publication Date: 2018
    detail.hit.zdb_id: 2028830-X
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  • 9
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    CANreduce 2.0 Adherence-Focused Guidance for Internet Self-Help Among Cannabis Users: Three-Arm Randomized Controlled Trial
    JMIR Publications Inc. ; 2021
    In:  Journal of Medical Internet Research Vol. 23, No. 4 ( 2021-4-30), p. e27463-
    Details
    In: Journal of Medical Internet Research, JMIR Publications Inc., Vol. 23, No. 4 ( 2021-4-30), p. e27463-
    Abstract: Despite increasing demand for treatment among cannabis users in many countries, most users are not in treatment. Internet-based self-help offers an alternative for those hesitant to seek face-to-face therapy, though low effectiveness and adherence issues often arise. Objective Through adherence-focused guidance enhancement, we aimed to increase adherence to and the effectiveness of internet-based self-help among cannabis users. Methods From July 2016 to May 2019, cannabis users (n=775; male: 406/575, 70.6%, female: 169/575, 29.4%; age: mean 28.3 years) not in treatment were recruited from the general population and were randomly assigned to (1) an adherence-focused guidance enhancement internet-based self-help intervention with social presence, (2) a similar intervention with an impersonal service team, and (3) access to internet as usual. Controls who were placed on a waiting list for the full intervention after 3 months underwent an assessment and had access to internet as usual. The primary outcome measurement was cannabis-use days over the preceding 30 days. Secondary outcomes included cannabis-dependence severity, changes in common mental disorder symptoms, and intervention adherence. Differences between the study arms in primary and secondary continuous outcome variables at baseline, posttreatment, and follow-up were tested using pooled linear models. Results All groups exhibited reduced cannabis-use days after 3 months (social presence: –8.2 days; service team: –9.8 days; internet as usual: –4.2 days). The participants in the service team group (P=.01, d=.60) reported significantly fewer cannabis-use days than those in the internet as usual group; the reduction of cannabis use in the social presence group was not significant (P=.07, d=.40). There was no significant difference between the 2 intervention groups regarding cannabis-use reduction. The service team group also exhibited superior improvements in cannabis-use disorder, cannabis-dependence severity, and general anxiety symptoms after 3 months to those in the internet as usual group. Conclusions The adherence-focused guidance enhancement internet-based self-help intervention with an impersonal service team significantly reduced cannabis use, cannabis-use disorder, dependence severity, and general anxiety symptoms. Trial Registration ISRCTN Registry ISRCTN11086185; http://www.isrctn.com/ISRCTN11086185
    Type of Medium: Online Resource
    ISSN: 1438-8871
    URL: Article
    DOI: 10.2196/27463
    Language: English
    Publisher: JMIR Publications Inc.
    Publication Date: 2021
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  • 10
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    Effect of Sleep Disturbance Symptoms on Treatment Outcome in Blended Cognitive Behavioral Therapy for Depression (E-COMPARED Study): Secondary Analysis
    JMIR Publications Inc. ; 2022
    In:  Journal of Medical Internet Research Vol. 24, No. 3 ( 2022-3-21), p. e30231-
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    In: Journal of Medical Internet Research, JMIR Publications Inc., Vol. 24, No. 3 ( 2022-3-21), p. e30231-
    Abstract: 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 (β=.16, 95% CI –0.04 to 0.36). However, baseline sleep disturbance symptoms were negatively associated with treatment outcome for bCBT (β=.49, 95% CI 0.22-0.76) but not for TAU (β=–.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- (β=.06, 95% CI −0.11 to 0.23) or 6-month (β=.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.
    Type of Medium: Online Resource
    ISSN: 1438-8871
    URL: Article
    DOI: 10.2196/30231
    Language: English
    Publisher: JMIR Publications Inc.
    Publication Date: 2022
    detail.hit.zdb_id: 2028830-X
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