scholarly journals Web-based Cognitive Behavioral Therapy Blended with Face-to-Face Sessions for Major Depression: a Randomized Clinical Trial (Preprint)

2018 ◽  
Author(s):  
Shigetsugu Nakao ◽  
Atsuo Nakagawa ◽  
Yoshiyo Oguchi ◽  
Dai Mitsuda ◽  
Noriko Kato ◽  
...  

BACKGROUND Meta-analyses of a large number of randomized controlled trials have shown that cognitive behavioral therapy (CBT) has comparable efficacy to antidepressant medication, but therapist availability and cost-effectiveness is a problem. OBJECTIVE This study aimed to evaluate the effectiveness of a web-based CBT blended with face-to-face sessions that reduce therapist time in patients with major depression who were unresponsive to antidepressant medications. METHODS A 12-week, assessor-masked, parallel-group, waiting-list controlled, randomized trial was conducted in three medical institutions located in Tokyo. Outpatients aged 20–65 years with a primary diagnosis of major depression (taking one or more antidepressant medications at an adequate dose for ≥ 6 weeks, 17-item GRID-Hamilton Depression Rating Scale [GRID-HAMD] score ≥ 14) were randomly assigned (1:1) to blend CBT or waiting-list groups using a computer allocation system, stratified by the study site with the minimization method, to balance age and baseline GRID-HAMD score. The CBT intervention was given in a combined format, consisting of a web-based program and twelve 45-minute face-to-face sessions. Thus, across 12 weeks, a participant could receive up to 540 minutes of contact with a therapist, which was approximately two-thirds of the therapist contact time provided in the conventional CBT protocol, which typically provides sixteen 50-minute sessions. The primary outcome was the alleviation of depressive symptoms, as measured by a change in the total GRID-HAMD score from baseline (at randomization) to post-treatment (at 12 weeks). Additionally, in an exploratory analysis, we investigated whether the expected positive effects of the intervention were sustained during follow-up, 3 months after the post-treatment assessment. Analyses were performed on an intention-to-treat basis, and the primary outcome was analyzed using a mixed-effects model for repeated measures. RESULTS A total of 40 participants were randomized to either blend CBT (n=20) or waiting-list (n=20) groups. All patients completed the 12-week treatment protocol, and all were included in the intention-to-treat analyses. Participants in the blend CBT group had significantly alleviated depressive symptoms at week 12, as shown by greater least squares mean changes in GRID-HAMD score, than those in the waiting-list group (−8.9 points vs. −3.0 points; mean between-group difference = −5.95; 95% CI, −9.53 to −2.37; p =0.0002). The follow-up effects within the blend CBT group, as measured by GRID-HAMD score, was sustained at 3-months follow-up (week 24) after treatment (week 12) (post-treatment: 9.4 ± 5.2 vs. follow-up: 7.2 ± 5.7, p= 0.009). CONCLUSIONS Although our findings need to be confirmed in larger and longer-term studies with active controls, the present findings suggest that a combined form of CBT is effective in reducing depressive symptoms in patients with major depression who were unresponsive to antidepressant medications. CLINICALTRIAL Japanese Clinical Trials Registry UMIN Clinical Trials Registry Identifier: UMIN000009242.

10.2196/10743 ◽  
2018 ◽  
Vol 20 (9) ◽  
pp. e10743 ◽  
Author(s):  
Shigetsugu Nakao ◽  
Atsuo Nakagawa ◽  
Yoshiyo Oguchi ◽  
Dai Mitsuda ◽  
Noriko Kato ◽  
...  

Background Meta-analyses of several randomized controlled trials have shown that cognitive behavioral therapy (CBT) has comparable efficacy to antidepressant medication, but therapist availability and cost-effectiveness is a problem. Objective This study aimed to evaluate the effectiveness of Web-based CBT blended with face-to-face sessions that reduce therapist time in patients with major depression who were unresponsive to antidepressant medications. Methods A 12-week, assessor-masked, parallel-group, waiting- list controlled, randomized trial was conducted at 3 medical institutions in Tokyo. Outpatients aged 20-65 years with a primary diagnosis of major depression who were taking ≥1 antidepressant medications at an adequate dose for ≥6 weeks and had a 17-item GRID-Hamilton Depression Rating Scale (HAMD) score of ≥14 were randomly assigned (1:1) to blended CBT or waiting-list groups using a computer allocation system, stratified by the study site with the minimization method, to balance age and baseline GRID-HAMD score. The CBT intervention was given in a combined format, comprising a Web-based program and 12 45-minute face-to-face sessions. Thus, across 12 weeks, a participant could receive up to 540 minutes of contact with a therapist, which is approximately two-thirds of the therapist contact time provided in the conventional CBT protocol, which typically provides 16 50-minute sessions. The primary outcome was the alleviation of depressive symptoms, as measured by a change in the total GRID-HAMD score from baseline (at randomization) to posttreatment (at 12 weeks). Moreover, in an exploratory analysis, we investigated whether the expected positive effects of the intervention were sustained during follow-up, 3 months after the posttreatment assessment. Analyses were performed on an intention-to-treat basis, and the primary outcome was analyzed using a mixed-effects model for repeated measures. Results We randomized 40 participants to either blended CBT (n=20) or waiting-list (n=20) groups. All patients completed the 12-week treatment protocol and were included in the intention-to-treat analyses. Participants in the blended CBT group had significantly alleviated depressive symptoms at week 12, as shown by greater least squares mean changes in the GRID-HAMD score, than those in the waiting list group (−8.9 points vs −3.0 points; mean between-group difference=−5.95; 95% CI −9.53 to −2.37; P<.001). The follow-up effects within the blended CBT group, as measured by the GRID-HAMD score, were sustained at the 3-month follow-up (week 24) and posttreatment (week 12): posttreatment, 9.4 (SD 5.2), versus follow-up, 7.2 (SD 5.7); P=.009. Conclusions Although our findings warrant confirmation in larger and longer term studies with active controls, these suggest that a combined form of CBT is effective in reducing depressive symptoms in patients with major depression who are unresponsive to antidepressant medications. Trial Registration University Hospital Medical Information Network Clinical Trials Registry: UMIN000009242; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010852 (Archived by WebCite at http://www.webcitation. org/729VkpyYL)


2021 ◽  
Author(s):  
Annemiek van Dijke ◽  
Gisela R.M. Emmory-Lijde ◽  
Mathijs Deen

BACKGROUND Background: The prevalence of major depression is very high and it is considered one of the most hindering disorders, associated with a strong social- and financial impact. Despite the effectiveness of traditional cognitive behavioral therapy (CBT), response, improvement, remission and recovery rates are low and relapse percentages are considerably high. This study is the first to investigate the effectiveness of online videoconferencing CBT with smartphone app support in patients with major depression. With this ‘modern’ way of online CBT, we aim to enhance the effectiveness of CBT OBJECTIVE Objective: The objective is to assess the results of online videoconferencing CBT with app-support compared to TAU in patients with depression. To enhance therapy outcome and patient satisfaction for the treatment of depression. METHODS Methods: A retrospective cohort study was conducted in an outpatient treatment center (PsyQ-Parnassia, the Netherlands). Routine Outcome Monitoring (ROM) data was collected from September 2018 to March 2020, at pre- and post-treatment. Seven hundred and seventy patients were included; 40 for psyQ-online and 730 for psyQ-TAU. The primary outcome measure is the symptoms of depression measured with the Quick Inventory of Depressive Symptomatology (QIDS-SR-16; Trivedi et al., 2004). To assess ‘significant change’ in depressive symptoms we compared pre-and post-treatment scores for PsyQ-online group compared with the PsyQ-TAU group. Clinical significant change or remission was defined as ‘going from above the clinical cut-off score at pre-treatment to below the cut-off score’ which equals ‘normalcy’ or ‘no depression’ (in this case below 6) at post-treatment. ‘Reliable change’ was defined as ‘whether people changed sufficiently that the change is unlikely to be due to simple measurement unreliability’. Reliable changes were grouped in four categories: (1) Recovered = reliable and clinical significant change in QIDS-SR-16, (2) Improved = reliable change, without clinical significant change, (3) No change = no reliable change and no clinical significant change, and (4) Deteriorated = negative reliable change in the QIDS-SR-16 (Jakobsen et al., 2017). To investigate patients satisfaction for online psychotherapy when compared to the patients in the PsyQ-TAU group, we used KLANT scores (Huijbrechts et al., 2009). RESULTS Results: The psyQ-online patients showed significantly higher improvement, remission and recovery percentages compared to the psyQ-TAU patients. Online patients were more satisfied with their therapy compared to TAU patients. CONCLUSIONS Conclusion: ‘Significant reduction’ in depressive symptoms and high percentages of ‘improvement’, ‘remission’ and ‘recovery’, can be obtained when performing online cbt with smartphone-application-support for depression. This even enhances CBT-outcome in highly satisfied patients. CLINICALTRIAL n/a


SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A203-A204
Author(s):  
J Arnedt ◽  
D Conroy ◽  
A Mooney ◽  
K DuBuc ◽  
S Balstad ◽  
...  

Abstract Introduction Telemedicine is increasingly an option for delivery of healthcare services, but its efficacy and acceptability for delivering CBT for insomnia has not been adequately tested. In a randomized controlled non-inferiority trial, we compared face-to-face and telemedicine delivery (via the AASM SleepTM platform) of CBT for insomnia for improving sleep and daytime functioning at post-treatment and 12-week follow-up. Methods Sixty-five adults with chronic insomnia (46 women, mean age 47.2 ± 16.3 years) were recruited primarily from insomnia clinics and screened for disqualifying sleep, medical, and mental health disorders. Eligible participants were randomized to 6 sessions of CBT for insomnia delivered face-to-face (n=32) or via AASM SleepTM (n=33). Participants completed self-report measures of insomnia (Insomnia Severity Index, ISI) and daytime functioning (fatigue, depression, anxiety, and overall functioning) at pre-treatment, post-treatment, and 12-week follow-up. The ISI was the primary non-inferiority outcome. Results Telemedicine was non-inferior to face-to-face delivery of CBT for insomnia, based on a non-inferiority margin of 4 points on the ISI (β = -0.07, 95% CI -2.28 to 2.14). Compared to pre-treatment, ISI scores improved significantly at post-treatment (β = -9.02, 95% CI -10.56 to -7.47) and at 12-week follow-up (β = -9.34, 95% CI -10.89 to -7.79). Similarly, daytime functioning measures improved from pre- to post-treatment, with sustained improvements at 12-week follow-up. Scores on the fatigue scale were lower in the telemedicine group at both post-treatment (F=4.64, df=1,119, p&lt;.03) and follow-up (F=5.79, df=1,119, p&lt;.02). Conclusion Insomnia and daytime functioning improve similarly whether CBT for insomnia is delivered via telemedicine or face-to-face. Telemedicine delivery of CBT for insomnia should be implemented more systematically to improve access to this evidence-based treatment. Support American Sleep Medicine Foundation Grant # 168-SR-17 (JT Arnedt, PhD)


2021 ◽  
Vol 24 (2) ◽  
pp. 292-305
Author(s):  
Behzad Salmani ◽  
◽  
Jaafar Hasani ◽  

Background & Aim: This study aimed at comparing efficacy of cognitive behavioral therapy, Zolpidem 10 mg, and waiting list group on illness perception and sleep efficiency in individuals with chronic insomnia disorder. Materials & Methods: Participants included 74 (female = 43) individuals with chronic insomnia disorder who were recruited from 2018 December to 2020 February by purposive sampling (inclusive & exclusive criteria). Then, patients randomly allocated to one of the three conditions, including cognitive behavioral therapy (N=25), pharmacotherapy (Zolpidem 10 mg.; N=29), and the waiting list (N=20). All patients were assessed three times at pretreatment, post-treatment, and 3-month follow-up by the Persian version of Brief Illness Perception Questionnaire and Sleep Efficiency Index. The data were analyzed by mixed analysis of variance with Bonferroni post-hoc test and repeated measure analysis of variance. Ethical Considerations: All stages of the research have been carried after taking supervising and approving of Kharazmi University's ethics in research committee. Findings: The patients who received cognitive behavioral therapy compared to patients in waiting list group, obtained significantly lower scores in illness perception and sleep efficiency during post-treatment and 3-month follow-up. Efficacy of pharmacotherapy only observed during post-treatment but there were no significant differences between pharmacotherapy and waiting list patients during 3-month follow-up. Conclusion: Cognitive behavioral therapy for insomnia reduced significantly illness perceptions and sleep efficiency during 3 months. All the treatment gains remain stable even 3 months later treatment ends. In addition, not receiving any treatment in waiting list and gradually discontinued the treatment in pharmacotherapy group leads to decreasing of sleep efficiency and increasing of illness perception.


2019 ◽  
Vol 50 (1) ◽  
pp. 11-19 ◽  
Author(s):  
Morten Hvenegaard ◽  
Stine B. Moeller ◽  
Stig Poulsen ◽  
Matthias Gondan ◽  
Ben Grafton ◽  
...  

AbstractBackgroundAlthough cognitive-behavioural therapy (CBT) is an effective treatment for depression, less than half of patients achieve satisfactory symptom reduction during treatment. Targeting known psychopathological processes such as rumination may increase treatment efficacy. The aim of this study was to test whether adding group rumination-focused CBT (RFCBT) that explicitly targets rumination to routine medical management is superior to adding group CBT to routine medical management in treating major depression.MethodsA total of 131 outpatients with major depression were randomly allocated to 12 sessions group RFCBT v. group CBT, each in addition to routine medical management. The primary outcome was observer-rated symptoms of depression at the end of treatment measured on the Hamilton Rating Scale for Depression. Secondary outcomes were rumination at post-treatment and depressive symptoms at 6 months follow-up (Trial registered: NCT02278224).ResultsRFCBT significantly improved observer-rated depressive symptoms (Cohen's d 0.38; 95% CI 0.03–0.73) relative to group CBT at post-treatment on the primary outcome. No post-treatment differences were found in rumination or in depressive symptoms at 6 months follow-up, although these secondary analyses may have been underpowered.ConclusionsThis is the first randomized controlled trial providing evidence of benefits of RFCBT in major depression compared with CBT. Group RFCBT may be a beneficial alternative to group CBT for major depression.


SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A139-A140
Author(s):  
Janannii Selvanathan ◽  
Chi Pham ◽  
Mahesh Nagappa ◽  
Philip Peng ◽  
Marina Englesakis ◽  
...  

Abstract Introduction Patients with chronic non-cancer pain often report insomnia as a significant comorbidity. Cognitive behavioral therapy for insomnia (CBT-I) is recommended as the first line of treatment for insomnia, and several randomized controlled trials (RCTs) have examined the efficacy of CBT-I on various health outcomes in patients with comorbid insomnia and chronic non-cancer pain. We conducted a systematic review and meta-analysis on the effectiveness of CBT-I on sleep, pain, depression, anxiety and fatigue in adults with comorbid insomnia and chronic non-cancer pain. Methods A systematic search was conducted using ten electronic databases. The duration of the search was set between database inception to April 2020. Included studies must be RCTs assessing the effects of CBT-I on at least patient-reported sleep outcomes in adults with chronic non-cancer pain. Quality of the studies was assessed using the Cochrane risk of bias assessment and Yates quality rating scale. Continuous data were extracted and summarized using standard mean difference (SMD) with 95% confidence intervals (CIs). Results The literature search resulted in 7,772 articles, of which 14 RCTs met the inclusion criteria. Twelve of these articles were included in the meta-analysis. The meta-analysis comprised 762 participants. CBT-I demonstrated a large significant effect on patient-reported sleep (SMD = 0.87, 95% CI [0.55–1.20], p &lt; 0.00001) at post-treatment and final follow-up (up to 9 months) (0.59 [0.31–0.86], p &lt; 0.0001); and moderate effects on pain (SMD = 0.20 [0.06, 0.34], p = 0.006) and depression (0.44 [0.09–0.79], p= 0.01) at post-treatment. The probability of improving sleep and pain following CBT-I at post-treatment was 81% and 58%, respectively. The probability of improving sleep and pain at final follow-up was 73% and 57%, respectively. There were no statistically significant effects on anxiety and fatigue. Conclusion This systematic review and meta-analysis showed that CBT-I is effective for improving sleep in adults with comorbid insomnia and chronic non-cancer pain. Further, CBT-I may lead to short-term moderate improvements in pain and depression. However, there is a need for further RCTs with adequate power, longer follow-up periods, CBT for both insomnia and pain, and consistent scoring systems for assessing patient outcomes. Support (if any):


2021 ◽  
Author(s):  
Xiaochen Luo ◽  
Matteo Bugatti ◽  
Lucero Molina ◽  
Jacqueline L. Tilley ◽  
Brittain Mahaffey ◽  
...  

BACKGROUND The role of working alliance is largely unknown for internet-based interventions (IBI), an effective alternative for traditional psychotherapy. OBJECTIVE This study examined the conceptual invariance, trajectory, and outcome associations of working alliance in internet-based interventions incorporating or excluding clinician support via text or video. METHODS One hundred and forty-three adults with subclinical anxiety, stress, and/or depression symptoms were randomized to one of three treatment conditions for 7 weeks. All participants received access to MyCompass, an internet-delivered Cognitive Behavioral Therapy program. Participants in Condition 1 did not receive clinician support. Participants in Condition 2 and 3 received supplemental asynchronous clinician support via text or video respectively. Working alliance was measured weekly. Symptom outcomes were assessed at baseline, post-treatment, and 1-month follow-up. RESULTS We found scalar invariance of working alliance, indicating that working alliance was conceptually invariant across three conditions. Working alliance decreased significantly over time only in the text support group. Stronger baseline level and Faster increases in alliance predicted better outcomes at both post-treatment and follow-up only in the video support group. CONCLUSIONS Working alliance is methodologically comparable with or without clinician support and is generally established at initial sessions of IBI. Better alliance contributed to better outcomes only when clinician support is available via videos. CLINICALTRIAL clinicaltrials.gov ID: NCT05122429


2020 ◽  
Author(s):  
Eyal Karin ◽  
Monique Francis Crane ◽  
Blake Farran Dear ◽  
Olav Nielssen ◽  
Gillian Ziona Heller ◽  
...  

BACKGROUND Missing cases present a challenge to our ability to evaluate the effects of web-based psychotherapy trials. As missing cases are often lost to follow up, less is known about their characteristics, their likely clinical outcomes, or the likely effect of the treatment being trialled. OBJECTIVE To explore the characteristics of missing cases, their likely treatment outcomes, and the ability of different statistical models to approximate missing post-treatment data. METHODS A sample of internet-delivered cognitive behavioural therapy participants, in routine care (n = 6701 with 36% missing cases at post-treatment), was used to identify predictors of dropping out of treatment and predictors that moderated clinical outcomes, such as psychological distress, anxiety and depressive symptoms. These variables were then incorporated into a range of statistical models that approximated replacement outcomes for missing cases, with the results compared using sensitivity and cross-validation analyses. RESULTS Treatment adherence, as measured by the rate of an individual’s progress through the treatment modules, and higher symptom scores at pre-treatment, were identified as the dominant predictors of missing cases probability (Nagelkerke R2 = 60.8%), as well as the rate of symptom change. Low treatment adherence, in particular, was associated with increased odds for presenting as missing cases during post-treatment assessment (eg, OR = 161.1:1) and at the same time, attenuate the rate of symptom change across anxiety (up to 28% of the total symptom 48% reduction effect), depression (up to 41% of the total 48% symptom reduction effect) and psychological distress symptom outcomes (up to 52% of the total 37% symptom reduction effect) at the end of an eight week window. Reflecting this pattern of results, statistical replacement methods that overlooked the features of treatment adherence, and baseline severity, underestimated missing case symptom outcomes by as much as 40% at post-treatment. CONCLUSIONS The treatment outcomes of the cases that were missing at follow up were distinct from the remaining observed sample. Thus, overlooking the features of missing cases is likely to result in an inaccurate estimate of the effect of treatment. CLINICALTRIAL


2020 ◽  
Vol 26 (3) ◽  
pp. 88-93
Author(s):  
Abdulaziz Abushaala ◽  
Helen Sargent ◽  
Jennifer McLean ◽  
Deborah Grech-Marguerat ◽  
Hisham Khalil

Background/aims There is a growing backlog of patients with sino-nasal disorders waiting for a follow-up appointment. This study aimed to identify rhinology patients on the outpatient follow-up list who could be removed from the waiting list for a face to face follow-up appointment and instead either given a phone consultation by a clinical nurse specialist or discharged from the service. Methods The clinical records of patients on the waiting list for a follow-up appointment at a nasal disorders clinic were reviewed by a panel comprising a consultant rhinologist, a rhinology fellow, a specialist registrar and two nurse specialists. Results A total of 300 clinical records of patients on the follow-up list of the Rhinology clinic were identified, of which 253 were found to have a sino-nasal disorder. Of these, 137 patients (54%) were discharged from the rhinology face to face follow-up clinics, while 116 patients (46%) were given face to face review appointments. Conclusions A multi-professional rhinology review panel is an effective way of managing the waiting list of an outpatient rhinology clinic and providing nurse-led telephone consultations could decrease the strain on resources while maintaining patient safety.


Pain Medicine ◽  
2020 ◽  
Vol 21 (11) ◽  
pp. 2811-2822
Author(s):  
Brandon C Yarns ◽  
Mark A Lumley ◽  
Justina T Cassidy ◽  
W Neil Steers ◽  
Sheryl Osato ◽  
...  

Abstract Objective Emotional awareness and expression therapy (EAET) emphasizes the importance of the central nervous system and emotional processing in the etiology and treatment of chronic pain. Prior trials suggest EAET can substantially reduce pain; however, only one has compared EAET with an established alternative, demonstrating some small advantages over cognitive behavioral therapy (CBT) for fibromyalgia. The current trial compared EAET with CBT in older, predominately male, ethnically diverse veterans with chronic musculoskeletal pain. Design Randomized comparison trial. Setting Outpatient clinics at the West Los Angeles VA Medical Center. Subjects Fifty-three veterans (mean age = 73.5 years, 92.4% male) with chronic musculoskeletal pain. Methods Patients were randomized to EAET or CBT, each delivered as one 90-minute individual session and eight 90-minute group sessions. Pain severity (primary outcome), pain interference, anxiety, and other secondary outcomes were assessed at baseline, post-treatment, and three-month follow-up. Results EAET produced significantly lower pain severity than CBT at post-treatment and follow-up; differences were large (partial η2 = 0.129 and 0.157, respectively). At post-treatment, 41.7% of EAET patients had &gt;30% pain reduction, one-third had &gt;50%, and 12.5% had &gt;70%. Only one CBT patient achieved at least 30% pain reduction. Secondary outcomes demonstrated small to medium effect size advantages of EAET over CBT, although only post-treatment anxiety reached statistical significance. Conclusions This trial, although preliminary, supports prior research suggesting that EAET may be a treatment of choice for many patients with chronic musculoskeletal pain. Psychotherapy may achieve substantial pain reduction if pain neuroscience principles are emphasized and avoided emotions are processed.


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