A randomized noninferiority trial evaluating remotely-delivered stepped care for depression using internet cognitive behavioral therapy (CBT) and telephone CBT.
Ontology highlight
ABSTRACT:
SUBMITTER: Mohr DC
PROVIDER: S-EPMC6916718 | biostudies-literature | 2019 Dec
REPOSITORIES: biostudies-literature
Publications
A randomized noninferiority trial evaluating remotely-delivered stepped care for depression using internet cognitive behavioral therapy (CBT) and telephone CBT.
Mohr David C DC Lattie Emily G EG Tomasino Kathryn Noth KN Kwasny Mary J MJ Kaiser Susan M SM Gray Elizabeth L EL Alam Nameyeh N Jordan Neil N Schueller Stephen M SM
Behaviour research and therapy 20190930
This trial examined whether a stepped care program for depression, which initiated treatment with internet cognitive behavioral therapy, including telephone and messaging support, and stepped up non-responders to telephone-administered cognitive behavioral therapy (tCBT), was noninferior, less costly to deliver, and as acceptable to patients compared to tCBT alone. Adults with a diagnosis of major depressive episode (MDE) were randomized to receive up to 20 weeks of stepped care or tCBT. Stepped ...[more]
Similar Datasets
Project description:BackgroundInternet-based cognitive behavioral therapy (I-CBT) leads to a reduction of fatigue severity and disability in adults with chronic fatigue syndrome (CFS). However, not all patients profit and it remains unclear how I-CBT is best embedded in the care of CFS patients.ObjectiveThis study aimed to compare the efficacy of stepped care, using therapist-assisted I-CBT, followed by face-to-face (f2f) cognitive behavioral therapy (CBT) when needed, with f2f CBT (treatment as usual [TAU]) on fatigue severity. The secondary aim was to investigate treatment efficiency.MethodsA total of 363 CFS patients were randomized to 1 of the 3 treatment arms (n=121). There were 2 stepped care conditions that differed in the therapists' feedback during I-CBT: prescheduled or on-demand. When still severely fatigued or disabled after I-CBT, the patients were offered f2f CBT. Noninferiority of both stepped care conditions to TAU was tested using analysis of covariance. The primary outcome was fatigue severity (Checklist Individual Strength). Disabilities (Sickness Impact Profile -8), physical functioning (Medical Outcomes Survey Short Form-36), psychological distress (Symptom Checklist-90), and proportion of patients with clinically significant improvement in fatigue were the secondary outcomes. The amount of invested therapist time was compared between stepped care and TAU. Exploratory comparisons were made between the stepped care conditions of invested therapist time and proportion of patients who continued with f2f CBT.ResultsNoninferiority was indicated, as the upper boundary of the one-sided 98.75% CI of the difference in the change in fatigue severity between both forms of stepped care and TAU were below the noninferiority margin of 5.2 (4.25 and 3.81, respectively). The between-group differences on the secondary outcomes were also not significant (P=.11 to P=.79). Both stepped care formats required less therapist time than TAU (median 8 hours, 9 minutes and 7 hours, 25 minutes in stepped care vs 12 hours in TAU; P<.001). The difference in therapist time between both stepped care formats was not significant. Approximately half of the patients meeting step-up criteria for f2f CBT after I-CBT did not continue.ConclusionsStepped care, including I-CBT followed by f2f CBT when indicated, is noninferior to TAU of f2f CBT and requires less therapist time. I-CBT for CFS can be used as a first step in stepped care.Trial registrationNederlands Trial Register NTR4809; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4809 (Archived by WebCite at http://www.webcitation.org/74SWkw1V5).
| S-EPMC6437617 | biostudies-literature
Project description:BackgroundTelephone helplines are frequently and repeatedly used by individuals with chronic mental health problems and web interventions may be an effective tool for reducing depression in this population.AimTo evaluate the effectiveness of a 6 week, web-based cognitive behaviour therapy (CBT) intervention with and without proactive weekly telephone tracking in the reduction of depression in callers to a helpline service.Method155 callers to a national helpline service with moderate to high psychological distress were recruited and randomised to receive either Internet CBT plus weekly telephone follow-up; Internet CBT only; weekly telephone follow-up only; or treatment as usual.ResultsDepression was lower in participants in the web intervention conditions both with and without telephone tracking compared to the treatment as usual condition both at post intervention and at 6 month follow-up. Telephone tracking provided by a lay telephone counsellor did not confer any additional advantage in terms of symptom reduction or adherence.ConclusionsA web-based CBT program is effective both with and without telephone tracking for reducing depression in callers to a national helpline.Trial registrationControlled-Trials.comISRCTN93903959.
| S-EPMC3227639 | biostudies-literature
Project description:Aim:To examine the efficacy of transdiagnostic internet-delivered cognitive behavioural therapy (iCBT), mindfulness-enhanced iCBT, and stand-alone online mindfulness training compared with a usual care control group (TAU) for clinical anxiety and depression. Method:Individuals (N = 158) with a DSM-5 diagnosis of a depressive and/or anxiety disorder were randomised to one of the three clinician-guided online interventions, or TAU over a 14-week intervention period. The primary outcomes were self-reported depression (PHQ-9) and anxiety (GAD-7) severity at post-treatment. Secondary outcomes included adherence rates, functional impairment (WHODAS-II), general distress (K-10), and diagnostic status at the 3-month follow-up (intervention groups). Results:All three programs achieved significant and large reductions in symptoms of depression (g = 0.89-1.53), anxiety (g = 1.04-1.40), and distress (g = 1.25-1.76); and medium to large reductions in functional impairment (g = 0.53-0.98) from baseline to post-treatment and 3-month follow-up. Intention-to-treat linear mixed models showed that all three online programs were superior to usual care at reducing symptoms of depression (g = 0.89-1.18) and anxiety (g = 1.00-1.23). Conclusion:Transdiagnostic iCBT, mindfulness-enhanced iCBT and online mindfulness training are more efficacious for treating depression and anxiety disorders than usual care, and represent an accessible treatment option for these disorders.
| S-EPMC7044661 | biostudies-literature
Project description:Anxiety and depressive symptoms are common problems in adolescence that could be addressed by means of preventive interventions. Even though transdiagnostic cognitive behavior therapy (T-CBT) is potentially an ideal strategy to deal with anxiety and depression, it has rarely been used for preventive purposes. In addition, so far, no study has used internet-delivered T-CBT to prevent anxiety and depression in adolescents. This study aimed to examine the utility of AMTE, an internet-delivered T-CBT program, for the indicated prevention of anxiety and depression in adolescents. AMTE was applied to 30 adolescents (56.7% females, age range = 12-18 years, Mage = 14.00, SDage = 1.89) who showed subclinical symptoms of anxiety and/or depression. Participants were assessed at pre- and post-treatment and follow-up (3 months). We found that after the program, the symptoms of self-reported anxiety and depression, clinician-rated symptom severity, and self-reported and parent-reported severity of the main problems had significantly improved. In addition, there were significant improvements in anxiety sensitivity and emotional avoidance. Finally, we found high feasibility and acceptability of the program. AMTE is feasible and potentially effective for the indicated prevention of anxiety and depression as well as of clinical transdiagnostic factors, in adolescents.
| S-EPMC9101842 | biostudies-literature
Project description:ObjectivesTo evaluate the efficacy of an Internet behavioral weight loss program; and determine if adding periodic in-person sessions to an Internet intervention improves outcomes.Methods481 healthy overweight adults (28% minority) were randomized to one of 3 delivery methods of a behavioral weight loss program with weekly meetings: Internet (n=161), InPerson (n=158), or Hybrid (Internet+InPerson, n=162). Outcome variables were weight at baseline and 6 months and percent of subjects achieving a 5 and 7% weight loss. The study took place in two centers in Vermont and Arkansas from 2003 to 2008.ResultsConditions differed significantly in mean weight loss [8.0 (6.1) kg vs. 5.5 (5.6) kg vs. 6.0 (5.5) kg], for InPerson, Internet, and Hybrid respectively, p<0.01, n=462). Weight loss for InPerson was significantly greater than the Internet and Hybrid conditions (p<0.05). Although the proportion reaching a 5% weight loss did not differ, the proportion losing 7% did differ significantly (56.3% vs. 37.3% vs. 44.4% for InPerson, Internet, and Hybrid respectively, p<0.01).ConclusionsThese results demonstrate that the Internet is a viable alternative to in-person treatment for the delivery and dissemination of a behavioral weight-control intervention. The addition of periodic in-person sessions did not improve outcomes.
| S-EPMC3101104 | biostudies-literature
Project description:BACKGROUND:Depression is a common and serious problem among adolescents, but few seek or have access to therapy. Internet-delivered cognitive behavioral therapies (ICBTs), developed to increase treatment access, show promise in reducing depression. The inclusion of coach support in treatment is desired and may be needed. OBJECTIVE:The aim of this study was to determine the efficacy of an ICBT protocol blended with weekly real-time therapist sessions via chat; blended treatment, for adolescent depression, including major depressive episode (MDE). The protocol has previously been evaluated in a controlled study. METHODS:In a two-arm randomized controlled trial, adolescents 15 to 19 years of age were recruited through a community setting at the national level in Sweden (n=70) and allocated to either 8 weeks of treatment or to minimal attention control. Depression was assessed at baseline, at posttreatment, and at 12 months following treatment (in the intervention group). The primary outcome was self-reported depression level as measured with the Beck Depression Inventory II at posttreatment. The intervention was offered without the need for parental consent. RESULTS:Over two weeks, 162 adolescents registered and completed the baseline screening. Eligible participants (n=70) were on average 17.5 years of age (SD 1.15), female (96%, 67/70), suffered from MDE (76%, 53/70), had no previous treatment experience (64%, 45/70), and reported guardian(s) to be aware about their depression state (71%, 50/70). The average intervention completion was 74% (11.8 of 16 modules and sessions). Following the treatment, ICBT participants demonstrated a significant decrease in depression symptoms compared with controls (P<.001), corresponding to a large between-group effect (intention-to-treat analysis: d=0.86, 95% CI 0.37-1.35; of completer analysis: d=0.99, 95% CI 0.48-1.51). A significant between-group effect was observed in the secondary depression outcome (P=.003); clinically significant improvement was found in 46% (16/35) of ICBT participants compared with 11% (4/35) in the control group (P=.001). CONCLUSIONS:The results are in line with our previous study, further demonstrating that adolescents with depression can successfully be engaged in and experience significant improvement following ICBT blended with therapist chat sessions. Findings on participants' age and baseline depression severity are of interest in relation to used study methods. TRIAL REGISTRATION:ClinicalTrials.gov NCT02363205; https://clinicaltrials.gov/ct2/show/NCT02363205.
| S-EPMC6858617 | biostudies-literature
Project description:Importance:Internet-delivered cognitive behavior therapy is an effective treatment for children and adolescents with obsessive-compulsive disorder and has the potential to markedly increase access to treatment for patients while being cost-effective for health care organizations. Objective:To investigate whether internet-delivered cognitive behavior therapy implemented within a stepped care model is noninferior to, and cost-effective compared with, the gold standard of face-to-face cognitive behavior therapy for pediatric obsessive-compulsive disorder. Design, Setting, and Participants:Multicenter, single-blind, randomized clinical noninferiority trial implemented at 2 specialist pediatric obsessive-compulsive disorder clinics in Stockholm and Gothenburg, Sweden. Participants are 152 children and adolescents aged 7 to 17 years with obsessive compulsive disorder, recruited through the 2 clinics and online self-referral. Patients will be randomized 1:1 to the stepped care intervention or face-to-face therapy. Blind evaluations will be conducted after treatment and at 3-month and 6-month follow-ups. At the 6-month follow-up (primary end point), noninferiority will be tested and resource use will be compared between the 2 treatment groups. Data will be analyzed according to intention-to-treat principles. Intervention:Patients randomized to stepped care will first receive internet-delivered cognitive behavior therapy for 16 weeks; patients who are classified as nonresponders 3 months after treatment completion will receive additional face-to-face therapy. The control group will receive 16 weeks of face-to-face cognitive behavior therapy immediately following randomization and nonresponders at the 3-month follow-up will, as in the stepped care group, receive additional face-to-face therapy. Main Outcomes and Measures:Noninferiority is defined as a 4-point difference on the primary outcome measure (Children's Yale-Brown Obsessive Compulsive Scale). Discussion:Recruitment started October 6, 2017, and was completed May 24, 2019. Results from the primary end point will be available by May 2020. The naturalistic follow-ups (1, 2, and 5 years after the end of treatment) will continue to 2025. There are no interim analyses planned or stopping rules for the trial. Trial Registration:ClinicalTrials.gov identifier: NCT03263546.
| S-EPMC6820063 | biostudies-literature
Project description:Increased quality of life (QoL) is rated by patients as a primary factor in determining recovery from psychopathology. Cognitive-behavioral therapies (CBTs) are the most well-researched psychotherapies for internalizing disorders and appear effective at reducing symptoms even when delivered by trainees. Existing research suggests that the effects of CBTs on QoL are more modest than their effects on symptoms. However, little is known about the effects of trainee-delivered CBT on life satisfaction, a subjective measure of QoL. We analyzed data from 93 clients treated by students (n=23) in a graduate-level training clinic using an intent-to-treat approach, completers case analyses, and random forest imputation. Across methods of handling missing data, improvements in anxiety, depression, and CBT skills were more marked than improvements in QoL. Exploratory analyses suggested baseline life satisfaction was the strongest predictor of end-of-treatment life satisfaction. Future research should explore alternatives to "standard" CBT for clients with low life satisfaction.
| S-EPMC9536488 | biostudies-literature
Project description:BackgroundTreatment dropout continues to be reported from internet-delivered cognitive behavioral therapy (iCBT) interventions, and lower completion rates are generally associated with lower treatment effect sizes. However, evidence is emerging to suggest that completion of a predefined number of modules is not always necessary for clinical benefit or consideration of the needs of each individual patient.ObjectiveThe aim of this study is to perform a qualitative analysis of patients' experiences with an iCBT intervention in a routine care setting to achieve a deeper insight into the phenomenon of dropout.MethodsA total of 15 purposively sampled participants (female: 8/15, 53%) from a larger parent randomized controlled trial were interviewed via telephone using a semistructured interview schedule that was developed based on the existing literature and research on dropout in iCBT. Data were analyzed using a descriptive-interpretive approach.ResultsThe experience of treatment leading to dropout can be understood in terms of 10 domains: relationship to technology, motivation to start, background knowledge and attitudes toward iCBT, perceived change in motivation, usage of the program, changes due to the intervention, engagement with content, experience interacting with the supporter, experience of web-based communication, and termination of the supported period.ConclusionsPatients who drop out of treatment can be distinguished in terms of their change in motivation: those who felt ready to leave treatment early and those who had negative reasons for dropping out. These 2 groups of participants have different treatment experiences, revealing the potential attributes and nonattributes of dropout. The reported between-group differences should be examined further to consider those attributes that are strongly descriptive of the experience and regarded less important than those that have become loosely affiliated.
| S-EPMC8663602 | biostudies-literature
Project description:Background: Depression is a highly prevalent mental disorder, but only a fraction of those affected receive evidence-based treatments. Recently, Internet-based interventions were introduced as an efficacious and cost-effective approach. However, even though depression is a heterogenous construct, effects of treatments have mostly been determined using aggregated symptom scores. This carries the risk of concealing important effects and working mechanisms of those treatments. Methods: In this study, we analyze outcome and long-term follow-up data from the EVIDENT study, a large (N = 1,013) randomized-controlled trial comparing an Internet intervention for depression (Deprexis) with care as usual. We use Network Intervention Analysis to examine the symptom-specific effects of the intervention. Using data from intermediary and long-term assessments that have been conducted over 36 months, we intend to reveal how the treatment effects unfold sequentially and are maintained. Results: Item-level analysis showed that scale-level effects can be explained by small item-level effects on most depressive symptoms at all points of assessment. Higher scores on these items at baseline predicted overall symptom reduction throughout the whole assessment period. Network intervention analysis offered insights into potential working mechanisms: while deprexis directly affected certain symptoms of depression (e.g., worthlessness and fatigue) and certain aspects of the quality of life (e.g., overall impairment through emotional problems), other domains were affected indirectly (e.g., depressed mood and concentration as well as activity level). The configuration of direct and indirect effects replicates previous findings from another study examining the same intervention. Conclusions: Internet interventions for depression are not only effective in the short term, but also exert long-term effects. Their effects are likely to affect only a small subset of problems. Patients reporting these problems are likely to benefit more from the intervention. Future studies on online interventions should examine symptom-specific effects as they potentially reveal the potential of treatment tailoring. Clinical Trial Registration: ClinicalTrials.gov, Identifier: NCT02178631.
| S-EPMC8095668 | biostudies-literature