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A pragmatic factorial randomized controlled trial of transdiagnostic internet-delivered cognitive behavioural therapy: Exploring benefits of homework reflection questionnaires and twice-weekly therapist support.

ABSTRACT: With the growing demand for internet-delivered cognitive behavioural therapy (iCBT), this pragmatic factorial (2 × 2 × 2) randomized controlled trial evaluated strategies for facilitating iCBT engagement and outcomes in routine care. Specifically, the benefits to patients and therapists of using homework reflection questionnaires and offering patients twice-weekly therapist support were examined. Patients (n = 632) accepted into iCBT for depression and/or anxiety were randomly assigned to complete homework reflection questionnaires or not (factor 1), receive once- or twice-weekly support (factor 2), and to receive care from therapists employed in one of two settings (iCBT clinic or a community mental health clinic; factor 3). Outcomes were measured at pre-treatment, and 8, 12, and 24-weeks post-enrollment. Therapist time was tracked and a focus group was conducted to examine therapist experiences. No differences in patient outcomes were found between therapists employed in the two settings; as such, these two groups were combined for further analyses. In terms of engagement, homework reflection questionnaires were associated with fewer website log-ins and days accessing iCBT; twice-weekly support was associated with more patient emails sent to therapists. Despite engagement differences, homework reflection questionnaires and twice-weekly support did not significantly impact primary outcomes; all groups showed large improvements in depression and anxiety that were maintained at 24-week follow-up. Therapists perceived a number of benefits and challenges associated with responding to homework reflection questionnaires and offering twice-weekly support; most notably the strategies did not benefit all patients. Twice-weekly support was associated with increased therapist time and organizational challenges. It is concluded that neither completion of homework questionnaires nor offering twice-weekly support significantly improve iCBT in routine care.

SUBMITTER: Hadjistavropoulos HD

PROVIDER: S-EPMC7734229 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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A pragmatic factorial randomized controlled trial of transdiagnostic internet-delivered cognitive behavioural therapy: Exploring benefits of homework reflection questionnaires and twice-weekly therapist support.

Hadjistavropoulos H D HD Peynenburg V V Thiessen D L DL Nugent M M Adlam K K Owens K M B KMB Karin E E Dear B F BF Titov N N

Internet interventions 20201201

With the growing demand for internet-delivered cognitive behavioural therapy (iCBT), this pragmatic factorial (2 × 2 × 2) randomized controlled trial evaluated strategies for facilitating iCBT engagement and outcomes in routine care. Specifically, the benefits to patients and therapists of using homework reflection questionnaires and offering patients twice-weekly therapist support were examined. Patients (<i>n</i> = 632) accepted into iCBT for depression and/or anxiety were randomly assigned to ...[more]

PMID: 33335846

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Project description:In routine care, internet-delivered cognitive behaviour therapy (iCBT) regularly includes therapist support delivered via secure email, but the optimal response time to emails is unknown. In this study, we compared the benefits of therapists providing support once-weekly versus therapists providing support once-weekly supplemented with a one-business-day response to all patient emails. This pragmatic randomized controlled trial included therapists employed by a specialized iCBT clinic or community mental health clinics, where providing iCBT is a secondary service. Patients with depression and/or anxiety who enrolled in transdiagnostic iCBT (5 core lessons over 8 weeks) were randomized to: 1) once-weekly support supplemented with a one-business-day response to patient emails by specialized therapists (n = 233); 2) once-weekly support also offered by specialized therapists (n = 216); or 3) once-weekly support offered by community clinic therapists (n = 226). Outcomes were measured at 8, 12, 24, and 52-weeks post-enrollment. Patient engagement and treatment experiences (e.g., treatment satisfaction, therapist alliance) were also assessed and a focus group was conducted with therapists. Supplementing once-weekly therapist support with a one-business-day response to patient emails resulted in therapists sending more emails to patients (M: 13 versus 9) and required more therapist time over treatment (M: 155 versus 109 min), but was not associated with improved outcomes, patient engagement or treatment experiences. All groups showed large improvements in symptoms of depression and anxiety maintained at 52-week follow-up, strong engagement and positive treatment experiences. Therapists viewed challenges of responding to patient emails within one-business-day to outweigh benefits. Contrary to expectations, supplementing once-weekly therapist support with a one-business-day response to all patient emails did not benefit patients and increased therapist time as well as therapist challenges when delivering iCBT in routine care.

Project description:A 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial (the TWICE study) conducted in Japanese primary osteoporosis patients with a high risk of fractures demonstrated that a 28.2-?g twice-weekly regimen of teriparatide can provide comparable efficacy to a 56.5-?g once-weekly regimen of teriparatide, while also improving safety.IntroductionWhile a 56.5-?g once-weekly regimen of teriparatide has high efficacy for osteoporosis, treatment continuation rates are low, with one of the major causes being adverse drug reactions such as nausea or vomiting. The TWICE study was therefore conducted to investigate whether a twice-weekly regimen with 28.2-?g teriparatide can provide comparable efficacy to the 56.5-?g once-weekly regimen while improving safety.MethodsA 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial was conducted in Japan. Patients with primary osteoporosis aged ??65 years at high risk of fractures (n?=?553) were randomly allocated to the 28.2-?g twice-weekly group (n?=?277) or the 56.5-?g once-weekly group (n?=?276). The primary endpoint was the percentage change in lumbar spine (L2-L4) bone mineral density (BMD) at final follow-up.ResultsThe percentage changes in lumbar spine (L2-L4) BMD at final follow-up in the 28.2-?g twice-weekly and 56.5-?g once-weekly groups were 7.3% and 5.9%, respectively; the difference (95% confidence interval [CI]) in percentage change was 1.3% (0.400-2.283%). Since the lower limit of the 95% CI was above the pre-specified non-inferiority margin (-?1.6%), non-inferiority of the 28.2-?g twice-weekly group was demonstrated. Adverse drug reactions were significantly less frequent in the 28.2-?g twice-weekly group (39.7% vs 56.2%; p?<?0.01); the incidence of major adverse drug reactions was lower, and the number of subjects who discontinued due to adverse drug reactions was less in the 28.2-?g twice-weekly group.ConclusionsA 28.2-?g twice-weekly regimen of teriparatide can provide comparable efficacy to a 56.5-?g once-weekly regimen while improving safety.Clinical trial registrationJapicCTI-163477 .

Project description:Residual kidney function (RKF) contributes to improved survival in hemodialysis (HD) patients. However, it is not clear whether RKF allows a comparable survival rate in patients undergoing twice-weekly HD compared with thrice-weekly HD.We enrolled 685 patients from a prospective multicenter observational cohort. RKF and HD adequacy was monitored regularly over 3-year follow-up. Patients with RKF were divided into groups undergoing twice-weekly HD (n?=?113) or thrice-weekly HD (n?=?137). Patients without RKF undergoing thrice-weekly HD (n?=?435) were included as controls. Fluid balance and dialysis-associated characteristics were followed and clinical outcomes evaluated using all-cause mortality and cardiovascular events (CVE).In patients with RKF, baseline and follow-up RKF were significantly higher in patients undergoing twice-weekly HD than in those undergoing thrice-weekly HD. Total Kt/V urea (dialysis plus residual renal) in patients with RKF undergoing twice-weekly HD was greater than or equal to those in patients with or without RKF undergoing thrice-weekly HD. Compared with patients with RKF undergoing thrice-weekly HD, patients with RKF undergoing twice-weekly HD had no fluid excess, but their normalized protein catabolic rate became lower since 24-month follow up. In multivariable analyses, patients with RKF undergoing twice-weekly HD had a noninferior risk of mortality (hazard ratio [HR], 0.83; 95% confidence interval [95% CI], 0.34-2.01, P?=?0.68) and of CVE (HR, 0.60; 95% CI, 0.28-1.29, P?=?0.19) compared with patients without RKF undergoing thrice-weekly HD. However, this group showed an independent association with a greater risk of mortality compared with patients with RKF undergoing thrice-weekly HD (HR, 4.20; 95% CI, 1.02-17.32, P?=?0.04).In conclusion, patients with RKF undergoing twice-weekly HD had an increased risk of mortality compared with those undergoing thrice-weekly HD. Decisions about twice-weekly HD should consider not only RKF, but also other risk factors such as normalized protein catabolic rate.

Project description:BackgroundTransdiagnostic iCBT has been shown to be effective for the treatment of emotional disorders. Less is known about the optimal level of therapist and patient involvement in these interventions. Specific characteristics of Internet-delivered interventions include treatment adherence (e.g., amount of review of the materials) and guidance (e.g., amount of therapist support). Exploring the importance of these elements in treatment outcome may help to maximize the efficiency of Internet-delivered psychological interventions.AimIn this study, we aimed to analyze the relationship between patient and therapist involvement (i.e., platform usage and amount of therapist guidance) in a sample of patients with emotional disorders who received transdiagnostic iCBT in Spanish public specialized mental healthcare services.MethodThis is a secondary analysis of a randomized controlled trial. The sample included 63 patients who completed transdiagnostic iCBT for emotional disorders. Platform usage metrics included number of logins into the platform and number of times the participants reviewed the modules. Therapist guidance was measured as the number of support phone calls with a therapist and their total duration (minutes). Logistic regressions and ROC analyses were performed to explore the predictive value of platform usage and therapist guidance in symptom reduction. Clinical outcomes included depressive and anxiety symptoms assessed at baseline and post-intervention. The bivariate relationship between the platform usage and therapist guidance variables was also explored.ResultsOverall, platform usage and therapist guidance were not associated with symptom improvement. However, the patient and therapist involvement parameters were intercorrelated. Specifically, the number of calls and their duration were associated with a greater number of logins (r = 0.61; p < .001) and more frequent reviews of the modules (0.46 ≤ r ≤ 0.60; p < .001). Higher baseline depression and anxiety were, respectively, associated with greater improvements in depression (r = -0.37, p = .003) and anxiety after treatment completion (r = -0.48, p < .001).DiscussionThe results suggest that there is no reliable cut-off point for platform usage and therapist guidance in predicting optimal symptom reduction. However, significant associations were found between platform usage and guidance variables that warrant additional research. More research on this topic is necessary to further clarify the role of these and other platform usage and guidance variables in Internet-delivered iCBT outcomes.

Dataset Information

A pragmatic factorial randomized controlled trial of transdiagnostic internet-delivered cognitive behavioural therapy: Exploring benefits of homework reflection questionnaires and twice-weekly therapist support.

Publications

A pragmatic factorial randomized controlled trial of transdiagnostic internet-delivered cognitive behavioural therapy: Exploring benefits of homework reflection questionnaires and twice-weekly therapist support.

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