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A Randomised Controlled Trial of Therapist-Assisted, Internet-Delivered Cognitive Behavior Therapy for Women with Maternal Depression.

ABSTRACT: Postpartum depression impacts up to 15% of Canadian women following childbirth. Remarkably, many women suffering from this disorder do not receive appropriate treatment. The aim of this study was to conduct a parallel-group randomized controlled trial to determine the efficacy of Therapist-Assisted Internet-delivered Cognitive Behavior Therapy (TA-ICBT) for the treatment of postpartum depression. This study was registered with the International Standard Randomized Controlled Trials (85456371) and received funding from Canadian Institutes of Health Research (#101526) and the Saskatchewan Health Research Foundation. Fifty women who gave birth to an infant in the past year, who scored above 10 on the Edinburgh Postnatal Depression Scale (EPDS), and who resided in Saskatchewan, Canada were eligible to participate. Participants were randomly assigned to receive either TA-ICBT (n = 25) or waitlist control (n = 25). The efficacy of the treatment was investigated at baseline and at seven- to 10-week follow-up. TA-ICBT participants were also contacted four-weeks following treatment completion. Symptoms of postpartum depression decreased more for participants in the TA-ICBT group (average reduction of 6.24 points on the EPDS; n = 21 included in analyses) compared to those participants in the waitlist control group (average reduction of 2.42 points on the EPDS; n = 20 included in analyses), and these results were clinically significant and maintained at four-week follow-up. TA-ICBT participants demonstrated a reduction in postnatal anxiety, general stress, and parental distress, and an increase in psychological and environmental quality of life when compared to the waitlist control participants. Study implications, limitations, and future research directions are discussed. Trial registration: Controlled-Trials.com ISRCTN85456371.

SUBMITTER: Pugh NE

PROVIDER: S-EPMC4773121 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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A Randomised Controlled Trial of Therapist-Assisted, Internet-Delivered Cognitive Behavior Therapy for Women with Maternal Depression.

Pugh Nicole E NE Hadjistavropoulos Heather D HD Dirkse Dale D

PloS one 20160301 3

Postpartum depression impacts up to 15% of Canadian women following childbirth. Remarkably, many women suffering from this disorder do not receive appropriate treatment. The aim of this study was to conduct a parallel-group randomized controlled trial to determine the efficacy of Therapist-Assisted Internet-delivered Cognitive Behavior Therapy (TA-ICBT) for the treatment of postpartum depression. This study was registered with the International Standard Randomized Controlled Trials (<h4>Isrctn</ ...[more]

PMID: 26930488

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Project description:ObjectivesCognitive behavioral therapy (CBT) is the most promising treatment for gambling disorder (GD) but only 21% of those with problematic gambling seek treatment. CBT over the Internet might be one way to reach a larger population. The aim of this study was to assess the effectiveness of Internet-delivered CBT with therapist guidance compared to an active control treatment.MethodsUsing a single-blinded design, 71 treatment-seeking gamblers (18-75 years) diagnosed with GD were randomized to 8 weeks of Internet-delivered CBT guided by telephone support, or 8 weeks of Internet-delivered motivational enhancement paired with motivational interviewing via telephone (IMI). The primary outcome was gambling symptoms measured at a first face-to-face assessment, baseline (treatment start), every 2 weeks, post-treatment, and 6-month follow-up. Gambling expenditures, time spent gambling, depression, anxiety, cognitive distortions, and quality of life were assessed as secondary outcomes. Analysis was performed on the full analysis sample (n = 60), with intention-to-treat sensitivity analyses (n = 69).ResultsIn the CBT group, 80% stayed in treatment until the final week, compared to 67% in IMI. Post-treatment and at 6-month follow-up, no differences were found between CBT and IMI for any outcome measure. An exploratory analysis of the total sample (n = 60) showed a significant effect of time during treatment on gambling symptoms (d, [95% CI] 0.52, [-1.15, 2.02]) and all secondary outcomes except the gambling diary (depression (0.89, [-1.07-2.65]); anxiety (0.69, [-1.20-2.38])); cognitive distortions (0.84, [-0.73-2.29]); quality of life (0.60, [-0.61-1.70])). Post-treatment, there were no clinical gambling symptoms in either group. Some deterioration was seen between post-treatment and 6-month follow-up on gambling symptoms (0.42, [-1.74-2.43]), depression (0.59, [-0.82-1.86]), and anxiety (0.30, [-0.99-1.48]). Additionally, it was observed that the largest reduction in gambling symptoms was between the first assessment and baseline.ConclusionBoth treatments offered in this study were effective at reducing gambling symptoms. It is also possible that the process of change started before treatment, which gives promise to low-intensity interventions for GD. Additional research is needed as this approach could be both cost-effective and has the potential to reach more patients in need of treatment than is currently possible.Clinical trial registrationhttps://www.isrctn.com/, identifier ISRCTN38692394.

Project description:ObjectiveAccess to effective treatments for adolescents with depression needs to improve. Few studies have evaluated behavioural activation (BA) for adolescent depression, and none remotely delivered BA. This study explored the feasibility and acceptability of therapist-guided and self-guided internet-delivered BA (I-BA) in preparation for a future randomised controlled trial (RCT).DesignA single-blinded randomised controlled feasibility trial.SettingA specialist outpatient clinic in Sweden.ParticipantsThirty-two adolescents with mild-to-moderate major depression, aged 13-17 years.InterventionsTen weeks of therapist-guided I-BA or self-guided I-BA, or treatment as usual (TAU). Both versions of I-BA included parental support. TAU included referral to usual care within child and youth psychiatry or primary care.OutcomesFeasibility measures included study take-up, participant retention, acceptability, safety and satisfaction. The primary outcome measure was the blinded assessor-rated Children's Depression Rating Scale, Revised. The primary endpoint was the 3-month follow-up.Results154 adolescents were screened and 32 were randomised to therapist-guided I-BA (n=11), self-guided I-BA (n=10) or TAU (n=11). Participant retention was acceptable, with two drop-outs in TAU. Most participants in TAU had been offered interventions by the primary endpoint. The mean number of completed chapters (total of 8) for adolescents was 7.5 in therapist-guided I-BA and 5.4 in self-guided I-BA. No serious adverse events were recorded. Satisfaction was acceptable in both I-BA groups. Following an intent-to-treat approach, the linear mixed-effects model revealed that both therapist-guided and self-guided I-BA (Cohen's d=2.43 and 2.23, respectively), but not TAU (Cohen's d=0.95), showed statistically significant changes on the primary outcome measure with large within-group effect sizes.ConclusionsBoth therapist-guided and self-guided I-BA are acceptable and potentially efficacious treatments for adolescents with depression. It is feasible to conduct a large-scale RCT to establish the efficacy and cost-effectiveness of I-BA versus TAU.Trial registration numberClinicalTrials.gov Registry (NCT04117789).

Project description:OBJECTIVES:To evaluate the cost-effectiveness of a therapist-guided internet-delivered cognitive behaviour therapy (ICBT) intervention for adolescents with obsessive-compulsive disorder (OCD) compared with untreated patients on a waitlist. DESIGN:Single-blinded randomised controlled trial. SETTING:A research clinic within the regular child and adolescent mental health service in Stockholm, Sweden. PARTICIPANTS:Sixty-seven adolescents (12-17 years) with a Diagnostic and Statistical Manual of Mental Disorders Fifth Edition diagnosis of OCD. INTERVENTIONS:Either a 12-week, therapist-guided ICBT intervention or a wait list condition of equal duration. PRIMARY OUTCOME MEASURES:Cost data were collected at baseline and after treatment, including healthcare use, supportive resources, prescription drugs, prescription-free drugs, school absence and productivity loss, as well as the cost of ICBT. Health outcomes were defined as treatment responder rate and quality-adjusted life years gain. Bootstrapped mixed model analyses were conducted comparing incremental costs and health outcomes between the groups from the societal and healthcare perspectives. RESULTS:Compared with waitlist control, ICBT generated substantial societal cost savings averaging US$-144.98 (95% CI -159.79 to -130.16) per patient. The cost reductions were mainly driven by reduced healthcare use in the ICBT group. From the societal perspective, the probability of ICBT being cost saving compared with waitlist control was approximately 60%. From the healthcare perspective, the cost per additional responder to ICBT compared with waitlist control was approximately US$78. CONCLUSIONS:The results suggest that therapist-guided ICBT is a cost-effective treatment and results in societal cost savings, compared with patients who do not receive evidence-based treatment. Since, at present, most patients with OCD do not have access to evidence-based treatments, the results have important implications for the increasingly strained national and healthcare budgets. Future studies should compare the cost-effectiveness of ICBT with regular face-to-face CBT. TRIAL REGISTRATION NUMBER:NCT02191631.

Project description:ImportanceSocial anxiety disorder (SAD) is a prevalent childhood-onset disorder associated with lifelong adversity and high costs for the individual and society at large. Cognitive behavioral therapy (CBT) is an established evidence-based treatment for SAD, but its availability is limited.ObjectiveTo assess the efficacy and cost-effectiveness of therapist-guided internet-delivered cognitive behavioral therapy (ICBT) for SAD in youths vs an active comparator, internet-delivered supportive therapy (ISUPPORT).Design, setting, and participantsThis single-masked, superiority randomized clinical trial enrolled participants at a clinical research unit integrated within the child and adolescent mental health services in Stockholm, Sweden, from September 1, 2017, to October 31, 2018. The final participant reached the 3-month follow-up (primary end point) in May 2019. Children and adolescents 10 to 17 years of age with a principal diagnosis of SAD and their parents were included in the study.InterventionsICBT and ISUPPORT, both including 10 online modules, 5 separate parental modules, and 3 video call sessions with a therapist.Main outcomes and measuresThe Clinician Severity Rating (CSR), derived from the Anxiety Disorder Interview Schedule, rated by masked assessors 3 months after the end of treatment. The CSR ranges from 0 to 8, with scores of 4 or higher indicating caseness. Secondary outcomes included masked assessor-rated diagnostic status of SAD and global functioning, child- and parent-reported social anxiety and depressive symptoms, and health-related costs.ResultsOf the 307 youths assessed for eligibility, 103 were randomized to 10 weeks of therapist-guided ICBT (n = 51) or therapist-guided ISUPPORT (n = 52) for SAD. The sample consisted of 103 youths (mean [SD] age, 14.1 [2.1] years; 79 [77%] female). Internet-delivered cognitive behavioral therapy was significantly more efficacious than ISUPPORT in reducing the severity of SAD symptoms. Mean (SD) CSR scores for ICBT at baseline and at the 3-month follow-up were 5.06 (0.95) and 3.96 (1.46), respectively, compared with 4.94 (0.94) and 4.48 (1.30) for ISUPPORT. There was a significant between-group effect size of d = 0.67 (95% CI, 0.21-1.12) at the 3-month follow-up. Similarly, all of the secondary outcome measures demonstrated significant differences with small to large effect sizes, except for child-rated quality of life (nonsignificant). The cost-effectiveness analyses indicated cost savings associated with ICBT compared with ISUPPORT, with the main drivers of the savings being lower medication costs (z = 2.38, P = .02) and increased school productivity (z = 1.99, P = .047) in the ICBT group. There was 1 suicide attempt in the ISUPPORT group; no other serious adverse events occurred in either group.Conclusions and relevanceIn this randomized clinical trial, internet-delivered cognitive behavioral therapy was an efficacious and cost-effective intervention for children and adolescents with SAD. Implementation in clinical practice could markedly increase the availability of effective interventions for SAD.Trial registrationClinicalTrials.gov Identifier: NCT03247075.

Project description:BACKGROUND:Obsessive-compulsive disorder (OCD) is a highly disabling psychological disorder with a chronic course if left untreated. Cognitive behavioral therapy (CBT) has been shown to be an effective treatment, but access to face-to-face CBT is not always possible. Internet-based CBT (iCBT) has become an increasingly viable option. However, no study has compared iCBT to an analogous control condition using a randomized controlled trial (RCT). OBJECTIVE:A 2-armed RCT was used to compare a therapist-assisted 12-module iCBT to an analogous active attention control condition (therapist-assisted internet-based standard progressive relaxation training, iPRT) in adult OCD. This paper reports pre-post findings for OCD symptom severity. METHOD:In total, 179 participants (117 females, 65.7%) were randomized (stratified by gender) into iCBT or iPRT. The iCBT intervention included psychoeducation, mood and behavioral management, exposure and response prevention (ERP), cognitive therapy, and relapse prevention; the iPRT intervention included psychoeducation and relaxation techniques as a way of managing OCD-related anxiety but did not incorporate ERP or other CBT elements. Both treatments included audiovisual content, case stories, demonstrations of techniques, downloadable audio content and worksheets, and expert commentary. All participants received 1 weekly email, with a maximum 15-minute preparation time per client from a remote therapist trained in e-therapy. Emails aimed to monitor progress, provide support and encouragement, and assist in individualizing the treatment. Participants were assessed for baseline and posttreatment OCD severity with the telephone-administered clinician-rated Yale-Brown Obsessive-Compulsive Scale and other measures by assessors who were blinded to treatment allocation. RESULTS:No pretreatment differences were found between the 2 conditions. Intention-to-treat analysis revealed significant pre-post improvements in OCD symptom severity for both conditions (P<.001). However, relative to iPRT, iCBT showed significantly greater symptom severity improvement (P=.001); Cohen d for iCBT was 1.05 (95% CI 0.72-1.37), whereas for iPRT it was 0.48 (95% CI 0.22-0.73). The iCBT condition was superior in regard to reliable improvement (25/51, 49% vs 16/55, 29%; P=.04) and clinically significant pre-post-treatment changes (17/51, 33% vs 6/55, 11%; P=.005). Those undertaking iCBT post completion of iPRT showed further significant symptom amelioration (P<.001), although the sequential treatment was no more efficacious than iCBT alone (P=.63). CONCLUSION:This study is the first to compare a therapist-assisted iCBT program for OCD to an analogous active attention control condition using iPRT. Our findings demonstrate the large magnitude effect of iCBT for OCD; interestingly, iPRT was also moderately efficacious, albeit significantly less so than the iCBT intervention. The findings are compared to previous internet-based and face-to-face CBT treatment programs for OCD. Future directions for technology-enhanced programs for the treatment of OCD are outlined. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12611000321943; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=336704 (Archived by WebCite at http://www.webcitation.org/70ovUiOmd).

Dataset Information

A Randomised Controlled Trial of Therapist-Assisted, Internet-Delivered Cognitive Behavior Therapy for Women with Maternal Depression.

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A Randomised Controlled Trial of Therapist-Assisted, Internet-Delivered Cognitive Behavior Therapy for Women with Maternal Depression.

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