Dataset Information

Effects of Internet-Based Cognitive Behavioral Therapy for Harmful Alcohol Use and Alcohol Dependence as Self-help or With Therapist Guidance: Three-Armed Randomized Trial.

ABSTRACT:

Background

Alcohol use is a major contributor to health loss. Many persons with harmful use or alcohol dependence do not obtain treatment because of limited availability or stigma. They may use internet-based interventions as an alternative way of obtaining support. Internet-based interventions have previously been shown to be effective in reducing alcohol consumption in studies that included hazardous use; however, few studies have been conducted with a specific focus on harmful use or alcohol dependence. The importance of therapist guidance in internet-based cognitive behavioral therapy (ICBT) programs is still unclear.

Objective

This trial aims to investigate the effects of a web-based alcohol program with or without therapist guidance among anonymous adult help-seekers.

Methods

A three-armed randomized controlled trial was conducted to compare therapist-guided ICBT and self-help ICBT with an information-only control condition. Swedish-speaking adult internet users with alcohol dependence (3 or more International Classification of Diseases, Tenth Revision criteria) or harmful alcohol use (alcohol use disorder identification test>15) were included in the study. Participants in the therapist-guided ICBT and self-help ICBT groups had 12-week access to a program consisting of 5 main modules, as well as a drinking calendar with automatic feedback. Guidance was given by experienced therapists trained in motivational interviewing. The primary outcome measure was weekly alcohol consumption in standard drinks (12 g of ethanol). Secondary outcomes were alcohol-related problems measured using the total alcohol use disorder identification test-score, diagnostic criteria for alcohol dependence and alcohol use disorder, depression, anxiety, health, readiness to change, and access to other treatments or support. Follow-up was conducted 3 (posttreatment) and 6 months after recruitment.

Results

During the recruitment period, from March 2015 to March 2017, 1169 participants were included. Participants had a mean age of 45 (SD 13) years, and 56.72% (663/1169) were women. At the 3-month follow-up, the therapist-guided ICBT and control groups differed significantly in weekly alcohol consumption (-3.84, 95% Cl -6.53 to -1.16; t₄₁₇=2.81; P=.005; Cohen d=0.27). No significant differences were found in weekly alcohol consumption between the self-help ICBT group and the therapist-guided ICBT at 3 months, between the self-help ICBT and the control group at 3 months, or between any of the groups at the 6-month follow-up. A limitation of the study was the large number of participants who were completely lost to follow-up (477/1169, 40.8%).

Conclusions

In this study, a therapist-guided ICBT program was not found to be more effective than the same program in a self-help ICBT version for reducing alcohol consumption or other alcohol-related outcomes. In the short run, therapist-guided ICBT was more effective than information. Only some internet help-seekers may need a multisession program and therapist guidance to change their drinking when they use internet-based interventions.

Trial registration

ClinicalTrials.gov NCT02377726; https://clinicaltrials.gov/ct2/show/NCT02377726.

SUBMITTER: Johansson M

PROVIDER: S-EPMC8663526 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

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: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).

Project description:Cognitive behavioral therapy is treatment of choice for insomnia, but availability is scarce. Self-help can increase availability at low cost, but evidence for its efficacy is limited, especially for the typical insomnia patient with co-morbid problems. We hypothesized that a cognitive behaviorally based self-help book is effective to treat insomnia in individuals, also with co-morbid problems, and that the effect is enhanced by adding brief therapist telephone support.Volunteer sample; 133 media-recruited adults with insomnia. History of sleep difficulties (mean [SD]) 11.8 [12.0] years. 92.5% had co-morbid problems (e.g. allergy, pain, and depression). Parallel randomized (block-randomization, n ? 21) controlled "open label" trial; three groups-bibliotherapy with (n = 44) and without (n = 45) therapist support, and waiting list control (n = 44). Assessments before and after treatment, and at three-month follow-up. Intervention was six weeks of bibliotherapeutic self-help, with established cognitive behavioral methods including sleep restriction, stimulus control, and cognitive restructuring. Therapist support was a 15-minute structured telephone call scheduled weekly. Main outcome measures were sleep diary data, and the Insomnia Severity Index.Intention-to-treat analyses of 133 participants showed significant improvements in both self-help groups from pre to post treatment compared to waiting list. For example, treatment with and without support gave shorter sleep onset latency (improvement minutes [95% Confidence Interval], 35.4 [24.2 to 46.6], and 20.6 [10.6 to 30.6] respectively), and support gave a higher remission rate (defined as ISI score below 8; 61.4%), than bibliotherapy alone (24.4%, p's < .001). Improvements were not seen in the control group (sleep onset latency 4.6 minutes shorter [-1.5 to 10.7], and remission rate 2.3%). Self-help groups maintained gains at three-month follow-up.Participants receiving self-help for insomnia benefited markedly. Self-help, especially if therapist-supported, has considerable potential to be as effective as individual treatment at lower cost, also for individuals with co-morbid problems.ClinicalTrials.gov: NCT01105052.

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:BackgroundStress-related disorders are associated with significant suffering, functional impairment, and high societal costs. Internet-based cognitive behavioral therapy (ICBT) is a promising treatment for stress-related disorders but has so far not been subjected to health economic evaluation.ObjectiveThe objective of this study was to evaluate the cost-effectiveness and cost-utility of ICBT for patients with stress-related disorders in the form of adjustment disorder (AD) or exhaustion disorder (ED). We hypothesized that ICBT, compared with a waitlist control (WLC) group, would generate improvements at low net costs, thereby making it cost-effective.MethodsHealth economic data were obtained in tandem with a randomized controlled trial of a 12-week ICBT in which patients (N=100) were randomized to an ICBT (n=50) or a WLC (n=50) group. Health outcomes and costs were surveyed pre- and posttreatment. We calculated incremental cost-effectiveness ratios (ICERs) based on remission rates and incremental cost-utility ratios (ICURs) based on health-related quality of life. Bootstrap sampling was used to assess the uncertainty of our results.ResultsThe ICER indicated that the most likely scenario was that ICBT led to higher remission rates compared with the WLC and was associated with slightly larger reductions in costs from pre- to posttreatment. ICBT had a 60% probability of being cost-effective at a willingness to pay (WTP) of US $0 and a 96% probability of being cost-effective at a WTP of US $1000. The ICUR indicated that ICBT also led to improvements in quality of life at no net societal cost. Sensitivity analyses supported the robustness of our results.ConclusionsThe results suggest that ICBT is a cost-effective treatment for patients suffering from AD or ED. Compared with no treatment, ICBT for these patients yields large effects at no or minimal societal net costs.Trial registrationClinicalTrials.gov NCT02540317; https://clinicaltrials.gov/ct2/show/NCT02540317.

Project description:BACKGROUND:Perfectionism is elevated across, and increases risk for, a range of psychological disorders as well as having a direct negative effect on day-to-day function. A growing body of evidence shows that cognitive behavioral therapy (CBT) reduces perfectionism and psychological disorders, with medium to large effect sizes. Given the increased desire for Web-based interventions to facilitate access to evidence-based therapy, Internet-based CBT self-help interventions for perfectionism have been designed. Existing Web-based interventions have not included personalized guidance which has been shown to improve outcome rates. OBJECTIVE:To assess the efficacy of an Internet-based guided self-help CBT intervention for perfectionism at reducing symptoms of perfectionism and psychological disorders posttreatment and at 6-month follow-up. METHODS:A randomized controlled trial method is employed, comparing the treatment arm (Internet-based guided self-help CBT) with a waiting list control group. Outcomes are examined at 3 time points, T1 (baseline), T2 (postintervention at 12 weeks), T3 (follow-up at 24 weeks). Participants will be recruited through universities, online platforms, and social media and if eligible will be randomized using an automatic randomizer. RESULTS:Data will be analyzed to estimate the between group (intervention, control) effect on perfectionism, depression, and anxiety. Completer and intent-to-treat analyses will be conducted. Additional analysis will be conducted to investigate whether the number of modules completed is associated with change. Data collection should be finalized by December 2016, with submission of results for publication expected in mid-year 2017. Results will be reported in line with recommendations in the Consolidated Standards of Reporting Trials Statement for Randomized Controlled Trials of Electronic and Mobile Health Applications and Online TeleHealth (CONSORT-EHEALTH). CONCLUSIONS:Findings will contribute to the literature on treatment of perfectionism, the effect of treating perfectionism on depression and anxiety, and the efficacy of Internet-based guided self-help interventions. CLINICALTRIAL:ClinicalTrials.gov NCT02756871; https://clinicaltrials.gov/ct2/show/NCT02756871 (Archived by WebCite at http://www.webcitation.org/6lmIlSRAa).