Dataset Information

Complaint-Directed Mini-Interventions for Depressive Complaints: A Randomized Controlled Trial of Unguided Web-Based Self-Help Interventions.

ABSTRACT:

Background

Prevention of depression is important due to the substantial burden of disease associated with it. To this end, we developed a novel, brief, and low-threshold Web-based self-help approach for depressive complaints called complaint-directed mini-interventions (CDMIs). These CDMIs focus on highly prevalent complaints that are demonstrably associated with depression and have a substantial economic impact: stress, sleep problems, and worry.

Objective

The aim was to evaluate the effectiveness of the Web-based self-help CDMIs in a sample of adults with mild-to-moderate depressive symptoms compared to a wait-list control group.

Methods

A two-armed randomized controlled trial was conducted. An open recruitment strategy was used. Participants were randomized to either the Web-based CDMIs or the no-intervention wait-list control group. The CDMIs are online, unguided, self-help interventions, largely based on cognitive behavioral techniques, which consist of 3 to 4 modules with up to 6 exercises per module. Participants are free to choose between the modules and exercises. Assessments, using self-report questionnaires, took place at baseline and at 3 and 6 months after baseline. The control group was given access to the intervention following the 3-month assessment. The primary goal of the CDMIs is to reduce depressive complaints. The primary outcome of the study was a reduction in depressive complaints as measured by the Inventory of Depressive Symptomatology Self-Report (IDS-SR). Secondary outcomes included reductions in stress, worry, sleep problems, and anxiety complaints, and improvements in well-being. Data were analyzed using linear mixed models.

Results

In total, 329 participants enrolled in the trial, of which 165 were randomized to the intervention group and 164 to the control group. Approximately three-quarters of the intervention group actually created an account. Of these participants, 91.3% (116/127) logged into their chosen CDMI at least once during the 3-month intervention period (median 3, range 0-166). After 3 months, there was a significant reduction in depressive symptomatology for participants in the intervention group compared to participants in the wait-list control group (reduction in depression: mean -4.47, 95% CI -6.54 to -2.40; Cohen d=-0.70). Furthermore, significant effects were observed for sleep problems, worry, anxiety, and well-being, with effect sizes ranging from -0.29 to -0.40. The intervention did not significantly reduce stress. At 6-month follow-up, the improvements in the intervention group were generally sustained.

Conclusions

This study shows that the online self-help CDMIs have a positive impact on various mental health outcomes. Future research should focus on which specific strategies may boost adherence, and increase the reach of the CDMIs among people with low socioeconomic status.

Clinicaltrial

Netherlands Trial Register (NTR): NTR4612; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4612 (Archived by WebCite at http://www.webcitation.org/6n4PVYddM).

SUBMITTER: Lokman S

PROVIDER: S-EPMC5244033 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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Complaint-Directed Mini-Interventions for Depressive Complaints: A Randomized Controlled Trial of Unguided Web-Based Self-Help Interventions.

Lokman Suzanne S Leone Stephanie S SS Sommers-Spijkerman Marion M van der Poel Agnes A Smit Filip F Boon Brigitte B

Journal of medical Internet research 20170104 1

<h4>Background</h4>Prevention of depression is important due to the substantial burden of disease associated with it. To this end, we developed a novel, brief, and low-threshold Web-based self-help approach for depressive complaints called complaint-directed mini-interventions (CDMIs). These CDMIs focus on highly prevalent complaints that are demonstrably associated with depression and have a substantial economic impact: stress, sleep problems, and worry.<h4>Objective</h4>The aim was to evaluate ...[more]

PMID: 28052840

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Project description:BackgroundDepression prevention and early intervention have become a top priority in the Netherlands, but with considerable room for improvement. To address this, Web-based complaint-directed mini-interventions (CDMIs) were developed. These brief and low-threshold interventions focus on psychological stress, sleep problems, and worry, because these complaints are highly prevalent, are demonstrably associated with depression, and have substantial economic impact.ObjectiveThe objective of this economic evaluation was to examine the added value of Web-based, unguided, self-help CDMIs compared with a wait-listed control group with unrestricted access to usual care from both a societal and a health care perspective.MethodsThis health economic evaluation was embedded in a randomized controlled trial. The study entailed 2 arms, in which 3 Web-based CDMIs were compared with a no-intervention waiting-list control group (which received the intervention after 3 months). We conducted measurements at baseline, and at 3 and 6 months. The primary outcome was the rate of responders to treatment on depressive symptoms as measured by the Inventory of Depressive Symptomatology Self-Report (IDS-SR). We estimated change in quality of life by calculating effect sizes (Cohen d) for individual pre- and posttreatment IDS-SR scores using a conversion factor to map a change in standardized effect size onto a corresponding change in utility. We calculated incremental cost-effectiveness ratios using bootstraps (5000 times) of seemingly unrelated regression equations and constructed cost-effectiveness acceptability curves for the costs per quality-adjusted life-year (QALY) gained.ResultsOf 329 study participants, we randomly assigned 165 to the CDMI group. At 3 months, the rate of responders to treatment was 13.9% (23/165) in the CDMI group and 7.3% (12/164) in the control group. At 3 months, participants in the CDMI group gained 0.15 QALYs compared with baseline, whereas participants in the control group gained 0.03 QALYs. Average total costs per patient at 3 months were €2094 for the CDMI group and €2230 for the control group (excluding baseline costs). Bootstrapped seemingly unrelated regression equations models resulted in a dominant incremental cost-effectiveness ratio (ie, lower costs and a higher rate of responders to treatment) for the CDMI group compared with the control group at 3 months, with the same result for the costs per QALY gained. Various sensitivity analyses attested to the robustness of the findings of the main analysis.ConclusionsBrief and low-threshold Web-based, unguided, self-help CDMIs have the potential to be a cost-effective addition to usual care for adults with mild to moderate depressive symptoms. The CDMIs improved health status, while reducing participant health care costs, and hence dominated the care-as-usual control condition. As intervention costs were relatively low, and the internet is readily available in the Western world, we believe CDMIs can be easily implemented on a large scale.Trial registrationNetherlands Trial Register NTR4612; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4612 (Archived by WebCite at http://www.webcitation.org/6n4PVYddM).

Project description:BACKGROUND:Depression is a major public health concern. E-health interventions for preventing and reducing depressive complaints have proven to be effective, and have the potential to make (mental) health care more accessible and efficient. However, the reach of these interventions needs to be improved, especially among people with a lower socioeconomic status (SES). Stimulating and supporting implementation of e-health in primary care, and offering guidance from general practice nurses (GP nurses) may be important strategies to achieve this. METHODS/DESIGN:The online 'Complaint Directed Mini-Interventions' (CDMIs) for stress, sleep and worry complaints, which were found to be (cost-)effective in a self-guided format, will be implemented in the primary care setting using a blended care format (i.e. combining e-health with face-to-face sessions) with minimal guidance provided by the GP nurse. The main aim is to evaluate whether a SES-sensitive implementation strategy improves the participation rate (i.e. reach) of lower-SES patients in the blended online CDMIs as compared to a regular implementation strategy in a cluster randomised controlled trial. Randomisation will occur at the level of the GP nurse, and 228 patients will be included in the study. The primary outcome is the participation rate (completing at least one face-to-face session and two online exercises) of the lower-SES target group. It is hypothesised that this percentage will be higher in the SES-sensitive group as compared to the regular group. Secondary objectives are to evaluate the implementation process, to monitor and evaluate psychological complaints (depression, sleep, stress, worry and anxiety) and well-being over time. Patient assessments will take place at baseline, 3 and 12 months post baseline. DISCUSSION:This study should contribute to our knowledge of reaching the lower-SES groups with a brief and complaint-specific blended approach for depressive complaints in primary care. It should also further our knowledge on successful strategies to implement depression prevention in primary care. TRIAL REGISTRATION:Netherlands Trial Register, ID: NL6595. Registered on 12 November 2017.

Project description:BACKGROUND:Research suggests that depressive disorders exist on a continuum, with subthreshold symptoms causing considerable population burden and increasing individual risk of developing major depressive disorder. An alternative strategy to professional treatment of subthreshold depression is population promotion of effective self-help interventions that can be easily applied by an individual without professional guidance. The evidence for self-help interventions for depressive symptoms is reviewed in the present work, with the aim of identifying promising interventions that could inform future health promotion campaigns or stimulate further research. METHODS:A literature search for randomised controlled trials investigating self-help interventions for depressive disorders or depressive symptoms was performed using PubMed, PsycINFO and the Cochrane Database of Systematic Reviews. Reference lists and citations of included studies were also checked. Studies were grouped into those involving participants with depressive disorders or a high level of depressive symptoms, or non-clinically depressed participants not selected for depression. A number of exclusion criteria were applied, including trials with small sample sizes and where the intervention was adjunctive to antidepressants or psychotherapy. RESULTS:The majority of interventions searched had no relevant evidence to review. Of the 38 interventions reviewed, the ones with the best evidence of efficacy in depressive disorders were S-adenosylmethionine, St John's wort, bibliotherapy, computerised interventions, distraction, relaxation training, exercise, pleasant activities, sleep deprivation, and light therapy. A number of other interventions showed promise but had received less research attention. Research in non-clinical samples indicated immediate beneficial effects on depressed mood for distraction, exercise, humour, music, negative air ionisation, and singing; while potential for helpful longer-term effects was found for autogenic training, light therapy, omega 3 fatty acids, pets, and prayer. Many of the trials were poor quality and may not generalize to self-help without professional guidance. CONCLUSION:A number of self-help interventions have promising evidence for reducing subthreshold depressive symptoms. Other forms of evidence such as expert consensus may be more appropriate for interventions that are not feasible to evaluate in randomised controlled trials. There needs to be evaluation of whether promotion to the public of effective self-help strategies for subthreshold depressive symptoms could delay or prevent onset of depressive illness, reduce functional impairment, and prevent progression to other undesirable outcomes such as harmful use of substances.

Project description:BackgroundDigital health apps are efficacious treatment options for mild-to-moderate depressive disorders. However, the extent to which psychological guidance increases the efficacy of these apps is controversial.ObjectiveWe evaluated the efficacy of a web-based intervention, called Selfapy, for unipolar depression. We also investigated differences between psychotherapist-guided and unguided versions.MethodsSelfapy is a cognitive behavioral therapy-based intervention for depressive disorders. Participants with mild-to-severe depressive disorders were assigned randomly to participate in either guided (weekly 25-minute duration telephone calls) intervention, unguided version, or waiting list (control group) for 12 weeks. We assessed depressive symptoms at the start of the study, midway through the intervention (6 weeks), at the end of the intervention (12 weeks), and at follow-up (6 months). The main outcome was difference in the Beck Depression Inventory score between the start of the study and the end of the intervention. Secondary outcomes were the Quick Inventory of Depressive Symptomatology-Self Report, the Hamilton Rating Depression Scale, and the Beck Anxiety Inventory.ResultsOf 401 participants, 301 participants (75.1%) completed the intervention. Changes in the Beck Depression Inventory from baseline differed significantly between groups at the postintervention (F2,398=37.20, P<.001). The reductions in scores for both guided and unguided intervention groups were greater than that for the control group, with large between-group effect sizes (guided vs control: d=1.63, 95% CI 1.37 to 1.93; unguided vs control: d=1.47, 95% CI 1.22 to 1.73) at postintervention. No significant differences were found between guided and unguided intervention groups (P=.18). At follow-up (6 months), treatment effects on the primary outcome were maintained for both intervention groups (guided: F1,194=0.62, P>.999; unguided: F1,176=0.13, P>.999).ConclusionsBoth guided and unguided versions of the intervention were highly effective in reducing depressive symptoms. Follow-up data suggest that these effects could be maintained. The guided version was not superior to the unguided version.Trial registrationGerman Clinical Trials Register DRKS00017191; https://tinyurl.com/2p9h5hnx.International registered report identifier (irrid)RR2-10.1186/s13063-021-05218-4.

Project description:BackgroundComputer-assisted treatment may reduce therapist contact and costs and promote client participation. This meta-analysis examined the efficacy and acceptability of an unguided computer-assisted therapy in patients with obsessive-compulsive disorder (OCD) compared with a waiting list or attention placebo.ObjectiveThis study aimed to evaluate the effectiveness and adherence of computer-assisted self-help treatment without human contact in patients with OCD using a systematic review and meta-analysis approach.MethodsRandomized controlled trials with participants primarily diagnosed with OCD by health professionals with clinically significant OCD symptoms as measured with validated scales were included. The interventions included self-help treatment through the internet, computers, and smartphones. We excluded interventions that used human contact. We conducted a search on PubMed, Cochrane Central Register of Controlled Trials, EMBASE, World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov, as well as the reference lists of the included studies. The risk of bias was evaluated using version 2 of the Cochrane risk-of-bias tool for randomized trials. We calculated the standardized mean differences for continuous outcomes and risk ratios for dichotomous outcomes. The primary outcomes were short-term improvement of OCD symptoms measured by validated scales and dropout for any reason.ResultsWe included 11 randomized controlled trials with a total of 983 participants. The results indicated that unguided computer-assisted self-help therapy was significantly more effective than a waiting list or psychological placebo (standard mean difference -0.47, 95% CI -0.73 to -0.22). Unguided computer-assisted self-help therapy had more dropouts for any reason than waiting list or psychological placebo (risk ratio 1.98, 95% CI 1.21 to 3.23). However, the quality of evidence was very low because of the risk of bias and inconsistent results among the included studies. The subgroup analysis showed that exposure response and prevention and an intervention duration of more than 4 weeks strengthen the efficacy without worsening acceptability. Only a few studies have examined the interaction between participants and systems, and no study has used gamification. Most researchers only used text-based interventions, and no study has used a mobile device. The overall risk of bias of the included studies was high and the heterogeneity of results was moderate to considerable.ConclusionsUnguided computer-assisted self-help therapy for OCD is effective compared with waiting lists or psychological placebo. An exposure response and prevention component and intervention duration of more than 4 weeks may strengthen the efficacy without worsening the acceptability of the therapy.Trial registrationPROSPERO (International Prospective Register of Systematic Reviews) CRD42021264644; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=264644.

Project description:BackgroundThe incidence of depression is increasing worldwide. Depression can lead to poor physical health and even suicide. However, in high-income countries, only about 50% of the people with depression receive appropriate therapy, and the detection rate of depression in low- and middle-income countries is relatively lower. Web-based self-management enables remote treatment and solves the problem of insufficient psychological treatment resources. Many past studies have evaluated the effectiveness of web-based self-management of depression, but there has been no synthesis of evidence. Therefore, this study conducted a meta-analysis of the effectiveness of web-based self-management for depressive symptoms.MethodSix electronic databases (Cochrane Central Register of Controlled Trials, PubMed, Web of Science, Embase, CINAHL, and PsycINFO) were searched in September 2020. All literature referring to the effects of web-based self-management on depression were shortlisted by performing the medical subject headings (MeSH) search combined with a text word search.ResultsA total of 18 eligible randomized controlled trials were identified, and the results from 3055 participants were consolidated. The web-based self-management group exhibited a greater reduction in depressive symptoms than the control group (g = - 0.46; 95% CI: 0.62,0.30), and there was no evidence of publication bias. Subgroup analysis revealed that patients with moderate-to-severe depression benefited from web-based self-management interventions. In terms of interventions, those based on cognitive behavioral therapy (CBT) were highly effective. We noted that the longer the intervention time, the better was the improvement in the status of depression. Furthermore, it was established that participants who communicated with therapists and showed greater adherence to the intervention experienced significant improvement in their symptoms. The results of the intervention group were better than those of the waiting-list, treatment-as-usual, and online psychoeducation groups.ConclusionsWeb-based self-management is a promising therapy for depression. Future research should aim to refine these aspects of the intervention to achieve a beneficial impact.

Project description:BACKGROUND:Cognitive behavioral therapy (CBT) is frequently used to treat depressive symptoms in people living with HIV. We developed an internet-based cognitive behavioral intervention for people with HIV and depressive symptoms, which was based on an effective self-help booklet. The Web-based intervention was previously found to be effective. OBJECTIVE:The objective of this study was to investigate potential mediators of the Web-based intervention. METHODS:This study was part of a randomized controlled trial, in which the intervention was compared with an attention-only waiting list control condition. Participants were 188 (97 in intervention group and 91 in control group) people with HIV and mild to moderate depressive symptoms recruited in HIV treatment centers in the Netherlands. A total of 22 participants (22/188, 11.7%) in the study were female and 166 (166/188, 88.3%) were male. The average age of the participants was 46.30 years (SD 10.63). The intervention comprised Web-based self-help CBT for 8 weeks, 1 to 2 hours a week, including minimal telephone support from a coach. The participants received Web-based questionnaires at pretest, 3 times during the intervention/or waiting period, and post intervention. The outcome was depressive symptoms. Factors tested as potential mediators were changes in behavioral activation, relaxation, the cognitive coping strategies catastrophizing and positive refocusing, goal re-engagement, and coping self-efficacy. RESULTS:Using multilevel structural equation modeling, changes in behavioral activation (P=.006) and goal re-engagement (P=.009) were found to be significant mediators of the intervention effect. The mediation effect seemed to occur between weeks 3 and 5 for behavioral activation and weeks 1 and 3 for goal re-engagement. Using (bivariate) autoregressive latent trajectory analysis, we found a return effect (from the dependent variable to the mediator) for goal re-engagement but not for behavioral activation, which suggested that the mediation effect of changes in behavioral activation was stronger than that in goal re-engagement. CONCLUSIONS:The results suggest that changes in behavioral activation and goal re-engagement may mediate the effect of the Web-based intervention for people with HIV and depressive symptoms. The results may lead to possible mechanisms of change of the intervention and improvement of therapy outcomes. TRIAL REGISTRATION:Netherlands Trial Register NTR5407; https://www.trialregister.nl/trial/5298.

Project description:BACKGROUND:We recently showed in a randomized controlled trial that Web-based self-help as an adjunct improved the effectiveness of multimodal inpatient psychotherapy for depression. OBJECTIVE:The aims of this study were (1) to determine whether a Web-based self-help adjunctive to multimodal inpatient psychotherapeutic treatment could also improve the course of depressive symptoms and (2) to identify predictors of residual depressive symptoms at follow-up. METHODS:Overall, 229 patients were randomized either to the Web-based self-help intervention group (Deprexis) or an active control group (Web-based information about depression and depressive symptoms) in addition to multimodal inpatient psychotherapy. Participants in both groups were able to access their respective Web-based programs for 12 weeks, which meant that they typically had access after discharge from the inpatient unit (mean hospitalization duration: 40 days, T1). Follow-up was performed 6 months after study intake (T3). RESULTS:At follow-up, participants of the Web-based self-help group had considerably lower symptom load regarding depressive symptoms (d=0.58) and anxiety (d=0.46) as well as a better quality of life (d=0.43) and self-esteem (d=0.31) than participants of the control group. Nearly 3 times as many participants of the intervention group compared with the control group achieved remission in accordance with less deterioration. The number needed to treat based on the Beck Depression Inventory-II (BDI-II) improved over time (T1: 7.84, T2: 7.09, and T3: 5.12). Significant outcome predictors were BDI at discharge and treatment group. CONCLUSIONS:Web-based self-help as an add-on to multimodal inpatient psychotherapy improved the short-term course of depressive symptoms beyond termination. Residual symptoms at discharge from inpatient treatment and utilization of the Web-based self-help were the major predictors of depressive symptoms at follow-up. Challenges and barriers (eg, costs, therapists' concerns, or technical barriers) of adding Web-based interventions to inpatient treatment have to be addressed. TRIAL REGISTRATION:ClinicalTrials.gov NCT02196896; https://clinicaltrials.gov/ct2/show/NCT02196896.

Project description:AimsOnline interventions reduce the treatment gap between the number of people with alcohol misuse and people who actually receive help. This study investigated the effectiveness and predictors of success of a Belgian online help programme.MethodsA real-life retrospective open cohort study evaluating the guided and unguided internet intervention on the Belgian online platform alcoholhulp.be. The intervention consisted of a 12-week programme based upon cognitive behaviour therapy, motivational interviewing and acceptance and commitment therapy. Inclusion criteria are age above 18 years, recording of alcohol consumption in the daily journal for at least 2 weeks, and minimum 2 chat sessions in the guided group.Outcomes were weekly alcohol consumption after 6 and 12 weeks and treatment response (drinking less than 10 or 20 standard units (SU) per week). Additional analysis was done on predictors of success.ResultsA total of 460 participants in the guided group and 968 in the self-help group met the inclusion criteria. Average baseline alcohol consumption in the two groups was 40 SU per week. Alcohol consumption decreased by 31 SU (Cohen's d 1.17, p < 0.001) after 12 weeks in the guided group and 23 SU (Cohen's d 0.83, p < 0.001) in the self-help group. The treatment response below 20 SU per week was 88% for the guided group and 73% for the self-help group. Significantly better results were obtained in the guided group compared to the self-help group (p < 0.005). Participants with a higher baseline alcohol consumption had a higher decrease in alcohol consumption in both groups. The personal goal to quit, the absence of drug use, a lower baseline alcohol consumption and a higher number of completed assignments predict a higher chance of treatment response. Attrition at 6 weeks was 26% in the guided group and 63% in the self-help group and increased to 59% and 82% respectively at 12 weeks.ConclusionsBoth guided and unguided internet interventions are effective in reducing alcohol consumption and achieving the guideline for participants motivated to use the platform on a regular base, with better results in guided intervention.

Dataset Information

Complaint-Directed Mini-Interventions for Depressive Complaints: A Randomized Controlled Trial of Unguided Web-Based Self-Help Interventions.

Background

Objective

Methods

Results

Conclusions

Clinicaltrial

Publications

Complaint-Directed Mini-Interventions for Depressive Complaints: A Randomized Controlled Trial of Unguided Web-Based Self-Help Interventions.

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