An Internet-based program for depressive symptoms using human and automated support: a randomized controlled trial.
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ABSTRACT: Purpose
The purpose of this study was to analyze the efficacy of an Internet-based program for depressive symptoms using automated support by information and communication technologies (ICTs) and human support.Patients and methods
An Internet-based program was used to teach adaptive ways to cope with depressive symptoms and daily problems. A total of 124 participants who were experiencing at least one stressful event that caused interference in their lives, many of whom had clinically significant depressive symptoms, were randomly assigned into either an intervention group with ICT support (automated mobile phone messages, automated emails, and continued feedback through the program); an intervention group with ICT support plus human support (brief weekly support phone call without clinical content); or a waiting-list control. At pre-, post-, and 12-month follow-up, they completed depression, anxiety, positive and negative effect, and perceived stress measures. Results were analyzed using both intention-to-treat and completers data. The majority were women (67.7%), with a mean age of 35.6 years (standard deviation =9.7).Results
The analysis showed that the two intervention groups improved significantly pre- to posttreatment, compared with the control group. Furthermore, improvements were maintained at the 12-month follow-up. Adherence and satisfaction with the program was high in both conditions.Conclusion
The Internet-based program was effective and well accepted, with and without human support, showing that ICT-based automated support may be useful. It is essential to continue to study other ICT strategies for providing support.
SUBMITTER: Mira A
PROVIDER: S-EPMC5384701 | biostudies-literature | 2017
REPOSITORIES: biostudies-literature
Publications
An Internet-based program for depressive symptoms using human and automated support: a randomized controlled trial.
Mira Adriana A Bretón-López Juana J García-Palacios Azucena A Quero Soledad S Baños Rosa María RM Botella Cristina C
Neuropsychiatric disease and treatment 20170331
<h4>Purpose</h4>The purpose of this study was to analyze the efficacy of an Internet-based program for depressive symptoms using automated support by information and communication technologies (ICTs) and human support.<h4>Patients and methods</h4>An Internet-based program was used to teach adaptive ways to cope with depressive symptoms and daily problems. A total of 124 participants who were experiencing at least one stressful event that caused interference in their lives, many of whom had clini ...[more]
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Project description:BACKGROUND:Internet-delivered treatments for depressive symptoms have proved to be successful in high-income Western countries. There may be potential for implementing such treatments in low- and middle-income countries such as Colombia, where access to mental health services is limited. OBJECTIVE:The objective of this study was to assess the efficacy of a culturally adapted cognitive behavioral internet-delivered treatment for college students with depressive symptoms in Colombia. METHODS:This was a randomized controlled trial with a 3-month follow-up. The program comprised seven modules. A total of 214 Colombian college students were recruited. They were assessed and randomly assigned to either the treatment group (n=107) or a waiting list (WL) control group (n=107). Participants received weekly support from a trained supporter. The primary outcome was symptoms of depression, as measured by the Patient Health Questionnaire - 9, and the secondary outcomes were anxiety symptoms assessed by the Generalized Anxiety Disorder questionnaire - 7. Other measures, including satisfaction with treatment, were evaluated after 7 weeks. RESULTS:Research attrition and treatment dropouts were high in this study. On average, 7.6 sessions were completed per user. The mean time spent on the program was 3 hours and 18 min. The linear mixed model (LMM) showed significant effects after treatment (t197.54=-5.189; P<.001) for the treatment group, and these effects were maintained at the 3-month follow-up (t39.62=4.668; P<.001). Within-group results for the treatment group yielded a large effect size post treatment (d=1.44; P<.001), and this was maintained at the 3-month follow-up (d=1.81; P<.001). In addition, the LMM showed significant differences between the groups (t197.54=-5.189; P<.001). The results showed a large effect size between the groups (d=0.91; P<.001). In the treatment group, 76.0% (16/107) achieved a reliable change, compared with 32.0% (17/107) in the WL control group. The difference between groups was statistically significant (X22=10.5; P=.001). CONCLUSIONS:This study was the first contribution to investigating the potential impact of a culturally adapted internet-delivered treatment on depressive symptoms for college students as compared with a WL control group in South America. Future research should focus on identifying variables associated both with premature dropout and treatment withdrawal at follow-up. TRIAL REGISTRATION:ClinicalTrials.gov NCT03062215; https://clinicaltrials.gov/ct2/show/NCT03062215.
| S-EPMC7055858 | biostudies-literature
Project description:ObjectiveThe purpose of this study was to develop a new Internet-based computerized cognitive behavior therapy (iCBT) program in Manga format, the Japanese cartoon, for workers and to examine the effects of the iCBT program on improving subthreshold depression using a randomized controlled trial (RCT) design among workers employed in private companies in Japan.MethodAll workers in a company (n = 290) and all workers in three departments (n = 1,500) at the headquarters of another large company were recruited by an invitation e-mail. Participants who fulfilled the inclusion criteria were randomly allocated to intervention or control groups (N = 381 for each group). A six-week, six-lesson iCBT program using Manga (Japanese comic) story was developed. The program included several CBT skills: self-monitoring, cognitive restructuring, assertiveness, problem solving, and relaxation. The intervention group studied the iCBT program at a frequency of one lesson per week. Depression (Beck Depression Inventory II; BDI-II) was assessed as a primary outcome at baseline, and three- and six-month follow-ups for both intervention and control groups were performed.ResultsThe iCBT program showed a significant intervention effect on BDI-II (t = -1.99, p<0.05) with small effect sizes (Cohen's d: -0.16, 95% Confidence Interval: -0.32 to 0.00, at six-month follow-up).ConclusionsThe present study first demonstrated that a computerized cognitive behavior therapy delivered via the Internet was effective in improving depression in the general working population. It seems critical to improve program involvement of participants in order to enhance the effect size of an iCBT program.Trial registrationUMIN Clinical Trials Registry UMIN000006210.
| S-EPMC4028193 | biostudies-literature
Project description:BackgroundA significant number of individuals with depression in Hong Kong remain undiagnosed and untreated through traditional face-to-face psychotherapy. Internet-based cognitive behavioral therapy (iCBT) has emerged as a tool to improve access to mental health services. However, iCBT remains underdeveloped in Chinese communities, particularly in Hong Kong.ObjectiveThis study aims to (1) develop and evaluate the effectiveness of a culturally and linguistically appropriate guided iCBT program for Hong Kong Chinese with depressive symptoms, and (2) explore their treatment adherence.MethodsAn 11-week guided iCBT program, "Confront and Navigate Depression Online" (CANDO), consisting of 8 online modules, was developed and implemented for Hong Kong residents. The program was accessible via either an online platform (web-based iCBT) or a smartphone app (app-based iCBT). A 3-arm randomized controlled trial was conducted, with participants recruited through open recruitment and referrals from 2 local non-governmental organizations. A total of 402 eligible participants with mild to moderate depressive symptoms were randomly allocated into 3 groups: (1) web-based iCBT (n=139); (2) app-based iCBT (n=131); and (3) waitlist control (WLC) group (n=132), who transitioned to the web-based iCBT group after waiting for 11 weeks. Therapist support was provided by a clinical psychologist through 3 counseling sessions and weekly assignment feedback. The primary outcomes were the Beck Depression Inventory-II (BDI-II) and the 9-item Patient Health Questionnaire (PHQ-9), while the secondary outcome measures included the 12-item General Health Questionnaire (GHQ-12), the Chinese Automatic Thoughts Questionnaire (CATQ), and the Chinese Affect Scale (CAS). These scales were administered at preintervention, postintervention, and at 3-month and 6-month follow-up assessments. Data analysis was conducted using linear mixed effects modeling, adhering to the intent-to-treat principle.ResultsParticipants in both the web- and app-based iCBT groups reported significant improvements compared with the WLC group on all primary (P<.001) and secondary measures (P<.001 and P=.009) at posttreatment. Large between-group effect sizes were observed in the reduction of depressive symptoms, with Cohen's d value of 1.07 (95% CI 0.81-1.34) for the web-based group and 1.15 (95% CI 0.88-1.43) for the app-based group on the BDI-II. Additionally, the web- and app-based groups showed effect sizes of 0.78 (95% CI 0.52-1.04) and 0.95 (95% CI 0.63-1.27) on PHQ-9, respectively. Medium to large effect sizes were observed for secondary outcomes at posttreatment. These positive effects were maintained at both the 3- and 6-month follow-ups, with medium to large within-group effect sizes. The adherence rate in the 2 iCBT groups was 154 out of 270 (57.0%) for completing all 8 online modules and 152 out of 270 (56.3%) for attending all 4 counseling sessions (including an intake interview). The recovery rate, as measured by the BDI-II at posttreatment, was 35 out of 90 (39%) for the web-based group and 36 out of 91 (40%) for the app-based group, compared with 3 out of 112 (3%) in the WLC group.ConclusionsCulturally and linguistically adapted iCBT is an effective and feasible treatment for Hong Kong Chinese with mild to moderate depressive symptoms, demonstrating a satisfactory recovery rate and treatment adherence. ICBT offers an accessible and viable alternative to face-to-face interventions in Hong Kong. The Hong Kong government should allocate more resources and support the use of iCBT as a tool to treat people with depressive symptoms.Trial registrationClinicalTrials.gov (NCT04388800); https://clinicaltrials.gov/study/NCT04388800.
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Project description:Background: Mental disorders are highly prevalent among university students. Distance-learning students are particularly burdened and have limited access to conventional university health services. Interventions for stress are sought after in distance learners and may help increase treatment coverage. Internet-based interventions have been shown to be effective in preventing and treating depression, but it remains unclear if interventions directed at academic stress also have this potential. Aim: The trial presented here investigates the effectiveness of an Internet- and App-based stress intervention in distance-learning students with elevated levels of depression. Methods: A sample of N = 200 students of a large German distance university with elevated levels of depression [Center for Epidemiological Studies' Depression Scale (CES-D) ≥ 16] will be randomly assigned to either an Internet- and App-based stress management intervention group (IG) or a control group (CG) receiving an Internet-based psychoeducational program for academic stress. The IG consists of eight Internet-based sessions promoting stress management skills using cognitive-behavioral and problem-solving techniques. A mobile App will be employed to facilitate training transfer. Self-report data will be assessed at baseline (T0), post-treatment (T1; 7 weeks), and 3-month follow-up (T2). Potential moderators will be assessed at baseline. The primary outcome is depression (CES-D) post-treatment. Secondary outcomes include mental health outcomes, modifiable risk and protective factors, and academic outcomes. Data will be analyzed on an intention-to-treat principle along with sensitivity analyses to assess the robustness of findings. Additional health economic analyses will be conducted. Discussion: Results will provide the basis to assess the acceptance and effectiveness of Internet-delivered stress interventions in distance-learning students with symptoms of depression. Ethics and dissemination: The study has been reviewed and approved by the University of Erlangen-Nuremberg ethics committee (Erlangen, Germany; 33_17 Bc). Results of the study will be disseminated through peer-reviewed publications. Trial Registration: German Clinical Trial Registration (DRKS), identifier DRKS00011800.
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Project description:BackgroundHealth promotion and growth-based interventions can effectively improve individual well-being; however, significant gaps in access and utilization still exist.ObjectiveThis study aims to develop and test the effectiveness and implementation of a new, widely targeted conversational agent prevention program (Zenny) designed to enhance well-being.MethodsA total of 1345 individuals in the United States were recruited online and randomly assigned to either (1) a self-help program intervention delivered via an automated conversational agent on WhatsApp or (2) an active control group that had access to evidence-based wellness resources available online. The primary outcomes were well-being (measured using the 5-item World Health Organization Well-being Scale), psychosocial flourishing (assessed with the Flourishing Scale), and positive psychological health (evaluated with the Mental Health Continuum-Short Form). Outcome measures were collected at baseline and again 1 month postassessment. All analyses were conducted using an intention-to-treat approach.ResultsBoth groups showed significant improvements in well-being (self-help program intervention group effect size: Cohen d=0.26, P<.001; active control group effect size: d=0.24, P<.001), psychosocial flourishing (intervention: d=0.19, P<.001; active control: d=0.18, P<.001), and positive psychological health (intervention: d=0.17, P=.001; active control: d=0.24, P<.001) at postassessment. However, there were no significant differences in effectiveness between the 2 groups (P ranged from .56 to .92). As hypothesized a priori, a greater number of days spent actively engaging with the conversational agent was associated with larger improvements in well-being at postassessment among participants in the intervention group (β=.109, P=.04).ConclusionsThe findings from this study suggest that the free conversational agent wellness self-help program was as effective as evidence-based web resources. Further research should explore strategies to increase participant engagement over time, as only a portion of participants were actively involved, and higher engagement was linked to greater improvements in well-being. Long-term follow-up studies are also necessary to assess whether these effects remain stable over time.Trial registrationClinicalTrials.gov NCT06208566; https://clinicaltrials.gov/ct2/show/NCT06208566; OSF Registries osf.io/ahe2r; https://doi.org/10.17605/osf.io/ahe2r.
| S-EPMC11662185 | biostudies-literature
Project description:BackgroundThe constant rise in the prevalence of major depressive disorder calls for new, effective, and accessible interventions that can rapidly and effectively reach a wide range of audiences. Recent developments in the digital health domain suggest that dedicated online platforms may potentially address this gap. Focusing on targeting ruminative thought, a major symptomatic hallmark of depression, in this study we hypothesized that delivering a digital health-based intervention designed to systematically facilitate thought progression would substantially alleviate depression.ObjectiveThe study aims to investigate the efficacy of a novel digital intervention on the reduction of depressive symptoms. This intervention was designed as an easy-to-use gamified app specifically aimed to facilitate thought progression through intense practicing of associative, semantically broad, fast, and creative thought patterns.MethodsA randomized clinical trial was conducted, comparing changes in depression symptoms between participants who used the app in the intervention group (n=74) and waitlist control group (n=27) over the course of 8 weeks. All participants filled out a battery of clinical questionnaires to assess the severity of depression at baseline and 4 and 8 weeks after starting the study. These primarily included the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Patient Health Questionnaire-9 as well as the Positive Affect Negative Affect Scale-Negative Affect Score, Ruminative Response Scale, and Symptoms of Depression Questionnaire. Additional questionnaires were implemented to assess anxiety, positive affect, anhedonia, and quality of life.ResultsThe results indicate that across multiple clinical measurements, participants in the intervention group who played the gamified app showed greater and faster improvement in depressive symptoms compared with their waitlist control counterparts. The difference between the groups in MADRS improvement was -7.01 points (95% CI -10.72 to -3.29; P<.001; Cohen d=0.67). Furthermore, the difference in improvement between groups persisted up to 4 weeks posttrial (MADRS differences at week 12: F49,2=6.62; P=.003; ηp2=0.21). At the end of the trial, participants who played the app showed high interest in continuing using the app.ConclusionsThe results demonstrate that a gamified app designed to facilitate thought progression is associated with improvement in depressive symptoms. Given its innovative and accessibility features, this gamified method aiming to facilitate thought progression may successfully complement traditional treatments for depression in the future, providing a safe and impactful way to enhance the lives of individuals experiencing depression and anxiety.Trial registrationClinicalTrials.gov NCT05685758; https://clinicaltrials.gov/study/NCT05685758.
| S-EPMC11582484 | biostudies-literature
Project description:BackgroundChronic pain from temporomandibular disorders remains an undertreated condition with debate regarding the most effective treatment modalities.ObjectiveThe aim of the study was to investigate the treatment effect of an internet-based multimodal pain program on chronic temporomandibular disorder pain and evaluate the feasibility of a larger randomized controlled trial.MethodsAn unblinded randomized controlled pilot trial was conducted with 43 participants (34 females, 9 males; median age 27, IQR 23-37 years) with chronic temporomandibular pain. Participants were recruited within the Public Dental Health Service and randomized to intervention (n=20) or active control (n=23). The intervention comprised a dentist-assisted internet-based multimodal pain program with 7 modules based on cognitive behavior therapy and self-management principles. The control group received conventional occlusal splint therapy. Primary outcomes included characteristic pain intensity, pain-related disability, and jaw functional limitation. Secondary outcomes were depression, anxiety, catastrophizing, and stress. Outcomes were self-assessed through questionnaires sent by mail at 3 and 6 months after treatment start. Feasibility evaluation included testing the study protocol and estimation of recruitment and attrition rates in the current research setting.ResultsOnly 49% of participants (21/43) provided data at the 6-month follow-up (internet-based multimodal pain program: n=7; control: n=14). Of the 20 participants randomized to the internet-based multimodal pain program, 14 started treatment and 8 completed all 7 modules of the program. Between-group analysis showed no significant difference for any outcome measure at 3- or 6-month follow-up-characteristic pain intensity (3 months: P=.58; 6 months: P=.41), pain-related disability (3 months: P=.51; 6 months: P=.12), jaw functional limitation (3 months: P=.45; 6 months: P=.90), degree of depression (3 months: P=.64; 6 months: P=.65), anxiety (3 months: P=.93; 6 months: P=.31), stress (3 months: P=.66; 6 months: P=.74), or catastrophizing (3 months: P=.86; 6 months: P=.85). Within-group analysis in the internet-based multimodal pain program group showed a significant reduction in jaw functional limitation score at the 6-month follow-up compared to baseline (Friedman: χ2=10.2, P=.04; Wilcoxon: z=-2.3, P=.02). In the occlusal splint group, jaw function limitation was also reduced at the 6-month follow-up (Friedman: χ2=20.0, P=.045; Wilcoxon: z=-2.3, P=.02), and there was a reduction in characteristic pain intensity at the 3- and 6-month follow-up (Friedman: χ2=25.1, P=.01; Wilcoxon 3 months: z=-3.0, P=.003; Wilcoxon 6 months: z=-3.3, P=.001).ConclusionsThis study was not able to demonstrate a difference in treatment outcome between an internet-based multimodal pain program and occlusal splint therapy in patients with chronic temporomandibular pain. However, the findings suggested that the internet-based multimodal pain program improves jaw function. The results also confirmed the treatment effect of occlusal splint therapy for chronic temporomandibular pain. Furthermore, because of the high attrition rate, this pilot study showed that a randomized controlled trial with this design is not feasible.Trial registrationClinicalTrials.gov NCT04363762; https://clinicaltrials.gov/show/NCT04363762.
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Project description:BackgroundDepression is a significant global public health issue, and in China, access to mental health services remains limited despite high demand. Research has shown that mindfulness can effectively alleviate depressive symptoms and that telehealth solutions offer a promising avenue for addressing this service gap. Despite this potential, there are currently few studies in China focusing on short-term online mindfulness training. Most existing online mindfulness studies relied on traditional 8-week programs, which can be challenging for participant adherence due to limited accessibility and high dropout rates. Additionally, limited research exists on short-term online mindfulness interventions, and findings remain inconsistent.ObjectiveThis study aimed to develop and evaluate an internet-based, self-guided, short-term mindfulness training (ISSMT) program based on the Monitor and Acceptance Theory (MAT) to reduce depression symptoms.MethodsThe ISSMT program was delivered via an online platform, "Hi Emotion," and was accessible to the general public. Interested individuals aged 18 years and older were randomized into either the ISSMT group or a wait-list control group. Participants in the ISSMT group received daily reminders to participate in a 15- to 20-minute session over a 14-day training period. Measurements, including mindfulness and depressive symptoms, were collected at baseline and weekly for the subsequent 3 weeks.ResultsA total of 205 adults participated in the 14-day online intervention. Linear mixed models were used to analyze both per-protocol (PP) and intention-to-treat (ITT) samples. Compared with the wait-list control group, participants in the ISSMT group showed significant improvements in mindfulness (Cohen d=0.44 for ITT; Cohen d=0.55 for PP) and reductions in depressive symptoms (Cohen d=0.50 for ITT; Cohen d=0.53 for PP). Furthermore, participants expressed high acceptance of this training format with a relatively low dropout rate (<40%).ConclusionsThe ISSMT program based on the MAT effectively enhanced mindfulness and alleviated depressive symptoms. This intervention could be considered for integration into psychosocial service systems to improve mental health outcomes and help bridge the gap between limited resources and the high demand for services in China. Future research should focus on personalizing these programs and incorporating advanced technologies to enhance their effectiveness and user engagement.Trial registrationOpen Science Framework; https://doi.org/10.17605/OSF.IO/8P4V6.
| S-EPMC11888059 | biostudies-literature
Project description:BackgroundPrior research has shown that the Sadness Program, a technician-assisted Internet-based cognitive behavioral therapy (iCBT) intervention developed in Australia, is effective for treating major depressive disorder (MDD). The current study aimed to expand this work by adapting the protocol for an American population and testing the Sadness Program with an attention control group.MethodsIn this parallel-group, randomized controlled trial, adult MDD participants (18-45 years) were randomized to a 10-week period of iCBT (n = 37) or monitored attention control (MAC; n = 40). Participants in the iCBT group completed six online therapy lessons, which included access to content summaries and homework assignments. During the 10-week trial, iCBT and MAC participants logged into the web-based system six times to complete self-report symptom scales, and a nonclinician technician contacted participants weekly to provide encouragement and support. The primary outcome was the Hamilton Rating Scale for Depression (HRSD), and the secondary outcomes were the Patient Health Questionnaire-9 and Kessler-10.ResultsIntent-to-treat analyses revealed significantly greater reductions in depressive symptoms in iCBT compared with MAC participants, using both the self-report measures and the clinician-rated HRSD (d = -0.80). Importantly, iCBT participants also showed significantly higher rates of clinical response and remission. Exploratory analyses did not support illness severity as a moderator of treatment outcome.ConclusionsThe Sadness Program led to significant reductions in depression and distress symptoms. With its potential to be delivered in a scalable, cost-efficient manner, iCBT is a promising strategy to enhance access to effective care.
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