Evaluation of an online-based self-help program for patients with generalized anxiety disorder - A randomized controlled trial
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SUBMITTER: Rubel J
PROVIDER: S-EPMC10847028 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:BackgroundOnly a small proportion of older patients with generalized anxiety disorder (GAD) seek professional help. Difficulties in accessing treatment may contribute to this problem. Guided self-help based on the principles of cognitive-behavioral therapy (GSH-CBT) is one way of promoting access to psychological treatment. Moreover, because the therapist's role in GSH-CBT is limited to supporting the patient, this role could be assumed by trained and supervised lay providers (LPs) instead of licensed providers. The main goal of this study is to evaluate the efficacy of GSH-CBT guided by LPs for primary threshold or subthreshold GAD in older adults.MethodsWe will conduct a multisite randomized controlled trial comparing an experimental group receiving GSH-CBT guided by LPs (n = 45) to a wait-list control group (n = 45). Treatment will last 15 weeks and will be based on a participant's manual. Weekly telephone sessions with LPs (30 min maximum) will be limited to providing support. Data will be obtained through clinician evaluations and self-assessment questionnaires. Primary outcomes will be the tendency to worry and severity of GAD symptoms. Secondary outcomes will be anxiety symptoms, sleep difficulties, functional deficit, diagnosis of GAD, and cognitive difficulties. For the experimental group, measurements will take place at pre- and post-treatment and at 6 and 12 months post-treatment. For the control group, three evaluations are planned: two pre-treatment evaluations (before and after the waiting period) and after receiving treatment (post-treatment). The efficacy of GSH-CBT will be established by comparing the change in the two groups on the primary outcomes.DiscussionThis project will provide evidence on the efficacy of a novel approach to treat GAD in older adults. If effective, it could be implemented on a larger scale and provide many older adults with much needed mental health treatment through an expanded workforce.Trial registrationThe trial was registered at ClinicalTrials.gov, number NCT03768544 , on December 7, 2018.
| S-EPMC8140311 | biostudies-literature
Project description:Online guided self-help may be an effective and scalable intervention for symptoms of generalized anxiety disorder (GAD) among university students in India. Based on an online screen for GAD administered at 4 Indian universities, 222 students classified as having clinical (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, criteria) or subthreshold (Generalized Anxiety Disorder Questionnaire, Fourth Edition, score ≥ 5.7) GAD were randomly assigned to receive either 3 months of guided self-help cognitive-behavioral therapy (n = 117) or a waitlist control condition (n = 105). Guided self-help participants recorded high program usage on average across all participants enrolled (M = 9.99 hr on the platform; SD = 20.87). Intent-to-treat analyses indicated that participants in the guided self-help condition experienced significantly greater reductions than participants in the waitlist condition on GAD symptom severity (d = -.40), worry (d = -.43), and depressive symptoms (d = -.53). No usage variables predicted symptom change in the guided self-help condition. Participants on average reported that the program was moderately helpful, and a majority (82.1%) said they would recommend the program to a friend. Guided self-help appears to be a feasible and efficacious intervention for university students in India who meet clinical or subthreshold GAD criteria. The trial is registered with ClinicalTrials.gov (NCT02410265). (PsycInfo Database Record (c) 2021 APA, all rights reserved).
| S-EPMC8744990 | biostudies-literature
Project description:BackgroundThere is growing evidence that Internet-based cognitive behavioral therapy (ICBT) is as effective as a stand-alone treatment and helps facilitating access to treatment. Given the complexity of the treatment, we argue that the effect of ICBT could be even greater if guided by a therapist, as this could increase treatment adherence. We modified an established and well-evaluated treatment approach and developed a mobile application for treating social anxiety disorder (SAD). In the present study, we compare the efficacy of app use alone (APP) with video-based, therapist-guided app use (TG-APP) and with a wait-list control group (WLC) in terms of symptom reduction, and various secondary outcomes such as increase in quality of life or decrease of general psychological distress.Methods/designA within-between interaction design with randomization to one of three conditions will be used. In the APP condition, patients receive only the app without any additional contact with therapists, while in the TG-APP condition, therapists provide 8 sessions of video-based treatment in addition to using the app. The study will be conducted in two university outpatient treatment centers with reliably diagnosed SAD patients. The primary outcome will be defined as change in SAD symptoms, as measured by the Liebowitz Social Anxiety Scale (expert rating). Furthermore, a wide range of self-reports and clinician ratings for other symptoms (depression, general psychopathology) or quality of life will be used. A simulation-based power analysis for a 3 × 2 interaction effect (group × time) on the primary outcome in a linear mixed model resulted in a total sample size of N = 165.DiscussionThe present study will be one of the first to examine the additional benefit of therapist-guided video sessions regarding the use of an app treating SAD. Study results are pivotal to future treatment application in SAD.
| S-EPMC9974392 | biostudies-literature
Project description:BACKGROUND:Generalized anxiety disorder (GAD) is one of the most common mental disorders among university students; however, many students go untreated due to treatment costs, stigma concerns, and limited access to trained mental health professionals. These barriers are heightened in universities in India, where there are scant mental health care services and severe stigma surrounding help seeking. OBJECTIVE:To evaluate the feasibility, acceptability, and efficacy of Internet-based, or "online," cognitive behavioral therapy (CBT)-based unguided and guided self-help interventions (using the programs GAD Online and Lantern, respectively) to reduce GAD symptoms in students with clinical and subthreshold GAD and, ultimately, reduce the prevalence and incidence of GAD among the student population. METHODS:Students will be recruited via 3 colleges in Hyderabad, India, and referred for a campus-wide online screening. Self-report data will be collected entirely online. A total of 300 qualifying students will be randomized in a 1:1:1 ratio to receive GAD Online, Lantern, or to be in a wait-list control condition, stratified by clinical and subthreshold GAD symptomatology. Students will complete a postintervention assessment after 3 months and a follow-up assessment 6 months later, at which point students in the wait-list control condition will receive one of the programs. The primary outcome is GAD symptom severity at 3 months postintervention. Secondary outcomes include GAD caseness at 9 months, other anxiety and depression symptoms, self-efficacy, and functional measures (eg, sleep, social functioning) at 3 and 9 months, respectively. Primary analyses will be differences between each of the intervention groups and the wait-list control group, analyzed on an intention-to-treat (ITT) basis using mixed-design ANOVA. RESULTS:The study commenced in February 2015. The sample was recruited over a 3-week period at each college. The trial is expected to end in December 2015. CONCLUSIONS:This trial will be the first to evaluate the use of Internet-based CBT programs compared with a wait-list control group for the treatment of GAD among students in Indian universities. If effective, these programs have the potential to reduce the mental health care treatment gap by providing readily accessible, private, and cost-effective evidence-based care to students with GAD who do not currently receive the treatment they need. TRIAL REGISTRATION:ClinicalTrials.gov NCT02410265 http://clinicaltrials.gov/ct2/show/NCT02410265 (Archived by WebCite at http://www.webcitation.org/6ddqH6Rbt).
| S-EPMC4704912 | biostudies-literature
Project description:The purpose of this study was to evaluate the feasibility and module content of a brief online self-help program for concerned gamblers, i.e., gamblers who perceived a need to change their gambling habits, in the context of a gambling helpline. The program consisted of four modules based on Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT), covering motivation to change, logging gambling behaviors, planning and implementing gambling-free activities, and managing risk situations. Gambling expenditures were also logged in the program, and their development over time were analyzed as longitudinal data using marginalized two-part models. Out of 4655 gamblers recruited via the helpline's webpage, 92% completed content in at least one module, and 23% were active in all four modules. Attrition was in general high, with only 10% retention in the gambling log for longer than 14 days. Gambling expenditures decreased for those who logged them for a shorter time period, whereas it increased for those who logged expenditures for a longer time period. This study shows that it is relatively easy to recruit participants to an online program for concerned gamblers in the context of a gambling helpline. However, since few users logged in to the program more than once, we suggest future online programs to have open modules with all content accessible at once.
| S-EPMC8572834 | biostudies-literature
Project description:BackgroundSocial anxiety symptoms are highly prevalent among adolescents and are associated with poor quality of life and low psychosocial functioning. If untreated, social anxiety often persists into adulthood and increases the risk for comorbid disorders. Therefore, early interventions for social anxiety to prevent negative long-term consequences are critical. However, adolescents rarely seek help and often avoid face-to-face psychotherapeutic interventions due to the perceived lack of autonomy and anonymity. Thus, online interventions represent a promising opportunity to reach adolescents who have social anxiety but do not seek help yet.ObjectiveThis study aims to evaluate the efficacy, moderators, and mediators of an online intervention developed to reduce social anxiety in adolescents.MethodsA total of 222 adolescents aged 11-17 years with subclinical social anxiety (N=166) or with a diagnosis of social anxiety disorder (N=56) are randomly assigned to the online intervention or a care-as-usual control group. The 8-week guided online intervention is based on the Cognitive Model of Social Phobia and evidence-based online interventions for social anxiety adapted to the specific needs of adolescents. The care-as-usual group will be given access to the online intervention after the follow-up assessment. Participants are assessed at baseline, at 4 and 8 weeks post intervention, and at 3-month follow-up assessment on the primary outcome, that is, social anxiety, on secondary outcomes (eg, level of functioning, fear and avoidance, general anxiety, depression, quality of life, self-esteem, and negative effects of the intervention), on potential moderators (eg, therapy motivation, therapy expectancy, and satisfaction with the intervention), and potential mediators (eg, therapeutic alliance and adherence to the intervention). Data will be analyzed based on an intention-to-treat approach and both groups (intervention and care-as-usual) will be compared at each assessment time point. Furthermore, potential mechanisms of change and generalization of intervention effects on daily life are assessed using an ecological momentary assessment procedure that includes items on maintaining mechanisms of social anxiety, social context, and affect. Participants are prompted 3 times a day during the first 8 weeks of the study and again for 2 weeks following the follow-up assessment.ResultsRecruitment is ongoing; initial results are expected in 2024.ConclusionsResults are discussed considering the potential of online interventions as a low-threshold prevention and treatment option for adolescents with social anxiety and in light of current advances in dynamic modeling of change processes and mechanisms in early intervention and psychotherapy in adolescents.Trial registrationClinicalTrials.gov NCT04782102; https://clinicaltrials.gov/ct2/show/NCT04782102.International registered report identifier (irrid)DERR1-10.2196/44346.
| S-EPMC10337443 | biostudies-literature
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:ContextGeneralized anxiety disorder (GAD) is one of the most common psychiatric disorders in older adults; however, few data exist to guide clinicians in efficacious and safe treatment. Selective serotonin reuptake inhibitors (SSRIs) are efficacious for younger adults with GAD, but benefits and risks may be different in older adults.ObjectiveTo examine the efficacy, safety, and tolerability of the SSRI escitalopram in older adults with GAD.Design, setting, and participantsA randomized controlled trial in primary care practices and related specialty clinics in Pittsburgh, Pennsylvania, of 177 participants aged 60 years or older with a principal diagnosis of GAD randomized to receive either escitalopram or placebo and conducted between January 2005 and January 2008.InterventionsTwelve weeks of 10 to 20 mg/d of escitalopram (n = 85) or matching placebo (n = 92).Main outcome measuresCumulative response defined by Clinical Global Impressions-Improvement score of much or very much improved; time to response; and anxiety and role functioning changes measured by the Clinical Global Impressions-Improvement scale, Hamilton Anxiety Rating Scale, Penn State Worry Questionnaire, Late-Life Function and Disability Instrument activity limitations subscale, and the role-emotional impairment and social function subscales of the Medical Outcome Survey 36-item Short Form.ResultsIn the primary analytic strategy in which participants (n = 33) were censored at the time of dropout, mean cumulative response rate for escitalopram was 69% (95% confidence interval [CI], 58%-80%) vs 51% (95% CI, 40%-62%) for placebo (P = .03). A conservative intention-to-treat analysis showed no difference in mean cumulative response rate between escitalopram and placebo (57%; 95% CI, 46%-67%; vs 45%; 95% CI, 35%-55%; P = .11). Participants treated with escitalopram showed greater improvement than with placebo in anxiety symptoms and role functioning (Clinical Global Impressions-Improvement scale: effect size, 0.93; 95% CI, 0.50-1.36; P < .001; Penn State Worry Questionnaire: 0.30; 95% CI, 0.23-0.48; P = .01; activity limitations: 0.32; 95% CI, 0.01-0.63; P = .04; and the role-emotional impairment and social function: 0.96; 95% CI, 0.03-1.90; P = .04). Adverse effects of escitalopram (P < .05 vs placebo) were fatigue or somnolence (35 patients [41.1%]), sleep disturbance (12 [14.1%]), and urinary symptoms (8 [9.4%]).ConclusionsOlder adults with GAD randomized to escitalopram had a higher cumulative response rate for improvement vs placebo over 12 weeks; however, response rates were not significantly different using an intention-to-treat analysis. Further study is required to assess efficacy and safety over longer treatment durations.Trial registrationclinicaltrials.gov Identifier: NCT00105586.
| S-EPMC2840403 | biostudies-literature
Project description:ObjectiveMindfulness meditation has met increasing interest as a therapeutic strategy for anxiety disorders, but prior studies have been limited by methodological concerns, including a lack of an active comparison group. This is the first randomized, controlled trial comparing the manualized Mindfulness-Based Stress Reduction (MBSR) program with an active control for generalized anxiety disorder (GAD), a disorder characterized by chronic worry and physiologic hyperarousal symptoms.MethodNinety-three individuals with DSM-IV-diagnosed GAD were randomly assigned to an 8-week group intervention with MBSR or to an attention control, Stress Management Education (SME), between 2009 and 2011. Anxiety symptoms were measured with the Hamilton Anxiety Rating Scale (HAMA; primary outcome measure), the Clinical Global Impressions-Severity of Illness and -Improvement scales (CGI-S and CGI-I), and the Beck Anxiety Inventory (BAI). Stress reactivity was assessed by comparing anxiety and distress during pretreatment and posttreatment administration of the Trier Social Stress Test (TSST).ResultsA modified intent-to-treat analysis including participants who completed at least 1 session of MBSR (n = 48) or SME (n = 41) showed that both interventions led to significant (P < .0001) reductions in HAMA scores at endpoint, but did not significantly differ. MBSR, however, was associated with a significantly greater reduction in anxiety as measured by the CGI-S, the CGI-I, and the BAI (all P values < .05). MBSR was also associated with greater reductions than SME in anxiety and distress ratings in response to the TSST stress challenge (P < .05) and a greater increase in positive self-statements (P = .004).ConclusionsThese results suggest that MBSR may have a beneficial effect on anxiety symptoms in GAD and may also improve stress reactivity and coping as measured in a laboratory stress challenge.Trial registrationClinicalTrials.gov identifier: NCT01033851.
| S-EPMC3772979 | biostudies-literature
Project description:BackgroundSelective serotonin reuptake inhibitors (SSRIs) are commonly used to treat pediatric anxiety disorders, including generalized anxiety disorder (GAD); however, their efficacy and tolerability are difficult to predict. This study evaluated the efficacy and tolerability of escitalopram in adolescents with GAD (DSM-IV-TR) and the impact of variants in HTR2A and serotonin transporter (SLC6A4) genes and cytochrome P450 2C19 (CYP2C19) phenotypes on response as well as CYP2C19 phenotype on escitalopram pharmacokinetics from February 2015 through November 2018.MethodsPatients were treated with escitalopram (forced titration to 15 mg/d, then flexible titration to 20 mg/d) (n = 26, mean ± SD age: 14.8 ± 1.7 years) or placebo (n = 25, mean ± SD age: 14.9 ± 1.6 years) for 8 weeks. Outcomes were the change in scores on the Pediatric Anxiety Rating Scale (PARS) and Clinical Global Impressions (CGI) scales as well as vital signs and adverse events. Plasma escitalopram and desmethylcitalopram area under the curve during 24 hours (AUC0-24) and maximum concentration (Cmax) were determined and compared across CYP2C19 phenotypes.ResultsEscitalopram was superior to placebo for mean ± SD baseline-to-endpoint change in PARS (-8.65 ± 1.3 vs -3.52 ± 1.1, P = .005) and CGI scores, and increasing CYP2C19 metabolism was associated with decreases in escitalopram Cmax (P = .07) and AUC0-24 (P < .05). Vital signs, corrected QT interval, and adverse events were similar in patients who received escitalopram and placebo.ConclusionsEscitalopram reduces anxiety symptoms, and pharmacogenetics variables influence the trajectory and magnitude of improvement. Variation in CYP2C19 metabolism accounts for significant differences in escitalopram pharmacokinetics, raising the possibility that CYP2C19 phenotype should be considered when prescribing escitalopram.Trial registrationClinicalTrials.gov identifier: NCT02818751.
| S-EPMC7504974 | biostudies-literature