A randomized controlled feasibility trial of internet-delivered guided self-help for generalized anxiety disorder (GAD) among university students in India.
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SUBMITTER: Newman MG
PROVIDER: S-EPMC8744990 | biostudies-literature |
REPOSITORIES: biostudies-literature
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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:This study investigated the reliability and factorial validity of General Anxiety Disorder-7 (GAD-7) in the context of university students in Bangladesh. The research aimed to assess whether the original one-dimensional model or a model containing both somatic and cognitive-emotional factors is appropriate. A repeated cross-sectional survey design based on convenience sampling was used to collect data from 677 university students. The factor structure of the GAD-7 was assessed by exploratory factor analysis (EFA) and confirmatory factor analysis (CFA), and its convergent validity was determined by investigating its correlations with Patient Health Questionnaire-9 (PHQ-9) and Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS). Results showed excellent reliability of GAD-7 as measured by Cronbach's α. CFA suggested that a modified one-factor model is appropriate for the sample. This model provided high values of comparative fit index (CFI), goodness of fit index (GFI), and Tucker Lewis Index (TLI), low value of standardized root mean square residual (SRMR) and a non-significant root mean square error of approximation (RMSEA). Correlation between GAD-7 and PHQ-9 was 0.751 and 0.934 between GAD-7 and PHQ-ADS. Overall, the study provided support for modified unidimensional structure for GAD-7 and showed high internal consistency along with good convergent validity.
| S-EPMC8675645 | biostudies-literature
Project description:ObjectivesThe feasibility of research into internet-delivered guided self-help Acceptance and Commitment Therapy (ACT) for family carers of people with dementia is not known. This study assessed this in an uncontrolled feasibility study.MethodFamily carers of people with dementia with mild to moderate anxiety or depression were recruited from primary and secondary healthcare services in the UK. Participants were offered eight, guided, self-help online ACT sessions adapted for the needs of family carers of people with dementia with optional online peer support groups. Pre-defined primary indicators of success included recruitment of 30 eligible carers over 6 months and ≥70% completing at least two online sessions.ResultsThirty-three participants (110% of the target sample) were recruited over 6 months and 30 participants (91%) completed two or more sessions, and thus both indicators of success were met. Further, 70% of participants completed seven or all eight sessions, and 27% of participants were lost to follow-up, but none of the reasons for early withdrawal were related to the intervention.ConclusionThis study supports the feasibility, including recruitment and treatment completion. A full-scale trial to assess the clinical- and cost-effectiveness of the intervention including its long-term effects is warranted.
| S-EPMC9629048 | biostudies-literature
Project description:OBJECTIVES:Social anxiety disorder (SAD) is one of the most common psychiatric disorders in youth, with a prevalence of about 3%-4% and increased risk of adverse long-term outcomes, such as depression. Cognitive-behavioural therapy (CBT) is considered the first-line treatment for youth with SAD, but many adolescents remain untreated due to limited accessibility to CBT. The aim of this study was to develop and evaluate the feasibility and preliminary efficacy of a therapist-guided internet-delivered CBT treatment, supplemented with clinic-based group exposure sessions (BIP SOFT). DESIGN:A proof-of-concept, open clinical trial with 6-month follow-up. PARTICIPANTS:The trial was conducted at a child and adolescent psychiatric research clinic, and participants (n=30) were 13-17 years old (83% girls) with a principal diagnosis of SAD. INTERVENTION:12 weeks of intervention, consisting of nine remote therapist-guided internet-delivered CBT sessions and three group exposure sessions at the clinic for the adolescents and five internet-delivered sessions for the parents. RESULTS:Adolescents were generally satisfied with the treatment, and the completion rate of internet modules, as well as attendance at group sessions, was high. Post-treatment assessment showed a significant decrease in clinician-rated, adolescent-rated and parent-rated social anxiety (d=1.17, 0.85 and 0.79, respectively), as well as in general self-rated and parent-rated anxiety and depression (d=0.76?and 0.51), compared with pretreatment levels. Furthermore, 47% of participants no longer met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for SAD at post-treatment. At a 6-month follow-up, symptom reductions were maintained, or further improved, and 57% of participants no longer met criteria for SAD. CONCLUSION:Therapist-guided and parent-guided internet-delivered CBT, supplemented with a limited number of group exposure sessions, is a feasible and promising intervention for adolescents with SAD. TRIAL REGISTRATION NUMBER:NCT02576171; Results.
| S-EPMC5735402 | biostudies-literature
Project description:BackgroundTherapist-supported, internet-delivered cognitive behavioral therapy (iCBT) is efficacious for generalized anxiety disorder (GAD), but few studies are yet to report its effectiveness in routine care.ObjectiveIn this study, we aim to examine whether a new 12-session iCBT program for GAD is effective in nationwide routine care.MethodsWe administered a specialized, clinic-delivered, therapist-supported iCBT for GAD in 1099 physician-referred patients. The program was free of charge for patients, and the completion time was not predetermined. We measured symptoms with web-based questionnaires. The primary measure of anxiety was the GAD 7-item scale (GAD-7); secondary measures were, for pathological worry, the Penn State Worry Questionnaire and, for anxiety and impairment, the Overall Anxiety Severity and Impairment Scale.ResultsPatients completed a mean 7.8 (SD 4.2; 65.1%) of 12 sessions, and 44.1% (485/1099) of patients completed all sessions. The effect size in the whole sample for GAD-7 was large (Cohen d=0.97, 95% CI 0.88-1.06). For completers, effect sizes were very large (Cohen d=1.34, 95% CI 1.25-1.53 for GAD-7; Cohen d=1.14, 95% CI 1.00-1.27 for Penn State Worry Questionnaire; and Cohen d=1.23, 95% CI 1.09-1.37 for Overall Anxiety Severity and Impairment Scale). Noncompleters also benefited from the treatment. Greater symptomatic GAD-7-measured relief was associated with more completed sessions, older age, and being referred from private or occupational care. Of the 894 patients with a baseline GAD-7 score ≥10, approximately 421 (47.1%) achieved reliable recovery.ConclusionsThis nationwide, free-of-charge, therapist-supported HUS Helsinki University Hospital-iCBT for GAD was effective in routine care, but further research must establish effectiveness against other treatments and optimize the design of iCBT for GAD for different patient groups and individual patients.
| S-EPMC8990365 | biostudies-literature
Project description:ObjectiveAccess to effective treatments for adolescents with depression needs to improve. Few studies have evaluated behavioural activation (BA) for adolescent depression, and none remotely delivered BA. This study explored the feasibility and acceptability of therapist-guided and self-guided internet-delivered BA (I-BA) in preparation for a future randomised controlled trial (RCT).DesignA single-blinded randomised controlled feasibility trial.SettingA specialist outpatient clinic in Sweden.ParticipantsThirty-two adolescents with mild-to-moderate major depression, aged 13-17 years.InterventionsTen weeks of therapist-guided I-BA or self-guided I-BA, or treatment as usual (TAU). Both versions of I-BA included parental support. TAU included referral to usual care within child and youth psychiatry or primary care.OutcomesFeasibility measures included study take-up, participant retention, acceptability, safety and satisfaction. The primary outcome measure was the blinded assessor-rated Children's Depression Rating Scale, Revised. The primary endpoint was the 3-month follow-up.Results154 adolescents were screened and 32 were randomised to therapist-guided I-BA (n=11), self-guided I-BA (n=10) or TAU (n=11). Participant retention was acceptable, with two drop-outs in TAU. Most participants in TAU had been offered interventions by the primary endpoint. The mean number of completed chapters (total of 8) for adolescents was 7.5 in therapist-guided I-BA and 5.4 in self-guided I-BA. No serious adverse events were recorded. Satisfaction was acceptable in both I-BA groups. Following an intent-to-treat approach, the linear mixed-effects model revealed that both therapist-guided and self-guided I-BA (Cohen's d=2.43 and 2.23, respectively), but not TAU (Cohen's d=0.95), showed statistically significant changes on the primary outcome measure with large within-group effect sizes.ConclusionsBoth therapist-guided and self-guided I-BA are acceptable and potentially efficacious treatments for adolescents with depression. It is feasible to conduct a large-scale RCT to establish the efficacy and cost-effectiveness of I-BA versus TAU.Trial registration numberClinicalTrials.gov Registry (NCT04117789).
| S-EPMC9806095 | biostudies-literature
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.
| S-EPMC8117054 | biostudies-literature
Project description:Severe health anxiety (hypochondriasis), or illness anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, is characterized by preoccupation with fear of suffering from a serious illness in spite of medical reassurance. It is a debilitating, prevalent disorder associated with increased health care utilization. Still, there is a lack of easily accessible specialized treatment for severe health anxiety.The aims of this paper were to (1) describe the development and setup of a new internet-delivered acceptance and commitment therapy (iACT) program for patients with severe health anxiety using self-referral and a video-based assessment; and (2) examine the feasibility and potential clinical efficacy of iACT for severe health anxiety.Self-referred patients (N=15) with severe health anxiety were diagnostically assessed by a video-based interview. They received 7 sessions of clinician-supported iACT comprising self-help texts, video clips, audio files, and worksheets over 12 weeks. Self-report questionnaires were obtained at baseline, post-treatment, and at 3-month follow-up. The primary outcome was Whiteley-7 Index (WI-7) measuring health anxiety severity. Depressive symptoms, health-related quality of life (HRQoL), life satisfaction, and psychological flexibility were also assessed. A within-group design was employed. Means, standard deviations, and effect sizes using the standardized response mean (SRM) were estimated. Post-treatment interviews were conducted to evaluate the patient experience of the usability and acceptability of the treatment setup and program.The self-referral and video-based assessments were well received. Most patients (12/15, 80%) completed the treatment, and only 1 (1/15, 7%) dropped out. Post-treatment (14/15, 93%) and 3-month follow-up (12/15, 80%) data were available for almost all patients. Paired t tests showed significant improvements on all outcome measures both at post-treatment and 3-month follow-up, except on one physical component subscale of HRQoL. Health anxiety symptoms decreased with 33.9 points at 3-month follow-up (95% CI 13.6-54.3, t11= 3.66, P=.004) with a large within-group effect size of 1.06 as measured by the SRM.Treatment adherence and potential efficacy suggest that iACT may be a feasible treatment for health anxiety. The uncontrolled design and small sample size of the study limited the robustness of the findings. Therefore, the findings should be replicated in a randomized controlled trial. Potentially, iACT may increase availability and accessibility of specialized treatment for health anxiety.Danish Data Protection Agency, Central Denmark Region: 1-16-02-427-14; https://www.rm.dk/sundhed/faginfo/forskning/datatilsynet/ (Archived by Webcite at http://www.webcitation.org/6yDA7WovM).
| S-EPMC5938695 | biostudies-other
Project description:Assessment of treatment response in psychotherapies can be undermined by lack of longitudinal measurement invariance (LMI) in symptom self-report inventories, by measurement error, and/or by wrong model assumptions. To understand and compare these threats to validity of outcome assessment in psychotherapy research, we studied LMI, sum scores, and Davidian Curve Item Response Theory models in a naturalistic guided internet psychotherapy treatment register of 2,218 generalized anxiety disorder (GAD) patients and 3,922 depressive disorder (DD) patients (aged ≥16 years). Symptoms were repeatedly assessed by Generalized Anxiety Disorder Assessment-7 (GAD-7) or Beck Depression Inventory. The symptom self-reports adhered to LMI under equivalence testing, suggesting sum scores are reasonable proxies for disorder status. However, the standard LMI assumption of normally distributed latent factors did not hold and inflated treatment response estimates by 0.2 to 0.3 standard deviation units compared with sum scores. Further methodological research on non-normally distributed latent constructs holds promise in advancing LMI and mental health assessment.
| S-EPMC9999284 | biostudies-literature
Project description:ObjectiveGeneralized anxiety disorder (GAD) during pregnancy is associated with several adverse maternal and perinatal outcomes. A reliable and valid screening tool for GAD should lead to earlier detection and treatment. Among pregnant Peruvian women, a brief screening tool, the GAD-7, has not been validated. This study aims to evaluate the reliability and validity of the GAD-7.MethodsOf 2,978 women who attended their first perinatal care visit and had the GAD-7 screening, 946 had a Composite International Diagnostic Interview (CIDI). The Cronbach's alpha was calculated to examine the reliability. We assessed the criterion validity by calculating operating characteristics. The construct validity was evaluated using factor analysis and association with health status on the CIDI. The cross-cultural validity was explored using the Rasch Rating Scale Model (RSM).ResultsThe reliability of the GAD-7 was good (Cronbach's alpha = 0.89). A cutoff score of 7 or higher, maximizing the Youden Index, yielded a sensitivity of 73.3% and a specificity of 67.3%. One-factor structure of the GAD-7 was confirmed by exploratory and confirmatory factor analysis. Concurrent validity was supported by the evidence that higher GAD-7 scores were associated with poor self-rated physical and mental health. The Rasch RSM further confirmed the cross-cultural validity of the GAD-7.ConclusionThe results suggest that the Spanish-language version of the GAD-7 may be used as a screening tool for pregnant Peruvian women. The GAD-7 has good reliability, factorial validity, and concurrent validity. The optimal cutoff score obtained by maximizing the Youden Index should be considered cautiously; women who screened positive may require further investigation to confirm GAD diagnosis.
| S-EPMC4411061 | biostudies-literature