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A randomized controlled trial of a smartphone-based application for the treatment of anxiety.

ABSTRACT: AbstractIntroduction: Generalized anxiety disorder (GAD) is prevalent among college students. Smartphone-based interventions may be a low-cost treatment method. Method: College students with self-reported GAD were randomized to receive smartphone-based guided self-help (n = 50), or no treatment (n = 50). Post-treatment and six-month follow-up outcomes included the Depression Anxiety Stress Scales-Short Form Stress Subscale (DASS Stress), the Penn State Worry Questionnaire (PSWQ-11), and the State-Trait Anxiety Inventory-Trait (STAI-T), as well as diagnostic status assessed by the GAD-Questionnaire, 4th edition. Results: From pre- to post-treatment, participants who received guided self-help (vs. no treatment) experienced significantly greater reductions on the DASS Stress (d = -0.408) and a greater probability of remission from GAD (d = -0.445). There was no significant between-group difference in change on the PSWQ-11 (d = -0.208) or STAI-T (d = -0.114). From post to six-month follow-up there was no significant loss of gains on DASS Stress scores (d = -0.141) and of those who had remitted, 78.6% remained remitted. Yet rates of remitted participants no longer differed significantly between conditions at follow-up (d = -0.229). Conclusion: Smartphone-based interventions may be efficacious in treating some aspects of GAD. Methods for improving symptom reduction and long-term outcome are discussed.

SUBMITTER: Newman MG

PROVIDER: S-EPMC7855205 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature

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A randomized controlled trial of a smartphone-based application for the treatment of anxiety.

Newman Michelle G MG Jacobson Nicholas C NC Rackoff Gavin N GN Bell Megan Jones MJ Taylor C Barr CB

Psychotherapy research : journal of the Society for Psychotherapy Research 20200714 4

AbstractIntroduction: Generalized anxiety disorder (GAD) is prevalent among college students. Smartphone-based interventions may be a low-cost treatment method. Method: College students with self-reported GAD were randomized to receive smartphone-based guided self-help (n = 50), or no treatment (n = 50). Post-treatment and six-month follow-up outcomes included the Depression Anxiety Stress Scales-Short Form Stress Subscale (DASS Stress), the Penn State Worry Qu ...[more]

PMID: 32662323

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Project description:The need for cost-effective interventions for people suffering from major depressive disorders is essential. Behavioral activation is an intervention that can largely benefit from the use of new mobile technologies (for example smartphones). Therefore, developing smartphone-based behavioral activation interventions might be a way to develop cost-effective treatments for people suffering from major depressive disorders. The aim of this study will be to test the effects of a smartphone-delivered behavioral activation treatment.The study will be a randomized controlled trial with a sample size of 120 participants, with 60 patients in each group. The treatment group includes an 8-week smartphone-based behavioral activation intervention, with minimal therapist contact. The smartphone-based intervention consists of a web-based psychoeducation, and a smartphone application. There is also a back-end system where the therapist can see reports from the patients or activities being reported. In the attention control group, we will include brief online education and then recommend use of a smartphone application that is not directly aimed at depression (for example, 'Effective meditation'). The duration of the control condition will also be 8?weeks. For ethical reasons we will give the participants in the control group access to the behavioral activation treatment following the 8-week treatment period.We believe that this trial has at least three important implications. First, we believe that smartphones can be integrated even further into society and therefore may serve an important role in health care. Second, while behavioral activation is a psychological treatment approach for which there is empirical support, the use of a smartphone application could serve as the therapist's prolonged arm into the daily life of the patient. Third, as we have been doing trials on guided Internet treatment for more than 10?years it is now time to move to the next generation of information technology - smartphones - which are not only relevant for Swedish conditions but also for developing countries in the world which are increasingly empowered by mobile phones with Internet connection.ClinicalTrials.gov NCT01463020.

Project description:BACKGROUND:Anxiety can cause difficulties during surgical procedures. The main objective of this study was to evaluate changes in patients' anxiety and perceived pain levels after receiving audiovisual and verbal information about miniscrew application. MATERIALS AND METHODS:Eighty-eight patients (30 males and 58 females) with a mean age of 18.18 ± 5.39 years who had fixed orthodontic treatment and required miniscrew anchorage took part in this questionnaire-based randomized controlled trial. The participants were randomly allocated to two groups and either watched a video depicting miniscrew application (study group, 44 patients) or were informed verbally about the procedure (control group, 44 patients) before miniscrew placement. The audiovisual information was given via a video containing footage of local anesthesia injection, topical antiseptic application, and miniscrew insertion. The Spielberger State-Trait Anxiety Inventory (STAI) was used to measure anxiety immediately before miniscrew application. Self-drilling miniscrews (8 mm length, 1.5 mm diameter; Aarhus System Miniscrews, American Orthodontics, Washington, USA) were placed in posterior buccal interdental region. Each patient received only one miniscrew. Postoperative pain (PP) was determined using a 100-mm horizontal visual analog scale (VAS). RESULTS:State and total anxiety scores were significantly higher in the study group than in the control group (p = 0.009 and p = 0.011 respectively). The mean PP scores (SD) for control and study groups were 12.86 (14.22) and 12.8 (16.22), respectively. The results of Mann-Whitney U test showed no significant difference (p > 0.05). Participants' PP scores did not have a significant effect on state, trait, or total anxiety scores. There was a weak but significant positive correlation between trait anxiety and state anxiety scores in both groups. CONCLUSION:Using an audiovisual method to inform patients about miniscrew placement increased anxiety levels but did not affect pain perception.

Project description:Evaluating and comparing the effectiveness of two smartphone-delivered treatments: one based on behavioural activation (BA) and other on mindfulness.Parallel randomised controlled, open, trial. Participants were allocated using an online randomisation tool, handled by an independent person who was separate from the staff conducting the study.General community, with recruitment nationally through mass media and advertisements.40 participants diagnosed with major depressive disorder received a BA treatment, and 41 participants received a mindfulness treatment. 9 participants were lost at the post-treatment.An 8-week long behaviour programme administered via a smartphone application. Mindfulness: An 8-week long mindfulness programme, administered via a smartphone application.The Beck Depression Inventory-II (BDI-II) and the nine-item Patient Health Questionnaire Depression Scale (PHQ-9).81 participants were randomised (mean age 36.0 years (SD=10.8)) and analysed. Results showed no significant interaction effects of group and time on any of the outcome measures either from pretreatment to post-treatment or from pretreatment to the 6-month follow-up. Subgroup analyses showed that the BA treatment was more effective than the mindfulness treatment among participants with higher initial severity of depression from pretreatment to the 6-month follow-up (PHQ-9: F (1, 362.1)=5.2, p<0.05). In contrast, the mindfulness treatment worked better than the BA treatment among participants with lower initial severity from pretreatment to the 6-month follow-up (PHQ-9: F (1, 69.3)=7.7, p<0.01); BDI-II: (F(1, 53.60)=6.25, p<0.05).The two interventions did not differ significantly from one another. For participants with higher severity of depression, the treatment based on BA was superior to the treatment based on mindfulness. For participants with lower initial severity, the treatment based on mindfulness worked significantly better than the treatment based on BA.Clinical Trials NCT01463020.

Project description:BackgroundAntipsychotic medications have limited benefits in schizophrenia, and cognitive behavioral therapy may be beneficial as an adjunct. There may be potential for implementing mobile cognitive behavioral therapy-based treatment for schizophrenia in addition to standard antipsychotic medications.ObjectiveThis study aims to determine whether PEAR-004, a smartphone-based investigational digital therapeutic, improves the symptoms of an acute psychotic exacerbation of schizophrenia when it is added to standard treatments.MethodsThis was a 12-week, multicenter, randomized, sham-controlled, rater-blinded, parallel group proof‑of‑concept study of 112 participants with moderate acute psychotic exacerbation in schizophrenia. This study was conducted in 6 clinical trial research sites in the United States from December 2018 to September 2019. The primary outcome, change in Positive and Negative Syndrome Scale (PANSS) from baseline to week 12 or the last available visit, was analyzed using the mixed-effects regression model for repeated measures, applied to an intent-to-treat sample.ResultsThe total PANSS scores slightly decreased from baseline over the study period in both groups; the treatment difference at day 85 between PEAR-004 and sham was 2.7 points, in favor of the sham (2-sided P=.09). The secondary scales found no benefit, except for transient improvement in depressive symptoms with PEAR-004. Application engagement was good, and patient and clinical investigator satisfaction was high. No safety concerns were observed. There was some evidence of study site heterogeneity for the onboarding processes and directions on PEAR-004 product use at baseline and throughout the study. However, these differences did not affect the efficacy results.ConclusionsIn the largest-to-date randomized, sham-controlled study of a digital therapeutic in schizophrenia, PEAR-004 did not demonstrate an effect on the primary outcome-total PANSS scores-when compared with a nonspecific digital sham control. The secondary and exploratory results also did not demonstrate any notable benefits, except for possible temporary improvement in depressive symptoms. This study provided many useful scientific and operational insights that can be used in the further clinical development of PEAR-004 and other investigational digital therapeutics.Trial registrationClinicalTrials.gov NCT03751280; https://clinicaltrials.gov/ct2/show/NCT03751280.

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A randomized controlled trial of a smartphone-based application for the treatment of anxiety.

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A randomized controlled trial of a smartphone-based application for the treatment of anxiety.

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