Clinical efficacy and psychological mechanisms of an app-based digital therapeutic for generalized anxiety disorder: a randomized controlled trial (Preprint)

2021 ◽  
Author(s):  
Alexandra Roy ◽  
Elizabeth A. Hoge ◽  
Pablo Abrante ◽  
Susan Druker ◽  
Tao Liu ◽  
...  
Keyword(s):  
Reinforcement Learning ◽  
Anxiety Disorder ◽  
Generalized Anxiety Disorder ◽  
Clinical Efficacy ◽  
Controlled Trial ◽  
Population Level ◽  
Generalized Anxiety ◽  
Number Needed To Treat ◽  
Treatment As Usual ◽  
Psychological Mechanisms

BACKGROUND Current treatments for Generalized Anxiety Disorder (GAD) yield suboptimal outcomes, partly because of insufficient targeting of underlying psychological mechanisms (e.g. avoidance reinforcement learning). Mindfulness training (MT), has shown efficacy for anxiety, yet widespread adoption has been limited, in part due to difficulty in scaling in-person-based delivery. Digital therapeutics are emerging as potential next-generation treatments, yet very few have been empirically validated. OBJECTIVE In this study, we tested the efficacy and mechanism of an app-delivered MT that was designed to target aberrant reinforcement learning. METHODS Individuals with GAD were randomized to receive Treatment as Usual (TAU, n=33) or TAU + app-delivered MT (n=28). Treatment-related changes in outcomes were assessed 1 and 2 months after treatment initiation. RESULTS In an intent-to-treat analysis, individuals in the MT group demonstrated a significant reduction in anxiety (GAD-7) relative to control (median (IQR) change in GAD-7: -8.5 (6.5) v. -1.0 (5.0), P<.001; 95% CI 6 to 10). Increases in mindfulness (non-reactivity subscale) mediated decreases in worry (PSWQ; P=.02), and decreases in worry mediated reductions in anxiety (P=.03). CONCLUSIONS This is the first report studying the efficacy and mechanism of app-delivered MT for GAD. These findings demonstrate the clinical efficacy of MT delivered as a digital therapeutic for individuals with anxiety (Number Needed to Treat=1.6). These results also link recent advances in our mechanistic understanding of anxiety with treatment development, showing that app-delivered MT targets key reinforcement learning pathways resulting in tangible, clinically-meaningful reductions in worry and anxiety. Evidence-based, mechanistically-targeted digital therapeutics have the potential to improve health on a population level at low cost. CLINICALTRIAL Developing a Novel Digital Therapeutic for the Treatment of Generalized Anxiety Disorder (NCT03683472). URL - https://clinicaltrials.gov/ct2/show/NCT03683472?term=judson+brewer&draw=2&rank=1

scholarly journals The efficacy of antidepressants for generalized anxiety disorder: a systematic review and meta-analysis

2005 ◽  
Vol 27 (1) ◽  
pp. 18-24 ◽  
Author(s):  
Ricardo Schmitt ◽  
Fernando Kratz Gazalle ◽  
Maurício Silva de Lima ◽  
Ângelo Cunha ◽  
Juliano Souza ◽  
...  
Keyword(s):  
Anxiety Disorder ◽  
Generalized Anxiety Disorder ◽  
Weighted Mean Difference ◽  
Meta Analysis ◽  
Generalized Anxiety ◽  
Number Needed To Treat ◽  
Relative Risks ◽  
Co Morbidity ◽  
Axis I ◽  
Calculated Number

OBJECTIVE: To investigate the efficacy and acceptability of antidepressants in the treatment of generalized anxiety disorder. METHODS: All randomized controlled trials assessing the use of antidepressants in generalized anxiety disorder up to may 2002 were included. Non randomized trials and those that included patients with both generalized anxiety disorder and another Axis I co-morbidity were excluded. Relative risks, weighted mean difference and number needed to treat were estimated. People who died or dropped out were regarded as having had no improvement. RESULTS: Antidepressants (imipramine, venlafaxine and paroxetine) were found to be superior to placebo in treating generalized anxiety disorder. The calculated number needed to treat for antidepressants in generalized anxiety disorder was 5.15. Dropout rates did not differ between antidepressants and placebo. CONCLUSION: The available evidence suggests that antidepressants would probably be a reasonable treatment for generalized anxiety disorder patients in the clinical context.

scholarly journals Therapist Behaviours in Internet-Delivered Cognitive Behaviour Therapy: Analyses of E-Mail Correspondence in the Treatment of Generalized Anxiety Disorder

2012 ◽  
Vol 41 (3) ◽  
pp. 280-289 ◽  
Author(s):  
Björn Paxling ◽  
Susanne Lundgren ◽  
Anita Norman ◽  
Jonas Almlöv ◽  
Per Carlbring ◽  
...  
Keyword(s):  
Anxiety Disorder ◽  
Generalized Anxiety Disorder ◽  
Self Efficacy ◽  
Cognitive Behaviour Therapy ◽  
Psychological Treatment ◽  
Controlled Trial ◽  
Generalized Anxiety ◽  
Behaviour Therapy ◽  
Cognitive Behaviour ◽  
State Worry

Background: Internet-delivered cognitive behaviour therapy (iCBT) has been found to be an effective way to disseminate psychological treatment, and support given by a therapist seems to be important in order to achieve good outcomes. Little is known about what the therapists actually do when they provide support in iCBT and whether their behaviour influences treatment outcome. Aims: This study addressed the content of therapist e-mails in guided iCBT for generalized anxiety disorder. Method: We examined 490 e-mails from three therapists providing support to 44 patients who participated in a controlled trial on iCBT for generalized anxiety disorder. Results: Through content analysis of the written correspondence, eight distinguishable therapist behaviours were derived: deadline flexibility, task reinforcement, alliance bolstering, task prompting, psychoeducation, self-disclosure, self-efficacy shaping, and empathetic utterances. We found that task reinforcement, task prompting, self-efficacy shaping and empathetic utterances correlated with module completion. Deadline flexibility was negatively associated with outcome and task reinforcement positively correlated with changes on the Penn State Worry Questionnaire. Conclusions: Different types of therapist behaviours can be identified in iCBT, and though many of these behaviours are correlated to each other, different behaviours have an impact on change in symptoms and module completion.

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