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Open Access 01-12-2019 | Anxiety Disorder | Study protocol

The ReThink study: a 3-arm parallel randomized trial of cognitive bias modification, with and without adherence promotion, for adolescent anxiety disorder: trial design and protocol

Authors: Shelley Reetz, Gregory Clarke, Robin Weersing, Nader Amir, John Dickerson, Frances L. Lynch, Michael C. Leo, Andreea M. Rawlings, Mi H. Lee, Sara Gille

Published in: BMC Psychiatry | Issue 1/2019

Abstract

Background

Anxiety disorders are the most common mental health problem among youth, contribute to reduced quality of daily life, and are associated with high rates of comorbidity. However, treatment rates for anxiety are very low, causing a sizeable treatment gap. There is an immediate need to identify treatment interventions that are effective, affordable, and can be delivered easily to the youth population. Cognitive Bias Modification (CBM) is one potentially effective intervention that could reach youth on a large scale, especially when self-administered at home. Thus, we aim to assess the benefit of CBM to treat youth anxiety. Further, we aim to test whether adding an adherence promotion (AP) component to the CBM intervention can improve outcomes, and whether CBM delivered both with and without the AP component is cost effective.

Methods

This is a 12-month randomized controlled trial (RCT) conducted within an existing healthcare system. Potentially eligible youth (ages 12 to 17) will be identified by reviewing the electronic health record (EHR) for clinical anxiety diagnoses, which are then confirmed via research interview. We aim to enroll 498 participants and randomize them 1:1:1 to one of three arms: Arm 1 is a Low-Ratio version of the CBM program (nearly identical to the other CBM versions, but minimally effective); Arm 2 is a High-Ratio “active” CBM program; and Arm 3 is the High-Ratio CBM program with an added AP component. Participants will complete assessments at baseline, 1-, 3-, 6- and 12-months post-baseline. Youth in all three arms will self-administer the CBM program at home and will be asked to complete twelve intervention sessions over a four-week period. Arm 3 participants (High-Ratio CBM + AP) will also receive up to four telephone calls from phone coaches during the intervention period to provide technical assistance, encouragement, and motivational enhancement to increase adherence. The primary clinical outcome will be anxiety remission at 6-month follow-up.

Discussion

This study protocol describes the method and design for an RCT to test whether self-administered CBM both with and without adherence promotion can be an effective at-home treatment for anxious youth.

Trial registration

ClinicalTrials.gov: NCT02156531, First Posted June 5, 2014.

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Title: The ReThink study: a 3-arm parallel randomized trial of cognitive bias modification, with and without adherence promotion, for adolescent anxiety disorder: trial design and protocol
Authors: Shelley Reetz
Gregory Clarke
Robin Weersing
Nader Amir
John Dickerson
Frances L. Lynch
Michael C. Leo
Andreea M. Rawlings
Mi H. Lee
Sara Gille
Publication date: 01-12-2019
Publisher: BioMed Central
Keywords: Anxiety Disorder
Anxiety
Published in: BMC Psychiatry / Issue 1/2019
Electronic ISSN: 1471-244X
DOI: https://doi.org/10.1186/s12888-019-2296-z

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

The ReThink study: a 3-arm parallel randomized trial of cognitive bias modification, with and without adherence promotion, for adolescent anxiety disorder: trial design and protocol

Abstract

Background

Methods

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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