Interpretation Training to Reduce Anxiety: Evaluating Technology-based Delivery Models and Methods to Reduce Attrition

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1748 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-20

Study Completion Date

2020-12-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The project aims to compare effectiveness and target engagement of CBM-I delivered via computer vs. mobile phone, and test if adding minimal human contact for participants at risk of dropout improves retention and outcomes.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Web-based Interpretation Training For Anxiety

NCT02382003

Anxiety

COMPLETED PHASE2

Cognitive-Behavioral Treatment and Interpretation Modification Training for Adults With Generalized Anxiety Disorder

NCT01681329

Generalized Anxiety Disorder

COMPLETED NA

Attention Training for Generalized Anxiety Disorder

NCT00602563

Generalized Anxiety Disorder

COMPLETED NA

Transdiagnostic Cognitive Behavioral Treatment for Anxiety

NCT03810456

Anxiety Disorders

COMPLETED PHASE2/PHASE3

Brief Anxiety Skills Training Intervention for Veterans in Primary Care

NCT04829240

Anxiety

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Approximately 25-30% of the U.S. population will experience anxiety pathology severe enough to qualify for an anxiety disorder diagnosis during their lifetime. Critically, the majority will not receive treatment, creating a serious need to consider alternative approaches to delivering mental health services that can meet needs on a larger scale. Cognitive Bias Modification (CBM) interventions for anxiety hold considerable promise as a way to meet these needs. These programs alter biased ways of thinking, such as selective assignment of threat interpretations, which are known to cause and maintain anxiety. CBM for interpretation bias (CBM-I) has established efficacy when administered via computer in the laboratory, and there is clear evidence for target engagement (i.e., change in interpretations, the identified mechanism). Now, effectiveness needs to be tested in the community, using sufficiently large samples to evaluate key moderators of its effects, including delivery method (computer vs. mobile phone) and the addition of minimal human contact (for those at risk of attrition). Addressing attrition is critical given high rates of drop out for web-based interventions. Via the PI's MindTrails web site (established with the lab's prior NIMH R34MH106770 award), the lab already has the infrastructure to deliver CBM to the public and recruit large anxious samples. Moreover, the PI and Co-I have established infrastructure to do mobile sensing of mood and CBM-I delivery via mobile phones. Thus, the project can respond to NIMH's request for "Effectiveness trials that can contribute to advancing the personalization of mental health care." The current proposal aims to compare effectiveness and target engagement of CBM-I delivered via computer vs. mobile phone, and test if adding minimal human contact for participants at risk of dropout improves retention and outcomes. Study 1 will provide a pilot feasibility and user experience test of the CBM-I program on mobile phones. Study 2 will examine the lab's current online, computer-based CBM-I data to help determine empirical indicators of attrition. Study 3 will provide the primary test of moderators of effectiveness. Namely, in Study 3, high anxious participants will be randomized to one of 2 conditions: 1) CBM-I training delivered by computer or mobile phone (at existing MindTrails site); 2) Alternate intervention group-Psychoeducation only. CBM-I and Psychoeducation conditions include 5 weekly training sessions. Based on theoretically- and empirically-derived predictors of attrition, participants identified as high-risk for dropout in condition 1 will then be randomly assigned to add minimal human contact (using a modified TeleCoach protocol) or no change. Using this adaptive intervention, known as Sequential, Multiple Assignment, Randomized Trial (SMART), the project can test both the effects of CBM-I delivery method and the added value of human contact to improve retention for participants at high-risk for dropping out.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Participants will be aware whether they are completing the intervention by phone or computer, and will know if they are receiving coaching or not.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CBM-I, low attrition

Computer- or phone-based Cognitive Bias Modification - Interpretation training

Group Type EXPERIMENTAL

Cognitive Bias Modification - Interpretation training

Intervention Type BEHAVIORAL

Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.

CBM-I, high attrition, coach

Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching

Group Type EXPERIMENTAL

Cognitive Bias Modification - Interpretation training

Intervention Type BEHAVIORAL

Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.

Coaching

Intervention Type BEHAVIORAL

Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.

CBM-I, high attrition, no coach

Computer- or phone-based Cognitive Bias Modification - Interpretation training

Group Type EXPERIMENTAL

Cognitive Bias Modification - Interpretation training

Intervention Type BEHAVIORAL

Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.

Psychoeducation

Online psychoeducation about anxiety

Group Type ACTIVE_COMPARATOR

Online psychoeducation about anxiety

Intervention Type BEHAVIORAL

Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive Bias Modification - Interpretation training

Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.

Intervention Type BEHAVIORAL

Coaching

Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.

Intervention Type BEHAVIORAL

Online psychoeducation about anxiety

Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18 and over
* Moderate to extremely severe anxiety range (i.e., 10 or higher) on the Depression, Anxiety, Stress Scales - Short Form: Anxiety Subscale
* Regular access to the Internet via Smartphone or computer