Web Based Therapist Training on Cognitive Behavior Therapy for Anxiety Disorders

February 1, 2016 updated by: Kenneth A. Kobak, Ph.D., Center for Psychological Consultation
Anxiety disorders are a major public health concern, having a profound impact on functioning, causing significant disability, loss of productivity and suffering. Effective treatments exist for these disorders, but few clinicians are trained in these methods. This project attempts to remedy this shortcoming by using web-based tools to facilitate access to this training, thus increasing the number of available therapists in order to help meet this unmet need.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The need for evidence-based mental health treatments i.e., 'treatment based on the best available science or research evidence', has been stressed from scientific, ethical, and economic perspectives. While empirical evidence supports both the efficacy and effectiveness of cognitive behavior therapy (CBT) for anxiety disorders, the demand for clinicians trained in these approaches far exceeds the supply. A major reason for this is the lack of trained cognitive behavior therapists. New technologies provide the opportunity to both facilitate accessibility to this specialized training by mental health professionals and to improve the quality of this training. Recent research has found that training clinicians using these new web-based technologies is highly effective, can significantly improve skills, and has significant advantages over traditional training programs. The long term goal of this project is to increase the number of available mental health professionals trained in cognitive behavior therapy for anxiety disorders by developing a set of web-based training tools enabling the widespread dissemination of this training. In Phase I the investigators developed a prototype online tutorial covering some core CBT principles and a Social Anxiety Disorder module. The investigators also tested the feasibility of live remote training through videoconferencing. In phase II investigators will expand the tutorial to include a comprehensive review of CBT principles and techniques and expand modules to include the full spectrum of anxiety and anxiety-related disorders (i.e., Obsessive Compulsive Disorder, Panic Disorder, Generalized Anxiety Disorder, Posttraumatic Stress Disorder and Social Anxiety Disorder). Investigators will also evaluate the efficacy of live remote training in improving clinical skills. A cohort of 50 clinicians from diverse educational and professional backgrounds will be recruited. Improvement in trainees' conceptual knowledge will be evaluated pre and post tutorial, and improvement in trainees' clinical skills in applying the CBT concepts will be evaluated by blind ratings of clinical adherence and competence at three time points: before on-line training, and before and after videoconference training. User satisfaction with both the on-line tutorial and the videoconference training will also be evaluated. Impact of training on post-training patient outcomes will be evaluated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53717
        • Center for Telepsychology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinicians are eligible for this therapist training study if they are a licensed health care professional or are currently in a counseling related graduate training program

Exclusion Criteria:

  • None, except for above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Internet-Based Training
On-line tutorial followed by live remote training via videoconferencing
Behavioral: Internet Based CBT Training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
System Usability Scale
Time Frame: after completion of tutorial, an expected average of 2 weeks
User satisfaction with the technical aspects of the tutorial was assessed using the ratings on the System Usability Scale (SUS), a reliable, well-validated 10-item scale designed to evaluate the usability and user satisfaction with web-based applications and other technologies.
after completion of tutorial, an expected average of 2 weeks
CBT Concepts
Time Frame: After completing the on line tutorial, an expected average of two weeks
Improvement in trainees' knowledge of CBT concepts will be evaluated using a 38-item pre and post test of the items covering the tutorial content.
After completing the on line tutorial, an expected average of two weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Yale Adherence and Competence Scale (YACS)
Time Frame: At day 0 (baseline) (i.e., priot to any training), and after completing the on line tutorial (an expected average of two weeks), and after completing the appled training (an exected average of 8 weeks).
The Yale Adherence and Competence Scale (YACS) is a well-validated, scale for rating therapist adherence and competence in delivering cognitive behavioral treatments. It has been used as an outcome measure in several studies evaluating the effectiveness of different CBT rater training approaches . Therapist competence in administering specific CBT techniques is evaluated on a scale ranging from 1 (very poor) to 7 (excellent).
At day 0 (baseline) (i.e., priot to any training), and after completing the on line tutorial (an expected average of two weeks), and after completing the appled training (an exected average of 8 weeks).
User Satisfaction Questionnaire
Time Frame: After completing the on line tutorial (an expected average of 2 weeks)
This scale evaluates how well subjects liked the clinical content of the on-line tutorial. It contains 14 statements, each of which are rated on a 4-point scale (strongly agree, agree, disagree, strongly disagree), and covers several dimensions of the user experience . The scale ranges from 15 to 60, and has good internal consistency reliability (Cronbach's Alpha =.90, Phase I study results). An overall mean score of 45 (i.e., an average score of 3 ("agree" on all items)) is considered adequate to demonstrate acceptable user satisfaction with the clinical content.
After completing the on line tutorial (an expected average of 2 weeks)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
GAD-7
Time Frame: Weekly for 8 weeks of patient treatment, post training
The GAD-7 is a well-validated self-report scale originally developed as a brief measure of GAD. It has since been validated as measure of anxiety across the domain of anxiety disorders.
Weekly for 8 weeks of patient treatment, post training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Center for Psychological Consultation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R44MH086951 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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