Outcomes of Cognitive Behavioral Therapy (CBT) Interventions Provided by Unlicensed Professionals

May 5, 2023 updated by: Sabine Wilhelm, PhD, Massachusetts General Hospital

Outcomes of Cognitive Behavioral Therapy (CBT) Interventions Provided by Unlicensed Professionals in a General Hospital Setting

To examine the effectiveness and clinical care outcomes of cognitive-behavioral therapy interventions at Massachusetts General Hospital (MGH).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Cognitive behavioral interventions are the most widely studied and evidenced-based psychosocial treatment approaches for mental health and health related behavioral problems. Despite their documented efficacy, there is a scarcity of licensed mental health professionals who are available to treat patients with problems that would be amenable to Cognitive Behavioral Therapy (CBT). While CBT interventions have a strong base in terms of efficacy in randomized trials, effectiveness and dissemination studies are lacking in comparison, and hence, these interventions are not reaching the patients in most need of services. Complicating the problem further, insurance companies typically do not reimburse for services provided by trainees who are not licensed. This is a public mental health problem because it limits the degree to which CBT clinicians can be trained to deliver these treatments, and a particular problem at MGH because referring providers do not have a place to send their patient for CBT services, as trainees constitute a large portion of clinical staff. To address this issue, the current study seeks to document outcomes of CBT interventions delivered by credentialed but not licensed trainees. This information can be used to guide policy and reimbursement guidelines for trainees, as well as promote the ability to disseminate efficacious interventions. Information gained from this project will be used to provide feedback to insurance companies, licensing boards, and mental health community stakeholders regarding decision making re: reimbursement for care provided by supervised trainees. Additionally, this may be used as a pilot study for a comparative effectiveness study comparing trainees to licensed staff psychologists.

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • 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
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Cognitive-Behavioral Therapy and Behavioral Medicine Programs, Massachusetts General Hospital

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients presenting to the Behavioral Medicine Service are generally individuals with an acute or chronic medical condition or medically related concern with or without an associated DSM-IV psychiatric disorder, as well as adult patients who require assistance with changing health or health-risk behaviors. Patients presenting to the OCD program typically have obsessive compulsive disorder, body dysmorphic disorder, Tourette syndrome, compulsive skin picking, or trichotillomania. Patients presenting to the general CBT program typically have panic disorder, social phobia, generalized anxiety disorder, depression, specific phobia, post traumatic stress disorder, attention deficit hyperactivity disorder, or an eating disorder. Patients at any of the programs have an identifiable behavior or behavioral pattern/ mood problem that they would like to change.
  • Age 18 or older
  • Ability to provide informed consent and comply with the study procedures
  • Ability to complete self-report questionnaires (either written hardcopy or computer-based version) with adequate accommodation, if necessary
  • Patients with a PCP at MGH, receiving specialty care at MGH, or employees of MGH.

Exclusion Criteria:

  • Exhibit active suicidality (suicidal ideation with intent or plan) to the point that more intensive treatment (i.e. acute hospitalization) is required.
  • Active untreated and unstable bipolar disorder (i.e. stable bipolar disorder under care of a psychiatrist is allowed).
  • Psychosis.
  • Mental retardation.
  • Any condition that, after the baseline evaluation, is determined to preclude treatment with cognitive behavioral therapy.
  • Received more than 4 sessions of CBT for the target disorder within the past 3 years.

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Behavioral Therapy
Behavioral: Cognitive behavioral therapy (CBT)
The participant will then undergo a structured clinical interview with a supervised psychology intern/fellow, which will take approximately 1-3 hours over the course of 1-3 sessions. The initial assessment will be followed by up to 24 sessions of cognitive behavioral therapy tailored to their particular diagnosis (most diagnoses/problems require approximately 12 sessions, some require fewer, others require more). The length of treatment will depend on the primary diagnosis/ problem and the complexity and severity of the case. The clinician and patient will agree on a treatment plan after the initial evaluation, targeting a particular mental health or health related behavioral problem with Cognitive Behavioral Therapy. This treatment plan will include an agreed upon number of treatment sessions (up to 24).
Other Names:
  • CBT
Experimental: Behavioral Medicine with Cognitive Behavioral Therapy
Participants enrolled in this arm of this study will be treated by the behavioral medicine interns with cognitive behavioral therapy focused on both their general health concerns and mental health concerns.
Behavioral: Cognitive behavioral therapy (CBT)
The participant will then undergo a structured clinical interview with a supervised psychology intern/fellow, which will take approximately 1-3 hours over the course of 1-3 sessions. The initial assessment will be followed by up to 24 sessions of cognitive behavioral therapy tailored to their particular diagnosis (most diagnoses/problems require approximately 12 sessions, some require fewer, others require more). The length of treatment will depend on the primary diagnosis/ problem and the complexity and severity of the case. The clinician and patient will agree on a treatment plan after the initial evaluation, targeting a particular mental health or health related behavioral problem with Cognitive Behavioral Therapy. This treatment plan will include an agreed upon number of treatment sessions (up to 24).
Other Names:
  • CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Schwartz Outcome Scale (SOS-10)
Time Frame: at baseline, and at visits 1 through 24, which will occur approximately 1 week apart.
The Schwartz Outcome Scale (SOS-10) is designed to measure a broad domain of psychological health. It appears to be sensitive to change with treatment. So, we will be measuring whether the total score of this scale changes throughout treatment, i.e., whether the CBT interventions tend to improve psychological health.
at baseline, and at visits 1 through 24, which will occur approximately 1 week apart.

Collaborators and Investigators

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

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Sabine Wilhelm, PhD, Massachusetts General Hospital

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.

Helpful Links

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

January 1, 2010

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

February 22, 2010

First Submitted That Met QC Criteria

February 24, 2010

First Posted (Estimate)

February 25, 2010

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009P002479

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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