Back to resultsOutcomes of Cognitive Behavioral Therapy (CBT) Interventions Provided by Unlicensed Professionals
Primary Purpose
Obsessive Compulsive Disorder, Body Dysmorphic Disorder, Tourette Syndrome
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy (CBT)
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring OCD, BDD, Tourette syndrome, trichotillomania, Compulsive Skin Picking, panic disorder, social phobia, generalized anxiety disorder, depression, PTSD, ADHD, eating disorder, Specific Phobia
Eligibility Criteria
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.
Sites / Locations
- Cognitive-Behavioral Therapy and Behavioral Medicine Programs, Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cognitive Behavioral Therapy
Behavioral Medicine with Cognitive Behavioral Therapy
Arm Description
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.
Outcomes
Primary Outcome Measures
The Schwartz Outcome Scale (SOS-10)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01075672
First Posted
February 22, 2010
Last Updated
May 5, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01075672
Brief Title
Outcomes of Cognitive Behavioral Therapy (CBT) Interventions Provided by Unlicensed Professionals
Official Title
Outcomes of Cognitive Behavioral Therapy (CBT) Interventions Provided by Unlicensed Professionals in a General Hospital Setting
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To examine the effectiveness and clinical care outcomes of cognitive-behavioral therapy interventions at Massachusetts General Hospital (MGH).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder, Body Dysmorphic Disorder, Tourette Syndrome, Trichotillomania, Panic Disorder, Social Phobia, Generalized Anxiety Disorder, Depression, Post-Traumatic Stress Disorder, Attention Deficit Hyperactivity Disorder, Eating Disorder, Specific Phobia, General Medical Condition
Keywords
OCD, BDD, Tourette syndrome, trichotillomania, Compulsive Skin Picking, panic disorder, social phobia, generalized anxiety disorder, depression, PTSD, ADHD, eating disorder, Specific Phobia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Title
Behavioral Medicine with Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy (CBT)
Other Intervention Name(s)
CBT
Intervention Description
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).
Primary Outcome Measure Information:
Title
The Schwartz Outcome Scale (SOS-10)
Description
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.
Time Frame
at baseline, and at visits 1 through 24, which will occur approximately 1 week apart.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Wilhelm, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cognitive-Behavioral Therapy and Behavioral Medicine Programs, Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mghocd.org/
Description
Click here to go to the official website of the OCD clinic at Massachusetts General Hospital
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Outcomes of Cognitive Behavioral Therapy (CBT) Interventions Provided by Unlicensed Professionals
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