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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Sabine Wilhelm, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01075672
First received: February 22, 2010
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention
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
Behavioral: Cognitive behavioral therapy (CBT)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Outcomes of Cognitive Behavioral Therapy (CBT) Interventions Provided by Unlicensed Professionals in a General Hospital Setting

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • The Schwartz Outcome Scale (SOS-10) [ Time Frame: at baseline, and at visits 1 through 24, which will occur approximately 1 week apart. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 250
Study Start Date: January 2010
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: CBT

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 or psychiatrist (who provides medication on an ongoing basis with no plan to terminate the medication treatment over the upcoming year) 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075672

Contacts
Contact: Liza Rosenfield, B.A. 617-643-4387 erosenfield@partners.org

Locations
United States, Massachusetts
Cognitive-Behavioral Therapy and Behavioral Medicine Programs, Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Katherine Crowe, BA    617-643-4387    kcrowe2@partners.org   
Principal Investigator: Sabine Wilhelm, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Sabine Wilhelm, PhD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Sabine Wilhelm, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01075672     History of Changes
Other Study ID Numbers: 2009P002479
Study First Received: February 22, 2010
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
trichotillomania
OCD
BDD
Tourette syndrome
Compulsive Skin Picking
panic disorder
social phobia
generalized anxiety disorder
depression
PTSD
ADHD
eating disorder
Specific Phobia

Additional relevant MeSH terms:
Trichotillomania
Anxiety Disorders
Body Dysmorphic Disorders
Depression
Depressive Disorder
Eating Disorders
Obsessive-Compulsive Disorder
Panic Disorder
Phobic Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Tourette Syndrome
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Compulsive Personality Disorder
Mental Disorders
Somatoform Disorders
Behavioral Symptoms
Mood Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Mental Disorders Diagnosed in Childhood
Impulse Control Disorders

ClinicalTrials.gov processed this record on August 18, 2014