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

• ClinicalTrials.gov Identifier: NCT01075672
• Recruitment Status: Unknown
• First Posted: February 25, 2010
• Last Update Posted: May 7, 2018
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Sabine Wilhelm, Massachusetts General Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
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)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 250 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Outcomes of Cognitive Behavioral Therapy (CBT) Interventions Provided by Unlicensed Professionals in a General Hospital Setting
• Study Start Date: January 2010
• Estimated Primary Completion Date: January 2020
• Estimated Study Completion Date: January 2020

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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 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.

Contacts and Locations

Locations

United States, Massachusetts

Cognitive-Behavioral Therapy and Behavioral Medicine Programs, Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

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

More Information

Additional Information:

Click here to go to the official website of the OCD clinic at Massachusetts General Hospital 

• Responsible Party: Sabine Wilhelm, PhD, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01075672
• Other Study ID Numbers: 2009P002479
• First Posted: February 25, 2010
• Last Update Posted: May 7, 2018
• Last Verified: May 2018

Keywords provided by Sabine Wilhelm, Massachusetts General Hospital:

OCD; BDD; Tourette syndrome; trichotillomania; Compulsive Skin Picking; panic disorder; social phobia; generalized anxiety disorder; depression; PTSD; ADHD; eating disorder; Specific Phobia

Additional relevant MeSH terms:

Tourette Syndrome; Disease; Depression; Stress Disorders, Traumatic; Attention Deficit Disorder with Hyperactivity; Anxiety Disorders; Stress Disorders, Post-Traumatic; Feeding and Eating Disorders; Obsessive-Compulsive Disorder; Phobic Disorders; Panic Disorder; Phobia, Social; Trichotillomania; Body Dysmorphic Disorders; Pathologic Processes; Behavioral Symptoms; Mental Disorders; Trauma and Stressor Related Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Disruptive, Impulse Control, and Conduct Disorders