Clinical trial NCT01075672: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2010-02-25
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Schwartz Outcome Scale (SOS-10)
timeFrame: at baseline, and at visits 1 through 24, which will occur approximately 1 week apart.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Cognitive-Behavioral Therapy and Behavioral Medicine Programs, Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Sabine Wilhelm, PhD
role: PRINCIPAL_INVESTIGATOR
References: