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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01075672
• Other study ID #: 2009P002479
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2010
• Est. completion date: January 2025

Study information

• Verified date: May 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Body Dysmorphic Disorder
• Body Dysmorphic Disorders
• Depression
• Disease
• Eating Disorder
• Feeding and Eating Disorders
• General Medical Condition
• Generalized Anxiety Disorder
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder
• Panic Disorder
• Phobia, Social
• Phobic Disorders
• Post-Traumatic Stress Disorder
• Social Phobia
• Specific Phobia
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Tourette Syndrome
• Trichotillomania

Intervention

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).

Locations

Country	Name	City	State
United States	Cognitive-Behavioral Therapy and Behavioral Medicine Programs, Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at baseline, and at visits 1 through 24, which will occur approximately 1 week apart.

External Links

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