ClinicalTrials.gg
Active, not recruitingNCT01075672Updated Feb 23, 2026

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

An interventional study of Cognitive behavioral therapy (CBT) in Obsessive Compulsive Disorder, Body Dysmorphic Disorder and Tourette Syndrome, sponsored by Massachusetts General Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-23.

Primary conditionTrichotillomaniaRegistry: Obsessive-Compulsive DisorderReclassifiedWhy we changed it
Registry
Obsessive-Compulsive Disorder — the first condition term the registry derived for this study.
ClinicalTrials.gg
Trichotillomania
Why
  1. The study's listed conditions name Trichotillomania, a narrower term within Obsessive-Compulsive Disorder.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • 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
03

In context

Trichotillomania Reclassified

48 studies on the registry are indexed under Trichotillomania; 8 are open to participants now.

This study's planned enrollment of 250 is above the median of 39 across 45 interventional studies indexed under Trichotillomania.

Browse Trichotillomania studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.

Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Compared within Trichotillomania, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Obsessive-Compulsive Disorder. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 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

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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • Experimental
    Cognitive Behavioral Therapy

    Behavioral: Cognitive behavioral therapy (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)

Interventions

  • BehavioralCognitive 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).

    Also known as: CBT

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: at baseline, and at visits 1 through 24, which will occur approximately 1 week apart.

07

Study locations

1 site
  • Cognitive-Behavioral Therapy and Behavioral Medicine Programs, Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2010, a primary completion of Jan 2027 and a completion of Jan 2027. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 22, 2010
First posted
Feb 25, 2010
Start
Jan 2010
Primary completionEst.
Jan 2027
CompletionEst.
Jan 2027
Last update
Feb 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01075672
Responsible party
Sabine Wilhelm, PhD (PhD, Massachusetts General Hospital) — Principal investigator
First posted
Feb 25, 2010
Start date
Jan 2010
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Feb 23, 2026

Study contacts

Sabine Wilhelm, PhD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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