NCT01075672

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jan 2010Jan 2027

Study Start

First participant enrolled

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2010

Completed
16.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

17 years

First QC Date

February 22, 2010

Last Update Submit

February 19, 2026

Conditions

Tourette SyndromeDepressionPost-Traumatic Stress DisorderAttention Deficit Hyperactivity DisorderEating DisorderSpecific PhobiaGeneral Medical ConditionObsessive Compulsive DisorderBody Dysmorphic DisorderTrichotillomaniaPanic DisorderSocial PhobiaGeneralized Anxiety Disorder

Keywords

OCDBDDTourette syndrometrichotillomaniaCompulsive Skin Pickingpanic disordersocial phobiageneralized anxiety disorderdepressionPTSDADHDeating disorderSpecific Phobia

Outcome Measures

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.

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

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL
Behavioral: Cognitive behavioral therapy (CBT)

Behavioral Medicine with Cognitive Behavioral Therapy

EXPERIMENTAL

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

Cognitive behavioral therapy (CBT)BEHAVIORAL

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
Behavioral Medicine with Cognitive Behavioral TherapyCognitive Behavioral Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Boston, Massachusetts, 02114, United States

Location

Related Links

MeSH Terms

Conditions

Obsessive-Compulsive DisorderBody Dysmorphic DisordersTourette SyndromeTrichotillomaniaPanic DisorderPhobia, SocialGeneralized Anxiety DisorderDepressionStress Disorders, Post-TraumaticAttention Deficit Disorder with HyperactivityFeeding and Eating DisordersPhobia, SpecificExcoriation Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersSomatoform DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersDisruptive, Impulse Control, and Conduct DisordersPhobic DisordersBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersAttention Deficit and Disruptive Behavior DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsSelf-Injurious Behavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sabine Wilhelm, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 22, 2010

First Posted

February 25, 2010

Study Start

January 1, 2010

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

February 23, 2026

Record last verified: 2026-02

Locations

US(1)