NCT03175068

Brief Summary

Many patients with Major Depressive Disorder (MDD) and generalized Social Anxiety Disorder (gSAD) are treated with cognitive behavioral therapy (CBT) but few have meaningful improvement. MDD and gSAD are diseases of brain dysfunction that manifest as impaired emotion regulation; CBT teaches emotion regulation strategies but how it works in the brain remains largely unknown. Individual differences in brain function related to emotion regulation may make some patients better suited for CBT and CBT may remedy the brain dysfunction that underlies these disorders. This project will compare CBT with a placebo psychotherapy (i.e., supportive therapy) in MDD and gSAD to test, validate, and refine brain-based markers and examine mechanisms of change to examine how CBT works and for whom.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
203

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 31, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 5, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

March 2, 2022

Status Verified

March 1, 2022

Enrollment Period

5 years

First QC Date

May 31, 2017

Last Update Submit

March 1, 2022

Conditions

Major Depressive DisorderSocial Anxiety Disorder

Keywords

Functional magnetic resonance imagingElectroencephalographyCognitive Behavioral TherapySupportive Therapy

Outcome Measures

Primary Outcomes (1)

  • BOLD Effects Measured with Functional Magnetic Resonance Imaging (fMRI)

    Patients were randomized to either 12 weeks of cognitive behavioral therapy or supportive therapy. Healthy control (HC) participants did not receive treatment but completed the same assessments at the same time points as patients. Mean BOLD effects in emotion processing and cognitive control tasks at baseline, at mid-point of treatment (for patients)/time interval (for HC), and at end of treatment (for patients)/time interval (for HC). Target areas are analyzed from fMRI scans. The scans were completed on Weeks 0, 6, and 12. Average BOLD effects were calculated for each group.

    Weeks 0, 6, and 12

Study Arms (2)

CBT

ACTIVE COMPARATOR

The clinical psychologist will use a manualized CBT approach tailored to MDD or gSAD. Over a 12-week period sessions will include core CBT strategies -- psychoeducation, cognitive intervention (e.g., cognitive restructuring), behavioral changes (i.e., fear exposure, behavioral activation strategies) and relapse prevention.

Behavioral: CBT

ST

PLACEBO COMPARATOR

The clinical psychologist will use an ST approach that resembles client-centered therapy of Carl Rogers (1951) which has been used as a control psychotherapy. The manual is based on supportive psychotherapy principles. Over a 12-week period sessions will emphasize reflective listening and elicitation of affect. In contrast to CBT, therapists allow patients to determine the focus of each session, pulling for emotion, validating emotions when possible, and offering empathetic comments. Therapists will refrain from delineating any CBT theoretical framework and avoided cognitive and behavioral techniques that might overlap with CBT.

Behavioral: ST

Interventions

CBTBEHAVIORAL

CBT works by changing people's attitudes and their behavior by focusing on the thoughts, images, beliefs and attitudes that are held (a person's cognitive processes) and how these processes relate to the way a person behaves, as a way of dealing with emotional problems.

Also known as: Cognitive Behavioral Therapy
CBT
STBEHAVIORAL

Treatment designed to improve, reinforce, or sustain a patient's physiological well-being or psychological self-esteem and self-reliance

Also known as: Supportive Therapy
ST

Eligibility Criteria

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

You may qualify if:

  • generally medically and neurologically healthy, including no evidence of mental retardation or serious cognitive impairment that would interfere with protocol adherence and/or task performance
  • between the ages of 18 - 65 years old, inclusive
  • right-handed
  • primary diagnosis of MDD or gSAD based on the SCID DSM-5. Patients will be permitted to have limited comorbid and/or history of internalizing psychopathologies (e.g., generalized anxiety disorder, specific phobia, adjustment disorder)

You may not qualify if:

  • personal current or past manic/hypomanic episode or psychotic symptoms
  • active suicidal ideation as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)
  • prior history of standard CBT (failure or success)
  • any current or recent (past 4 weeks) use of medication (prescription or non-prescription) with psychotropic effects
  • psychotherapy other than CBT or psychotropic medication use during the study
  • cognitive dysfunction (traumatic brain injury, mental retardation, dementia)
  • active moderate or severe alcohol and/or substance use disorders
  • For healthy controls: history or current Axis I disorder.
  • presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles)
  • inability to tolerate small, enclosed spaces without anxiety (e.g., claustrophobia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60608, United States

Location

Related Publications (1)

  • Feurer C, Jimmy J, Bhaumik R, Duffecy J, Medrano GR, Ajilore O, Shankman SA, Langenecker SA, Craske MG, Phan KL, Klumpp H. Anterior cingulate cortex activation during attentional control as a transdiagnostic marker of psychotherapy response: a randomized clinical trial. Neuropsychopharmacology. 2022 Jun;47(7):1350-1357. doi: 10.1038/s41386-021-01211-2. Epub 2021 Oct 30.

    PMID: 34718341DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorPhobia, Social

Interventions

Cognitive Behavioral TherapyPalliative Care

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersPhobic DisordersAnxiety Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Heide Klumpp, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 31, 2017

First Posted

June 5, 2017

Study Start

July 5, 2017

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

March 2, 2022

Record last verified: 2022-03

Locations

US(1)