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Trial record 8 of 5466 for:    "Depressive Disorder" [DISEASE] AND Behavioral

Neurocognitive Predictors of Behavioral Therapy Response in Depression

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ClinicalTrials.gov Identifier: NCT02602340
Recruitment Status : Recruiting
First Posted : November 11, 2015
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Laureate Institute for Brain Research, Inc.

Brief Summary:
This project aims to identify brain and behavioral characteristics of individuals experiencing symptoms of depression that will predict the effectiveness of Behavioral Activation Therapy. Brain imaging aspects of the study will use functional magnetic resonance imaging (fMRI) and electroencephalography (EEG). Behavioral assessments will include self-report questionnaires, computer-based and observational tasks, and interviews. Assessments will focus on how individuals process positive information (such as reward) and negative information (such as distressing images), as well as how people make decisions. These assessments will be conducted across 2-3 in-person sessions prior to beginning the treatment, and will be repeated across 2-3 in-person sessions after completing treatment. A blood draw will also be conducted pre- and post- treatment. Behavior Activation therapy will consist of 10, 90-minute weekly therapy sessions conducted in small groups.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Behavioral Activation therapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Neurocognitive Predictors of Behavioral Therapy Response in Depression
Study Start Date : October 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Behavioral Activation therapy
Participants will complete 10, 90-minute sessions of Behavioral Activation therapy, conducted using a group format. Each group will include 8-12 participants. Behavioral Activation therapy seeks to target behaviors that might maintain or worsen the depression.
Behavioral: Behavioral Activation therapy
Behavioral Activation therapy




Primary Outcome Measures :
  1. Change in depressive symptoms as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale. [ Time Frame: Trajectory of change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment ]
    Test the predictive effects of imaging and behavioral factors on change in symptoms at baseline compared to within 6 weeks after completing treatment.


Secondary Outcome Measures :
  1. Change in depression-related behaviors as assessed by the Behavioral Activation Depression Scale (BADS) Short Form. [ Time Frame: Trajectory of change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment ]
    Test the predictive effects of imaging and behavioral factors on change in symptoms at baseline compared to within 6 weeks after completing treatment.

  2. Change in anxiety symptoms as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale. [ Time Frame: Trajectory of change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment ]
    Test the predictive effects of imaging and behavioral factors on change in symptoms at baseline compared to within 6 weeks after completing treatment.

  3. Change in level of disability as measured by the Sheehan Disability Scale [ Time Frame: Trajectory of change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment ]
    Test the predictive effects of imaging and behavioral factors on change in symptoms at baseline compared to within 6 weeks after completing treatment.

  4. Change in depressive symptoms as measured by the Beck Depression Inventory - II. [ Time Frame: Change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment ]
    Test the predictive effects of imaging and behavioral factors on change in symptoms at baseline compared to within 6 weeks after completing treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: 18-55
  2. All genders
  3. All races
  4. Eligibility as clinically significant depression will be determined by:

    • Scoring greater than 9 on the Patient Health Questionnaire (PHQ-9) or meeting diagnostic criteria for Diagnostic and Statistical Manual (DSM-5) Major Depressive Disorder
    • Self-report that they are interested in obtaining treatment for depression.
    • Through structured diagnostic interviews, it is determined that depressive symptoms are the primary disorder of concern.
  5. Able to provide written, informed consent
  6. Have sufficient proficiency in English language to understand and complete interviews, questionnaires, and all other study procedures

Exclusion Criteria:

  1. Has a history of unstable liver or renal insufficiency; glaucoma; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.
  2. A history of drug abuse in the past 6 months, including alcohol, cocaine, marijuana, opiates, amphetamines, methamphetamines, phencyclidine, benzodiazepines, barbiturates, methadone, and oxycodone. Current alcohol use will be ruled out using a breath test and urine testing will be used to rule out current use of other drugs of abuse.
  3. Has any of the following Diagnostic and Statistical Manual (DSM-5) disorders:

    • Schizophrenia Spectrum and Other Psychotic Disorders
    • Bipolar and Related Disorders
    • Obsessive-Compulsive and Related Disorders
    • Anorexia or Bulimia Nervosa
    • Substance use disorder within 6 months
  4. Moderate to severe traumatic brain injury (>30 min. loss of consciousness or >24 hours posttraumatic amnesia) or other neurocognitive disorder with evidence of neurological deficits, neurological disorders, or severe or unstable medical conditions that might be compromised by participation in the study.
  5. Active suicidal ideation with intent or plan
  6. Current use of a medication that could affect brain functioning (e.g., anxiolytics, antipsychotics, or mood stabilizers). However, participants reporting current use of prescribed antidepressants (selective serotonin reuptake inhibitors) will be included as long as the dose has been stable for 6 weeks prior to enrolling in the study.
  7. Prescription of a medication outside of the accepted range, as determined by the best clinical practices and current research
  8. Taking drugs that affect the fMRI hemodynamic response (e.g., methylphenidate, acetazolamide, excessive caffeine intake > 1000 mg/day).
  9. MRI contraindications including: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit), persons who have ever been a professional metal worker/welder, history of eye surgery/eyes washed out because of metal, vision problems uncorrectable with lenses, inability to lie still on one's back for 60-120 minutes; prior neurosurgery; tattoos or cosmetic makeup with metal dyes, unwillingness to remove body piercings, and pregnancy
  10. Unwillingness or inability to complete any of the major aspects of the study protocol, including magnetic resonance imaging (i.e., due to claustrophobia), blood draws, or behavioral assessment. However, failing to complete some individual aspects of these assessment sessions will be acceptable (i.e., being unwilling to answer individual items on some questionnaires or being unwilling to complete a behavioral task).
  11. Non-correctable vision or hearing problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602340


Contacts
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Contact: Akalvizhy Elanko, B.S. 918-344-8611 raupperle@laureateinstitute.org
Contact: Robin Aupperle, Ph.D. 918-502-5744 raupperle@laureateinstitute.org

Locations
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United States, Oklahoma
Laureate Institute for Brain Research Recruiting
Tulsa, Oklahoma, United States, 74136
Sponsors and Collaborators
Laureate Institute for Brain Research, Inc.
Investigators
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Principal Investigator: Robin L Aupperle, Ph.D. Laureate Institute for Brain Research

Publications:
Addis, M. and C. Martell, Overcoming Depression One Step at a Time: The New Behavioral Activation Approach to Getting Your Life Back. 2004, Oakland, CA: New Harbinger Publications.
Martell, C.R., S. Dimidjian, and R. Herman-Dunn, Behavioral activation for depression: A clinician's guide. 2013: Guilford Press.

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Responsible Party: Laureate Institute for Brain Research, Inc.
ClinicalTrials.gov Identifier: NCT02602340     History of Changes
Other Study ID Numbers: 2015-006-01
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders