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Cognitive Behavior Therapy for Depression (CBT)

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ClinicalTrials.gov Identifier: NCT01868711
Recruitment Status : Recruiting
First Posted : June 4, 2013
Last Update Posted : December 1, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Ronit Kishon, New York State Psychiatric Institute

Brief Summary:
Psychological mindedness(PM) is a metacognitive process in which the person uses his cognitive and affective abilities to understand his thoughts, feelings, and his behaviors as they interact with his internal experiences and his external experiences in the world. It dynamically modifies his behavior to move towards self-actualization in a manner positive to himself and the world. We investigate whether the assessment of PM can distinguish depressed patients who benefit from CBT.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Cognitive Behavior Therapy Not Applicable

Detailed Description:

Cognitive Behavior Therapy (CBT) is one of the most effective psychotherapy for depression. Yet, it is effective only for 40% of the depressed people who receive this treatment. Currently, there is no method of predicting who can be helped among depressed patients by CBT. In this study, we examine whether the level of psychological mindedness can predict who may benefit from CBT among depressed patients.

Participants who are clinically depressed are randomized to 12 sessions of CBT and supportive therapy. The evaluation process and all sessions will be administered virtually using HIPAA-compliant video teleconferencing. Participants must have access to the internet and have video conferencing capabilities. Besides the virtual sessions, participants will need to come in person once for a urine & blood test (protocol #6669) and twice for an electroencephalogram (EEG) (protocol #6559).

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It is important to note that subjects who enroll in the study can't take any psychiatric medications, nor can they attend any other psychotherapy besides what is offered in the study. Should the participant decide to make alternations and use medication, this will not affect their participation in psychotherapy or this study.

Participants who are eligible for the study will begin within two weeks after the evaluation visit. An evaluator will rate the HDRS-17 and CG I-Severity. If they are still eligible, they will sign the study consent form, have the study explained, including its risks and possible benefits, as well as alternatives and its voluntary nature. Once they sign the consent form, patients will complete a battery of self-report instruments online. Also, they will be interviewed by a clinician with a structured clinical interview of PM. They will then be randomized between CBT and supportive therapy (control group) and will schedule their weekly virtual sessions with the study therapist. During 12 weeks, they will be clinically monitored by Beck Depression Inventory at the beginning of every session and HDRS-17 every three weeks. They will complete study measures at week six and after the 12 weeks sessions.

Study participants who do not remit (end treatment HDRS-17 > 7) at the end of the CBT trial will receive a referral for alternative psychotherapy per the patient's preference.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Depressed patients will be randomized between cognitive behavor therapy and supportive therapy.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychological Mindedness as a Predictor of Success in Cognitive Behavior Therapy for Depressed Patients
Actual Study Start Date : July 2009
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: *Cognitive behavior therapy
Depressed patients will receive 12 virtual sessions of cognitive behavior therapy (CBT) for depression. CBT Includes behavior activation, correcting distorted thoughts, and other tools to reduce symptoms.
Behavioral: Cognitive Behavior Therapy
Other Name: Supportive psychotherapy

Supportive psychotherapy
Supportive psychotherapy aims to strengthen the patient's ability to cope effectively with various life stressors. Specifically, in our study, supportive psychotherapy will be geared towards reducing or alleviating symptoms of depression. The sessions will be administered virtually.
Behavioral: Cognitive Behavior Therapy
Other Name: Supportive psychotherapy




Primary Outcome Measures :
  1. Level of depression as measured by the Hamilton Depression Rating Scale [ Time Frame: Up to 12 weeks. ]
    Outcome measure of depression will be assessed as the change in depression between baseline (pre-treatment) and post treatment (up to 12 weeks).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females between the ages of 18 and 65 (inclusive).
  • Primary DSM-IV-TR diagnosis of major depression
  • A negative urine toxicology, i.e., a urine specimen that does not test positive for the use of drugs of abuse or use of benzodiazepines.
  • Ability to give informed consent.
  • Fluent in English

Exclusion Criteria:

  • Patients who have a "lifetime" history of Schizophrenia or other current psychotic disorder, Major Depressive Disorder with Psychotic or Catatonic features, Bipolar I Affective Disorder, or Organic Mental Disease.
  • DSM-V substance abuse or dependence within the past 6 months (except nicotine or caffeine).
  • Active suicidal or homicidal ideation, or judged to be at serious suicide risk.
  • Any unstable medical or neurological condition.
  • Presently receiving psychotherapy or psychotropic medications.
  • Prior History of CBT for Depression treatment failure.
  • Left-handedness

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): NCT01868711


Contacts
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Contact: Ronit Kishon, Ph.D. 646 724 4171 Ronit.Kishon@nyspi.columbia.edu

Locations
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United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Ronit Kishon, PhD    646-724-4171    Ronit.Kishon@nyspi.columbia.edu   
Principal Investigator: Ronit Kishon, PhD         
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Ronit Kishon, Ph.D. New York State Psychiatric Institute, Columbia University
  Study Documents (Full-Text)

Documents provided by Ronit Kishon, New York State Psychiatric Institute:
Additional Information:
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Responsible Party: Ronit Kishon, Assistant Professor of Psychology, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01868711    
Other Study ID Numbers: 6806R
R21MH121915-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ronit Kishon, New York State Psychiatric Institute:
Cognitive Behavior Therapy
Self-awarness
Supportive Therapy
Virtual psychotherapy
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders