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Cognitive Behavior Therapy for Depression Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01868711
Recruitment Status : Recruiting
First Posted : June 4, 2013
Last Update Posted : September 20, 2018
Information provided by (Responsible Party):
Ronit Kishon, New York State Psychiatric Institute

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Cognitive Behavior Therapy Not Applicable

Detailed Description:

Cognitive Behavior Therapy (CBT) was found to be the most effective psychotherapy for depression. Yet, it is effective only for 40% of the depressed people who receive this treatment. Until this day there is no method of predicting whom can be helped among depressed patients by CBT. In this study we examine whether level of psychological mindedness can predict who may benefit from CBT among depressed patients. Subjects who are found to be clinically depressed are given 14 sessions of CBT.

The screening procedure for this study includes a 20-30 minute telephone or in-person interview. Clinical staff members trained in diagnostic interviewing will conduct an initial phone interview to determine likely diagnostic suitability. If the subject is deemed preliminarily eligible for participation, meaning he or she is clinically depressed, they will then be invited for an in-person psychiatric evaluation conducted at the Depression Evaluation Services at New York State Psychiatric Institute.

Upon arrival the subject will read the Depression Evaluation Services consent form for evaluation.Questions will be answered and the consent will be offered to read and sign,if agreeable. The evaluation will include a clinical interview, a structured clinical interview (the SCID-IV), collection of blood samples for routine medical tests, including thyroid function tests, and a urine sample [for urine analysis and toxicology screen].

Important to note: subjects who enroll in the study need to not take any psychiatric medications or they must be on the same medications for 3 months and the same dose for 4 weeks. During the psychotherapy, the patients will continue to see their own physician for medications. Medication management will NOT be within the province of this protocol. During the study there will be an ongoing consultation with the outside physician, particularly with regard to changes in medication and/or dosage. Should the MD or patient decide to make alternations in use of medication, this will not affect the patient's participation in psychotherapy or in this study.

Subjects who were found to be eligible for the study will return 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 be asked to 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 instrument. Also they will be interviewed by a clinician with a structured clinical interview of PM. After that they will schedule their weekly CBT sessions with the study therapist. During 14 weeks they will be clinically monitored by Beck Depression Inventory at the beginning of every session and HDRS-17 every four weeks. They will complete study measures at week 8 and after the the 14 weeks sessions.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychological Mindedness as a Predictor of Success in Cognitive Behavior Therapy for Depressed Patients
Study Start Date : July 2009
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: *Cognitive behavior therapy *Therapy
Depressed patient will receive 14 sessions of cognitive behavior therapy (CBT) for depression. Includes behavior activation, correcting distorted thoughts, and other tools to reduce symptoms
Behavioral: Cognitive Behavior Therapy

Fourteen sessions of cognitive behavior therapy for depression. The patient will be psycho educated about symptoms of depression. The patient will learn to use the following basic cognitive-behavioral techniques for the treatment of depression:

Constructing an 'Action Schedule', setting goals, doing 'Behavioral Experiments', and constructing a thought record, checking accuracy of thoughts, re framing thoughts when necessary and learn to engage in problem solving for particular situations.

Primary Outcome Measures :
  1. Level of depression as measured by the Hamilton Depression Rating Scale [ Time Frame: The change from baseline level of depression at post treatment level of depression, after 14 sessions of CBT ]
    Outcome measure of depression will be assessed as the change in depression between baseline (pre-treatment) and post treatment (after 14 sessions of CBT for depression).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males or females between the ages of 18 and 70 (inclusive).
  • Primary DSM-IV-TR diagnosis of major depression
  • A negative urine toxicology, i.e., a urine specimen that does not test positive for 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.
  • Prior History of CBT for Depression treatment failure.

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 identifier (NCT number): NCT01868711

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Contact: Ronit Kishon, Ph.D. 646 774 8030
Contact: Jonathan W Stewart, MD 646 774 8060

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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    646-774-8030   
Contact: Jonathan W Stewart, MD    646 774 8070   
Principal Investigator: Ronit Kishon, PhD         
Sponsors and Collaborators
New York State Psychiatric Institute
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Principal Investigator: Ronit Kishon, Ph.D. New York State Psychiatric Institute, Columbia University

Additional Information:
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Responsible Party: Ronit Kishon, Assistant Professor of Psychology, New York State Psychiatric Institute Identifier: NCT01868711     History of Changes
Other Study ID Numbers: 6806R
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ronit Kishon, New York State Psychiatric Institute:
Major Depressive Disorder
Cognitive Behavior Therapy
Psychological Mindedness
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms