Cognitive Behavior Therapy for Depression (CBT)
Psychological Mindedness as a Predictor of Success in Cognitive Behavior Therapy for Depressed Patients
Study Overview
Status
Conditions
Intervention / Treatment
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). Dr. Jürgen Kayser who is heading the EEG lab is a co-PI on this grant.
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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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- New York State Psychiatric Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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Other Names:
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Other: 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.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Level of depression as measured by the Hamilton Depression Rating Scale
Time Frame: Up to 12 weeks.
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Outcome measure of depression will be assessed as the change in depression between baseline (pre-treatment) and post treatment (up to 12 weeks).
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Up to 12 weeks.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ronit Kishon, Ph.D., New York State Psychiatric Institute, Columbia University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6806R
- R21MH121915-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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