Psychological Mindedness as a Predictor of Success in Cognitive Behavior Therapy for Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by New York State Psychiatric Institute
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01868711
First received: May 20, 2013
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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 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. Moreover, there may be a relationship between PM and measures of brain function that also correlate with success in CBT. Therefore, we measure PM, neurophysiological measures (EEG and ERP's), and cognitive tests before and after CBT treatment of 70 adults with depression.


Condition Intervention
Major Depressive Disorder
Dysthymia
Behavioral: Cognitive Behavior Therapy for Depression

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Psychological Mindedness as a Predictor of Success in CBT for Depressed Patients

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Level of depression as measured by the Hamilton Rating Scale for Depression [ Time Frame: The change from baseline level of depression at post treatment level of depression, afer 14 sessions of CBT ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 70
Study Start Date: July 2008
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Behavior Therapy for Depression
Depressed patients, age 18 to 70, will receive 14 individual manualized sessions of cognitive behavior therapy for depression, for a period of 14 weeks.
Behavioral: Cognitive Behavior Therapy for Depression
Other Names:
  • CBT
  • Short term therapy
  • Time limited therapy
  • Manualized therapy
  • Evidence based therapy
Behavioral: Cognitive Behavior Therapy for Depression

The CBT protocol represents incorporation and integration from several sources. These include (a) prior experience with the treatment of depression and (b) previously published cognitive therapy (CT) manuals published by Beck (1995). The present protocol encourages therapist flexibility in approach, yet during the treatment specific tools and methods of coping with depression are given to each patient. 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.

Other Name: CBT for Depression

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 and other neurophysiological and cognitive variables 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 HRSD-17 and CGI-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. Patients will be tested on EEG, ERP and cognitive tests the same day or another day based on their convenience. 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 HRSD-17 every four weeks. They will complete study measures at week 8 and after the the 14 weeks sessions. They will be tested on EEG, ERP and cognitive tests after the 14 weeks of therapy.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females between the ages of 18 and 70 (inclusive).
  • Primary DSM-IV-TR diagnosis of major depression, dysthymia or depressive disorder not otherwise specified (NOS).
  • 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-IV 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.
  • Hearing loss greater than 30 dB hearing level or greater than 10 dB difference in hearing level between ears.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01868711

Contacts
Contact: Ronit Kishon, Ph.D. 212 543 5312 rk159@columbia.edu
Contact: Jonathan W Stewart, MD 212 543 5745 jws6@columbia.edu

Locations
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Ronit Kishon, PhD    212-543-5312    rk159@columbia.edu   
Contact: Jonathan W Stewart, MD    212 543 5745    jws6@columbia.edu   
Principal Investigator: Ronit Kishon, PhD         
Sponsors and Collaborators
New York State Psychiatric Institute
  More Information

Additional Information:
No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01868711     History of Changes
Other Study ID Numbers: 5768
Study First Received: May 20, 2013
Last Updated: May 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
Major Depressive Disorder
Dysthymia
Cognitive Behavior Therapy
Psychological Mindedness

Additional relevant MeSH terms:
Depressive Disorder
Depression
Dysthymic Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 20, 2014