Cognitive Behavior Therapy for Depression Depression

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.

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.