Clinical trial NCT01868711: Cognitive Behavior Therapy for Depression
Official title: Psychological Mindedness as a Predictor of Success in Cognitive Behavior Therapy for Depressed Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Cognitive Behavior Therapy
Self-awarness
Supportive Therapy
Virtual psychotherapy
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-06-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Depressed patients will be randomized between cognitive behavor therapy and supportive therapy.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Level of depression as measured by the Hamilton Depression Rating Scale
timeFrame: Up to 12 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute, Columbia University
name: Ronit Kishon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: