Cognitive Behavior Therapy for Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

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.
    

Intervention name(s): Cognitive Behavior Therapy
Intervention type(s): Behavioral
Other intervention name(s): Supportive psychotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Depressed patients will be randomized between cognitive behavor therapy and supportive therapy.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive Behavior Therapy; Self-awarness; Supportive Therapy; Virtual psychotherapy