Psychological Mindedness as a Predictor of Success in Cognitive Behavior Therapy for Depression
Major Depressive Disorder
Behavioral: Cognitive Behavior Therapy for Depression
|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|
- Level of depression as measured by the Hamilton Depression Rating Scale [ 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).
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
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: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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01868711
|Contact: Ronit Kishon, Ph.D.||646 774 email@example.com|
|Contact: Jonathan W Stewart, MD||646 774 firstname.lastname@example.org|
|United States, New York|
|New York State Psychiatric Institute||Recruiting|
|New York, New York, United States, 10032|
|Contact: Ronit Kishon, PhD 646-774-8030 email@example.com|
|Contact: Jonathan W Stewart, MD 646 774 8070 firstname.lastname@example.org|
|Principal Investigator: Ronit Kishon, PhD|