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| Sponsored by: |
Weill Medical College of Cornell University |
| Information provided by: | Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT00657631 |
Purpose
Symptoms of schizophrenia have historically been treatment resistant despite advances in psychopharmacology. Acceptance and Commitment Therapy (ACT) has been shown through some preliminary research to be effective with psychotic symptoms (1,14) ACT is considered part of the "third wave of CBT" along with Dialectical Behavior Therapy (DBT; 21) and Mindfulness-based Cognitive Therapy (MBCT; 23). The target of change in ACT is acceptance of symptoms as experiences that a person can have without experiencing distress, and while living a life in accordance with one's values.
The current study will assess the effectiveness of ACT (8 sessions) for delusions. Participants will continue to receive treatment as usual throughout the study. The intervention will follow the protocol of ACT described in Hayes, Strosahl and Wilson (16) in which treatment will consist of building acceptance, willingness, and commitment to change, clarifying values, defusion of thoughts and feelings, as well as defusion of self. These therapeutic aims will be achieved by the practice of various exercises in and out of session as well as the discussion of various metaphors within session. It is hypothesized that participants will exhibit decreased distress due to delusions, decreased delusional conviction and a reduction of overall anxiety levels from participants' baselines.
| Condition | Intervention |
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Schizophrenia Delusional Disorder |
Behavioral: Acceptance and Commitment Therapy |
| MedlinePlus related topics: | Schizophrenia |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Acceptance and Commitment Therapy for Delusions |
| Estimated Enrollment: | 12 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | October 2008 |
| Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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A: Experimental
Acceptance and Commitment Therapy will be administered to all subjects.
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Behavioral: Acceptance and Commitment Therapy
Considered part of the "third wave of CBT" along with Dialectical Behavior Therapy (DBT; 21) and Mindfulness-based Cognitive Therapy (MBCT; 23), ACT is built upon the strong, research-based foundation of CBT. However, while CBT for psychosis focuses on reducing symptoms, ACT focuses on changing the way in which the person experiences his or her symptoms so that the person can still live his or her life in accordance with his or her life values. Specifically, CBT attempts to reduce delusions by disputing the evidence for the delusion and ACT attempts to increase the person's ability to live his or her life while still experiencing delusions (1).
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Twelve patients will be recruited from New York Presbyterian Hospital, Weill Medical College, Payne Whitney Clinic (Manhattan Campus), outpatient psychiatric program. Patients will be randomly assigned to a length of baseline before beginning the 8-week ACT treatment. There will be a five-week baseline period for all patients after which two patients will be introduced to ACT treatment in weekly increments so that the final two patients to enter treatment will have 10 weeks of baseline. All patients will receive treatment as usual throughout baseline and ACT treatment. During baseline, patients will be assessed by independent raters every week and during ACT treatment, patients will be assessed every other week and at a one-month follow-up. Each participant's assessment results will be compared over time, so that there will be an established baseline level of functioning which will be compared to his or her level of functioning during treatment, at the end of treatment, and finally at the one-month follow-up.If a subject decompensates during the course of the treatment and needs temporary hospitalization, he or she will be able to return to the research study upon discharge from the hospital, if he or she continues to meet inclusion and exclusion criteria, and has a capacity to consent. The capacity to consent will be reassessed by the PI asking the patient the major points of the study and the patient's psychiatrist also re-evaluating competency to consent. Also, if PI or subject's treating psychiatrist notices significant changes in patient's mental status, they can suggest and reassess patient's competency. The same assessment procedures will be used (see above).Hypotheses: This study will illustrate how patients' distress, anxiety and tension due to delusional thinking decreases over time when comparing baseline to treatment, treatment to outcome, and then outcome to follow-up. Additionally, the number of delusional thoughts and the rate of re-hospitalization will decrease over time.
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients will be considered for inclusion in the study if they meet DSM IV diagnostic criteria for:
Exclusion Criteria:
Contacts and Locations| Contact: Yulia Landa, Psy.D. | 212-821-0711 | yul9003@med.cornell.edu |
| Contact: Michelle Sheets, M.A. | 646-621-5423 | thomasine78@yahoo.com |
| United States, New York | |||||
| Weill Cornell Medical College Oupatient Treatment Program of New York Presbyterian Hospital | Not yet recruiting | ||||
| New York, New York, United States, 10065 | |||||
| Principal Investigator: Yulia Landa, Psy.D. | |||||
| Sub-Investigator: Michelle Sheets, MA | |||||
| Weill Medical College of Cornell University |
| Principal Investigator: | Yulia Landa, Psy.D. | Weill Cornell Medical College |
More Information
| Responsible Party: | Weill Cornell Medical College ( Yulia Landa, Psy.D. Assistant Professor of Clinical Psychology ) |
| Study ID Numbers: | 0801009613 |
| First Received: | April 8, 2008 |
| Last Updated: | April 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00657631 |
| Health Authority: | United States: Institutional Review Board |
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