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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 8, 2008 | ||||
| Last Updated Date | October 9, 2009 | ||||
| Start Date ICMJE | April 2008 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
This study will illustrate how patients' distress due to delusional thinking decreases over time when comparing baseline to treatment, treatment to outcome, and then outcome to follow-up. [ Time Frame: 4-6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00657631 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Acceptance and Commitment Therapy for Delusions | ||||
| Official Title ICMJE | Acceptance and Commitment Therapy for Delusions | ||||
| Brief Summary | 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 (Bach & Hayes, 2002). ACT is considered part of the "third wave of CBT" along with Dialectical Behavior Therapy (DBT; Linehan, 1993) and Mindfulness-based Cognitive Therapy (MBCT; Segal, Williams, & Teasdale, 2001). 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 assessed the effectiveness of ACT (8 sessions) for delusions. Participants received treatment as usual throughout the study. The intervention followed the protocol of ACT described in Hayes, Strosahl and Wilson (1999) 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 attempted to be achieved by the practice of various exercises in and out of session as well as the discussion of various metaphors within session. It was hypothesized that participants will exhibit decreased distress due to delusions, decreased delusional conviction and a reduction of overall anxiety levels from participants' baselines. |
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| Detailed Description | Four patients were recruited from New York Presbyterian Hospital, Weill Medical College, Payne Whitney Clinic (Manhattan Campus), outpatient psychiatric program. Patients were randomly assigned to a length of baseline before beginning the 8-week ACT treatment. There was be a five-week baseline period for all patients after which two patients will be introduced to ACT treatment in weekly increments. All patients received treatment as usual throughout baseline and ACT treatment. During baseline, patients were assessed by an independent rater every week and during ACT treatment, patients were assessed every other week and at a one-month follow-up. Each participant's assessment results were 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. Hypotheses: It was hypothesized that patients' distress, anxiety and tension due to delusional thinking would decrease 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 was hypothesized to decrease over time. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Acceptance and Commitment Therapy | ||||
| Study Arms / Comparison Groups | Experimental: Acceptance and Commitment Therapy will be administered to all subjects. | ||||
| Publications * | Bach P, Hayes SC. The use of acceptance and commitment therapy to prevent the rehospitalization of psychotic patients: a randomized controlled trial. J Consult Clin Psychol. 2002 Oct;70(5):1129-39. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 4 | ||||
| Completion Date | June 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00657631 | ||||
| Responsible Party | Yulia Landa, Psy.D. Assistant Professor of Clinical Psychology, Weill Cornell Medical College | ||||
| Study ID Numbers ICMJE | 0801009613 | ||||
| Study Sponsor ICMJE | Weill Medical College of Cornell University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Weill Medical College of Cornell University | ||||
| Verification Date | October 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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