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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00657631
Other study ID # 0801009613
Secondary ID
Status Completed
Phase N/A
First received April 8, 2008
Last updated October 9, 2009
Start date April 2008
Est. completion date June 2009

Study information

Verified date October 2009
Source Weill Medical College of Cornell University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Patients will be considered for inclusion in the study if they meet DSM IV diagnostic criteria for:

- Schizophrenia

- Schizoaffective disorder

- Schizophreniform Disorder

- Delusional Disorder

- Brief Psychotic Disorder

- Psychotic Disorder NOS with current delusions (assessed via chart review)

Exclusion Criteria:

- Exclusion criteria include a current diagnosis of Mental Retardation

- Organic psychosis

- An inability to participant due to an acute medical condition

- Substance abuse within the past month, a high level of disorganization

- An inability to speak English

- Lack the ability to give informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Acceptance and Commitment Therapy
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), 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 (Hayes, Strosahl & Wilson, 1999).

Locations

Country Name City State
United States Weill Cornell Medical College Oupatient Treatment Program of New York Presbyterian Hospital New York New York

Sponsors (1)

Lead Sponsor Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

Beck, A. T. (1976). Cognitive Therapy and the Emotional Disorders. New York: International Universities Press.

Hayes, S. C., Strosahl, K. D. & Wilson, K. G. (1999). Acceptance and Commitment Therapy: An experiential approach to behavior change. New York: The Guilford Press.

Linehan, M. M. (1993). Cognitive-behavioral treatment of borderline personality disorder. New York: Guilford Press.

Segal, Z. V., Williams, J. M. G., & Teasdale, J. T. (2001). Mindfulness-based cognitive therapy for depression: A new approach to preventing relapse. New York: Guilford Press.

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4-6 months No
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