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Acceptance and Commitment Therapy for Delusions (ACT)

Primary Purpose

Schizophrenia, Delusional Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Acceptance and Commitment Therapy, Delusions

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Weill Cornell Medical College Oupatient Treatment Program of New York Presbyterian Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Acceptance and Commitment Therapy will be administered to all subjects.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 8, 2008
Last Updated
October 9, 2009
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT00657631
Brief Title
Acceptance and Commitment Therapy for Delusions
Acronym
ACT
Official Title
Acceptance and Commitment Therapy for Delusions
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Delusional Disorder
Keywords
Acceptance and Commitment Therapy, Delusions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Acceptance and Commitment Therapy will be administered to all subjects.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy
Other Intervention Name(s)
ACT
Intervention Description
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).
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yulia Landa, Psy.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College Oupatient Treatment Program of New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12362963
Citation
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. doi: 10.1037//0022-006x.70.5.1129.
Results Reference
background
Citation
Linehan, M. M. (1993). Cognitive-behavioral treatment of borderline personality disorder. New York: Guilford Press.
Results Reference
background
Citation
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.
Results Reference
background
Citation
Beck, A. T. (1976). Cognitive Therapy and the Emotional Disorders. New York: International Universities Press.
Results Reference
background
Citation
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.
Results Reference
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Acceptance and Commitment Therapy for Delusions

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