SchizophreniaACTNCT00657631
Acceptance and Commitment Therapy for Delusions
A study testing Acceptance and Commitment Therapy in people with Schizophrenia and Delusional Disorder, run by Weill Medical College of Cornell University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Delusional Disorder
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College Oupatient Treatment Program of New York Presbyterian Hospital
New York, New York, 10065
About this study
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.
Read the 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.
- Conditions
- Schizophrenia, Delusional Disorder
- Being tested
- Acceptance and Commitment Therapy
- Keywords
- Acceptance and Commitment Therapy, Delusions
- Medical subject headings
- Schizophrenia, Schizophrenia, Paranoid, Delusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
Also called ACT
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).
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Acceptance and Commitment Therapy will be administered to all subjects. Receives: Behavioral: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Investigators
- Yulia Landa, Psy.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657631
- Sponsor's protocol ID
- 0801009613
- Acronym
- ACT
- Status last verified
- Oct 2009
- First submitted
- 8 Apr 2008
- Last updated
- 12 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1037//0022-006x.70.5.1129.
PubMed 12362963Linehan, 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.
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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy for Delusions
- ClinicalTrials.gov ID
- NCT00657631
- Acronym / sponsor ID
- ACT / 0801009613
- Conditions
- Schizophrenia, Delusional Disorder
- Keywords
- Acceptance and Commitment Therapy, Delusions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 14 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Acceptance and Commitment TherapyAcceptance and Commitment Therapy will be administered to all subjects. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients will be considered for inclusion in the study if they meet DSM IV diagnostic criteria for:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapyAlso: ACTConsidered 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). | Behavioural | A |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2009.
- Background: PubMed 12362963Bach 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.
- BackgroundLinehan, M. M. (1993). Cognitive-behavioral treatment of borderline personality disorder. New York: Guilford Press.
- BackgroundSegal, 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.
- BackgroundBeck, A. T. (1976). Cognitive Therapy and the Emotional Disorders. New York: International Universities Press.
- BackgroundHayes, S. C., Strosahl, K. D. & Wilson, K. G. (1999). Acceptance and Commitment Therapy: An experiential approach to behavior change. New York: The Guilford Press.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yulia Landa, Psy.D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Schizophrenia and Delusional Disorder, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00657631, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2009.