Psychotic DisordersNCT00307216
Graduated Recovery Intervention Program for Enhancing Treatment for First-Episode Psychosis
A study testing Graduated Recovery Intervention Program (GRIP) and Treatment as usual (TAU) in people with Psychotic Disorders and Schizophrenia, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This study will determine the effectiveness of the Graduated Recovery Intervention Program, a manual-based individual therapy program, in enhancing the clinical benefit of routine treatment for individuals recovering from their first episodes of psychosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychotic Disorders, Schizophrenia
- What is being tested?
- Graduated Recovery Intervention Program (GRIP) and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Dec 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets DSM-IV criteria for schizophrenia, schizophreniform disorder, or schizoaffective disorder
- Has been in treatment for psychosis for less than 3 years
- Clinically stable (based on clinician judgement)
- IQ score greater than 70
- Currently receiving keyworker services at UNC Hospital's OASIS program
Who cannot join
- Organic brain disorder
- Substance-induced psychotic disorder
- Mental retardation
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Hospitals OASIS Program for Early Psychosis
Chapel Hill, North Carolina, 27514
About this study
Official title: Randomized Controlled Trial of the Graduated Recovery Intervention Program for First-Episode Psychosis
This study will determine the effectiveness of the Graduated Recovery Intervention Program, a manual-based individual therapy program, in enhancing the clinical benefit of routine treatment for individuals recovering from their first episodes of psychosis.
Read the detailed description
Several mental disorders can be classified as psychotic disorders, such as schizophrenia and manic depression. Psychosis is a defining feature of psychotic disorders, and is characterized by delusions and hallucinations that result in extreme impairment of a person's ability to think clearly. First-episode psychosis refers to the first time someone experiences psychotic symptoms or a psychotic episode. The symptoms can be disturbing and unfamiliar to those who have not previously experienced them. The person experiencing first-episode psychosis may not understand what is happening, and may become confused and distressed. Psychosis is treatable, however, and most people recover. Standard treatment for psychosis entails a combination of behavioral therapy and drug therapy. GRIP is a comprehensive psychosocial intervention for people recovering from an initial episode of non-affective psychosis. The purpose of GRIP is to improve occupational functioning after first-episode psychosis and promote goal pursuit and effective illness self-management. This study will determine the effectiveness of GRIP in enhancing the clinical benefit of routine treatment for individuals recovering from their first episodes of psychosis.
Participants in this study will be randomly assigned to receive either treatment as usual (TAU) or TAU plus GRIP. Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis. Participants assigned to receive TAU plus GRIP will attend therapy sessions weekly for up to 36 weeks, in addition to routine appointments. GRIP includes four phases, each of which focuses on one of the following topics: engagement and wellness management; substance use; persistent symptoms; and functional recovery. Assessments of social functioning, psychotic symptoms, attitudes toward treatment, substance use, and hospital readmission rate will be assessed at baseline, mid-treatment, post-treatment, and at the follow-up visit 3 months post-treatment.
- Conditions
- Psychotic Disorders, Schizophrenia
- Being tested
- Graduated Recovery Intervention Program (GRIP), Treatment as usual (TAU)
- Keywords
- First Episode Psychosis, Early Psychosis, Psychosocial Intervention
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graduated Recovery Intervention Program (GRIP)Behavioural
GRIP is a manual-based comprehensive psychosocial intervention for people recovering from an initial episode of nonaffective psychosis. The purpose of GRIP is to improve occupational functioning after first-episode psychosis and promote goal pursuit and effective illness self-management. Participants assigned to receive TAU plus GRIP will attend therapy sessions weekly for up to 36 weeks, in addition to routine appointments. GRIP includes four phases, each of which focuses on one of the following topics: engagement and wellness management, substance use, persistent symptoms, and functional recovery.
Treatment as usual (TAU)Behavioural
Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive Graduated Recovery Intervention Program plus treatment as usual Receives: Behavioral: Graduated Recovery Intervention Program (GRIP); Behavioral: Treatment as usual (TAU) |
| 2 | Active comparator | Participants will receive treatment as usual Receives: Behavioral: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Role Functioning Scale
Measured: Measured at baseline, post-test, and Month 3 follow-up
Heinrichs-Carpenter Quality of Life Scale (QLS)
Measured: Measured at baseline, post-test, and Month 3 follow-up
Multidimensional Scale of Perceived Social Support (MSPSS)
Measured: Measured at baseline, post-test, and Month 3 follow-up
Global Functioning Scale
Measured: Measured at baseline, post-test, and Month 3 follow-up
Secondary outcomes (12)
Brief Evaluation of Medication Influences and Beliefs
Measured: Measured at baseline, post-test, and Month 3 follow-up
Positive and Negative Syndrome Scale (PANSS)
Measured: Measured at baseline, post-test, and Month 3 follow-up
Calgary Depression Scale for Schizophrenia (CDSS)
Measured: Measured at baseline, post-test, and Month 3 follow-up
Brief Trauma Questionnaire (BTQ)
Measured: Measured at baseline, post-test, and Month 3 follow-up
PTSD Checklist (PCL)
Measured: Measured at baseline, post-test, and Month 3 follow-up
Alcohol Use Scale and Drug Use Scale (AUS/DUS)
Measured: Measured at baseline, post-test, and Month 3 follow-up
Number of hospital admissions
Measured: Measured at baseline, post-test, and Month 3 follow-up
Ambiguous Intentions Hostility Questionnaire (AIHQ)
Measured: Measured at baseline, post-test, and Month 3 follow-up
Goal attainment ratings
Measured: Measured at post-test
Scales of Wellbeing
Measured: Measured at baseline, post-test, and Month 3 follow-up
Social Skills Performance Assessment (SSPA)
Measured: Measured at baseline, post-test, and Month 3 follow-up
Treatment Compliance Scale (TCS)
Measured: Measured at post-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2006 (estimated)
- Study startApr 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, David Penn, PhD, University of North Carolina, Chapel Hill
- Investigators
- David L. Penn, PhD, Principal investigator, University of North Carolina, Chapel HillDiana O. Perkins, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307216
- Sponsor's protocol ID
- R34MH071252
- Other IDs
- R34MH071252, DATR A2-AISZ
- Status last verified
- Mar 2013
- First submitted
- 23 Mar 2006
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of the Graduated Recovery Intervention Program for First-Episode Psychosis
- ClinicalTrials.gov ID
- NCT00307216
- Acronym / sponsor ID
- R34MH071252
- Conditions
- Psychotic Disorders, Schizophrenia
- Keywords
- First Episode Psychosis, Early Psychosis, Psychosocial Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 27 Mar 2006 (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.
This study will determine the effectiveness of the Graduated Recovery Intervention Program, a manual-based individual therapy program, in enhancing the clinical benefit of routine treatment for individuals recovering from their first episodes of psychosis.
Detailed description
Several mental disorders can be classified as psychotic disorders, such as schizophrenia and manic depression. Psychosis is a defining feature of psychotic disorders, and is characterized by delusions and hallucinations that result in extreme impairment of a person's ability to think clearly. First-episode psychosis refers to the first time someone experiences psychotic symptoms or a psychotic episode. The symptoms can be disturbing and unfamiliar to those who have not previously experienced them. The person experiencing first-episode psychosis may not understand what is happening, and may become confused and distressed. Psychosis is treatable, however, and most people recover. Standard treatment for psychosis entails a combination of behavioral therapy and drug therapy. GRIP is a comprehensive psychosocial intervention for people recovering from an initial episode of non-affective psychosis. The purpose of GRIP is to improve occupational functioning after first-episode psychosis and promote goal pursuit and effective illness self-management. This study will determine the effectiveness of GRIP in enhancing the clinical benefit of routine treatment for individuals recovering from their first episodes of psychosis.
Participants in this study will be randomly assigned to receive either treatment as usual (TAU) or TAU plus GRIP. Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis. Participants assigned to receive TAU plus GRIP will attend therapy sessions weekly for up to 36 weeks, in addition to routine appointments. GRIP includes four phases, each of which focuses on one of the following topics: engagement and wellness management; substance use; persistent symptoms; and functional recovery. Assessments of social functioning, psychotic symptoms, attitudes toward treatment, substance use, and hospital readmission rate will be assessed at baseline, mid-treatment, post-treatment, and at the follow-up visit 3 months post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Graduated Recovery Intervention Program (GRIP), Behavioral: Treatment as usual (TAU)Participants will receive Graduated Recovery Intervention Program plus treatment as usual |
| 2 | Active comparator | Behavioral: Treatment as usual (TAU)Participants will receive treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meets DSM-IV criteria for schizophrenia, schizophreniform disorder, or schizoaffective disorder
- Has been in treatment for psychosis for less than 3 years
- Clinically stable (based on clinician judgement)
- IQ score greater than 70
- Currently receiving keyworker services at UNC Hospital's OASIS program
Key exclusion criteria (3 listed)
- Organic brain disorder
- Substance-induced psychotic disorder
- Mental retardation
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 |
|---|---|---|
| Graduated Recovery Intervention Program (GRIP)GRIP is a manual-based comprehensive psychosocial intervention for people recovering from an initial episode of nonaffective psychosis. The purpose of GRIP is to improve occupational functioning after first-episode psychosis and promote goal pursuit and effective illness self-management. Participants assigned to receive TAU plus GRIP will attend therapy sessions weekly for up to 36 weeks, in addition to routine appointments. GRIP includes four phases, each of which focuses on one of the following topics: engagement and wellness management, substance use, persistent symptoms, and functional recovery. | Behavioural | 1 |
| Treatment as usual (TAU)Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis. | Behavioural | 1, 2 |
Primary outcome
Role Functioning Scale
Time frame: Measured at baseline, post-test, and Month 3 follow-up
Heinrichs-Carpenter Quality of Life Scale (QLS)
Time frame: Measured at baseline, post-test, and Month 3 follow-up
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Measured at baseline, post-test, and Month 3 follow-up
Global Functioning Scale
Time frame: Measured at baseline, post-test, and Month 3 follow-up
12 secondary outcomes
Brief Evaluation of Medication Influences and Beliefs
Time frame: Measured at baseline, post-test, and Month 3 follow-up
Positive and Negative Syndrome Scale (PANSS)
Time frame: Measured at baseline, post-test, and Month 3 follow-up
Calgary Depression Scale for Schizophrenia (CDSS)
Time frame: Measured at baseline, post-test, and Month 3 follow-up
Brief Trauma Questionnaire (BTQ)
Time frame: Measured at baseline, post-test, and Month 3 follow-up
PTSD Checklist (PCL)
Time frame: Measured at baseline, post-test, and Month 3 follow-up
Alcohol Use Scale and Drug Use Scale (AUS/DUS)
Time frame: Measured at baseline, post-test, and Month 3 follow-up
Number of hospital admissions
Time frame: Measured at baseline, post-test, and Month 3 follow-up
Ambiguous Intentions Hostility Questionnaire (AIHQ)
Time frame: Measured at baseline, post-test, and Month 3 follow-up
Goal attainment ratings
Time frame: Measured at post-test
Scales of Wellbeing
Time frame: Measured at baseline, post-test, and Month 3 follow-up
Social Skills Performance Assessment (SSPA)
Time frame: Measured at baseline, post-test, and Month 3 follow-up
Treatment Compliance Scale (TCS)
Time frame: Measured at post-test
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 29 Mar 2013.
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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.
David L. Penn, PhD principal investigator
University of North Carolina, Chapel Hill
Diana O. Perkins, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graduated Recovery Intervention Program (GRIP) and Treatment as usual (TAU) in people with Psychotic Disorders and Schizophrenia, run by University of North Carolina, Chapel Hill 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 5 inclusion and 3 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 29 Mar 2013. 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?
Role Functioning Scale (time frame: Measured at baseline, post-test, and Month 3 follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2013.