PsychosisPhase 2NCT01511406
Cognitive Behavioral Therapy for Patients With an Early Psychosis
A Phase 2 study testing cognitive behavioral therapy in people with Psychosis and Schizophrenia, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of the present study is to examine whether cognitive behavior therapy will reduce depressive symptoms and increase self-esteem for patients with a first episode psychosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychosis, Schizophrenia, Depressive Symptoms
- What is being tested?
- cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2011to Oct 2014
- Phase
- Phase 2
- 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
- Participants are eligible for the study if they are diagnosed with a psychotic disorder or bipolar disorder with psychosis according to DSM-IV (i.e. schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder or psychosis NOS
- Aged between 18-65 years
- Are capable of giving a written consent to participate in the study.
Who cannot join
- A history of head injury, neurological disorders, developmental disorders, and all episodes of psychosis being judged as substance-induced rather than a primary episode of a psychotic disorder.
- Being in treatment for more than five years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Cognitive Behavioral Therapy Improve Depressive Symptoms and Self-Esteem in Patients With a First Episode Psychosis? A Randomized Controlled Study
The purpose of the present study is to examine whether cognitive behavior therapy will reduce depressive symptoms and increase self-esteem for patients with a first episode psychosis.
Read the detailed description
A growing body of evidence supports the use of Cognitive Behavioural Therapy (CBT) for the treatment of schizophrenia. The strength of evidence is especially strong for patients with persistent hallucinations and delusions. As it comes to the effect of CBT for patients with a first episode psychosis the picture is more unclear. The main reason is probably that the CBT interventions to a less extent have been adjusted to fit first episode psychosis patients. The main problems for patients with a first episode psychosis (FEP) is rarely persistent hallucinations and delusions but they struggle with social anxiety, depression, alcohol and drug abuse and low self esteem. Forthcoming studies examining the effect of CBT for patients with a first episode psychosis should aim to have a focus on these symptoms.
The main aim of the present study is to examine whether CBT has any effect on depressive symptoms and self-esteem in patients with a FEP.
The study will include patients with a first episode psychosis with Axis-I DSM IV diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, and psychosis not otherwise specified. To be included in the study the patients should meet the criteria of an affective episode the last year or have a score on Calgary Depression of Schizophrenia Scale above four. Patients are randomly selected to either a treatment group or a control (placebo) group. The aim is to include 30 patients in each group. Patients in the treatment group will receive a manual-based CBT intervention comprising up to 26 sessions during a six months period. The control group will receive treatment as usual (TAU).
The patients are assessed before the entry of the study and after 6 months (end of treatment). Moreover they will be assessed after 9 months of ending therapy.
Hypothesis:
In this study we hypothesize that
- patients receiving CBT will have less depressive symptoms than TAU-patients at the and of treatment and at six months follow up
- CBT-patients will demonstrate a better improvement in their self-esteem than TAU-patients at the end of treatment and at six months follow up.
To our knowledge, no previous studies have examined outcome after CBT treatment with regards to depressive symptoms and self-esteem. Furthermore, this is the first randomized controlled study in Norway of CBT among patients with a FEP.
- Conditions
- Psychosis, Schizophrenia, Depressive Symptoms, Self-esteem
- Being tested
- cognitive behavioral therapy
- Keywords
- Psychosis, Schizophrenia, Cognitive behavioral therapy, Self esteem, Depression
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral therapyBehavioural
Also called CBT
Patients allocated to the treatment arm will receive up to 26 sessions of cognitive behavioral therapy
| Study group | Role | What they receive |
|---|---|---|
| cognitive behavioral therapy | Experimental | Cognitive behavioral therapy up to 26 sessions Receives: Behavioral: cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calgary Depression rating Scale for Schizophrenia (CDSS)
Measure depressive symptoms for patients with a psychosis
Measured: up to nine months after end of intervention
Secondary outcomes (1)
Rosenberg Self Esteem Scale
Measure the level of self esteem among patients with a psychosis
Measured: up to nine months after end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startJan 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stiftelsen Helse og Rehabilitering
- Responsible party
- Sponsor
- Investigators
- Jan I Røssberg, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511406
- Sponsor's protocol ID
- CBT2011
- Status last verified
- Oct 2014
- First submitted
- 27 Dec 2011
- Last updated
- 23 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sonmez N, Romm KL, Ostefjells T, Grande M, Jensen LH, Hummelen B, Tesli M, Melle I, Rossberg JI. Cognitive behavior therapy in early psychosis with a focus on depression and low self-esteem: A randomized controlled trial. Compr Psychiatry. 2020 Feb;97:152157. doi: 10.1016/j.comppsych.2019.152157. Epub 2019 Dec 26.
PubMed 31935529
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Cognitive Behavioral Therapy Improve Depressive Symptoms and Self-Esteem in Patients With a First Episode Psychosis? A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01511406
- Acronym / sponsor ID
- CBT2011
- Conditions
- Psychosis, Schizophrenia, Depressive Symptoms, Self-esteem
- Keywords
- Psychosis, Schizophrenia, Cognitive behavioral therapy, Self esteem, Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Stiftelsen Helse og Rehabilitering
- Study start
- Jan 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 18 Jan 2012 (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.
The purpose of the present study is to examine whether cognitive behavior therapy will reduce depressive symptoms and increase self-esteem for patients with a first episode psychosis.
Detailed description
A growing body of evidence supports the use of Cognitive Behavioural Therapy (CBT) for the treatment of schizophrenia. The strength of evidence is especially strong for patients with persistent hallucinations and delusions. As it comes to the effect of CBT for patients with a first episode psychosis the picture is more unclear. The main reason is probably that the CBT interventions to a less extent have been adjusted to fit first episode psychosis patients. The main problems for patients with a first episode psychosis (FEP) is rarely persistent hallucinations and delusions but they struggle with social anxiety, depression, alcohol and drug abuse and low self esteem. Forthcoming studies examining the effect of CBT for patients with a first episode psychosis should aim to have a focus on these symptoms.
The main aim of the present study is to examine whether CBT has any effect on depressive symptoms and self-esteem in patients with a FEP.
The study will include patients with a first episode psychosis with Axis-I DSM IV diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, and psychosis not otherwise specified. To be included in the study the patients should meet the criteria of an affective episode the last year or have a score on Calgary Depression of Schizophrenia Scale above four. Patients are randomly selected to either a treatment group or a control (placebo) group. The aim is to include 30 patients in each group. Patients in the treatment group will receive a manual-based CBT intervention comprising up to 26 sessions during a six months period. The control group will receive treatment as usual (TAU).
The patients are assessed before the entry of the study and after 6 months (end of treatment). Moreover they will be assessed after 9 months of ending therapy.
Hypothesis:
In this study we hypothesize that
- patients receiving CBT will have less depressive symptoms than TAU-patients at the and of treatment and at six months follow up
- CBT-patients will demonstrate a better improvement in their self-esteem than TAU-patients at the end of treatment and at six months follow up.
To our knowledge, no previous studies have examined outcome after CBT treatment with regards to depressive symptoms and self-esteem. Furthermore, this is the first randomized controlled study in Norway of CBT among patients with a FEP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cognitive behavioral therapy | Experimental | Behavioral: cognitive behavioral therapyCognitive behavioral therapy up to 26 sessions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants are eligible for the study if they are diagnosed with a psychotic disorder or bipolar disorder with psychosis according to DSM-IV (i.e. schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder or psychosis NOS
- Aged between 18-65 years
- Are capable of giving a written consent to participate in the study.
Key exclusion criteria (2 listed)
- A history of head injury, neurological disorders, developmental disorders, and all episodes of psychosis being judged as substance-induced rather than a primary episode of a psychotic disorder.
- Being in treatment for more than five years
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 |
|---|---|---|
| cognitive behavioral therapyAlso: CBTPatients allocated to the treatment arm will receive up to 26 sessions of cognitive behavioral therapy | Behavioural | cognitive behavioral therapy |
Primary outcome
Calgary Depression rating Scale for Schizophrenia (CDSS)
Time frame: up to nine months after end of intervention
Measure depressive symptoms for patients with a psychosis
1 secondary outcome
Rosenberg Self Esteem Scale
Time frame: up to nine months after end of intervention
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 23 Oct 2014.
- Derived from this study: PubMed 31935529Sonmez N, Romm KL, Ostefjells T, Grande M, Jensen LH, Hummelen B, Tesli M, Melle I, Rossberg JI. Cognitive behavior therapy in early psychosis with a focus on depression and low self-esteem: A randomized controlled trial. Compr Psychiatry. 2020 Feb;97:152157. doi: 10.1016/j.comppsych.2019.152157. Epub 2019 Dec 26.
Related trials for Psychosis
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
RecruitingPhase 2/3
ACP-204 in Adults With Alzheimer's Disease Psychosis
Alzheimer's Disease Psychosis
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.
Jan I Røssberg, MD, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cognitive behavioral therapy in people with Psychosis and Schizophrenia, run by Oslo University Hospital at 1 site in Norway.
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 3 inclusion and 2 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 23 Oct 2014. 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 Norway. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Calgary Depression rating Scale for Schizophrenia (CDSS) (time frame: up to nine months after end of intervention). 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 NCT01511406, which also lists 1 linked publication.
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 23 Oct 2014.