Schizophrenia Spectrum and Other Psychotic DisordersNCT03501888
Cognitive Behavior Therapy for Patients With Psychoses.
A study testing Cognitive Behavior Therapy and Acceptance and Commitment Therapy in people with Schizophrenia Spectrum and Other Psychotic Disorders, run by Karolinska Institutet.
Trial summary
Patients with psychoses are randomized either to group treatment (ACT) or individual CBT for 18 sessions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia Spectrum and Other Psychotic Disorders
- What is being tested?
- Cognitive Behavior Therapy and 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
- 16 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to 31 Aug 2016
- 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
None listed.
Who cannot join
- Patients with drug abuse diagnosis
- organic brain injury,
- patients with grave somatic illness with secondary psychotic symptoms.
About this study
Official title: A Single Blind Randomized Controlled Trial Comparing Cognitive Behavior Group Therapy and Individual Cognitive Behavioural Therapy for Patients With Psychoses
Patients with psychoses are randomized either to group treatment (ACT) or individual CBT for 18 sessions.
Read the detailed description
Since patients in the early stage of the illness seem to benefit more from CBT than patients with chronic conditions the present research will focus on patients with psychosis at the early stages of their illness. Patients with first episode psychosis from the Northern Stockholm Psychiatry (Midhagen) and the South West Stockholm Psychiatry (TIPS) will be included.
Scores on Alcohol Use disorder identification Test (AUDIT) and Drug Use disorder Identification Test (DUDIT) will be used as a covariate in order to control for the patients' s drug and alcohol use habits.
The study is single blind randomized controlled trials of manualized Cognitive Behavior Group Therapy (CBGT) versus an active treatment condition of individual CBT for patients with first episode psychosis. A total of 16 patients are enrolled and randomly allocated to either CBGT or to individual CBT treatment. Then 18 structured CBGT or individual CBT sessions approximately once a week will be offered. Three experienced CBT trained therapists will perform the therapies. Two therapists will be allocated to each group composed by approximately 5 patients.
The group therapies are conducted according to the Acceptance and Commitment Therapy (ACT) for psychosis manual (an 18 Session Group Therapy Protocol by Pearson A. \& Tingey R.). The individual therapies are conducted according to non-manualized ordinary clinical procedure. The ACT manual is originally constructed for patients with chronic schizophrenia and has therefore been adapted by the therapists to be appropriate for patients with first episode psychosis. The therapists have taken a course in ACT and they receive ACT-supervision during the trial.
Assessments in both studies will be carried out at baseline, after therapy completion and 6 months later by an independent rater blind to group allocation and not involved in the treatment of the patients. The raters blindness will be measured.
- Being tested
- Cognitive Behavior Therapy, Acceptance and Commitment Therapy
- Keywords
- Acceptance and Commitment Therapy, ACT, Cognitive Behavior Therapy, CBT, Schizophrenia, Psychoses
- Medical subject headings
- Schizophrenia Spectrum and Other Psychotic Disorders, Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior TherapyBehavioural
Also called CBT
18 sessions of individual treatment, no manual.
Acceptance and Commitment TherapyBehavioural
Also called ACT
18 sessions of group treatment, manual based.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavior Therapy (CBT) | Active comparator | CBT: individually, ca 18 weeks. Receives: Behavioral: Cognitive Behavior Therapy |
| Acceptance and Commitment Therapy (ACT) | Active comparator | ACT: given in a group setting: ca 18 weeks. Receives: Behavioral: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of psychoses
measured with PANSS (subscales: positive and negative symptoms).
Measured: Up to 11 months
Secondary outcomes (9)
Quality of Life,
Quality of life is measured by Brunnsviken Brief Quality of Life Inventory.
Measured: Up to 11 months
Symptoms of depression
Symptoms of Depression; Becks Depression Inventory.
Measured: Up to 11 months
Self Esteem
Self esteem is measured by Self Concept Questionaire
Measured: Up to 11 months
Values,
Living in accordance with ones values is measured by Bull´s eye Values Survey.
Measured: Up to 11 months
Psychological inflexibility and Experiential Avoidance.
Psychological inflexibility and experiential avoidance is measured with Acceptance and Action Questionaire II
Measured: Up to 11 months
Treatment safety
Treatment safety is evaluated through assessment of adverse effects or events by registering suicide, suicide attempts, re-hospitalization and severe depressive symptom exacerbation).
Measured: Up to 11 months
Symptoms of anxiety
Becks Anxiety Inventory,
Measured: Up to 11 months
Alcohol use
Alcohol Use Disorder Identification Test
Measured: Upt to 11 months
Drug use
Drug Use Disorder Identification Test.
Measured: Up to 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study startOct 2015
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia Spectrum and Other Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Helena Fatouros-Bergman, Karolinska Institutet
- Investigators
- Helena Fatouros-Bergman, PhD, Principal investigator, Karolinska Insitutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501888
- Sponsor's protocol ID
- Karolinska Inst
- Status last verified
- Apr 2018
- First submitted
- 30 Jan 2017
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blind Randomized Controlled Trial Comparing Cognitive Behavior Group Therapy and Individual Cognitive Behavioural Therapy for Patients With Psychoses
- ClinicalTrials.gov ID
- NCT03501888
- Acronym / sponsor ID
- Karolinska Inst
- Keywords
- Acceptance and Commitment Therapy, ACT, Cognitive Behavior Therapy, CBT, Schizophrenia, Psychoses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Oct 2015
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 18 Apr 2018 (actual)
- 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.
Patients with psychoses are randomized either to group treatment (ACT) or individual CBT for 18 sessions.
Detailed description
Since patients in the early stage of the illness seem to benefit more from CBT than patients with chronic conditions the present research will focus on patients with psychosis at the early stages of their illness. Patients with first episode psychosis from the Northern Stockholm Psychiatry (Midhagen) and the South West Stockholm Psychiatry (TIPS) will be included.
Scores on Alcohol Use disorder identification Test (AUDIT) and Drug Use disorder Identification Test (DUDIT) will be used as a covariate in order to control for the patients' s drug and alcohol use habits.
The study is single blind randomized controlled trials of manualized Cognitive Behavior Group Therapy (CBGT) versus an active treatment condition of individual CBT for patients with first episode psychosis. A total of 16 patients are enrolled and randomly allocated to either CBGT or to individual CBT treatment. Then 18 structured CBGT or individual CBT sessions approximately once a week will be offered. Three experienced CBT trained therapists will perform the therapies. Two therapists will be allocated to each group composed by approximately 5 patients.
The group therapies are conducted according to the Acceptance and Commitment Therapy (ACT) for psychosis manual (an 18 Session Group Therapy Protocol by Pearson A. \& Tingey R.). The individual therapies are conducted according to non-manualized ordinary clinical procedure. The ACT manual is originally constructed for patients with chronic schizophrenia and has therefore been adapted by the therapists to be appropriate for patients with first episode psychosis. The therapists have taken a course in ACT and they receive ACT-supervision during the trial.
Assessments in both studies will be carried out at baseline, after therapy completion and 6 months later by an independent rater blind to group allocation and not involved in the treatment of the patients. The raters blindness will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavior Therapy (CBT) | Active comparator | Behavioral: Cognitive Behavior TherapyCBT: individually, ca 18 weeks. |
| Acceptance and Commitment Therapy (ACT) | Active comparator | Behavioral: Acceptance and Commitment TherapyACT: given in a group setting: ca 18 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Patients with drug abuse diagnosis
- organic brain injury,
- patients with grave somatic illness with secondary psychotic symptoms.
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 Behavior TherapyAlso: CBT18 sessions of individual treatment, no manual. | Behavioural | Cognitive Behavior Therapy (CBT) |
| Acceptance and Commitment TherapyAlso: ACT18 sessions of group treatment, manual based. | Behavioural | Acceptance and Commitment Therapy (ACT) |
Primary outcome
Symptoms of psychoses
Time frame: Up to 11 months
measured with PANSS (subscales: positive and negative symptoms).
9 secondary outcomes
Quality of Life,
Time frame: Up to 11 months
Symptoms of depression
Time frame: Up to 11 months
Self Esteem
Time frame: Up to 11 months
Values,
Time frame: Up to 11 months
Psychological inflexibility and Experiential Avoidance.
Time frame: Up to 11 months
Treatment safety
Time frame: Up to 11 months
Symptoms of anxiety
Time frame: Up to 11 months
Alcohol use
Time frame: Upt to 11 months
Drug use
Time frame: Up to 11 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 18 Apr 2018.
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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.
Helena Fatouros-Bergman, PhD principal investigator
Karolinska Insitutet
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Therapy and Acceptance and Commitment Therapy in people with Schizophrenia Spectrum and Other Psychotic Disorders, run by Karolinska Institutet.
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 0 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 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Symptoms of psychoses (time frame: Up to 11 months). 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 18 Apr 2018; AzTrials last refreshed its copy on 4 Nov 2026.