PsychosisNCT03920384
Improving Psychological Therapy for Psychosis: A Case Series
A study testing Experimental intervention arm in people with Psychosis, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Standard psychological therapy for psychosis (Cognitive Behavioural Therapy) is made up of different 'ingredients', also called treatment components. In therapy, different treatment components can be included or excluded depending on the needs of the individual. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Psychosis
- What is being tested?
- Experimental intervention arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Mar 2018to 5 Oct 2021
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Are aged 16 or over
- Are competent and willing to provide written, informed consent
- Are experiencing delusions (A score of ≥3 on PANSS item P1, P5 or P6)
Who cannot join
- Significant developmental disability
- Currently receiving or have received CBTp in the last 6 months
- Significant difficulty with the English language
Trial locations and contacts
1 site in 1 country.
About this study
Standard psychological therapy for psychosis (Cognitive Behavioural Therapy) is made up of different 'ingredients', also called treatment components. In therapy, different treatment components can be included or excluded depending on the needs of the individual. In this study, the investigators want to find out if standard psychological therapy for psychosis can be improved by including new treatment components. Therefore, participants in this study will be offered psychological therapy for psychosis with new treatment components included or standard psychological therapy for psychosis without new treatment components included. Which of these two options participants are offered will be decided by chance, and during the study neither the study participants nor the researcher will know which of these two variations of psychological therapy are given. Researchers call this a randomized double-blind study. The investigators are aiming to use the results from this study to guide the improvement of psychological therapies for psychosis.
Read the detailed description
Individuals with psychosis often experience delusions, hallucinations and disorganised thinking. Clinicians call these 'positive symptoms' as they are seen as an addition to regular functioning. Psychosis can also lead to loss of some functions such as lower motivation and decreased interest in activities; these are called 'negative symptoms'. Even though most people receive medication for psychosis, psychological therapies such as Cognitive Behavioural Therapy for psychosis (CBTp) are also important in terms of managing symptoms and increasing well-being. Standard CBTp is made up of different treatment components and in therapy, different treatment components can be included or excluded depending on the needs of the individual. In this study the investigators are looking to identify treatment components that are beneficial to CBTp. In particular, the aim is to test whether adding some newly developed treatment components to CBTp can lead to additional benefits to patients, in terms of reducing unhelpful thinking styles. This will be done through a double-blind randomized case-series design, where participants will either receive standard CBTp or standard CBTp with added treatment components.
Four weeks before the intervention starts, throughout therapy, as well as four weeks after therapy, participants will complete weekly questionnaires to assess symptoms and thinking patterns. This will allow the researcher to measure weekly changes before, during and after the therapy. Additional questionnaires and interviews as well as computer tasks will also be completed before the therapy starts (baseline), mid-therapy and post-therapy to gain more insight into changes in mood, quality of life, thinking patterns and symptoms. In addition, to study the long-term effect of the intervention, participants will be asked to complete a follow-up assessment session 12 weeks after the therapy is completed. Participants and clinicians will also be given the opportunity to give feedback on their experience of having received/delivered the therapy. This will be done through an interview with the researcher, and will give us further insight into how future therapies for psychosis might be improved, both from a clinician and patient perspective.
- Conditions
- Psychosis
- Being tested
- Experimental intervention arm, Active control arm
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental intervention armBehavioural
Psychological therapy for psychosis with new therapy components
Active control armBehavioural
Standard psychological therapy for psychosis without new therapy components
| Study group | Role | What they receive |
|---|---|---|
| Experimental therapy arm | Experimental | 16 (minimum 4, maximum 20) sessions of therapy for psychosis including new therapeutic ingredients Receives: Behavioral: Experimental intervention arm |
| Standard Psychological Therapy for Psychosis | Active comparator | 16 (minimum 4 maximum 20) sessions of standard psychological therapy for psychosis. Receives: Behavioral: Active control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Session by session change in positive symptoms as measured by the The Psychotic Symptom Rating Scales (PSYRATS, Haddock et al.,1999).
The PSYRATS is a widely used measure including 17 items assessing different dimensions of delusions and auditory hallucinations that include distress, loudness, conviction, frequency, disruption to life and preoccupation. Each dimension is rated on a 0-4 point scale, with scores on the auditory hallucination subscale (11 items) ranging from 0-44 and scores on the delusion subscale (6 items) ranging from 0-24. Higher scores indicate greater symptom severity.
Measured: Administered weekly 4 weeks prior to therapy start, weekly after each therapy session (maximum 20 sessions) and weekly for 4 weeks after therapy intervention has been completed as well as 12 weeks follow-up after intervention completion.
Session by session change in cognitive biases measured by Davos Assessment of Cognitive Biases Scales (DACOBS: van der Gaag et al., 2013).
This scale consists of 42 statements relating to seven (six-item) subscales; 1) Jumping to conclusions bias 2) Belief inflexibility bias 3) Attention to threat bias 4) External attribution bias 5) Social cognition problems 6) Subjective cognitive problems and 7) Safety behaviours. Respondents score each statement using a 7-point rating scale, ranging from 'totally disagree' (1) to 'totally agree' (7). For the session-by session data, the subscales Jumping to conclusions, Belief Inflexibility Bias and External Attribution bias subscales will be administered. Each cognitive bias subscale obtains a score from 7-42, with a higher score indicating higher propensity towards a cognitive bias.
Measured: Assessed weekly for 4 weeks prior to therapy start, weekly after each therapy session (maximum 20 sessions) and weekly for 4 weeks after therapy intervention has been completed.
Secondary outcomes (9)
Jumping to conclusions task (Garety et al., 1991; Moritz et al., 2010).
A computerised task where participants are presented with two lakes of coloured fish in opposing ratios (e.g. Lake A 80% red 20% green, Lake B 80% green 20% red). The participant is told that the fisherman will fish from one of these lakes only (but which lake is unknown). After each "catch" the participant is asked to make 2 judgements: 1) probability that the fish is caught from lake A or B and 2) Whether they are ready to make a decision on what lake the fish is caught from. This task measures participants tendency to jump to conclusions.
Measured: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
Bias Against Disconfirmatory Evidence (BADE) task (Woodward et al., 2006)
A computerised version of the BADE task will be employed. In this task, participants will be presented a series of with delusion-neutral scenarios. For each scenario they will be asked to rate the plausibility of 4 interpretations each scenario will have a one "true" interpretation two "lure" interpretation and one "absurd" interpretation. After making their ratings, participants will be presented with additional scenario descriptions, which will provide further information, and participants will be allowed to adjust their ratings if necessary
Measured: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
Positive and Negative Syndrome Scale (PANSS; Kay et al., 1987)
PANSS is a structured clinical interview that estimates symptom severity for people with schizophrenia and psychosis. The scale consists of 30 items measuring positive (P1-P7), negative (N1-N7) and general (G1-G16) symptom severity. Each of the items is scored on a 1-7 point scale ranging from absent (1) to extreme (7). Total scores range from 30-210, with higher scores indicating greater symptom severity.
Measured: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
Internalized Stigma of Mental Illness Scale (ISMI; Ritsher et al., 2003)
This is a 29-item questionnaire that assesses subjective levels of self-stigma. Participants are asked to rate the extent to which they agree with a set of statements on a 1-4 point scale scale ranging from strongly disagree (1) to strongly agree (4). Items add up to 5 subscales, including: alienation, stereotype endorsement, discrimination experience, social withdrawal and stigma resistance. Scores for subscales and total scores are calculated by adding the item scores and dividing by total number of answered items, with higher scores indicating higher internalized stigma.
Measured: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
Calgary Depression Scale for Schizophrenia (CDSS; Addington et al., 1990).
Measures depressive symptoms in schizophrenia. The scale consists of a structured interview with nine questions, and are scored on a 0-3 scale ranging from absent (0) to severe (3). Total score range 0-27 with higher scores indicating higher severity of depressive symptoms.
Measured: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-18; Ritsner et al., 2005).
An 18-item self-administered questionnaire designed to assess quality of life in patients with psychotic and mood disorders. It is a self-administered scale where participants are asked to rate questions on a 1-5 scale, ranging from "not at all or never" (1) to "Frequently or all of the time" (5). Total scores range from 18-90 and a higher score indicates higher a quality of life.
Measured: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
The Global Assessment of Functioning (GAF; American Psychological Association, APA, 1987)
The GAF scale is a rating scale for assessing a person's psychological, social and occupational functioning. The scale total ranges from 1-100, where a lower score indicates a more severe illness in terms of symptoms and social functioning.
Measured: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
The Reflective Function Questionnaire (RFQ short version: Fonagy & Ghinai (unpublished manuscript)
8-item scale to assess mentalising capacity in adults. Total scores range from 8-42. The RFQ-8 contains median scored items where scores in the middle ("partly agree" or "partly disagree") get high scores, while responses in the extreme ends of the scale reflect poor mentalising capacity.
Measured: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
Change in cognitive biases measured by Davos Assessment of Cognitive Biases Scales (DACOBS: van der Gaag et al., 2013).
This scale consists of 42 statements relating to seven (six-item) subscales; 1) Jumping to conclusions bias 2) Belief Inflexibility bias 3) Attention to threat bias 4) External attribution bias 5) Social cognition problems 6) Subjective cognitive problems and 7) Safety behaviours. Respondents score each statement using a 7- point rating scale, ranging from 'totally disagree' (1) to 'totally agree' (7). Each cognitive bias subscale obtains a score from 7-42, with a higher score indicating higher propensity towards a cognitive bias.
Measured: Full scale administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start27 Mar 2018
- Primary completion5 Oct 2021
- Study completion5 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe 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
- Model description
- Randomised case series
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emma Eliasson, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920384
- Sponsor's protocol ID
- 203489
- Status last verified
- Apr 2021
- First submitted
- 26 Feb 2019
- Last updated
- 28 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Psychological Therapy for Psychosis: A Case Series
- ClinicalTrials.gov ID
- NCT03920384
- Acronym / sponsor ID
- 203489
- Conditions
- Psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 5 Oct 2021 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 18 Apr 2019 (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.
Standard psychological therapy for psychosis (Cognitive Behavioural Therapy) is made up of different 'ingredients', also called treatment components. In therapy, different treatment components can be included or excluded depending on the needs of the individual. In this study, the investigators want to find out if standard psychological therapy for psychosis can be improved by including new treatment components. Therefore, participants in this study will be offered psychological therapy for psychosis with new treatment components included or standard psychological therapy for psychosis without new treatment components included. Which of these two options participants are offered will be decided by chance, and during the study neither the study participants nor the researcher will know which of these two variations of psychological therapy are given. Researchers call this a randomized double-blind study. The investigators are aiming to use the results from this study to guide the improvement of psychological therapies for psychosis.
Detailed description
Individuals with psychosis often experience delusions, hallucinations and disorganised thinking. Clinicians call these 'positive symptoms' as they are seen as an addition to regular functioning. Psychosis can also lead to loss of some functions such as lower motivation and decreased interest in activities; these are called 'negative symptoms'. Even though most people receive medication for psychosis, psychological therapies such as Cognitive Behavioural Therapy for psychosis (CBTp) are also important in terms of managing symptoms and increasing well-being. Standard CBTp is made up of different treatment components and in therapy, different treatment components can be included or excluded depending on the needs of the individual. In this study the investigators are looking to identify treatment components that are beneficial to CBTp. In particular, the aim is to test whether adding some newly developed treatment components to CBTp can lead to additional benefits to patients, in terms of reducing unhelpful thinking styles. This will be done through a double-blind randomized case-series design, where participants will either receive standard CBTp or standard CBTp with added treatment components.
Four weeks before the intervention starts, throughout therapy, as well as four weeks after therapy, participants will complete weekly questionnaires to assess symptoms and thinking patterns. This will allow the researcher to measure weekly changes before, during and after the therapy. Additional questionnaires and interviews as well as computer tasks will also be completed before the therapy starts (baseline), mid-therapy and post-therapy to gain more insight into changes in mood, quality of life, thinking patterns and symptoms. In addition, to study the long-term effect of the intervention, participants will be asked to complete a follow-up assessment session 12 weeks after the therapy is completed. Participants and clinicians will also be given the opportunity to give feedback on their experience of having received/delivered the therapy. This will be done through an interview with the researcher, and will give us further insight into how future therapies for psychosis might be improved, both from a clinician and patient perspective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised case series
| Arm | Type | Receives |
|---|---|---|
| Experimental therapy arm | Experimental | Behavioral: Experimental intervention arm16 (minimum 4, maximum 20) sessions of therapy for psychosis including new therapeutic ingredients |
| Standard Psychological Therapy for Psychosis | Active comparator | Behavioral: Active control arm16 (minimum 4 maximum 20) sessions of standard psychological therapy for psychosis. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Are aged 16 or over
- Are competent and willing to provide written, informed consent
- Are experiencing delusions (A score of ≥3 on PANSS item P1, P5 or P6)
Key exclusion criteria (3 listed)
- Significant developmental disability
- Currently receiving or have received CBTp in the last 6 months
- Significant difficulty with the English language
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 |
|---|---|---|
| Experimental intervention armPsychological therapy for psychosis with new therapy components | Behavioural | Experimental therapy arm |
| Active control armStandard psychological therapy for psychosis without new therapy components | Behavioural | Standard Psychological Therapy for Psychosis |
Primary outcome
Session by session change in positive symptoms as measured by the The Psychotic Symptom Rating Scales (PSYRATS, Haddock et al.,1999).
Time frame: Administered weekly 4 weeks prior to therapy start, weekly after each therapy session (maximum 20 sessions) and weekly for 4 weeks after therapy intervention has been completed as well as 12 weeks follow-up after intervention completion.
The PSYRATS is a widely used measure including 17 items assessing different dimensions of delusions and auditory hallucinations that include distress, loudness, conviction, frequency, disruption to life and preoccupation. Each dimension is rated on a 0-4 point scale, with scores on the auditory hallucination subscale (11 items) ranging from 0-44 and scores on the delusion subscale (6 items) ranging from 0-24. Higher scores indicate greater symptom severity.
Session by session change in cognitive biases measured by Davos Assessment of Cognitive Biases Scales (DACOBS: van der Gaag et al., 2013).
Time frame: Assessed weekly for 4 weeks prior to therapy start, weekly after each therapy session (maximum 20 sessions) and weekly for 4 weeks after therapy intervention has been completed.
This scale consists of 42 statements relating to seven (six-item) subscales; 1) Jumping to conclusions bias 2) Belief inflexibility bias 3) Attention to threat bias 4) External attribution bias 5) Social cognition problems 6) Subjective cognitive problems and 7) Safety behaviours. Respondents score each statement using a 7-point rating scale, ranging from 'totally disagree' (1) to 'totally agree' (7). For the session-by session data, the subscales Jumping to conclusions, Belief Inflexibility Bias and External Attribution bias subscales will be administered. Each cognitive bias subscale obtains a score from 7-42, with a higher score indicating higher propensity towards a cognitive bias.
9 secondary outcomes
Jumping to conclusions task (Garety et al., 1991; Moritz et al., 2010).
Time frame: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
Bias Against Disconfirmatory Evidence (BADE) task (Woodward et al., 2006)
Time frame: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
Positive and Negative Syndrome Scale (PANSS; Kay et al., 1987)
Time frame: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
Internalized Stigma of Mental Illness Scale (ISMI; Ritsher et al., 2003)
Time frame: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
Calgary Depression Scale for Schizophrenia (CDSS; Addington et al., 1990).
Time frame: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-18; Ritsner et al., 2005).
Time frame: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
The Global Assessment of Functioning (GAF; American Psychological Association, APA, 1987)
Time frame: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
The Reflective Function Questionnaire (RFQ short version: Fonagy & Ghinai (unpublished manuscript)
Time frame: Administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
Change in cognitive biases measured by Davos Assessment of Cognitive Biases Scales (DACOBS: van der Gaag et al., 2013).
Time frame: Full scale administered at 6 study assessment points: Pre-baseline (4 weeks prior to therapy start), Baseline (pre-therapy start), Post therapy session 8, Post-Therapy completion (maximun 20 sessions), as well as weeks 4 and 12 post therapy completion.
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 28 Feb 2022.
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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.
Emma Eliasson principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental intervention arm in people with Psychosis, run by University of Edinburgh at 1 site in United Kingdom.
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 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 28 Feb 2022. 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 Kingdom. 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?
Session by session change in positive symptoms as measured by the The Psychotic Symptom Rating Scales (PSYRATS, Haddock et al.,1999). (time frame: Administered weekly 4 weeks prior to therapy start, weekly after each therapy session (maximum 20 sessions) and weekly for 4 weeks after therapy intervention has been completed as well as 12 weeks follow-up after intervention completion.). The study lists 2 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 28 Feb 2022.