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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03920384
Recruitment Status Recruiting
First Posted April 18, 2019
Last update posted March 25, 2020
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.
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.
|Experimental: Experimental therapy arm
16 (minimum 4, maximum 20) sessions of therapy for psychosis including new therapeutic ingredients
Behavioral: Experimental intervention arm
Psychological therapy for psychosis with new therapy components
|Active Comparator: Standard Psychological Therapy for Psychosis
16 (minimum 4 maximum 20) sessions of standard psychological therapy for psychosis.
Behavioral: Active control arm
Standard psychological therapy for psychosis without new therapy components
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- 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)
- Significant developmental disability
- Currently receiving or have received CBTp in the last 6 months
- Significant difficulty with the English language
Contact: Emma Eliasson + 44 (0)131 573 6220 email@example.com
Contact: Prof. Matthias Schwannauer +44 (0)131 651 3954 firstname.lastname@example.org
United Kingdom, Scotland
Lothian NHS Board
University of Edinburgh
Principal Investigator: Emma Eliasson University of Edinburgh