Improving Psychological Therapy for Psychosis: A Case Series

NCT ID: NCT03920384

Last Updated: 2022-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-27
• Study Completion Date: 2021-10-05

Brief 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. 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.

Conditions

Psychosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental therapy arm

16 (minimum 4, maximum 20) sessions of therapy for psychosis including new therapeutic ingredients

Group Type: EXPERIMENTAL

Experimental intervention arm

Intervention Type: BEHAVIORAL

Psychological therapy for psychosis with new therapy components

Standard Psychological Therapy for Psychosis

16 (minimum 4 maximum 20) sessions of standard psychological therapy for psychosis.

Group Type: ACTIVE_COMPARATOR

Active control arm

Intervention Type: BEHAVIORAL

Standard psychological therapy for psychosis without new therapy components

Interventions

Experimental intervention arm

Psychological therapy for psychosis with new therapy components

Intervention Type: BEHAVIORAL

Active control arm

Standard psychological therapy for psychosis without new therapy components

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• Significant developmental disability
• Currently receiving or have received CBTp in the last 6 months
• Significant difficulty with the English language

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emma Eliasson

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

Lothian NHS Board

Edinburgh, Scotland, United Kingdom

Countries

United Kingdom

Other Identifiers

203489

Identifier Type: -

Identifier Source: org_study_id