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Improving Psychological Therapy for Psychosis: A Case Series

U

University of Edinburgh

Status

Completed

Conditions

Psychosis

Treatments

Behavioral: Active control arm
Behavioral: Experimental intervention arm

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

19 participants in 2 patient groups

Experimental therapy arm
Experimental group
Description:
16 (minimum 4, maximum 20) sessions of therapy for psychosis including new therapeutic ingredients
Treatment:
Behavioral: Experimental intervention arm
Standard Psychological Therapy for Psychosis
Active Comparator group
Description:
16 (minimum 4 maximum 20) sessions of standard psychological therapy for psychosis.
Treatment:
Behavioral: Active control arm

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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