NCT05281640: PICASSO

Psychological Interventions for Complex PTSD And Schizophrenia-Spectrum Disorder: PICASSO Trial

Completed NA Last updated 23 February 2024

What this trial tests

NA trial testing Affect Dysregulation intervention in Psychosis in 57 participants. Completed in 31 August 2023.

Timeline

28 February 2022

Primary endpoint
31 August 2023

31 August 2023

Quick facts

Lead sponsor	Edinburgh Napier University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	57
Start date	28 February 2022
Primary completion	31 August 2023
Estimated completion	31 August 2023
Sites	2 locations across United Kingdom

Drugs / interventions tested

• Affect Dysregulation intervention
• Negative Self Concept intervention
• Disturbed Relationships intervention

Conditions studied

• Psychosis — all drugs for Psychosis →
• Complex Post-Traumatic Stress Disorder — all drugs for Complex Post-Traumatic Stress Disorder →
• Schizophrenia — all drugs for Schizophrenia →

Sponsor

Edinburgh Napier University

Who can join

Adults 18 to 65, any sex, with Psychosis or Complex Post-Traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Psychosis is a highly distressing mental health condition, affecting up to 3% of the population. Conceptually, it has much in common with complex post-traumatic stress disorder (CPTSD), a recently introduced condition in ICD-11. Both involve negative self-esteem, impaired emotion regulation ability, interpersonal difficulties and intrusive trauma- related experiences (i.e. intrusive thoughts, flashbacks, nightmares). Both have been causally related to childhood trauma, such as abuse, neglect and loss.

The current project will examine the feasibility of conducting an 'Umbrella trial' to test whether CPTSD is causally related to psychosis, and develop more effective trauma-focused psychological interventions for psychotic symptoms by treating underlying experiences of/reactions to trauma. An Umbrella trial involves running several individual randomised controlled trials concurrently. In this study, each trial will test whether psychological interventions designed to reduce different CPTSD symptoms cause improvements in psychotic symptoms. If the investigators can establish feasibility of this Umbrella trial, and if a definitive version shows that interventions for CPTSD also reduce psychosis, then this would be a breakthrough in both the conceptualisation and treatment of psychosis which will help transform the care of people with psychosis. Demonstrating the feasibility of our proposed methodology would also help to accelerate the development of interventions for other mental health problems.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Trauma-Focused Treatment in Early and Lifetime Psychosis: A Scoping Review.
   Jankowski SE, Bennett R, Tao B, Neria Y, et al · · 2025 · PMID 41275365 · DOI 10.1093/schbul/sbaf202