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

Summary

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.

Conditions

• Psychosis
• Complex Post-Traumatic Stress Disorder
• Schizophrenia

Interventions

BEHAVIORAL

Affect Dysregulation intervention

See relevant study arm for description

BEHAVIORAL

Negative Self Concept intervention

See relevant study arm for description

BEHAVIORAL

Disturbed Relationships intervention

See relevant study arm for description

Sponsors & Collaborators

• NHS Lothian

  collaborator OTHER_GOV

• NHS Greater Glasgow and Clyde

  collaborator OTHER

• University of Glasgow

  collaborator OTHER

• University of Sheffield

  collaborator OTHER

• University of Manchester

  collaborator OTHER

• University of Ulster

  collaborator OTHER

• Edinburgh Napier University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-28

Primary Completion

2023-08-31

Completion

2023-08-31

Countries

• United Kingdom

Study Locations