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

NCT05281640 | Completed DMC

• 1 other identifier: 123
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

schizophrenia; psychosis; umbrella trial; complex post traumatic stress disorder; affect dysregulation; negative self concept; disturbed relationships; childhood trauma

Outcome Measures

Primary Outcomes (2)

• Feasibility data

  Data on participant recruitment rates and retention. The recruitment target is N=60 across the two sites. This outcome relates to the number of participants recruited and randomised in each site during the recruitment period compared with the recruitment target.

  Duration of recruitment window - 15 months

• Data completion on PANSS interview

  This outcome addresses the data completion rates at baseline and end of treatment (8 weeks)on the Positive and Negative Syndrome Scale (PANSS). This is the anticipated primary outcome for a future trial. Data completion refers to the number of participants completing the PANSS interview at each time point, divided by the number of participants randomised. The interview measures positive and negative psychotic symptoms along with general psychopathology, and higher scores indicate greater illness severity.

  Week 8 (end of treatment)

Secondary Outcomes (7)

• Data completion on PANSS interview

  Week 12 (follow up)

• Complex PTSD symptoms - International Trauma Questionnaire (ITQ)

  Weeks 0, 8 & 12

• Adverse effects of psychotherapy (AEP)

  Weeks 8 & 12

• Quality of life - Schizophrenia Quality of Life Scale (SQOLS)

  Weeks 0, 8 & 12

• Subjective recovery - Questionnaire about the Process of Recovery (QPR)

  Weeks 0, 8 & 12

Study Arms (6)

Affect Dysregulation intervention

EXPERIMENTAL

The AD module focuses on skills training in relation to identifying and labelling feelings, emotion management, distress tolerance, and acceptance of feelings and experiencing positive emotions. The module will be delivered by a trained therapist,in each site. Sessions are one hour long and six sessions will be delivered over an 8-week therapy window.

Behavioral: Affect Dysregulation intervention

Treatment as usual (1)

NO INTERVENTION

TAU will include ongoing standard care - antipsychotic medication as well as monitoring by psychiatrists and community psychiatric nurses (CPNs).

Negative Self Concept intervention

EXPERIMENTAL

The NSC module focus on the impact of trauma on one's self concept, how to stay in the present moment and combat dissociation, introduce self - compassion and mindfulness skills, challenge thinking patterns including tackling negative thoughts rules and assumptions that relate to ones-self, how to be more nurturing towards one's self, explore personal qualities and develop a balanced view of self. The module will be delivered by a trained therapist,in each site. Sessions are one hour long and six sessions will be delivered over an 8-week therapy window.

Behavioral: Negative Self Concept intervention

Treatment as usual (2)

NO INTERVENTION

TAU will include ongoing standard care - antipsychotic medication as well as monitoring by psychiatrists and community psychiatric nurses (CPNs).

Disturbed Relationships intervention

EXPERIMENTAL

The DR module will focus on exploration and revision of maladaptive schemas, effective assertiveness, awareness of social context, and flexibility in interpersonal expectations and behaviours that are displayed in social interactions. The module will be delivered by a trained therapist,in each site. Sessions are one hour long and six sessions will be delivered over an 8-week therapy window.

Behavioral: Disturbed Relationships intervention

Treatment as usual (3)

NO INTERVENTION

TAU will include ongoing standard care - antipsychotic medication as well as monitoring by psychiatrists and community psychiatric nurses (CPNs).

Interventions

Affect Dysregulation intervention BEHAVIORAL

See relevant study arm for description

Affect Dysregulation intervention

Negative Self Concept intervention BEHAVIORAL

See relevant study arm for description

Negative Self Concept intervention

Disturbed Relationships intervention BEHAVIORAL

See relevant study arm for description

Disturbed Relationships intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of schizophrenia-spectrum disorder (confirmed using Clinical Interview for Psychotic Disorder, CIPD)
• Presence of symptoms of Affect Dysregulation, Negative Self Concept or Disturbed Relationships as a result of exposure to traumatic life events (confirmed using the Trauma and Life Events Checklist, TALE and the International Trauma Questionnaire, ITQ - at least one of the two symptoms ≥2)
• Aged 18-65
• Have a mental health keyworker.

You may not qualify if:

• Primary diagnosis of alcohol, substance-use disorder or bipolar affective disorder
• Developmental disability
• Non-English speaking
• Lacking capacity to consent to participate
• Unmanageable risk of violence to research or clinical staff (as judged by research team)
• Significant risk of harm to self that is not being adequately managed by existing mental health services (as judged by research team).

Sponsors & Collaborators

• Edinburgh Napier University: lead
• NHS Lothian: collaborator
• NHS Greater Glasgow and Clyde: collaborator
• University of Glasgow: collaborator
• University of Sheffield: collaborator
• University of Manchester: collaborator
• University of Ulster: collaborator

Study Sites (2)

NHS Lothian

Edinburgh, United Kingdom

Location

NHS Greater Glasgow & Clyde

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical research data will be gathered at baseline, post-intervention (week 8) and follow-up (week 12) by research assistants (RAs). RAs will be masked to group allocation to demonstrate to future funders this is achievable in an Umbrella trial. Blind-breaks will be recorded, and minimised using previously successful strategies (e.g., separate offices / diaries)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Mental Health and Director of Research

Model Details: This study is a pilot/feasibility Umbrella trial, comprising of 3 'interventionist-causal' trials (IC-RCTs)

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 16, 2022
• Study Start: February 28, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)