What is the Feasibility of Narrative Exposure Therapy (NET) for People Experiencing Psychosis?

Официальное название

What is the Feasibility and Potential Impact of Narrative Exposure Therapy (NET) for People Experiencing Psychosis?

Обзор

The goal of this interventional study is to evaluate the feasibility of Narrative Exposure Therapy (NET) for people experiencing psychosis. The secondary goal of this study is to evaluate the potential impact of NET in reducing symptoms of psychosis and post-traumatic stress. Participants will be patients accessing local NHS mental health services who are between the age of 18 to 65 years-old who have been diagnosed with a psychotic disorder and have a history of trauma. The main questions the study aims to answer are: Is NET feasible to deliver to people experiencing psychosis Can NET impact symptoms of psychosis in people experiencing psychosis? Can NET impact symptoms posttraumatic stress in people experiencing psychosis? Can NET impact symptoms of depression, anxiety and stress in people experiencing psychosis? Participants will be asked to: Undertake the NET intervention with a trained NET therapist (the number of sessions will be decided based on the need of the participant) Complete a questionnaire to assess the traumas they have experienced over the course of their life (called the 'Trauma and Life Events' Scale) Complete a weekly interview to assess their symptoms of psychosis (called the 'Simplified Negative and Positive Symptoms Interview') Complete weekly measures to assess symptoms of post-traumatic stress (called the 'International Trauma Questionnaire') Complete weekly measures to assess symptoms of depression, anxiety and stress (using the Depression, Anxiety and Stress 21 item Scale \[DASS-21\]) Complete a follow-up interview to discuss their personal experience of the NET intervention)

Вмешательства

• Другое Narrative Exposure Therapy (NET)
  NET always begins with a face-to-face personal interview between the patient and the therapist to carefully assess life events using checklists, followed by an interview about trauma reactions and a thorough psychoeducation about the findings and suggested procedure of NET. In another session, he arousing and meaningful specific events from birth to present are symbolized in their valence in an autobiographical timeline (or 'lifeline'). The patient is then encouraged to share their life story, f

Первичные конечные точки

• Change Interview [Срок оценки: The Change Interview will be conducted at the follow-up phase of study which will occur 4 weeks within the final NET session.]

Вторичные конечные точки (3)

• PANSS-6 [Срок оценки: From baseline to the end of follow up which occurs within 4 weeks of the final NET session.]
• International Trauma Questionnaire (ITQ) [Срок оценки: From baseline to the end of follow up which occurs within 4 weeks of the final NET session.]
• DASS-21 (Depression, Anxiety, and Stress Scale) [Срок оценки: From baseline to the end of follow up which occurs within 4 weeks of the final NET session.]

Критерии участия

Inclusion Criteria: For the purposes of this study the term 'psychosis' covers a range of conditions recognised in standard diagnostic systems such as the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5; APA, 2013) and the International Classification of Diseases - Eleventh Revision (ICD-11; WHO, 2018). Examples include, but are not limited to:

• Schizophrenia Spectrum and Other Psychotic Disorders
• Schizophrenia
• Schizoaffective Disorder
• Brief Psychotic Disorder
• Delusional Disorder
• Substance/Medication-Induced Psychotic Disorder
• Postpartum (Postnatal) Psychosis

Individuals will be eligible to take part in the study if they meet all of the following:

• Age - between 18 and 65 years old.
• Language - able to speak and understand English well enough to take part in the research activities.
• Diagnosis - have a psychosis-related diagnosis as defined above.
• Trauma history - have experienced more than one traumatic event in their lifetime. A traumatic event means something that was deeply distressing, frightening, or life-threatening, such as abuse, assault, serious accident, disaster, or war.
• Current care - are under the care of a Local Mental Health Team (LMHT) within Nottinghamshire Healthcare NHS Foundation Trust and on the Care Programme Approach (CPA) pathway. CPA is an NHS care plan for people with complex mental health needs, setting out the support they will receive and who will provide it.
• Mobility - can travel independently to an NHS clinic or can be supported to attend.
• Consent - able to understand the study information and give informed consent to take part (in line with the Mental Capacity Act, 2005).

Exclusion Criteria: People will not be able to take part in the study if any of the following apply

• Recent change in antipsychotic medication - If the person has recently started, stopped, or changed their antipsychotic medication. This is because there are no specific medical tests ("biomarkers") to predict how someone will respond to a new medication, and the effects can vary greatly between individuals. The first few weeks after a medication change can be a time of increased risk for worsening symptoms or relapse. Research also shows that stopping and starting medication can temporarily affect thinking skills such as memory and attention.

Recent serious mental health crisis -

If the person has experienced a significant adverse event within the last three months, such as:

• A suicide attempt
• A hospital admission for mental health reasons This is because there is currently little research on how trauma-focused therapy affects people with severe mental illness who have recently been suicidal, and starting therapy too soon after a crisis may not be safe.

Currently receiving another structured psychological therapy - For example, Cognitive Behavioural Therapy (CBT) or another regular talking therapy programme. This is to ensure that the results of the study reflect the effects of Narrative Exposure Therapy (NET) alone, without being influenced by another therapy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07237529 · 25052

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗