A Pilot Trial of Group Cognitive Behavioral Therapy for Psychosis (the Feeling Safe Programme)

Official title

A Randomized Controlled Pilot Trial of Group Cognitive Behavioral Therapy (the Feeling Safe Programme) for Psychosis

Overview

Schizophrenia is a serious psychiatric disorder characterized by delusions, hallucinations, negative symptoms and disorganized behaviour. Antipsychotic medication is the main treatment for schizophrenia, but many people do not respond to treatment, and most who do respond continue to have significant symptoms. Thus, there is a need for additional treatment strategies. Cognitive behavioural therapy for psychosis (CBTp) was developed to reduce distress associated with psychotic symptoms and improve functioning. The Feeling Safe Program is a CBTp treatment that was developed by a team at University of Oxford to address paranoia and the belief that one is at risk of being harmed by others (persecutory delusions). In a recent study, 50% of participants recovered from their persecutory delusions after individual Feeling Safe Program treatment and these gains were maintained at 12 months. Currently, there are no published findings on the effectiveness of this Programme delivered in a group format. Group formats can offer benefits such as ease of service delivery, cost-effectiveness and decreasing isolation. The proposed study will explore the efficacy of the Feeling Safe Programme in a group format compared to treatment as usual.

Detailed description

With a lifetime prevalence rate of \~0.5%, schizophrenia is a serious psychiatric disorder characterized by negative (e.g., anhedonia, apathy) and positive symptoms (e.g., hallucinations, delusions) that can vary in presentation. Although treatments for schizophrenia and psychosis have improved significantly, up to 34% of clients do not respond to conventional pharmacological treatment, including first and second-generation antipsychotics. In addition, as treatment resistance in schizophrenia is defined as less than 20% improvement on standardized rating scales, and with only about 20% of individuals reporting favourable outcomes, a significant percentage of treatment responders will experience persistent symptoms. Persistent persecutory delusions in particular cause significant impairment of psychological well being, with 47% scoring lower than 2 standard deviations below the mean of non-clinical individuals. Thus, there is a need for additional treatment strategies to promote quality of life and meaningful recovery.

Cognitive Behavioural Therapy (CBT) is comprised of a wide range of techniques and interventions, and is broadly described as a structured, symptom-focused, goal-oriented therapy that aims to improve quality of life by changing a patient's thoughts or thinking patterns considered to maintain problematic symptoms. There is consistent support for CBT treatment for a range of psychiatric and psychosocial difficulties including depression, anxiety disorders, substance abuse, eating disorders, and personality disorders. CBT for psychosis (CBTp) interventions have been developed to reduce distress associated with psychotic symptoms, promote hope, and increase functioning. Qualitative research embedded within trials demonstrates that when service users are exposed to high quality CBT-P, delivered by competent trial therapists, they have high satisfaction and experience it as recovery-orientated, collaborative and validating.

The Feeling Safe Programme was recently developed by a team at University of Oxford. The aim was to develop a CBT treatment for people with schizophrenia that had a success rate for psychosis that was more similar to CBT treatments for anxiety disorders. Developed with over a decade's research, The Feeling Safe Programme has proved to be an effective psychological treatment for persecutory delusions. For example, in a recent randomized controlled trial, half of the outpatient participants recovered from their persecutory delusions after undergoing individual treatment through the Feeling Safe Programme, and these gains were maintained at 12 months. Specifically, The Feeling Safe Programme led to significant reductions in delusional conviction and severity.

There is some evidence that group CBTp is an effective and promising intervention and group CBTp may be more cost effective than individual CBTp. In a recent Cochrane systematic review of group cognitive behavioural therapy for schizophrenia, group CBT appeared to be better than standard care or other psychosocial interventions on improving total symptoms of schizophrenia and global functioning. The authors also note that due to low sample sizes, no firm conclusions concerning the efficacy of group CBTp for people with schizophrenia can be made and that more high-quality research, reporting useable and relevant data is needed. This study would help to fill that need.

Goals and Aims of the Study: While there is some limited evidence of the effectiveness of group CBT for schizophrenia, there are no published findings on the effectiveness of this Feeling Safe Programme delivered in a group format. The proposed study will explore the efficacy of the Feeling Safe Programme in a group format compared to treatment as usual (TAU). Further, it will explore the experiences of individuals participating in the Feeling Safe Programme delivered in a group format.

Interventions

• Behavioral Cognitive Behavioral Therapy for Psychosis
  Feeling Safe CBT: The treatment approach is modular and manualised. Group modules will include: Sleep (7 sessions), Worry (6 sessions), Self-Confidence (5 sessions) and Feeling Safe Enough (6 sessions), targeted at dropping safety behaviours in behavioural tests in order to reduce threat beliefs and build safety beliefs. Participants who experience auditory hallucinations will have the option to do the module: Feeling Safe Alongside Hearing Voices (5 sessions) individually. Clients will choose t

Primary outcome measures

• World Health Organization Quality of Life - Brief Version (WHOQOL-BREF) [Time frame: At baseline and at end of study arm (week 24)]
• Modified Psychotic Symptoms Rating Scale (PSYRATS) [Time frame: At baseline and at end of study arm (week 24)]
• Paranoid Thoughts Scale (GPTS) [Time frame: At baseline and at end of study arm (week 24)]
• Alcohol Use Disorders Identification Test (AUDIT-C) [Time frame: At baseline and at end of study arm (week 24)]
• Drug Abuse Screening Test (DAST-10) [Time frame: At baseline and at end of study arm (week 24)]
• Safety Behaviours Questionnaire-Persecutory Beliefs (SBQ) [Time frame: At baseline and at end of study arm (week 24)]
• Brief Core Schema Scales (BCSS) [Time frame: At baseline and at end of study arm (week 24)]
• Interpretation of Voices Inventory (IVI) [Time frame: At baseline and at end of study arm (week 24)]
• Insomnia Severity Index (ISI) [Time frame: At baseline and at end of study arm (week 24)]
• Dunn Worry Questionnaire (DWQ) [Time frame: At baseline and at end of study arm (week 24)]

Secondary outcome measures (3)

• Participation Rating Scale [Time frame: At baseline and weekly during group (up to 24 weeks)]
• Group Cohesiveness Scale (GCS) [Time frame: At baseline and at end of each of the 4 group modules (at weeks 7, 12, 17 and 24)]
• Feeling Safe Weekly Rating Scale [Time frame: At baseline and weekly during group (up to 24 weeks)]

Eligibility criteria

Inclusion criteria

• Diagnosis of schizophrenia, schizoaffective disorder, delusional disorder based on the Diagnostic and Statistical Manual of Mental Disorders (DSM), Fifth Edition, (American Psychiatric Association, 2013), as assessed by a Royal staff psychiatrist or psychologist.
• From the Outpatient Integrated Schizophrenia Recovery Program (includes the Outpatient service, Day Program, and Regional Psychosis Clinic)
• Ability to read and write English
• Able to talk openly about psychotic symptoms even if they don't recognize them as such.
• Interested in learning ways to cope with symptoms
• Able to participate regularly, for 75 minutes once per week, in person
• Willingness and capacity to be a participant in the study as evidenced by a signed written informed consent

Exclusion criteria

• Current participation in individual or group CBT
• Previous participation in the Feeling Safe Programme
• Acute psychotic episode
• Have a current primary diagnosis of substance use disorder or personality disorder
• A stated inability to refrain from using substances before/during study visits
• Have an organic syndrome such as delirium, dementia, or amnesia
• Have a moderate to severe intellectual disability

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Canada · 1 center

• Royal Ottawa Mental Health Centre — Ottawa

Publications

• Yudko E, Lozhkina O, Fouts A. A comprehensive review of the psychometric properties of the Drug Abuse Screening Test. J Subst Abuse Treat. 2007 Mar;32(2):189-98. doi: 10.1016/j.jsat.2006.08.002. Epub 2006 Nov 21. PMID 17306727
• Wongpakaran T, Wongpakaran N, Intachote-Sakamoto R, Boripuntakul T. The Group Cohesiveness Scale (GCS) for psychiatric inpatients. Perspect Psychiatr Care. 2013 Jan;49(1):58-64. doi: 10.1111/j.1744-6163.2012.00342.x. Epub 2012 Jun 12. PMID 23293998
• Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667. PMID 9626712
• Skinner HA. The drug abuse screening test. Addict Behav. 1982;7(4):363-71. doi: 10.1016/0306-4603(82)90005-3. PMID 7183189
• Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. doi: 10.1111/j.1360-0443.1993.tb02093.x. PMID 8329970
• Salkovskis PM Ed. (1996). Frontiers of Cognitive Therapy. New York: Guilford.
• Rosebrock L, Lambe S, Mulhall S, Petit A, Loe BS, Saidel S, Pervez M, Mitchell J, Chauhan N, Prouten E, Chan C, Aynsworth C, Murphy E, Jones J, Powling R, Chapman K, Dudley R, Morrison A, O'Regan E, Clark DM, Waite F, Freeman D. Understanding agoraphobic avoidance: the development of the Oxford Cognitions and Defences Questionnaire (O-CDQ). Behav Cogn Psychother. 2022 Feb 15;50(3):1-12. doi: 10.10 PMID 35166196
• Potkin SG, Kane JM, Correll CU, Lindenmayer JP, Agid O, Marder SR, Olfson M, Howes OD. The neurobiology of treatment-resistant schizophrenia: paths to antipsychotic resistance and a roadmap for future research. NPJ Schizophr. 2020 Jan 7;6(1):1. doi: 10.1038/s41537-019-0090-z. PMID 31911624

Identifiers

NCT: NCT07408934 · 2023034

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗