An interventional study of Cognitive Behavioral Therapy for Psychosis in Schizophrenia and Schizoaffective Disorder, sponsored by The Royal Ottawa Mental Health Centre. Enrolling by invitation at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by The Royal Ottawa Mental Health Centre · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Feeling Safe CBT: Participants will receive up to 24 weeks of Feeling Safe CBT for Psychosis therapy. Group modules will include: Sleep (7 sessions), Worry (6 sessions), Self-Confidence (5 sessions) and Feeling Safe Enough (6 sessions). Participants who experience auditory hallucinations will have the option to do the module: Feeling Safe Alongside Hearing Voices (5 sessions) individually.
Behavioral: Cognitive Behavioral Therapy for Psychosis
Treatment-as-Usual (TAU): Participants in the TAU arm will continue with their current treatment as decided by their treatment team. TAU is defined as interdisciplinary treatment provided by disciplines such as psychiatry, psychology, social work, nursing, occupational therapy, recreational therapy, and dietary. Participants who are randomly assigned to the TAU arm will be offered the CBT intervention after completion of the wait list arm (24-week wait period).
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 the modules they wish to participate in. They will be required to choose a minimum of 2 modules, and will be encouraged to do the Feeling Safe Enough module. The minimum number of sessions a participant can attend will be 10. The maximum number of group sessions participants can attend will be 24. Groups will run weekly for 75-90 minutes. Each CBT group will have approximately six participants. The same therapists will provide the individual therapy.
World Health Organization Quality of Life - Brief Version (WHOQOL-BREF)
The World Health Organization Quality of Life - Brief Version (WHOQOL-BREF; WHOQOL Group, 1998) is a 26-item self-report questionnaire (with a scoring range 1-5) which assesses 4 domains of quality of life: physical health, psychological health, social relationships, and environment. It also includes a measure of overall quality of life and general health. Scores are converted to a 0-100 scale, where higher scores are indicative of better quality of life.
Time frame: At baseline and at end of study arm (week 24)
Modified Psychotic Symptoms Rating Scale (PSYRATS)
The Modified Psychotic Symptoms Rating Scale (PSYRATS; Haddock et al., 1999) is a 17-item measure of delusions and auditory hallucinations. Rated on a five-point scale (0-4; none to severe). Rates symptoms from the previous week. Two subscales obtained: Auditory Hallucinations Scale (11 items, scores range from 0-44) and Delusions Scale (6 items, scores range from 0-24). Higher scores reflect greater symptom severity.
Time frame: At baseline and at end of study arm (week 24)
Paranoid Thoughts Scale (GPTS)
The Paranoid Thoughts Scale (GPTS; Green et al., 2008) is a 32-item self-report measure of paranoia comprised of two subscales to assess: ideas of reference and ideas of persecution. Each item is rated on a five-point scale (1-5). Scores on each scale can range from 16-80. Higher scores indicate greater levels of paranoid thinking.
Time frame: At baseline and at end of study arm (week 24)
Alcohol Use Disorders Identification Test (AUDIT-C)
The Alcohol Use Disorders Identification Test (AUDIT-C; Saunders et al., 1993; Bush et al., 1998) is a short 3-item alcohol screening tool. Questions are rated on a scale from 0-4, giving a possible total score from 0-12, with lower scores indicative of lower risk.
Time frame: At baseline and at end of study arm (week 24)
Drug Abuse Screening Test (DAST-10)
The Drug Abuse Screening Test (DAST-10; Skinner, 1982; Yudko, Lozhkina \& Fouts, 2007) is a brief 10-item self-report measure for identifying individuals who are abusing psychoactive drugs. It also provides a score of the degree of problems related to drug use and misuse. Total score can range from 0-10, with higher scores indicative of more severe levels of drug abuse.
Time frame: At baseline and at end of study arm (week 24)
Safety Behaviours Questionnaire-Persecutory Beliefs (SBQ)
The Safety Behaviours Questionnaire-Persecutory Beliefs (SBQ; Freeman et al., 2001) is a semi-structured interview assessing safety behaviours used in the last month. Seven types of safety behaviours are assessed including: avoidance, in-situation, escape, compliance, help-seeking, aggression, delusional. When safety behaviours are indicated, the frequency is rated on a 4-point scale (1-4). The total score can range from 0-28. Higher scores reflect greater frequency and reliance on defensive/safety behaviours.
Time frame: At baseline and at end of study arm (week 24)
Brief Core Schema Scales (BCSS)
The Brief Core Schema Scales (BCSS; Fowler et al, 2006) is a 24-item self-report concerning beliefs about the self and others. Items are assessed on a 5-point rating scale (0-4). Scores are obtained for 4 subscales including negative-self, positive-self, negative-others, and positive-others, with a range from 0-24 for each. Higher scores on negative subscales indicate pathology while higher scores on positive subscales suggest adaptive functioning.
Time frame: At baseline and at end of study arm (week 24)
Interpretation of Voices Inventory (IVI)
The Interpretation of Voices Inventory (IVI; Morrison, Wells \& Nothard, 2002) is a 26-item assessment of positive and negative interpretations of voice hearing. Items are divided into three subscales including: meta-physical beliefs about voices (13 items), positive beliefs about voices (8 items), and interpretations of loss of control (5 items). Items are rated from 1 (not at all) to 4 (very much). Totals for the subscales range from 13-52 for the meta-physical subscale, 8-32 for the positive beliefs subscale and 5-20 for the loss of control subscale. Higher scores indicate more identification with the experience.
Time frame: At baseline and at end of study arm (week 24)
Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI; Morin et al., 2011) is a 7-item self-report questionnaire assessing the nature, severity and impact of insomnia. The ISI uses a 5-point Likert scale to rate each item (0-4). The total score can range from 0-28 and is interpreted as: absence of insomnia (0-7), subthreshold insomnia (8-14), moderate insomnia (15-21), severe insomnia (22-28). Higher scores are indicative of more severe symptoms of insomnia.
Time frame: At baseline and at end of study arm (week 24)
Dunn Worry Questionnaire (DWQ)
The Dunn Worry Questionnaire (DWQ; Freeman et al., 2020) is a 10-item self-report questionnaire asking how a person typically thinks about negative problems. Items are scored on a scale from 0-4, with higher scores indicative of more worry. The total score is obtained by adding all 10 items together, with a score of 21 or higher indicating clinically high levels of worry.
Time frame: At baseline and at end of study arm (week 24)
Beck Depression Inventory-II (BDI-II)
The Beck Depression Inventory-II (BDI-II; Beck et al., 1996) is a 21-item self-report inventory that measures severity of depression. Items are rated on a scale from 0-3 for severity. The total score can range from 0-63, where a score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Time frame: At baseline and at end of study arm (week 24)
Social Phobia Inventory (SPIN)
The Social Phobia Inventory (SPIN; Connor et al., 2000) is a 17-item self-rating questionnaire for social anxiety disorder. The scale includes items assessing the following domains: fear, avoidance, physiologic arousal. Items are rated on a scale from 0-4, with a score range of 0-68. A score above 19 may indicate the presence of social anxiety disorder.
Time frame: At baseline and at end of study arm (week 24)
Columbia-Suicide Severity Rating Scale (C-SSRS)
The Columbia-Suicide Severity Rating Scale (C-SSRS; Posner et al., 2011) is a suicide risk assessment tool that helps to identify if someone is at risk for suicide, to assess the severity and immediacy of that risk and gauge the level of support needed. Interpretation of the scale is based on a stratification into low, medium and high risk categories. Lower risk would require further evaluation, moderate risk indicates a more significant concern requiring a comprehensive risk assessment and a higher risk warrants immediate intervention and a thorough safety assessment.
Time frame: At baseline and at end of study arm (week 24)
Process of Recovery Questionnaire (QPR)
The Process of Recovery Questionnaire (QPR; Law et al., 2014) is a 15-item self-report measure that asks people about aspects of recovery that are meaningful to them. Items are scored on a 4-point scale (0-4). The total score ranges from 0-60, with higher scores indicative of greater personal recovery.
Time frame: At baseline and at end of study arm (week 24)
Feeling Safe Weekly Rating Scale
At the start of each group session, participants will be asked to complete the Feeling Safe Weekly Rating Scale. Rated on a scale from 0-100, questions assess intensity of delusional conviction, distress, feelings of safety, happiness and engagement in valued activities. Higher scores are indicative of more intensity of the item being measured.
Time frame: At baseline and weekly during group (up to 24 weeks)
Plan to share: No
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The Royal Ottawa Mental Health Centre