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

NCT07408934 | Enrolling By Invitation

• 1 other identifier: 2023034
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia and Schizoaffective Disorder

Keywords

schizophrenia; schizoaffective disorder; CBT; RCT; group therapy; Feeling Safe

Outcome Measures

Primary Outcomes (14)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  At baseline and at end of study arm (week 24)

Secondary Outcomes (3)

• Participation Rating Scale

  At baseline and weekly during group (up to 24 weeks)

• Group Cohesiveness Scale (GCS)

  At baseline and at end of each of the 4 group modules (at weeks 7, 12, 17 and 24)

• Feeling Safe Weekly Rating Scale

  At baseline and weekly during group (up to 24 weeks)

Other Outcomes (2)

• The Oxford Agoraphobic Avoidance Scale

  At baseline and at end of study arm (week 24)

• Oxford Cognitions and Defences Questionnaire

  At baseline and at end of study arm (week 24)

Study Arms (2)

Feeling Safe CBT for Psychosis group therapy

EXPERIMENTAL

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)

NO INTERVENTION

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).

Interventions

Cognitive Behavioral Therapy for Psychosis BEHAVIORAL

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.

Feeling Safe CBT for Psychosis group therapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Royal Ottawa Mental Health Centre: lead

Study Sites (1)

Royal Ottawa Mental Health Centre

Ottawa, Ontario, K1Z 7K4, Canada

Location

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MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Deanna Mercer, M.D.

  Royal Ottawa Mental Health Centre

  PRINCIPAL INVESTIGATOR

• Lisa Murata, BScN, MEd

  Royal Ottawa Mental Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: February 13, 2026
• Study Start: August 16, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)