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Schizophrenia and Schizoaffective DisorderNCT07408934

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

A study testing Cognitive Behavioral Therapy for Psychosis in people with Schizophrenia and Schizoaffective Disorder, run by The Royal Ottawa Mental Health Centre at 1 site in Canada.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cognitive Behavioral Therapy for Psychosis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteCanada
Study dates
16 Aug 2024to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site

  • Royal Ottawa Mental Health Centre

    Ottawa, Ontario, K1Z 7K4

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Cognitive Behavioral Therapy for Psychosis
Keywords
schizophrenia, schizoaffective disorder, CBT, RCT, group therapy, Feeling Safe
Medical subject headings
Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral Therapy for PsychosisBehavioural

    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.

Study groups in NCT07408934
Study groupRoleWhat they receive
Feeling Safe CBT for Psychosis group therapyExperimentalFeeling 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.
Receives: Behavioral: Cognitive Behavioral Therapy for Psychosis
Treatment-as-Usual (TAU)No interventionTreatment-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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (12)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

  11. 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.

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

  12. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2026
  2. Study start16 Aug 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07408934
Sponsor's protocol ID
2023034
Status last verified
Aug 2026
First submitted
4 Dec 2025
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 9626712

  • Skinner HA. The drug abuse screening test. Addict Behav. 1982;7(4):363-71. doi: 10.1016/0306-4603(82)90005-3.

    PubMed 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.

    PubMed 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 May;50(3):257-268. doi: 10.1017/S1352465822000030. Epub 2022 Feb 15.

    PubMed 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.

    PubMed 31911624

  • Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.

    PubMed 22193671

  • Nucifora FC Jr, Woznica E, Lee BJ, Cascella N, Sawa A. Treatment resistant schizophrenia: Clinical, biological, and therapeutic perspectives. Neurobiol Dis. 2019 Nov;131:104257. doi: 10.1016/j.nbd.2018.08.016. Epub 2018 Aug 29.

    PubMed 30170114

  • Morrison AP, Wells A, Nothard S. Cognitive and emotional predictors of predisposition to hallucinations in non-patients. Br J Clin Psychol. 2002 Sep;41(Pt 3):259-70. doi: 10.1348/014466502760379127.

    PubMed 12396254

  • Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.

    PubMed 21532953

  • Millan MJ, Andrieux A, Bartzokis G, Cadenhead K, Dazzan P, Fusar-Poli P, Gallinat J, Giedd J, Grayson DR, Heinrichs M, Kahn R, Krebs MO, Leboyer M, Lewis D, Marin O, Marin P, Meyer-Lindenberg A, McGorry P, McGuire P, Owen MJ, Patterson P, Sawa A, Spedding M, Uhlhaas P, Vaccarino F, Wahlestedt C, Weinberger D. Altering the course of schizophrenia: progress and perspectives. Nat Rev Drug Discov. 2016 Jul;15(7):485-515. doi: 10.1038/nrd.2016.28. Epub 2016 Mar 4.

    PubMed 26939910

  • Lincoln TM, Ziegler M, Mehl S, Kesting ML, Lullmann E, Westermann S, Rief W. Moving from efficacy to effectiveness in cognitive behavioral therapy for psychosis: a randomized clinical practice trial. J Consult Clin Psychol. 2012 Aug;80(4):674-86. doi: 10.1037/a0028665. Epub 2012 Jun 4.

    PubMed 22663901

  • Lecomte T, Leclerc C, Corbiere M, Wykes T, Wallace CJ, Spidel A. Group cognitive behavior therapy or social skills training for individuals with a recent onset of psychosis? Results of a randomized controlled trial. J Nerv Ment Dis. 2008 Dec;196(12):866-75. doi: 10.1097/NMD.0b013e31818ee231.

    PubMed 19077853

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy for Psychosis in people with Schizophrenia and Schizoaffective Disorder, run by The Royal Ottawa Mental Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

World Health Organization Quality of Life - Brief Version (WHOQOL-BREF) (time frame: At baseline and at end of study arm (week 24)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07408934, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

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