Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 5:08 AM
Study NCT ID:
NCT07408934
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-02-13
First Post:
2025-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Trial of Group Cognitive Behavioral Therapy for Psychosis (the Feeling Safe Programme)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2025-12-04', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The Oxford Agoraphobic Avoidance Scale', 'timeFrame': 'At baseline and at end of study arm (week 24)', 'description': 'The Oxford Agoraphobic Avoidance Scale (O-AS; Lambe et al., 2021) is an 8-item self-report questionnaire measuring agoraphobic avoidance comprised of two subscales: avoidance and distress. For the avoidance subscale, each item is first rated as 0=yes and 1=no, with a possible score range from 0-8, with higher scores indicative of greater avoidance. For the distress subscale, items rated as avoidant, are then rated on the amount of distress associated with doing the task, on a scale from 0 (No distress) to 10 (Extreme distress). The possible range on the distress subscale is 0-80, with higher scores indicative of greater distress.'}, {'measure': 'Oxford Cognitions and Defences Questionnaire', 'timeFrame': 'At baseline and at end of study arm (week 24)', 'description': 'The Oxford Cognitions and Defences Questionnaire (O-CDQ; Rosebrock et al, 2022) measures negative beliefs and coping strategies related to fear, paranoia, panic. It is comprised of 33 items and 3 main subscales: Threat Cognitions (14 items related to worries about bad things happening), Anxious Avoidance (11 items related to avoiding feared situations) and Within-Situation Safety Behaviours (8 items related to defences or actions taken to feel safe in feared situations). Items are rated on 4-point scale (0=never and 3=always). Scores can range from 0-42 for the Threat Cognitions subscale, 0-33 for the Anxious Avoidance subscale and 0-24 for the Within-Situation Safety Behaviours subscale, with higher scores indicative of greater severity.'}], 'primaryOutcomes': [{'measure': 'World Health Organization Quality of Life - Brief Version (WHOQOL-BREF)', 'timeFrame': 'At baseline and at end of study arm (week 24)', 'description': '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.'}, {'measure': 'Modified Psychotic Symptoms Rating Scale (PSYRATS)', 'timeFrame': 'At baseline and at end of study arm (week 24)', 'description': '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.'}, {'measure': 'Paranoid Thoughts Scale (GPTS)', 'timeFrame': 'At baseline and at end of study arm (week 24)', 'description': '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.'}, {'measure': 'Alcohol Use Disorders Identification Test (AUDIT-C)', 'timeFrame': 'At baseline and at end of study arm (week 24)', 'description': '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.'}, {'measure': 'Drug Abuse Screening Test (DAST-10)', 'timeFrame': 'At baseline and at end of study arm (week 24)', 'description': '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.'}, {'measure': 'Safety Behaviours Questionnaire-Persecutory Beliefs (SBQ)', 'timeFrame': 'At baseline and at end of study arm (week 24)', 'description': '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.'}, {'measure': 'Brief Core Schema Scales (BCSS)', 'timeFrame': 'At baseline and at end of study arm (week 24)', 'description': '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.'}, {'measure': 'Interpretation of Voices Inventory (IVI)', 'timeFrame': 'At baseline and at end of study arm (week 24)', 'description': '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.'}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': 'At baseline and at end of study arm (week 24)', 'description': '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.'}, {'measure': 'Dunn Worry Questionnaire (DWQ)', 'timeFrame': 'At baseline and at end of study arm (week 24)', 'description': '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.'}, {'measure': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': 'At baseline and at end of study arm (week 24)', 'description': '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.'}, {'measure': 'Social Phobia Inventory (SPIN)', 'timeFrame': 'At baseline and at end of study arm (week 24)', 'description': '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.'}, {'measure': 'Columbia-Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'At baseline and at end of study arm (week 24)', 'description': '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.'}, {'measure': 'Process of Recovery Questionnaire (QPR)', 'timeFrame': 'At baseline and at end of study arm (week 24)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Participation Rating Scale', 'timeFrame': 'At baseline and weekly during group (up to 24 weeks)', 'description': "Group leaders will complete the Participation Rating Scale (Leclerc, 1998) which captures details about each group member's participation including positive behaviours such as attention, visual contact, verbal participation, asking questions, helping others, socializing, and negative behaviours such as disruptive behaviour and confusion. Items are rated from 0-4, where 0 is the absence of behaviour and 4 is the exceptional presence of a behaviour. Higher scores on the positive behaviours and lower scores on the negative behaviours are indicative of better participation."}, {'measure': 'Group Cohesiveness Scale (GCS)', 'timeFrame': 'At baseline and at end of each of the 4 group modules (at weeks 7, 12, 17 and 24)', 'description': 'The Group Cohesiveness Scale (GCS; Wongpakaran et al., 2013) is a scale to measure the cohesiveness of the group. The GCS is a 7-item self-report scale that measures two domains (cohesion and engagement) on a 5-point scale. Scores range from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 7-35, with higher scores indicating greater cohesion.'}, {'measure': 'Feeling Safe Weekly Rating Scale', 'timeFrame': 'At baseline and weekly during group (up to 24 weeks)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'schizoaffective disorder', 'CBT', 'RCT', 'group therapy', 'Feeling Safe'], 'conditions': ['Schizophrenia and Schizoaffective Disorder']}, 'referencesModule': {'references': [{'pmid': '17306727', 'type': 'BACKGROUND', 'citation': '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': '23293998', 'type': 'BACKGROUND', 'citation': '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': '9626712', 'type': 'BACKGROUND', 'citation': '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': '7183189', 'type': 'BACKGROUND', 'citation': 'Skinner HA. The drug abuse screening test. Addict Behav. 1982;7(4):363-71. doi: 10.1016/0306-4603(82)90005-3.'}, {'pmid': '8329970', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Salkovskis PM Ed. (1996). 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These de doctorat, Universite de Montreal."}, {'pmid': '24816049', 'type': 'BACKGROUND', 'citation': 'Law H, Neil ST, Dunn G, Morrison AP. Psychometric properties of the questionnaire about the process of recovery (QPR). Schizophr Res. 2014 Jul;156(2-3):184-9. doi: 10.1016/j.schres.2014.04.011. Epub 2014 May 9.'}, {'pmid': '37010211', 'type': 'BACKGROUND', 'citation': 'Lambe S, Bird JC, Loe BS, Rosebrock L, Kabir T, Petit A, Mulhall S, Jenner L, Aynsworth C, Murphy E, Jones J, Powling R, Chapman K, Dudley R, Morrison A, Regan EO, Yu LM, Clark D, Waite F, Freeman D. The Oxford Agoraphobic Avoidance Scale. Psychol Med. 2023 Mar;53(4):1233-1243. doi: 10.1017/S0033291721002713. Epub 2021 Aug 23.'}, {'pmid': '16023620', 'type': 'BACKGROUND', 'citation': 'Kessler RC, Birnbaum H, Demler O, Falloon IR, Gagnon E, Guyer M, Howes MJ, Kendler KS, Shi L, Walters E, Wu EQ. The prevalence and correlates of nonaffective psychosis in the National Comorbidity Survey Replication (NCS-R). Biol Psychiatry. 2005 Oct 15;58(8):668-76. doi: 10.1016/j.biopsych.2005.04.034. Epub 2005 Jul 14.'}, {'pmid': '27919182', 'type': 'BACKGROUND', 'citation': 'Howes OD, McCutcheon R, Agid O, de Bartolomeis A, van Beveren NJ, Birnbaum ML, Bloomfield MA, Bressan RA, Buchanan RW, Carpenter WT, Castle DJ, Citrome L, Daskalakis ZJ, Davidson M, Drake RJ, Dursun S, Ebdrup BH, Elkis H, Falkai P, Fleischacker WW, Gadelha A, Gaughran F, Glenthoj BY, Graff-Guerrero A, Hallak JE, Honer WG, Kennedy J, Kinon BJ, Lawrie SM, Lee J, Leweke FM, MacCabe JH, McNabb CB, Meltzer H, Moller HJ, Nakajima S, Pantelis C, Reis Marques T, Remington G, Rossell SL, Russell BR, Siu CO, Suzuki T, Sommer IE, Taylor D, Thomas N, Ucok A, Umbricht D, Walters JT, Kane J, Correll CU. Treatment-Resistant Schizophrenia: Treatment Response and Resistance in Psychosis (TRRIP) Working Group Consensus Guidelines on Diagnosis and Terminology. Am J Psychiatry. 2017 Mar 1;174(3):216-229. doi: 10.1176/appi.ajp.2016.16050503. Epub 2016 Dec 6.'}, {'pmid': '10473315', 'type': 'BACKGROUND', 'citation': 'Haddock G, McCarron J, Tarrier N, Faragher EB. Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychol Med. 1999 Jul;29(4):879-89. doi: 10.1017/s0033291799008661.'}, {'pmid': '35866377', 'type': 'BACKGROUND', 'citation': 'Guaiana G, Abbatecola M, Aali G, Tarantino F, Ebuenyi ID, Lucarini V, Li W, Zhang C, Pinto A. Cognitive behavioural therapy (group) for schizophrenia. Cochrane Database Syst Rev. 2022 Jul 12;7(7):CD009608. doi: 10.1002/14651858.CD009608.pub2.'}, {'pmid': '17903336', 'type': 'BACKGROUND', 'citation': 'Green CE, Freeman D, Kuipers E, Bebbington P, Fowler D, Dunn G, Garety PA. Measuring ideas of persecution and social reference: the Green et al. Paranoid Thought Scales (GPTS). Psychol Med. 2008 Jan;38(1):101-11. doi: 10.1017/S0033291707001638. Epub 2007 Oct 1.'}, {'pmid': '21535424', 'type': 'BACKGROUND', 'citation': "Gaynor K, Dooley B, Lawlor E, Lawoyin R, O'Callaghan E. Group cognitive behavioural therapy as a treatment for negative symptoms in first-episode psychosis. Early Interv Psychiatry. 2011 May;5(2):168-73. doi: 10.1111/j.1751-7893.2011.00270.x."}, {'pmid': '11681555', 'type': 'BACKGROUND', 'citation': 'Freeman D, Garety PA, Kuipers E. Persecutory delusions: developing the understanding of belief maintenance and emotional distress. Psychol Med. 2001 Oct;31(7):1293-306. doi: 10.1017/s003329170100455x.'}, {'pmid': '24297621', 'type': 'BACKGROUND', 'citation': 'Freeman D, Startup H, Dunn G, Wingham G, Cernis E, Evans N, Lister R, Pugh K, Cordwell J, Kingdon D. Persecutory delusions and psychological well-being. Soc Psychiatry Psychiatr Epidemiol. 2014 Jul;49(7):1045-50. doi: 10.1007/s00127-013-0803-y. Epub 2013 Dec 3.'}, {'pmid': '34246324', 'type': 'BACKGROUND', 'citation': 'Freeman D, Emsley R, Diamond R, Collett N, Bold E, Chadwick E, Isham L, Bird JC, Edwards D, Kingdon D, Fitzpatrick R, Kabir T, Waite F; Oxford Cognitive Approaches to Psychosis Trial Study Group. Comparison of a theoretically driven cognitive therapy (the Feeling Safe Programme) with befriending for the treatment of persistent persecutory delusions: a parallel, single-blind, randomised controlled trial. Lancet Psychiatry. 2021 Aug;8(8):696-707. doi: 10.1016/S2215-0366(21)00158-9. Epub 2021 Jul 8.'}, {'pmid': '30947766', 'type': 'BACKGROUND', 'citation': 'Freeman D, Bird JC, Loe BS, Kingdon D, Startup H, Clark DM, Ehlers A, Cernis E, Wingham G, Evans N, Lister R, Pugh K, Cordwell J, Dunn G. The Dunn Worry Questionnaire and the Paranoia Worries Questionnaire: new assessments of worry. Psychol Med. 2020 Apr;50(5):771-780. doi: 10.1017/S0033291719000588. Epub 2019 Apr 5.'}, {'pmid': '16563204', 'type': 'BACKGROUND', 'citation': 'Fowler D, Freeman D, Smith B, Kuipers E, Bebbington P, Bashforth H, Coker S, Hodgekins J, Gracie A, Dunn G, Garety P. The Brief Core Schema Scales (BCSS): psychometric properties and associations with paranoia and grandiosity in non-clinical and psychosis samples. Psychol Med. 2006 Jun;36(6):749-59. doi: 10.1017/S0033291706007355. Epub 2006 Mar 27.'}, {'pmid': '33455594', 'type': 'BACKGROUND', 'citation': 'Fordham B, Sugavanam T, Edwards K, Stallard P, Howard R, das Nair R, Copsey B, Lee H, Howick J, Hemming K, Lamb SE. The evidence for cognitive behavioural therapy in any condition, population or context: a meta-review of systematic reviews and panoramic meta-analysis. Psychol Med. 2021 Jan;51(1):21-29. doi: 10.1017/S0033291720005292. Epub 2021 Jan 18.'}, {'pmid': '27216902', 'type': 'BACKGROUND', 'citation': 'Elkis H, Buckley PF. Treatment-Resistant Schizophrenia. Psychiatr Clin North Am. 2016 Jun;39(2):239-65. doi: 10.1016/j.psc.2016.01.006. Epub 2016 Mar 30.'}, {'pmid': '10827888', 'type': 'BACKGROUND', 'citation': 'Connor KM, Davidson JR, Churchill LE, Sherwood A, Foa E, Weisler RH. Psychometric properties of the Social Phobia Inventory (SPIN). New self-rating scale. Br J Psychiatry. 2000 Apr;176:379-86. doi: 10.1192/bjp.176.4.379.'}, {'pmid': '9738608', 'type': 'BACKGROUND', 'citation': 'Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med. 1998 Sep 14;158(16):1789-95. doi: 10.1001/archinte.158.16.1789.'}, {'type': 'BACKGROUND', 'citation': 'Brabban A, Byrne R, Longden E & Morrison AP. (2017). The importance of human relationships, ethics and recovery-orientated values in the delivery of CBT for people with psychosis. Psychosis, 9:2, 157-166.'}, {'type': 'BACKGROUND', 'citation': 'Beck AT, Steer RA, & Brown G. (1996). Beck Depression Inventory-II (BDI-II).'}, {'type': 'BACKGROUND', 'citation': 'Beck JS. (1995). Cognitive therapy: Basics and beyond. New York: Guilford.'}, {'pmid': '20113303', 'type': 'BACKGROUND', 'citation': 'Bechdolf A, Knost B, Nelson B, Schneider N, Veith V, Yung AR, Pukrop R. Randomized comparison of group cognitive behaviour therapy and group psychoeducation in acute patients with schizophrenia: effects on subjective quality of life. Aust N Z J Psychiatry. 2010 Feb;44(2):144-50. doi: 10.3109/00048670903393571.'}, {'type': 'BACKGROUND', 'citation': 'American Psychiatric Association. (2013). Schizophrenia and other psychotic disorders. In: Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Washington, D.C.; American Psychiatric Association; 89-122.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nCognitive 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.\n\nCurrently, 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.', 'detailedDescription': "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.\n\nCognitive 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.\n\nThe 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.\n\nThere 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.\n\nGoals 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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.\n* From the Outpatient Integrated Schizophrenia Recovery Program (includes the Outpatient service, Day Program, and Regional Psychosis Clinic)\n* Ability to read and write English\n* Able to talk openly about psychotic symptoms even if they don't recognize them as such.\n* Interested in learning ways to cope with symptoms\n* Able to participate regularly, for 75 minutes once per week, in person\n* Willingness and capacity to be a participant in the study as evidenced by a signed written informed consent\n\nExclusion Criteria:\n\n* Current participation in individual or group CBT\n* Previous participation in the Feeling Safe Programme\n* Acute psychotic episode\n* Have a current primary diagnosis of substance use disorder or personality disorder\n* A stated inability to refrain from using substances before/during study visits\n* Have an organic syndrome such as delirium, dementia, or amnesia\n* Have a moderate to severe intellectual disability"}, 'identificationModule': {'nctId': 'NCT07408934', 'briefTitle': 'A Pilot Trial of Group Cognitive Behavioral Therapy for Psychosis (the Feeling Safe Programme)', 'organization': {'class': 'OTHER', 'fullName': 'The Royal Ottawa Mental Health Centre'}, 'officialTitle': 'A Randomized Controlled Pilot Trial of Group Cognitive Behavioral Therapy (the Feeling Safe Programme) for Psychosis', 'orgStudyIdInfo': {'id': '2023034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Feeling Safe CBT for Psychosis group therapy', 'description': '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.', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy for Psychosis']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment-as-Usual (TAU)', 'description': '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.\n\nParticipants 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': [{'name': 'Cognitive Behavioral Therapy for Psychosis', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Feeling Safe CBT for Psychosis group therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1Z 7K4', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Royal Ottawa Mental Health Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Deanna Mercer, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Ottawa Mental Health Centre'}, {'name': 'Lisa Murata, BScN, MEd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Ottawa Mental Health Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Royal Ottawa Mental Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}