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Cognitive Behavioural Therapy for psychosis (CBTp) in acute mental health inpatient settings

Crisis-focused Cognitive Behavioural Therapy for psychosis (CBTp) in inpatient settings (the CRISIS study): a feasibility randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN59055607
Enrollment
60
Registered
2021-02-18
Start date
2021-02-18
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute mental health inpatient service users experiencing psychosis Mental and Behavioural Disorders Psychosis, schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, or psychotic disorder not otherwise specified

Interventions

coping, self-management and problem solving
crisis plans and crisis cards
Participants will be randomly allocated to either Treatment as Usual (TAU) or CBTp plus TAU in a 1:1 ratio. The randomisation will be undertaken using www.sealedenvelope.com. Participant numbers will
formulation of the crisis
stabilisation and safety
change strategy work focusing on crisis appraisals and safety behaviours
and discharge, relapse planning and recovery toolkits. The first two components (engagement, assessment and identifying p

Sponsors

University College London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged =18 years 2. Meet criteria for a schizophrenia-spectrum diagnosis (schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, or psychotic disorder not otherwise specified) or meet criteria for an Early Intervention Service (EIS) for treatment of psychosis to allow for diagnostic uncertainty 3. Able to give informed consent and have the capacity to consent to participation in the study 4. Currently receiving care from an acute psychiatric inpatient team

Exclusion criteria

Exclusion criteria: 1. Non-English speakers (due to translation costs and difficulty of producing valid translations of the research instruments and intervention 2. Acquired brain injury or substance misuse judged to be the acute cause of the psychotic experiences 3. Already undertaking a structured psychological intervention delivered by a psychologist or trained therapist at the time of study

Design outcomes

Primary

MeasureTime frame
Feasibility measured using the following collected between baseline and 6 months: 1. Individual patient data collected on a pre-developed sheet adhering to CONSORT guidelines including patient eligibility status, number of referrals received by ward staff, the willingness of participants to consent, the willingness of participants to be randomised, and attrition 2. Therapy-specific data including the number of sessions attended, therapy resources used, mode of therapy, location of therapy sessions, number of sessions conducted prior to and post-discharge, time and duration of sessions, quantity of homework completed, and any serious adverse events 3. Patient outcome measure completion

Secondary

MeasureTime frame
1. Experiences of psychosis measured using the Positive and Negative Syndrome Scale (PANSS) completed by trained research assistants during a semi-structured clinical interview at baseline, 2, and 6 months. The PANSS is a 7-item sub-scale and participants can score from 1 (absent) to 7 (extreme) on each item. 2. Depression measured using the Beck Depression Inventory brief 7-item measure (BDI-7) completed by participant self-report (with assistance from the researcher) at baseline, 2, and 6 months. Participants can score from 0 (not present) to 3 (indicating severe) on each item (symptoms of sadness, pessimism, past failure, loss of pleasure, self-dislike, self-criticism, and suicidal thoughts) and have a total score of 21. 3. Hopelessness measured using the short-form of the Beck Hopelessness Scale (BHS) completed by participant self-report (with assistance from the researcher) at baseline, 2, and 6 months. The BHS is a recently developed 9-item version of the scale validated for psychiatric inpatients to include items 2, 6, 11, 12, 14, 16, 17, 18 and 20 from the original scale. Participants can score 0 (not present) or 1 (present) on each item (“My future seems dark to me” and “I have great faith in the future”). 4. Personal recovery measured using the 15-item Process of Recovery Questionnaire (QPR) completed by participant self-report (with assistance from the researcher) at baseline, 2, and 6 months. Participants can score from 0 (disagree strongly) to 4 (agree strongly) on each item (“I feel better about myself” and “I feel that my life has a purpose”), and score a total a maximum of 40 on the scale. 5. Anxiety measured using the Generalised Anxiety Disorder 7-item (GAD-7) measure completed by participant self-report (with assistance from the researcher) at baseline, 2, and 6 months. Participants can score from 0 (not at all) to 3 (nearly every day) on each item. 6. Subjective experiences of crisis in psychosis measured using a newly developed measure by t

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026