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The feasibility of cognitive behavioural therapy for depression and anxiety adapted for psychosis risk in primary care

Adapting primary care services to meet the needs of people with early signs of psychosis: A feasibility study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN60216932
Enrollment
64
Registered
2025-07-29
Start date
2021-10-01
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

Psychosis Mental and Behavioural Disorders

Interventions

Design: This feasibility study will use a within-participants, repeated measures design. An initial six-month control period will be implemented in participating services, comprising treatment as usua

Sponsors

University of Southampton
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Over the age of 18 years 2. Meet criteria for NHS IAPT services (i.e. have a primary diagnosis of mild to moderate anxiety or depression) 3. Meet one or more of the two item ARMS screen 4. Able to engage in IAPT provision of care 5. Capacity to consent as determined by their assessing clinician

Exclusion criteria

Exclusion criteria: 1. Unsuitable for IAPT services (e.g. due to severity of illness or organic problems) 2. Lack capacity to consent as determined by their assessing clinician 3. Meet EIP/CMHT threshold criteria (e.g. due to severity of illness) 4. At significant risk to themselves or others 5. Participating in any other interventional research

Design outcomes

Primary

MeasureTime frame
The following primary outcome measures are completed pre- and post-therapy: 1. Eligibility rate measured using the number of positive responses on the two-item at-risk mental states (ARMS) screen 2. Problem indicator measured using the frequency of problem descriptors in the routine clinical data captured at assessment 3. Acceptability measured via the rates for consent, therapy completion and completion of measures using the IAPT Minimum Data Set Measures: Generalised Anxiety Disorder Questionnaire (GAD-7), Patient Health Questionnaire (PHQ-9), Work and Social Adjustment Scale (WSAS), Anxiety Disorder Specific Measures (ADSM), and Phobia Scales 4. Data on acceptability will also be sought via qualitative feedback on intervention from clinicians and patients

Secondary

MeasureTime frame
The following secondary outcome measures are completed pre- and post-therapy: 1. Anxiety-specific measures that differ by presentation: IAPT CORE Minimum Data Set: GAD-7; PHQ-9; WSAS; ADSM; Phobia scales 2. At-risk mental states (ARMS) measures: two-Item screen, 16-Item Prodromal Questionnaire (PQ-16) 3. Relational measures: Psychosis Attachment Measure (PAM)-R 26-item measure of attachment, Experience in Close Relationships Scale (ECR)-12 12-item measure of attachment, and the Dysfunctional Working Models of Self and Others (DWM-S Adapted) 35-item measure of beliefs about self and others

Countries

England, United Kingdom

Contacts

Public ContactKatherine Newman-Taylor
knt@soton.ac.uk+44 (0)2382 126517

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026