NCT05344326

Brief Summary

Cognitive analytic therapy (CAT) is used within mental health services as a treatment for a range of mental health difficulties. Recent research has adapted CAT to be used as guided self-help for anxiety within Increasing Access to Psychological Therapies (IAPT). IAPT is a mental health service. Guided self help-CAT (CAT-GSH) is delivered by mental health professionals called Psychological Wellbeing Practitioners (PWPs). This current study aims to develop and pilot a CAT-GSH manual for depression for use in the same context and practitioners. Stage one uses past research and consultation meetings to help develop the treatment. Stage two will use different approaches to explore the acceptability and outcomes of the intervention.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
13

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

November 7, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

December 6, 2023

Status Verified

May 1, 2023

Enrollment Period

1.6 years

First QC Date

January 12, 2022

Last Update Submit

December 5, 2023

Conditions

Depression

Outcome Measures

Primary Outcomes (3)

  • Patient Health Questionnaire - PHQ9

    The PHQ9 is a 9-item self-administered questionnaire designed for detecting depression and is based on the DSM-IV criteria.

    Through participant involvement, roughly 4 months. Administered 8 times across assessment, treatment, and follow up. Once during assessment, weekly during intervention (6 times). Follow-up outcomes will be collected between 4-8 weeks after intervention.

  • Generalised Anxiety Disorder Assessment - GAD 7

    The GAD7 is also widely used within primary care settings and is a self-reported screening tool for generalised anxiety disorder.

    Through participant involvement, roughly 4 months. Administered 8 times across assessment, treatment, and follow up. Once during assessment, weekly during intervention (6 times). Follow-up outcomes will be collected between 4-8 weeks after intervention.

  • Work and Social Adjustment Scale - WSAS

    This scale measures social functioning.

    Through participant involvement, roughly 4 months. Administered 8 times across assessment, treatment, and follow up. Once during assessment, weekly during intervention (6 times). Follow-up outcomes will be collected between 4-8 weeks after intervention.

Study Arms (1)

CAT-GSH

EXPERIMENTAL

Participants, who provide informed consent, will be provided an assessment session, six fortnightly CAT-GSH sessions, and one follow-up session.

Other: Cognitive Analytic Therapy - Guided Self Help (CAT-GSH)

Interventions

Cognitive Analytic Therapy - Guided Self Help (CAT-GSH)OTHER

CAT-GSH is a novel intervention designed to help those with depression by focusing on the relationships within their life. GSH is used in step two of IAPT services and is typically six fortnightly sessions where the PWP helps the service user complete the self help manual.

CAT-GSH

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Depression is the main problem
  • They score above the clinical cut off (10 points) on the Patient Health Questionnaire (PHQ9; Kroenke and Spitzer, 2002)
  • Aged between 18 - 65
  • Would prefer to use CAT-GSH over other interventions
  • Consent to participate in study
  • Can engage with reading materials

You may not qualify if:

  • Patients who would normally be 'stepped up' due to complexity and risk
  • Patients are receiving other therapies
  • Substance users unable to abstain during sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barnsley IAPT Service

Barnsley, United Kingdom

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Rebecca Kelly

    University of Sheffield

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Kelly

CONTACT

01142226650rkelly2@sheffield.ac.uk

Amrit Sinha

CONTACT

01142226650a.sinha@sheffield.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The PWP and service users will be aware of the intervention
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Mixed methods, small N, case series
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2022

First Posted

April 25, 2022

Study Start

November 7, 2022

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

December 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

Only anonymized data will be shared. Personal data will not be.

Shared Documents
STUDY PROTOCOL
Time Frame
At the end of the study (approximately May 2023), data will be stored on the University of Sheffield's ORDA (online research hub) for 5 years according to the University of Sheffield's retention period.
Access Criteria
Information can be requested through ORDA by those who qualify for membership.

Locations

GB(1)