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Cognitive Analytic-Informed Guided Self-help for Depression

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cognitive Analytic Therapy - Guided Self Help (CAT-GSH)
Sponsored by
University of Sheffield
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Barnsley IAPT ServiceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAT-GSH

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
Work and Social Adjustment Scale - WSAS
This scale measures social functioning.

Secondary Outcome Measures

Full Information

First Posted
January 12, 2022
Last Updated
May 15, 2023
Sponsor
University of Sheffield
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1. Study Identification

Unique Protocol Identification Number
NCT05344326
Brief Title
Cognitive Analytic-Informed Guided Self-help for Depression
Official Title
Development and Piloting of a Low Intensity Cognitive Analytic-Informed Guided Self-help for Depression to be Used Within Increasing Access to Psychological Therapies (IAPT)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sheffield

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Aims Phase One 1) Develop a CAT-informed GSH manual (CAT-GSH) for depression Phase Two Pilot CAT-SH within IAPT setting To explore the impact of CAT-GSH on outcomes To investigate the acceptability of CAT-GSH Method Stage One Past research and consultation meetings will be consolidated into a matrix. This will inform the development of the treatment manual. Stage Two A mixed-methods, small N case series design will be utilized to pilot the CAT-GSH manual within IAPT services. Three Psychological Wellbeing Practitioners (PWP) and 10 service users will be recruited from Barnsley IAPT service. The PWPs will be provided a two-day training course before the study begins. This will cover information regarding the CAT-GSH, data management, and the protocol. To recruit 10 service user participants, it is predicted the first 60 people on the Barnsley IAPT waiting list would need to be screened to account for eligibility criteria, preference, and attrition. Participants will be offered to complete CAT-GSH 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 The exclusion criteria will be: Patients who would normally be 'stepped up' due to complexity and risk Patients are receiving other therapies Substance users unable to abstain during sessions The exclusion criteria are in line with IAPT step-two treatment guidance and support. The participants will be invited to an assessment session where they will be informed about the research, be provided with information sheets and consent sheets. The participants will have time to contact the researchers if they have any questions about the research. If they provide informed consent, they will be provided with six, fortnightly CAT-GSH sessions facilitated by the PWPs. In these sessions, they will also complete three outcome measures. The patient health questionnaire, the generalized anxiety disorder assessment, and the work and social adjustment scale. They will receive a follow-up session, with the PWP, where they will also complete the outcome measures and review their care. They will also arrange an interview with the primary research to explore their experiences of CAT-GSH. This will follow an interview schedule. The PWPs will also attend a separate, PWP group interview where they will also reflect on their experiences of delivering GSH. This will be provided by the researcher. The analysis stage of the process will then begin as the researchers explore the outcome measure data and the interview data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Mixed methods, small N, case series
Masking
None (Open Label)
Masking Description
The PWP and service users will be aware of the intervention
Allocation
N/A
Enrollment
13 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CAT-GSH
Arm Type
Experimental
Arm Description
Participants, who provide informed consent, will be provided an assessment session, six fortnightly CAT-GSH sessions, and one follow-up session.
Intervention Type
Other
Intervention Name(s)
Cognitive Analytic Therapy - Guided Self Help (CAT-GSH)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire - PHQ9
Description
The PHQ9 is a 9-item self-administered questionnaire designed for detecting depression and is based on the DSM-IV criteria.
Time Frame
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.
Title
Generalised Anxiety Disorder Assessment - GAD 7
Description
The GAD7 is also widely used within primary care settings and is a self-reported screening tool for generalised anxiety disorder.
Time Frame
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.
Title
Work and Social Adjustment Scale - WSAS
Description
This scale measures social functioning.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patients who would normally be 'stepped up' due to complexity and risk Patients are receiving other therapies Substance users unable to abstain during sessions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Kelly
Phone
01142226650
Email
rkelly2@sheffield.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Amrit Sinha
Phone
01142226650
Email
a.sinha@sheffield.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Kelly
Organizational Affiliation
University of Sheffield
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnsley IAPT Service
City
Barnsley
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen Carter

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Only anonymized data will be shared. Personal data will not be.
IPD Sharing 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.
IPD Sharing Access Criteria
Information can be requested through ORDA by those who qualify for membership.

Learn more about this trial

Cognitive Analytic-Informed Guided Self-help for Depression

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