Development of a Money Advice Intervention Within IAPT
Primary Purpose
Mental Health Issue, Anxiety, Depression
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Psychological Therapy
Debt Advice
Sponsored by
About this trial
This is an interventional treatment trial for Mental Health Issue
Eligibility Criteria
Inclusion Criteria:
- IAPT clients referred for 'high-intensity' one-to-one treatment in the South London and Maudsley NHS Trust (SLaM)
- Have mental health problems and experience of money problems that are effecting these
- Can access technology
Exclusion Criteria:
- Inability to give informed consent due to mental incapacity (as assessed by IAPT therapists)
- Participants whose care team specify concerns regarding taking part in the study.
Sites / Locations
- King's College LondonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Combined intervention
Arm Description
Participants accessing one-to-one psychological therapy from the IAPT service will be asked if they have any money worries affecting their mental health. Suitable participants will be offered one-to-one support from a money advisor, who they will access in tandem to their therapy.
Outcomes
Primary Outcome Measures
Reliable recovery - anxiety
Changes on the Generalized Anxiety Disorder - 7 (GAD-7), from above clinical cut off pre intervention (> 5) to below cut off post intervention (<5). The seven items on the scale ask participants to rate on a scale of 0 (not at all) to 3 (nearly everyday) how often they were bothered by each symptom. Total scores can range from 0 - 21, with higher scores indicating more anxiety.
Reliable recovery - depression
Patient Health Questionnaire - 9 (PHQ-9), from above clinical cut off pre intervention (> 5) to below cut off post intervention (<5). The nine items on the scale ask participants to rate on a scale of 0 (not at all) to 3 (nearly everyday) how often they were bothered by each symptom. Total scores can range from 0 - 27, with higher scores indicating more depressive symptoms.
Reliable recovery - adjustment
Work and Social Adjustment Scale - 5 (WSAS-5), from above clinical cut off pre intervention (> 10) to below cut off post intervention (<10). The five items on the scale ask participants to rate on a scale of 0 (not at all) to 8 (very severely) how much they feel they are impaired for each task. Total scores can range from 0 - 40, with higher scores indicating more impairment across work and social tasks.
Secondary Outcome Measures
Financial Outcomes and service satisfaction
This survey has been adapted for the purposes of this study. It uses questions taken from the audit measure of service satisfaction used by Citizen's Advice. Participants are asked to rate on a scale of 1 (not at all) to 5 (a great deal) how much they experienced six possible effects from the combined intervention. Scores range from 6 to 30, with higher scores indicating more positive outcomes in relation to personal finances from the intervention.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04926675
Brief Title
Development of a Money Advice Intervention Within IAPT
Official Title
Development of a Money Advice Intervention Within IAPT: Service User Case-studies
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King's College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is the second study of a larger project and will begin the process of testing and the development of an integrated intervention on a series of case studies. The combined intervention provides psychological therapy and debt advice in tandem. The treatment pathway is based on interviews and focus groups with service users and staff and the themes that emerged. It will be trialled in the NHS' Improving Access to Psychological Therapies (IAPT) service. Participants routinely accessing this service who have debt issues affecting their mental health will be asked if they'd like to also take up support for their money worries, which will be provided by Citizen's Advice (CA). Researchers will take exit interviews with both service users and staff at the end of the treatment to develop the protocol further. Researchers will also assess measures of mental health and wellbeing that are routinely taken by IAPT to review the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Issue, Anxiety, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Combined intervention
Arm Type
Experimental
Arm Description
Participants accessing one-to-one psychological therapy from the IAPT service will be asked if they have any money worries affecting their mental health. Suitable participants will be offered one-to-one support from a money advisor, who they will access in tandem to their therapy.
Intervention Type
Behavioral
Intervention Name(s)
Psychological Therapy
Intervention Description
Participants will be receiving their one-to-one psychological therapy from IAPT as usual. They typically receive between 6 and 12 sessions with a psychological practitioner.
Intervention Type
Behavioral
Intervention Name(s)
Debt Advice
Intervention Description
Participants will receive one-to-one support from a Citizen's Advice (CA) money advisor for as long as needed to resolve any money worries currently affecting their mental health.
Primary Outcome Measure Information:
Title
Reliable recovery - anxiety
Description
Changes on the Generalized Anxiety Disorder - 7 (GAD-7), from above clinical cut off pre intervention (> 5) to below cut off post intervention (<5). The seven items on the scale ask participants to rate on a scale of 0 (not at all) to 3 (nearly everyday) how often they were bothered by each symptom. Total scores can range from 0 - 21, with higher scores indicating more anxiety.
Time Frame
6-12 weeks
Title
Reliable recovery - depression
Description
Patient Health Questionnaire - 9 (PHQ-9), from above clinical cut off pre intervention (> 5) to below cut off post intervention (<5). The nine items on the scale ask participants to rate on a scale of 0 (not at all) to 3 (nearly everyday) how often they were bothered by each symptom. Total scores can range from 0 - 27, with higher scores indicating more depressive symptoms.
Time Frame
6-12 weeks
Title
Reliable recovery - adjustment
Description
Work and Social Adjustment Scale - 5 (WSAS-5), from above clinical cut off pre intervention (> 10) to below cut off post intervention (<10). The five items on the scale ask participants to rate on a scale of 0 (not at all) to 8 (very severely) how much they feel they are impaired for each task. Total scores can range from 0 - 40, with higher scores indicating more impairment across work and social tasks.
Time Frame
6 - 12 weeks
Secondary Outcome Measure Information:
Title
Financial Outcomes and service satisfaction
Description
This survey has been adapted for the purposes of this study. It uses questions taken from the audit measure of service satisfaction used by Citizen's Advice. Participants are asked to rate on a scale of 1 (not at all) to 5 (a great deal) how much they experienced six possible effects from the combined intervention. Scores range from 6 to 30, with higher scores indicating more positive outcomes in relation to personal finances from the intervention.
Time Frame
6-12 weeks
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:
IAPT clients referred for 'high-intensity' one-to-one treatment in the South London and Maudsley NHS Trust (SLaM)
Have mental health problems and experience of money problems that are effecting these
Can access technology
Exclusion Criteria:
Inability to give informed consent due to mental incapacity (as assessed by IAPT therapists)
Participants whose care team specify concerns regarding taking part in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Til Wykes, Prof. Dame.
Phone
0044 (20)7848 0596/5040
Ext
0596/5040
Email
till.wykes@kcl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah Belcher, Dr
Phone
0207 848 0334
Email
hannah.belcher@kcl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Til Wykes, Prof. Dame.
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College London
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Til Wykes, Prof
Email
til.wykes@kcl.ac.uk
First Name & Middle Initial & Last Name & Degree
Hannah Belcher, Dr
Phone
07970753826
Email
hannah.belcher@kcl.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
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Development of a Money Advice Intervention Within IAPT
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