- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04926675
Development of a Money Advice Intervention Within IAPT
October 25, 2024 updated by: Professor Dame Til Wykes, King's College London
Development of a Money Advice Intervention Within IAPT: Service User Case-studies
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom, SE5 8AF
- King's College London
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Combined intervention
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reliable recovery - anxiety
Time Frame: 6-12 weeks
|
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.
|
6-12 weeks
|
|
Reliable recovery - depression
Time Frame: 6-12 weeks
|
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.
|
6-12 weeks
|
|
Reliable recovery - adjustment
Time Frame: 6 - 12 weeks
|
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.
|
6 - 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Financial Outcomes and service satisfaction
Time Frame: 6-12 weeks
|
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.
|
6-12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Til Wykes, Prof. Dame., King's College London
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 27, 2021
Primary Completion (Actual)
June 30, 2023
Study Completion (Actual)
June 30, 2023
Study Registration Dates
First Submitted
May 28, 2021
First Submitted That Met QC Criteria
June 8, 2021
First Posted (Actual)
June 15, 2021
Study Record Updates
Last Update Posted (Actual)
October 29, 2024
Last Update Submitted That Met QC Criteria
October 25, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 300734
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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