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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04926675
Other study ID # 300734
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 27, 2021
Est. completion date June 30, 2023

Study information

Verified date March 2023
Source King's College London
Contact Til Wykes, Prof. Dame.
Phone 0044 (20)7848 0596/5040
Email till.wykes@kcl.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Psychological 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.
Debt Advice
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.

Locations

Country Name City State
United Kingdom King's College London London

Sponsors (1)

Lead Sponsor Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6-12 weeks
Primary 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. 6-12 weeks
Primary 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. 6 - 12 weeks
Secondary 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. 6-12 weeks
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