NCT04926675

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 15, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

September 27, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

1.8 years

First QC Date

May 28, 2021

Last Update Submit

October 25, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • Financial Outcomes and service satisfaction

    6-12 weeks

Study Arms (1)

Combined intervention

EXPERIMENTAL

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.

Behavioral: Psychological TherapyBehavioral: Debt Advice

Interventions

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.

Combined intervention
Debt AdviceBEHAVIORAL

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.

Combined intervention

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, SE5 8AF, United Kingdom

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Til Wykes, Prof. Dame.

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Interventional study of adding money advice to psychological treatment compared to usual treatment from routine data collection
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 28, 2021

First Posted

June 15, 2021

Study Start

September 27, 2021

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

October 29, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations