Mental Health IssueNCT04926675
Development of a Money Advice Intervention Within IAPT
A study testing Psychological Therapy and Debt Advice in people with Mental Health Issue and Anxiety, run by King's College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mental Health Issue, Anxiety, Depression
- What is being tested?
- Psychological Therapy and Debt Advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Sep 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Mental Health Issue, Anxiety, Depression
- Being tested
- Psychological Therapy, Debt Advice
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological TherapyBehavioural
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 AdviceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Psychological Therapy; Behavioral: Debt Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 - 12 weeks
Secondary outcomes (1)
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.
Measured: 6-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start27 Sep 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional study of adding money advice to psychological treatment compared to usual treatment from routine data collection
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Dame Til Wykes, King's College London
- Investigators
- Til Wykes, Prof. Dame., Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926675
- Sponsor's protocol ID
- 300734
- Status last verified
- Oct 2024
- First submitted
- 28 May 2021
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Money Advice Intervention Within IAPT: Service User Case-studies
- ClinicalTrials.gov ID
- NCT04926675
- Acronym / sponsor ID
- 300734
- Conditions
- Mental Health Issue, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 15 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional study of adding money advice to psychological treatment compared to usual treatment from routine data collection
| Arm | Type | Receives |
|---|---|---|
| Combined intervention | Experimental | Behavioral: Psychological Therapy, Behavioral: Debt AdviceParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological TherapyParticipants 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. | Behavioural | Combined intervention |
| Debt AdviceParticipants 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. | Behavioural | Combined intervention |
Primary outcome
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.
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.
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.
1 secondary outcome
Financial Outcomes and service satisfaction
Time frame: 6-12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Til Wykes, Prof. Dame. principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological Therapy and Debt Advice in people with Mental Health Issue and Anxiety, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliable recovery - anxiety (time frame: 6-12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.