Improving long-term benefits for depression and anxiety
| ISRCTN | ISRCTN21764748 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21764748 |
| IRAS number | 323641 |
| Secondary identifying numbers | NIHR204037, IRAS 323641, CPMS 55925 |
- Submission date
- 25/05/2023
- Registration date
- 30/05/2023
- Last edited
- 21/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and Study aims:
Depression and anxiety are associated with high rates of relapse and recurrence after receiving clinically and cost-effective evidence-based psychological treatment, i.e. cognitive behavioural therapy. After treatment for depression, the prevalence of a second episode is 50%, rising to 90% after three episodes. The recurrence rate following treatment for anxiety is similarly high, between 39% to 56%.
The impacts of depression and anxiety on social, occupational functioning, physical morbidity and mortality are high; exerting high economic and health burden. Depression and anxiety are estimated to reduce England’s national income (GNP) by approximately £80 million annually.
The NHS has a world-leading psychological therapy programme called ‘Improving Access to Psychological Therapy (IAPT)’ to help people with depression and anxiety. IAPT services follow National Institute for Health and Care Excellence guidelines recommending the delivery of care based on a stepped-care model, meaning people will be provided the least intrusive and most effective intervention first. Low intensity interventions at the first
treatment step, are based on cognitive behavioural therapy (CBT) and involve guided-self-help delivered in a variety of formats (e.g., face-to-face, group, telephone) over a maximum of 8 weeks.
IAPT reported 1.17 million people entered treatment last year and 51.1% achieved IAPT recovery criteria by the end of low and/or high intensity treatment interventions, meeting the national target. Despite having a considerable impact on short-term recovery, long-term effectiveness is more limited.
Research conducted in IAPT found that more than half of people receiving brief talking therapies deteriorated following treatment, with the vast majority doing so within 2 to 6 months.
Our aim is to help patients with depression and anxiety that have received brief talking therapies to stay well over time ensuring changes made during therapy transition to lifelong skills, and burden on services is reduced.
Who can participate?
-Patients: Aged 18 or over, received low intensity treatment in IAPT services located in Northern England and started with case-level depression and/or anxiety, and meet IAPT criteria for recovery in the last session attended.
-Practitioners: Trainees or qualified psychological wellbeing practitioners delivering low intensity interventions in IAPT services located in Northern England.
-Key informants: IAPT managers/service leads, policy-makers, commissioners, IAPT trainers, clinical academics, and national leads.
What does the study involve?
The proposed research will be conducted in three phases. Phase 1 will include qualitative interviews, Phase 2 will involve co-production workshops, and Phase 3 will involve a group meeting focused on reviewing the developed intervention and its implementation plan.
Phase 1: Participants are expected to allocate 15 minutes to provide consent and complete questionnaires and will be involved in a one-time interview for a maximum of 1 hour.
Phase 2: Participants are expected to allocate 15 minutes to provide consent and complete questionnaires. Different groups of stakeholders (i.e. patients and a mixed group of
professionals) will take part in a single co-development workshop for a maximum of 5 hours.
Phase 3: Participants are expected to allocate 15 minutes to provide consent and complete questionnaires and will take part in a group meeting for a maximum of 3 hours.
What are the possible benefits and risks of participating?
Although we cannot promise the study will help people personally, the information provided would help us understand what to do differently to help NHS patients in the future to stay well over time and ensure changes made during psychological treatment transition to lifelong skills.
Occasionally, people can feel upset if they think about something distressing that has happened to them. If this happens, people would be advised to make use of the support services listed and/or contact the Principal Investigator for this project.
Where is the study run from?
University of Manchester (UK)
When is the study starting and how long is it expected to run for?
December 2022 to December 2024
Who is funding the study?
The funder is the National Institute for Health Research (NIHR), Research for Patient Benefit (Ref: NIHR 204037). This study is organised and sponsored by the University of Manchester. The host trust for this project is Greater Manchester Mental Health NHS Foundation Trust (UK)
Who is the main contact?
Dr Cintia Faija, Cintia.faija@manchester.ac.uk
Contact information
Principal Investigator
Division of Nursing, Midwifery & Social Work
School of Health Sciences
Faculty of Biology, Medicine and Health
The University of Manchester
Jean McFarlane Building
Oxford Road
Manchester
M13 9PL
United Kingdom
 ORCID ID |
0000-0002-6497-9196 |
|---|---|
| Phone | +44 161 306 7858 |
| cintia.faija@manchester.ac.uk |
Study information
| Study design | Observational |
|---|---|
| Primary study design | Observational |
| Secondary study design | Mixed methods |
| Study setting(s) | Home, Internet/virtual, Telephone, University/medical school/dental school, Other |
| Study type | Other, Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Co-developing Improving Access to Psychological Therapies (IAPT) services to improve long-term benefits for patients with depression and anxiety |
| Study acronym | CO-IMPROVE |
| Study objectives | Depression and anxiety are associated with high rates of relapse and recurrence after receiving clinically and cost-effective evidence-based psychological treatment, i,e. cognitive behavioural therapy. After treatment for depression, the prevalence of a second episode is 50%, rising to 90% after three episodes. The recurrence rate following treatment for anxiety is similarly high, between 39% to 56%. The impacts of depression and anxiety on social, occupational functioning, physical morbidity and mortality are high; exerting high economic and health burden. Depression and anxiety are estimated to reduce England’s national income (GNP) by approximately £80 million annually [19]. The NHS has a world-leading psychological therapy programme called ‘Improving Access to Psychological Therapy (IAPT)’ to help people with depression and anxiety. IAPT services follow National Institute for Health and Care Excellence guidelines recommending the delivery of care based on a stepped-care model, meaning people will be provided the least intrusive and most effective intervention first. Low intensity interventions at the first treatment step, are based on cognitive behavioural therapy (CBT) and involve guided-self-help delivered in a variety of formats (e.g., face-to-face, group, telephone) over a maximum of 8 weeks. IAPT reported 1.17 million people entered treatment last year and 51.1% achieved IAPT recovery criteria by the end of low and/or high intensity treatment interventions, meeting the national target. In IAPT, a person is deemed to move to recovery if their symptoms were considered a clinical case at the start of their treatment (i.e., symptoms exceed a defined threshold as measured by the scoring tools) and not a clinical case at the end of their treatment (symptoms below the threshold). Despite having a considerable impact on short-term recovery, long-term effectiveness in IAPT is more limited. Specifically, 53% of patients completing low intensity interventions for depression/anxiety relapse within one year, with a further 13% experiencing recurrence in the following year. Of these, 49% relapse within 2 months and 79% within six months. This increases need for further treatment and negatively impacts on patients, services and health economies. The economic success of IAPT rests upon its ability to improve population health and offset treatment costs against substantially greater revenue from reduced healthcare use and work productivity losses. Analysis suggests that the IAPT programme is cost-effective, but that treatment costs are three times higher than initially expected. Current data suggests that attention is urgently needed to prevent relapse for over 300,000 patients annually, with potential for concomitant gains in direct and indirect service expenditure. Relapse has a detrimental impact on healthcare costs and is a significant risk to service efficiency, patient access and experiences. However, little is known about how to maintain treatment benefits and reduce risk of relapse in routine provision in IAPT without escalating costs; our research aims to fill this gap in knowledge. |
| Ethics approval(s) | Approved 17/05/2023, NHS North West - Greater Manchester (GM) West Research Ethics Committee (Barlow House, 3rd Floor, HRA NRES Centre, Manchester, M1 3DZ, UK; +44 207 104 8379; gmwest.rec@hra.nhs.uk ), ref: 23/NW/0109 |
| Health condition(s) or problem(s) studied | Adult patients with anxiety and/or depression meeting NHS Improving Access to Psychological Therapies (IAPT) recovery criteria at discharge of Step 2 care (guided-self-help) |
| Intervention | This is a mixed-methods study comprising three phases: Phase 1 seeks to develop an in-depth understanding of barriers and facilitators influencing relapse following low intensity interventions for depression/anxiety in IAPT. Semi-structured interviews will be conducted with patients and mixed stakeholders (e.g., IAPT practitioners, service leads) (n=20-25 for each study, determined by data saturation; 40-50 in total). Framework analysis will be used to inductively and deductively code interview transcripts. Phase 2 aims to use the evidence from Phase 1 to co-produce, with multiple stakeholders, an acceptable, evidence-based transdiagnostic relapse prevention toolkit for IAPT. An experienced-based co-design framework, comprised of co-design workshops, one conducted with patients and one with mixed stakeholders (N=9 for each, in line with RAND Methodology recommendations) will be conducted. Following workshops, smaller sustained group work will take place to co-develop how the toolkit would look like. Phase 3 aims to review and finalise, with multiple stakeholders (n=12-15), the developed toolkit. The best pathway for implementation will be identified to assist the uptake and facilitation of our transdiagnostic relapse prevention toolkit in IAPT services. |
| Intervention type | Other |
| Primary outcome measure | Phase 1 aims to explore patients and stakeholders perspectives on barriers and facilitators influencing Recovery maintenance/relapse following low intensity interventions for depression/anxiety in IAPT using semi-structured interviews. Framework analysis will be used to inductively and deductively code interview transcripts. Phase 2 aims to co-produce, with patients and stakeholders an acceptable, evidence-based transdiagnostic relapse prevention toolkit for IAPT. An experienced based co-design framework, comprised of co-design workshops, one conducted with patients and one with mixed stakeholders will be conducted. The RAND/UCLA Appropriateness Methodology will be used. Phase 3 aims to review and finalise the developed toolkit with patients and stakeholders using a consensus approach. In addition, the best pathway for implementation will be identified to assist the uptake and facilitation of our transdiagnostic relapse prevention toolkit in IAPT services. All patient participants will be asked to complete the following questionnaires to describe the clinical sample and to identify maintenance of recovery or relapse at the point of their participation in the research: 1. Patient Health Questionnaire (PHQ-9) 2. Generalised Anxiety Disorder Scale (GAD-7) 3. Work and Social Adjustment Scale (WSAS) 4. Post-Treatment Experiences Questionnaire (optional) |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/12/2022 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient, Health professional, Service user, Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 78 |
| Key inclusion criteria | Patients: 1. Aged 18 years or over 2. Received low intensity treatment in IAPT services located in Northern England and started with case-level depression and/or anxiety 3. Meet IAPT criteria for recovery in the last session attended. Following IAPT criteria, a person is considered to be at ‘caseness’ when their symptom score exceeds the accepted clinical threshold for the relevant measure of symptoms (PHQ-9 and GAD-7). A person moves to recovery if their symptoms were considered a clinical case at the start of their treatment and not a clinical case at the end of their treatment. IAPT services located in Northern England. Practitioners: Trainees or qualified psychological wellbeing practitioners delivering low intensity interventions in IAPT services located in Northern England. Key informants may include IAPT managers/service leads, policy-makers, commissioners, IAPT trainers, clinical academics, and national leads. |
| Key exclusion criteria | Individuals lacking the capacity to consent |
| Date of first enrolment | 12/06/2023 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
33 Victoria Square
Bolton
BL1 1RJ
United Kingdom
33 Market Street
Altrincham
Trafford
WA14 1PF
United Kingdom
Newcastle
NE3 3XT
United Kingdom
St Thomas Road
Huddersfield
HD1 3LT
United Kingdom
Calderdale Royal Hospital
Huddersfield Road
Halifax
HX3 0PW
United Kingdom
Ashton-under-lyne
OL6 7SR
United Kingdom
Sponsor information
University/education
Oxford Road
Manchester
M13 9PL
England
United Kingdom
| Phone | +44 1612755436 |
|---|---|
| FBMHethics@manchester.ac.uk | |
| Website | http://www.manchester.ac.uk/ |
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Research for Patient Benefit Programme, RfPB
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We will work with our PPI co-applicant and PPI advisory panel to develop a bespoke engagement strategy to target service users, IAPT practitioners, service managers, commissioners, national IAPT leads, policy-makers and third-sector networks. We will identify and address potential boundaries impeding knowledge flow between these groups. We will work with our PPI co-applicant and PPI advisory panel to ensure that communications are clear, concise and accessible, and take account of the needs and preferences of relevant audiences. We anticipate using a range of media including tailored and targeted summary briefings, engagement events, online communications (e.g. webinars, blogs) and mainstream/social media. Local, national and international dissemination will occur via patient, professional and research-orientated conferences and blogs. The selection of specific engagement activities and communication channels will be informed by current evidence on dissemination and knowledge mobilisation, to ensure our findings are available to policy makers to underpin new public health strategies and person-centred health policy and care. An appropriate NIHR ‘house-style’ will be adopted to build recognition and credibility for outputs. We will develop a written publication strategy, publishing in high-impact academic, professional and patient focused journals, ensuring that we make an enduring contribution to the evidence base. |
| IPD sharing plan | The data sets generated and analysed during the current study will not be publicly available due to privacy and ethical restrictions (i.e. potential for breach of anonymity) but is available upon reasonable request from the principal investigator of the project, Dr Cintia Faija, Email: cintia.faija@manchester.ac.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2 | 23/02/2023 | 30/05/2023 | No | No |
| HRA research summary | 20/09/2023 | No | No |
Additional files
Editorial Notes
21/05/2024: The following changes have been made:
1. The recruitment end date was changed from 31/05/2024 to 31/12/2024.
2. The overall study end date was changed from 31/05/2024 to 31/12/2024.
3. The intention to publish date was changed from 30/11/2024 to 30/05/2025.
20/09/2023: A link to the HRA research summary was added.
06/06/2023: The recruitment start date was changed from 05/06/2023 to 12/06/2023.
30/05/2023: Trial's existence confirmed by NHS HRA.
