Feasibility randomised controlled trial of Spring PGD, a digital guided therapy for prolonged grief disorder
| ISRCTN | ISRCTN87760956 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87760956 |
| IRAS number | 287681 |
| Secondary identifying numbers | SPON1830-20, CPMS 65849 |
- Submission date
- 21/11/2024
- Registration date
- 28/02/2025
- Last edited
- 04/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Prolonged grief disorder happens when someone can't stop thinking about a loved one who has died, and it makes them feel very distressed for at least 6 months. Every year in Wales, about 18,250 new people experience prolonged grief disorder, but there aren't many good treatments available. One type of therapy called cognitive-behavioural therapy (CBT) focusing on grief seems to help, but there aren't enough therapists trained in it, and it takes a long time. Using an app or website for therapy, with about 3 hours of guidance from a health professional, might save time and money. With help from the Welsh Government, we created a guided therapy programme for prolonged grief disorder called Spring PGD, based on input from people who have experienced it. Now, we're getting ready to test it in a clinical trial.
Who can participate?
People aged 18 years or older with prolonged grief disorder
What does the study involve?
The researcher will discuss the details of the study with the participant, and the participant will be able to ask any questions they may have. The participant will be asked to give consent verbally by phone/video call. The conversation will be recorded, and the researcher will complete an electronic version of the consent form. The participant will be given a copy of the consent form to keep along with the information sheet.
If it is agreed that Spring PGD is right for the participant, they will be randomly placed into one of two groups. One group will receive Spring PGD straight away, and the other will receive Spring PGD after 11 weeks.
The participant will be asked to complete some questionnaires. The participant may also be invited to take part in an interview about their expectations of Spring PGD. This will take an additional 30-60 minutes.
When the participant starts Spring PGD, an appointment with a therapist will be arranged. At the first appointment, the therapist will talk to the participant about their symptoms and show them the Spring PGD programme. The participant will then have access to the programme, which they will use in their own time at home, with regular guidance from the therapist. The guidance will be used to discuss the participant's progress and help them tackle any problems.
The participant will complete questionnaires about their symptoms at two more points during the study (11 and 22 weeks after joining). They may also be invited to take part in an interview about their experiences of using Spring PGD. Interviews will be recorded. Consent will be sought for these recordings, which will be stored anonymously. Direct quotations from these discussions may be published, but all quotations will be published anonymously.
The study will be conducted remotely. All meetings with the researcher will be conducted via telephone or video call.
The participant will receive a £10 shopping voucher or £10 via bank transfer, depending on their preference, as a token of appreciation for participating in the follow-up assessments of their symptoms. Additionally, if the participant is invited to take part in an interview, they will receive £25 for each completed interview.
What are the possible benefits and risks of participating?
Participants' input will contribute to the development of Spring PGD, with the aim of benefiting individuals with PGD in the future. It is hoped that participants may also experience an improvement in their own symptoms if Spring PGD proves to be effective.
It is acknowledged that some individuals may find it challenging or distressing to discuss mental health or engage in treatment. Additional support will be provided if the research causes any distress.
Where is the study run from?
Cardiff University (UK)
When is the study starting and how long is it expected to run for?
June 2020 to September 2026
Who is funding the study?
Health and Care Research Wales (UK)
Who is the main contact?
Dr Catrin Lewis, LewisCE7@Cardiff.ac.uk
Contact information
Public, Scientific, Principal Investigator
Hadyn Ellis Building
Maindy Road
Cardiff
CF24 4HQ
United Kingdom
 ORCID ID |
0000-0002-3818-9377 |
|---|---|
| Phone | +44 (0)2920688357 |
| LewisCE7@Cardiff.ac.uk |
Study information
| Study design | Exploratory single-blind randomized parallel group-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Digital guided self-help for Prolonged Grief Disorder (PGD) |
| Study objectives | To ascertain proof of concept for a co-produced guided digital therapy for PGD in comparison to wait list, to establish whether it is acceptable, and if findings appear to generalise to underserved groups. |
| Ethics approval(s) |
Approved 17/12/2020, Wales REC 2 (Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 (0)29 2078 5738; Wales.REC2@wales.nhs.uk), ref: 20/WA/0333 |
| Health condition(s) or problem(s) studied | Prolonged Grief Disorder (PGD) |
| Intervention | Participants will be randomised in a 1:1 ratio to receive immediate guided self-help treatment (Spring PGD) or to a waiting list control group. After a period of 11 weeks on the waiting list, participants in the control group will cross over to receive Spring PGD. Spring PGD is an 8-week intervention comprising audio-narrated content delivered in eight steps, featuring interactive elements allowing user input and control. The programme includes four characters with PGD following various bereavement experiences, with accompanying video content. A toolkit offers easy access to key programme components. Therapist guidance involves a one-hour meeting to establish rapport, provide log-in details, and demonstrate the programme. Subsequent fortnightly meetings, lasting 30 minutes, can be conducted face-to-face or remotely based on user and therapist preference. Additionally, users receive four brief contacts between sessions to discuss progress, address issues, and set new goals. Therapists can monitor patient progress via a clinician dashboard. Spring PGD will be administered by skilled therapists who have experience of working with people with PGD. A comprehensive therapist manual accompanies the intervention, providing detailed guidance and instructions for effective implementation. All participants will be assessed at baseline and at 11 and 22 weeks after randomisation. |
| Intervention type | Behavioural |
| Primary outcome measure | Prolonged grief measured using Prolonged Grief 13 Revised (PG-13-R) at baseline and 11 and 22 weeks after randomisation |
| Secondary outcome measures | 1. Traumatic stress symptoms measured using the International Trauma Questionnaire (ITQ) at baseline and 11 and 22 weeks after randomisation 2. Anxiety measured using the Generalised Anxiety Disorder 7 (GAD-7) at baseline and 11 and 22 weeks after randomisation 3. Symptoms of depression measured using Patient Health Questionnaire – 9 (PHQ-9) at baseline and 11 and 22 weeks after randomisation 4. Progress towards goals assessed using Goal Based Outcomes (GBOs) at baseline and 11 and 22 weeks after randomisation 5. Functional impairment measured using the Work and Social Adjustment Scale (WSAS) at baseline and 11 and 22 weeks after randomisation 6. Health-related quality of life measured using EQ5D-5L at baseline and 11 and 22 weeks after randomisation |
| Overall study start date | 01/06/2020 |
| Completion date | 30/09/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 42 |
| Key inclusion criteria | 1. Aged 16 years or over with no upper age limit 2. Diagnosis of PGD 3. PGD is the primary diagnosis 4. Regular access to the internet to complete the digital programme 5. Ability to comply with the requirements of the study |
| Key exclusion criteria | 1. Inability to understand spoken and/or written English 2. Inability to provide valid informed consent 3. Currently engaged in a course of psychological therapy 4. Change in psychotropic medication in the last 4 weeks 5. Current psychosis 6. Substance dependence 7. Active suicide risk |
| Date of first enrolment | 10/01/2025 |
| Date of final enrolment | 31/12/2025 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centres
2nd Floor Lakeside Building
University Hospital of Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom
Ynysmaerdy
Llantrisant
CF72 8XR
United Kingdom
Sponsor information
University/education
Cardiff Joint Research Office
2nd Floor Lakeside Building
University Hospital of Wales
Heath Park
Cardiff
CF14 4XW
Wales
United Kingdom
| Phone | +44 (0)29208 79277 |
|---|---|
| resgov@cardiff.ac.uk | |
| Website | http://www.cardiff.ac.uk/ |
"ROR" |
https://ror.org/03kk7td41 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Health & Care Research Wales, Ymchwil Iechyd a Gofal Cymru, Health Care Research Wales, HCRW
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The dissemination plan involves: 1. Collaborating with the Public Advisory Group to create a strategic plan for tailored outreach. The researchers will establish a dedicated project website and harness the expertise of the NCMH communications team to effectively promote the trial and their findings through a range of approaches tailored to different audiences. They will produce a Podcast for the NCMH Piece of Mind series and consult the Public Advisory Group on a range of other approaches that have been by NCMH to successfully promote research, such as webinars and public lectures (https://www.ncmh.info/videos-and-podcasts/). 2. Disseminating results to participants and the public, with the PAG selecting optimal methods like lay language reports, infographics, blog posts, animations, and public events for accessibility and engagement. 3. Sharing with the academic community by publishing the research protocol in an open-access journal. Post-trial, at least two academic papers will be published, with one presenting primary findings and the other detailing qualitative results. The researchers will explore hypothesis-driven secondary analyses and present the findings at national and international conferences. 4. Engaging policymakers and stakeholders by preparing a briefing paper for the Welsh and UK Governments to influence future PGD service provision. |
| IPD sharing plan | The datasets generated during the current study will be available upon request from ncmh-trials@Cardiff.ac.uk |
Editorial Notes
04/03/2025: Internal review.
21/11/2024: Study's existence confirmed by Wales REC 2.
