The impact of a positive psychology intervention on quality of life for women with polycystic ovary syndrome (PCOS)
| ISRCTN | ISRCTN64066164 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64066164 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/10/2013
- Registration date
- 06/12/2013
- Last edited
- 17/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Polycystic Ovary Syndrome (PCOS) is the most common endocrine disorder amongst women of reproductive age, affecting about 6.5% of women. PCOS is also the most prevalent cause of infertility. Women with PCOS are at an increased risk of miscarriage, cardiovascular disease, type 2 diabetes mellitus and cancer. Symptoms can include hirsutism (excessive hair growth), insulin resistance, infertility and obesity. Studies have shown that PCOS sufferers have higher levels of psychological distress than healthy individuals, including anxiety and depression. Studies show that PCOS can lead to lower quality of life and that women with PCOS are at an increased risk of suffering from a psychiatric disorder, including depression. Positive psychology interventions have been shown to help improve depressive symptoms in participants. Research has found that the positive psychology activity Three Good Things (whereby participants were asked to write down three things that went well each day and their causes) increased happiness and decreased depressive symptoms for six months. This study aims to assess the effectiveness of an online positive psychology intervention on improving the quality of life of women with PCOS.
Who can participate?
Patients aged 18 or over who have been diagnosed with PCOS by a clinician, live in the UK and have access to the internet.
What does the study involve?
Participants are randomly allocated to the intervention or the control group. The participants in the intervention group are invited to take part in a 4 week online positive psychology intervention. The positive psychology exercise is "Three Good Things". For this exercise participants are asked to write down three good things which have happened to them on each day of the intervention. They are directed to a website which enables them to fill in their three good things each day. Participants in the control group are asked to go about their usual routine and are offered the intervention after the follow-up period (6 weeks).
What are the possible benefits and risks of participating?
The positive psychology intervention, "Three Good Things", has been shown to increase happiness and decrease depressive symptoms. There are no known risks to participating in this study.
Where is the study run from?
The lead study centre is the University of Derby. The trial is being run in association with a PCOS clinic at the Royal Derby Hospital (UK)
When is the study starting and how long is it expected to run for?
January 2014 to November 2015
Who is funding the study?
University of Derby (UK)
Who is the main contact?
Sophie Williams
s.williams3@derby.ac.uk
Contact information
Scientific
University of Derby
Kedleston Road
Derby
DE22 1GB
United Kingdom
| s.williams3@derby.ac.uk |
Study information
| Study design | Single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A randomised controlled trial to investigate whether an online psychology intervention can improve the quality of life of women with polycystic ovary syndrome (PCOS) |
| Study objectives | Women with Polycystic Ovary Syndrome (PCOS) can experience a low quality of life: a non-invasive clinical trial offering an online positive psychology intervention to women with PCOS may, therefore, be beneficial. We propose to carry out a fully randomised clinical trial into the benefits of an online positive psychology intervention for Derby-based women with PCOS over a four week period, using quality of life as an endpoint. This will be the first study to investigate whether an online intervention can improve the quality of life of women with PCOS. |
| Ethics approval(s) | 1. University of Derby Psychology Research Ethics Committee (PREC), 21/08/2013, ref: 087-13-SW 2. NRES Committee East Midlands Nottingham 2, 14/11/2013, REC ref: 13/EM/0393 |
| Health condition(s) or problem(s) studied | Polycystic Ovary Syndrome (PCOS) |
| Intervention | Randomisation shall be stratified in order to ensure an equal distribution in length of diagnosis of PCOS. Pragmatic randomisation may be used if a participant has a strong preference to be in a particular group (either control or intervention). All participants in the control group will be offered the intervention after the follow-up period. Intervention group: Four week online positive psychology intervention - "Three Good Things" activity. |
| Intervention type | Other |
| Primary outcome measure | Quality of life, measured using the PCOS QoL (in development) at at baseline, 4 and 6 weeks |
| Secondary outcome measures | Anxiety and depression, measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 4 and 6 weeks |
| Overall study start date | 01/01/2014 |
| Completion date | 01/11/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Aged 18 or over 2. Diagnosed with Polycystic Ovary Syndrome by a clinician 3. Lives in the UK 4. Has access to the internet |
| Key exclusion criteria | 1. Participants with mental incapacity unable to give informed consent 2. Participants unable to understand verbal and written information in English (as the study is an online study and so translation for individuals not able to understand English is not possible) |
| Date of first enrolment | 12/01/2015 |
| Date of final enrolment | 17/04/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
DE22 1GB
United Kingdom
Sponsor information
University/education
c/o Chris Bussell
Head of Science
Kedleston Road
Derby
DE22 1GB
England
United Kingdom
"ROR" |
https://ror.org/02yhrrk59 |
|---|
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication of a ‘lessons learned paper’ in a journal within the next year. 2016 results published in thesis https://derby.openrepository.com/handle/10545/620535 |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
17/06/2019: Thesis added to publication and dissemination plan.
24/01/2018: Publication and dissemination plan and IPD sharing statement added.
26/09/2014: The overall trial end date was changed from 01/11/2014 to 01/11/2015.
