Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/10/2013
Date assigned
06/12/2013
Last edited
26/09/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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?
Participants must be aged 18 or over, have been diagnosed with PCOS by a clinician, live in the UK and have access to the internet.

What does the study involve?
Participants will be randomly allocated to the intervention or the control group. The participants in the intervention group will be invited to take part in a 4 week online positive psychology intervention. The positive psychology exercise will be ‘Three Good Things’. For this exercise participants will be asked to write down three good things which have happened to them on each day of the intervention. They will be directed to a website which will enable them to fill in their three good things each day. Participants in the control group will be asked to go about their usual routine and will be 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.

When is the study starting and how long is it expected to run for?
The study is expected to begin in January 2014 and is expected to run until November 2015.

Who is funding the study?
University of Derby, UK.

Who is the main contact?
Sophie Williams
s.williams3@derby.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Sophie Williams

ORCID ID

Contact details

University of Derby
Kedleston Road
Derby
DE22 1GB
United Kingdom
s.williams3@derby.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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)

Acronym

Study hypothesis

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.

On 26/09/2014 the anticipated end date was changed from 01/11/2014 to 01/11/2015.

Ethics approval

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

Study design

Single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Quality of Life using the PCOS QoL (in development). Measures will be at 3 time points; at baseline, 4 weeks and 6 weeks.

Secondary outcome measures

Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). Measures will be at 3 time points; at baseline, 4 weeks and 6 weeks.

Overall trial start date

01/01/2014

Overall trial end date

01/11/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant 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)

Recruitment start date

01/01/2014

Recruitment end date

01/11/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Derby
Derby
DE22 1GB
United Kingdom

Sponsor information

Organisation

University of Derby (UK)

Sponsor details

c/o Chris Bussell
Head of Science
Kedleston Road
Derby
DE22 1GB
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Derby (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes