PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesHow2dealNCT05679362
Online Brief CBT Intervention for Women With PCOS
A study testing online brief CBT intervention in people with PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries and Depression, Anxiety, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Primary Objective: -To study if an online individual brief CBT (group A) intervention is effective for psychological distress (anxiety and depression) compared to a CAU group in patients with PCOS at 3 and 6 months relative to baseline. Secondary Objective(s): 1. Read more about this study
- Who is it for?
- Ages 17 to 55 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Depression, Anxiety, Self Esteem
- What is being tested?
- online brief CBT intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2024to 1 Dec 2025
- 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 17 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- women with a confirmed diagnosis of PCOS based on the Rotterdam criteria
- body Mass Index (BMI) ≥18.5 kg/m2
- aged 18-55 years.
- mild depressive symptoms or anxiety scores based on the Hospital Anxiety and Depression Scale (HADS) and/or a negative body image based on the Body Cathexis Scale (BCS).
Who cannot join
- pregnancy
- current treatment for clinical depression, anxiety disorders or eating disorders
- suicidality (indicated by a score >2 on the Beck Depression Inventory II suicide item)
- having an endocrine disease (diabetes mellitus, thyroid function disorders, Cushing's disease, adrenal tumors, and congenital adrenal hyperplasia)
- inability to speak, read or write Dutch.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Erasmus MC
Rotterdam
Geranne Jiskoot, phd, L.jiskoot@erasmusmc.nl
Yvonne Louwers, phd, y.louwers@erasmusmc.nl
About this study
Official title: How 2 Deal With PCOS: a Randomized Online Intervention for Women With PCOS
Primary Objective:
-To study if an online individual brief CBT (group A) intervention is effective for psychological distress (anxiety and depression) compared to a CAU group in patients with PCOS at 3 and 6 months relative to baseline.
Read more
Secondary Objective(s):
- To study if an online group based brief CBT (group B) is more effective for anxiety and depression compared to CAU in patients with PCOS at 3 and 6 months relative to baseline.
- To determine if an online individual brief CBT (group A) is effective for improvements in QoL, coping strategies, body image and sleep quality compared to CAU in patients with PCOS at 3 and 6 months relative to baseline.
- To determine if an group based brief CBT (group B) is more effective for improvements in QoL, coping strategies, body image and sleep quality compared to CAU in patients with PCOS at 3 and 6 months relative to baseline.
- If A and B are effective compared to CAU, we will compare online individual brief CBT (group A) to online group based brief CBT (group B) for anxiety and depression, QoL, coping strategies, body image and sleep quality compared to in patients with PCOS at 3 and 6 months relative to baseline.
Read the detailed description
The online brief CBT intervention is designed to address three problems that have often been reported in women with PCOS. Therefore, the program contains three themes: Psychoeducation about PCOS; traditional CBT and problem-solving therapy.
Participants are randomized into one of three groups:
- individual treatment (A)
- group treatment (B)
- care as usual (CAU)
Treatment A and B include 5 sessions divided over a period of 3 months:
Week 1: Session 1 +homework assignments Week 3: Session 2 +homework assignments Week 5: Session 3 +homework assignments Week 8: Session 4 +homework assignments Week 12: Session 5 +homework assignments
The CAU group receives standard treatment for depressive symptoms from their general practitioner (GP).
- Being tested
- online brief CBT intervention
- Medical subject headings
- Polycystic Ovary Syndrome, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online brief CBT interventionBehavioural
Cognitive behavioral therapy
| Study group | Role | What they receive |
|---|---|---|
| immediate individual treatment (A) | Experimental | 5 online individual sessions Receives: Behavioral: online brief CBT intervention |
| immediate group treatment (B) | Experimental | 5 online group sessions with other women with PCOS Receives: Behavioral: online brief CBT intervention |
| care as usual (cau) | No intervention | The CAU group receives standard treatment for depressive symptoms from their general practitioner (GP). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Changes in depression scores as assessed by the Hospital anxiety and depression scale (HADS). HADS is a 14-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. A higher score indicates higher distress.
Measured: at start, after 3 and 6 months
Anxiety
Changes in anxiety scores as assessed by the Hospital anxiety and depression scale (HADS). HADS is a 14-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. A higher score indicates higher distress.
Measured: at start, after 3 and 6 months
Secondary outcomes (2)
QoL
The Polycystic Ovary Syndrome Quality of Life scale (PCOSQOL). The PCOSQOL is a 35-item questionnaire with four subscales: Impact of PCOS, Infertility, Hirsutism and Mood. Lower scores represent a decreased QoL.
Measured: at start, after 3 and 6 months
Coping
Coping Inventory for stressful situation (CISS). Scores for all items per scale are summed to form scale scores; higher scores indicate a greater use of that particular coping strategy.
Measured: at start, after 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Jun 2024 (estimated)
- Primary completion3 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Waterloo Foundation
- Responsible party
- Principal investigator, Geranne Jiskoot, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679362
- Sponsor's protocol ID
- How2deal
- Acronym
- How2deal
- Status last verified
- Apr 2024
- First submitted
- 16 Dec 2022
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How 2 Deal With PCOS: a Randomized Online Intervention for Women With PCOS
- ClinicalTrials.gov ID
- NCT05679362
- Acronym / sponsor ID
- How2deal / How2deal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- The Waterloo Foundation
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 3 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 11 Jan 2023 (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.
Primary Objective:
-To study if an online individual brief CBT (group A) intervention is effective for psychological distress (anxiety and depression) compared to a CAU group in patients with PCOS at 3 and 6 months relative to baseline.
Secondary Objective(s):
- To study if an online group based brief CBT (group B) is more effective for anxiety and depression compared to CAU in patients with PCOS at 3 and 6 months relative to baseline.
- To determine if an online individual brief CBT (group A) is effective for improvements in QoL, coping strategies, body image and sleep quality compared to CAU in patients with PCOS at 3 and 6 months relative to baseline.
- To determine if an group based brief CBT (group B) is more effective for improvements in QoL, coping strategies, body image and sleep quality compared to CAU in patients with PCOS at 3 and 6 months relative to baseline.
- If A and B are effective compared to CAU, we will compare online individual brief CBT (group A) to online group based brief CBT (group B) for anxiety and depression, QoL, coping strategies, body image and sleep quality compared to in patients with PCOS at 3 and 6 months relative to baseline.
Detailed description
The online brief CBT intervention is designed to address three problems that have often been reported in women with PCOS. Therefore, the program contains three themes: Psychoeducation about PCOS; traditional CBT and problem-solving therapy.
Participants are randomized into one of three groups:
- individual treatment (A)
- group treatment (B)
- care as usual (CAU)
Treatment A and B include 5 sessions divided over a period of 3 months:
Week 1: Session 1 +homework assignments Week 3: Session 2 +homework assignments Week 5: Session 3 +homework assignments Week 8: Session 4 +homework assignments Week 12: Session 5 +homework assignments
The CAU group receives standard treatment for depressive symptoms from their general practitioner (GP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| immediate individual treatment (A) | Experimental | Behavioral: online brief CBT intervention5 online individual sessions |
| immediate group treatment (B) | Experimental | Behavioral: online brief CBT intervention5 online group sessions with other women with PCOS |
| care as usual (cau) | No intervention | –The CAU group receives standard treatment for depressive symptoms from their general practitioner (GP). |
Who may qualify
- Ages
- 17 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- women with a confirmed diagnosis of PCOS based on the Rotterdam criteria
- body Mass Index (BMI) ≥18.5 kg/m2
- aged 18-55 years.
- mild depressive symptoms or anxiety scores based on the Hospital Anxiety and Depression Scale (HADS) and/or a negative body image based on the Body Cathexis Scale (BCS).
Key exclusion criteria (5 listed)
- pregnancy
- current treatment for clinical depression, anxiety disorders or eating disorders
- suicidality (indicated by a score >2 on the Beck Depression Inventory II suicide item)
- having an endocrine disease (diabetes mellitus, thyroid function disorders, Cushing's disease, adrenal tumors, and congenital adrenal hyperplasia)
- inability to speak, read or write Dutch.
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 |
|---|---|---|
| online brief CBT interventionCognitive behavioral therapy | Behavioural | immediate group treatment (B), immediate individual treatment (A) |
Primary outcome
Depression
Time frame: at start, after 3 and 6 months
Changes in depression scores as assessed by the Hospital anxiety and depression scale (HADS). HADS is a 14-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. A higher score indicates higher distress.
Anxiety
Time frame: at start, after 3 and 6 months
Changes in anxiety scores as assessed by the Hospital anxiety and depression scale (HADS). HADS is a 14-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. A higher score indicates higher distress.
2 secondary outcomes
QoL
Time frame: at start, after 3 and 6 months
Coping
Time frame: at start, after 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing online brief CBT intervention in people with PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries and Depression, Anxiety, run by Erasmus Medical Center at 1 site in Netherlands.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Apr 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joop Laven, Prof (031-107033760, j.laven@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: at start, after 3 and 6 months). The study lists 2 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 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.