Interpersonal PsychotherapyIPAPNCT06056453
Interpersonal Psychotherapy in Adolescents With Polycystic Ovary Syndrome
A study testing Interpersonal Psychotherapy in people with Interpersonal Psychotherapy and Polycystic Ovary Syndrome, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The main purpose of this study is to find out whether taking part in a group-based interpersonal psychotherapy (IPT) program designed to improve mood and lessen stress in girls with PCOS will improve depression, unhealthy eating behaviors, weight, and insulin resistance. Read more about this study
- Who is it for?
- Ages 12 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Interpersonal Psychotherapy, Polycystic Ovary Syndrome
- What is being tested?
- Interpersonal Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2021to 14 Jul 2023
- 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 12 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnosed with PCOS duration > 3 months
- 12-17 years old
- BMI > 75th percentile
- CESD > 16
Who cannot join
- Weekly or bi-weekly therapy with licensed behavioral health provider
- Inability to speak, read, or write in English (teen)
- Major medical conditions
- HbA1c > 7.0%
- Hormonal contraception < 3 months
- Metformin < 3 months
- Antidepressants/psychotropic medications < 4 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
The main purpose of this study is to find out whether taking part in a group-based interpersonal psychotherapy (IPT) program designed to improve mood and lessen stress in girls with PCOS will improve depression, unhealthy eating behaviors, weight, and insulin resistance.
- Being tested
- Interpersonal Psychotherapy
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal PsychotherapyBehavioural
IPT group-virtual
| Study group | Role | What they receive |
|---|---|---|
| IPT | Experimental | Participate in IPT 6-week intervention group. Receives: Behavioral: Interpersonal Psychotherapy |
| UC | No intervention | Continue with usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center for Epidemiologic Studies-Depression Scale
Depression symptoms will be assessed by the Center for Epidemiologic Studies-Depression Scale. Scores range from 1 to 4. The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
Measured: Baseline
Center for Epidemiologic Studies-Depression Scale
Depression symptoms will be assessed by the Center for Epidemiologic Studies-Depression Scale. Scores range from 1 to 4. The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
Measured: 6-Week Follow-Up Assessment
Center for Epidemiologic Studies-Depression Scale
Depression symptoms will be assessed by the Center for Epidemiologic Studies-Depression Scale. Scores range from 1 to 4. The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
Measured: 6-Month Follow-Up Assessment
Secondary outcomes (7)
Emotional Eating Scale Adapted for Children
Disordered eating will be assessed by the Emotional Eating Scale Adapted for Children. The scale has been adapted for children and assesses eating in response to negative affect, such as feeling sad or irritated. The scale ranges from "I have no desire to eat" to "I have a very strong desire to eat" and averages how many days a week the participant eats based on that feeling.
Measured: Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
Loss-of-Control Eating Disorder Questionnaire
Loss-of-control eating will be assessed via the 19-item Loss-of-Control Eating Disorder Questionnaire (LOC-ED-Q), which shows sound psychometric properties in adolescents using Yes/No.
Measured: Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
Reward Based Eating Drive Scale
Reward based eating will be assessed by the Reward Based Eating Drive Scale. This is a self-report questionnaire which assesses reward-based eating that shows sound psychometric properties. The total score is summed at the end; a higher total is indicative of reward-based eating.
Measured: Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
BMI
Fasting BMI (kg/m2) will be derived from measured height in triplicate by stadiometer and measured fasting weight by calibrated digital scale. BMI z-score and BMI %ile will be computed to determine eligibility (BMI ≥75th percentile).
Measured: Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
Insulin Resistance
Blood will be sampled via a venipuncture procedure following a 10-hour overnight fast to measure fasting insulin. Insulin resistance will be estimated from fasting insulin and glucose with the homeostatic model assessment of insulin resistance (HOMA-IR).
Measured: Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
Dysglycemia
Blood will be sampled via a venipuncture procedure following a 10-hour overnight fast to measure fasting insulin. Insulin resistance will be estimated from fasting insulin and glucose with the homeostatic model assessment of insulin resistance (HOMA-IR).
Measured: Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
Dyslipidemia
Blood will be sampled via a venipuncture procedure following a 10-hour overnight fast to measure dyslipidemia. Insulin resistance will be estimated from fasting insulin and glucose with the homeostatic model assessment of insulin resistance (HOMA-IR).
Measured: Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start20 Sep 2021
- Primary completion14 Jul 2023
- Study completion14 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interpersonal PsychotherapyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- American Psychological Association (APA)
- Responsible party
- Sponsor
- Investigators
- Lauren Gulley, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056453
- Sponsor's protocol ID
- 20-3033
- Acronym
- IPAP
- Status last verified
- Sep 2023
- First submitted
- 7 Dec 2022
- Last updated
- 28 Sep 2023
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interpersonal Psychotherapy in Adolescents With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT06056453
- Acronym / sponsor ID
- IPAP / 20-3033
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- American Psychological Association (APA)
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 28 Sep 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.
The main purpose of this study is to find out whether taking part in a group-based interpersonal psychotherapy (IPT) program designed to improve mood and lessen stress in girls with PCOS will improve depression, unhealthy eating behaviors, weight, and insulin resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPT | Experimental | Behavioral: Interpersonal PsychotherapyParticipate in IPT 6-week intervention group. |
| UC | No intervention | –Continue with usual care. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosed with PCOS duration > 3 months
- 12-17 years old
- BMI > 75th percentile
- CESD > 16
Key exclusion criteria (7 listed)
- Weekly or bi-weekly therapy with licensed behavioral health provider
- Inability to speak, read, or write in English (teen)
- Major medical conditions
- HbA1c > 7.0%
- Hormonal contraception < 3 months
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 |
|---|---|---|
| Interpersonal PsychotherapyIPT group-virtual | Behavioural | IPT |
Primary outcome
Center for Epidemiologic Studies-Depression Scale
Time frame: Baseline
Depression symptoms will be assessed by the Center for Epidemiologic Studies-Depression Scale. Scores range from 1 to 4. The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
Center for Epidemiologic Studies-Depression Scale
Time frame: 6-Week Follow-Up Assessment
Depression symptoms will be assessed by the Center for Epidemiologic Studies-Depression Scale. Scores range from 1 to 4. The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
Center for Epidemiologic Studies-Depression Scale
Time frame: 6-Month Follow-Up Assessment
Depression symptoms will be assessed by the Center for Epidemiologic Studies-Depression Scale. Scores range from 1 to 4. The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
7 secondary outcomes
Emotional Eating Scale Adapted for Children
Time frame: Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
Loss-of-Control Eating Disorder Questionnaire
Time frame: Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
Reward Based Eating Drive Scale
Time frame: Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
BMI
Time frame: Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
Insulin Resistance
Time frame: Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
Dysglycemia
Time frame: Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
Dyslipidemia
Time frame: Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- 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.
Lauren Gulley, PhD principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal Psychotherapy in people with Interpersonal Psychotherapy and Polycystic Ovary Syndrome, run by University of Colorado, Denver at 1 site in United States.
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 7 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: finished, as of the sponsor's last update on 28 Sep 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center for Epidemiologic Studies-Depression Scale (time frame: Baseline). The study lists 3 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 28 Sep 2023.