Pelvic PainNCT00895999
Psychosocial Treatment for Women With Depression and Pain
A study testing Interpersonal Therapy for Pain (IPT-P) and Enhanced Support and Connection to Counseling in people with Pelvic Pain and Depression, run by University of Rochester at 1 site in United States.
Trial summary
Patients with depression and pain have poorer outcomes in response to depression treatments than depressed patients without pain. While psychotherapy treatment studies have demonstrated improvement in pain and depression, no psychosocial interventions have been developed and tested prospectively specifically for… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Pain, Depression
- What is being tested?
- Interpersonal Therapy for Pain (IPT-P) and Enhanced Support and Connection to Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Dec 2011
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- major depression
- chronic pelvic pain
Who cannot join
- current or past psychosis
- moderate mental retardation or greater
- active suicidal intent
- active abuse of non-prescribed substances (< 3 months)
- current individual psychotherapy
- current pregnancy
Show all 9Show fewer
- terminal illness
- inability to communicate in English
- men
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Psychosocial Treatment for Gynecology Patients With Comorbid Depression and Pain
Patients with depression and pain have poorer outcomes in response to depression treatments than depressed patients without pain. While psychotherapy treatment studies have demonstrated improvement in pain and depression, no psychosocial interventions have been developed and tested prospectively specifically for patients with both conditions. Interpersonal psychotherapy (IPT), an effective treatment for depression, has been adapted successfully for physically ill patients and demonstrates good adherence, treatment satisfaction, and depression outcomes. The investigators propose to test a modified form of IPT-P for depressed patients with co-morbid pain.
- Conditions
- Pelvic Pain, Depression
- Being tested
- Interpersonal Therapy for Pain (IPT-P), Enhanced Support and Connection to Counseling
- Medical subject headings
- Pelvic Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal Therapy for Pain (IPT-P)Behavioural
IPT-P focuses on improving relationships as a way to improve depression and pain. The patient and therapist work together to improve communication and enhance relationships and social support. Patients choose a problem focus and goal related to both their pain and depression. Up to 8 IPT-P sessions are provided regardless of ability to pay.
Enhanced Support and Connection to CounselingBehavioural
Research staff connect patients with the Strong Family Therapy Services, Women's Behavioral Health Service, or other appropriate mental health care and reduce potential barriers from making it to the initial appointment. This support includes navigating insurance issues, addressing issues of childcare and transportation, helping to schedule the initial appointment, reminder calls, and follow-up after the scheduled intake. Research staff will also check-in monthly to see if the patients require any additional support to remain in mental health treatment. Up to 8 therapy sessions are covered regardless of ability to pay.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Female patients (n=30) who meet criteria for major depression and chronic pelvic pain will be randomly assigned to 8 individual sessions of IPT adapted for depression and pain. Receives: Behavioral: Interpersonal Therapy for Pain (IPT-P) |
| 2 | Other | Female patients (n=30) who meet criteria for major depression and chronic pelvic pain will be randomly assigned to Enhanced Support and Connection to Counseling (ESCC). Receives: Behavioral: Enhanced Support and Connection to Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
A self-report measure BDI and a clinician measure HRSD will evaluate depression severity. These measures are standards in primary care depression trials and in pain studies and have demonstrated sensitivity to detect changes in depress
Measured: 0, 12 wks, 24 wks, 36 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2009 (estimated)
- Study startMar 2007
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Ellen Poleshuck, University of Rochester
- Investigators
- Ellen Poleshuck, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895999
- Sponsor's protocol ID
- Poleshuck K23
- Other IDs
- 5K23MH079347
- Status last verified
- Mar 2014
- First submitted
- 8 May 2009
- Last updated
- 14 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Poleshuck E, Wittink M, Crean H, Gellasch T, Sandler M, Bell E, Juskiewicz I, Cerulli C. Using patient engagement in the design and rationale of a trial for women with depression in obstetrics and gynecology practices. Contemp Clin Trials. 2015 Jul;43:83-92. doi: 10.1016/j.cct.2015.04.010. Epub 2015 Apr 30.
PubMed 25937505Poleshuck EL, Gamble SA, Bellenger K, Lu N, Tu X, Sorensen S, Giles DE, Talbot NL. Randomized controlled trial of interpersonal psychotherapy versus enhanced treatment as usual for women with co-occurring depression and pelvic pain. J Psychosom Res. 2014 Oct;77(4):264-72. doi: 10.1016/j.jpsychores.2014.07.016. Epub 2014 Jul 26.
PubMed 25280823
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Treatment for Gynecology Patients With Comorbid Depression and Pain
- ClinicalTrials.gov ID
- NCT00895999
- Acronym / sponsor ID
- Poleshuck K23
- Conditions
- Pelvic Pain, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 May 2009 (estimated)
- 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.
Patients with depression and pain have poorer outcomes in response to depression treatments than depressed patients without pain. While psychotherapy treatment studies have demonstrated improvement in pain and depression, no psychosocial interventions have been developed and tested prospectively specifically for patients with both conditions. Interpersonal psychotherapy (IPT), an effective treatment for depression, has been adapted successfully for physically ill patients and demonstrates good adherence, treatment satisfaction, and depression outcomes. The investigators propose to test a modified form of IPT-P for depressed patients with co-morbid pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Interpersonal Therapy for Pain (IPT-P)Female patients (n=30) who meet criteria for major depression and chronic pelvic pain will be randomly assigned to 8 individual sessions of IPT adapted for depression and pain. |
| 2 | Other | Behavioral: Enhanced Support and Connection to CounselingFemale patients (n=30) who meet criteria for major depression and chronic pelvic pain will be randomly assigned to Enhanced Support and Connection to Counseling (ESCC). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- major depression
- chronic pelvic pain
Key exclusion criteria (9 listed)
- current or past psychosis
- moderate mental retardation or greater
- active suicidal intent
- active abuse of non-prescribed substances (< 3 months)
- current individual psychotherapy
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 Therapy for Pain (IPT-P)IPT-P focuses on improving relationships as a way to improve depression and pain. The patient and therapist work together to improve communication and enhance relationships and social support. Patients choose a problem focus and goal related to both their pain and depression. Up to 8 IPT-P sessions are provided regardless of ability to pay. | Behavioural | 1 |
| Enhanced Support and Connection to CounselingResearch staff connect patients with the Strong Family Therapy Services, Women's Behavioral Health Service, or other appropriate mental health care and reduce potential barriers from making it to the initial appointment. This support includes navigating insurance issues, addressing issues of childcare and transportation, helping to schedule the initial appointment, reminder calls, and follow-up after the scheduled intake. Research staff will also check-in monthly to see if the patients require any additional support to remain in mental health treatment. Up to 8 therapy sessions are covered regardless of ability to pay. | Behavioural | 2 |
Primary outcome
A self-report measure BDI and a clinician measure HRSD will evaluate depression severity. These measures are standards in primary care depression trials and in pain studies and have demonstrated sensitivity to detect changes in depress
Time frame: 0, 12 wks, 24 wks, 36 wks
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 14 Mar 2014.
- Derived from this study: PubMed 25937505Poleshuck E, Wittink M, Crean H, Gellasch T, Sandler M, Bell E, Juskiewicz I, Cerulli C. Using patient engagement in the design and rationale of a trial for women with depression in obstetrics and gynecology practices. Contemp Clin Trials. 2015 Jul;43:83-92. doi: 10.1016/j.cct.2015.04.010. Epub 2015 Apr 30.
- Derived from this study: PubMed 25280823Poleshuck EL, Gamble SA, Bellenger K, Lu N, Tu X, Sorensen S, Giles DE, Talbot NL. Randomized controlled trial of interpersonal psychotherapy versus enhanced treatment as usual for women with co-occurring depression and pelvic pain. J Psychosom Res. 2014 Oct;77(4):264-72. doi: 10.1016/j.jpsychores.2014.07.016. Epub 2014 Jul 26.
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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.
Ellen Poleshuck, PhD principal investigator
University of Rochester
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 Therapy for Pain (IPT-P) and Enhanced Support and Connection to Counseling in people with Pelvic Pain and Depression, run by University of Rochester 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 2 inclusion and 9 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 14 Mar 2014. 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?
A self-report measure BDI and a clinician measure HRSD will evaluate depression severity. These measures are standards in primary care depression trials and in pain studies and have demonstrated sensitivity to detect changes in depress (time frame: 0, 12 wks, 24 wks, 36 wks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00895999, which also lists 2 linked publications.
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 14 Mar 2014.