Partner Assisted Interpersonal PsychotherapyPhase 1/2NCT01732055
Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression
A Phase 1/2 study testing Partner-Assisted Interpersonal Psychotherapy and Treatment as Usual in people with Partner Assisted Interpersonal Psychotherapy and Treatment as Usual, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: To compare a novel psychotherapy, Partner-Assisted Interpersonal Psychotherapy (PA-IPT), with treatment as usual (TAU) in a sample of pregnant women seeking treatment for Major Depressive Disorder (MDD) at the University of North Carolina at Chapel Hill (UNC-CH) Perinatal Psychiatry Program. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Partner Assisted Interpersonal Psychotherapy, Treatment as Usual
- What is being tested?
- Partner-Assisted Interpersonal Psychotherapy and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Dec 2013
- Phase
- Phase 1/2
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females aged 18-45 years
- 16-29 weeks estimated gestational age
- Able to provide informed consent
- English or Spanish language literacy
- In a committed relationship cohabiting for at least 6 months with a Dyadic Adjustment Scale rating < 90 or with an identified family member or friend residing in the same home
- Meet criteria for Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition Text Revision (DSM-IV) diagnosis of Major Depressive Disorder (MDD)
- HRSD-17 score is equal or greater than 16 at diagnostic evaluation and randomization
- Medically healthy and without fetal anomaly according to history
Who cannot join
- No identified primary care, nurse midwife, or obstetrical physician to monitor pregnancy; participant or physician refuses to sign release of information
- By patient report, history of partner verbal, emotional, or physical abuse
- Partner unable or unwilling to participate
- DSM-IV diagnoses of bipolar 1 or 2 or any psychotic episode
- Substance abuse within the last 6 months
- Eating Disorder
Show all 10Show fewer
- Current use of other therapies for depression including individual psychotherapy, herbal remedies or other complementary/alternative therapies, antidepressant medication outside the study protocol
- Active suicidal ideation
- Identified partner has DSM-IV diagnoses of bipolar 1 or 2 or any psychotic episode
- Interpersonal violence or abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Hospitals and Clinics
Chapel Hill, North Carolina, 27599-7160
About this study
Purpose: To compare a novel psychotherapy, Partner-Assisted Interpersonal Psychotherapy (PA-IPT), with treatment as usual (TAU) in a sample of pregnant women seeking treatment for Major Depressive Disorder (MDD) at the University of North Carolina at Chapel Hill (UNC-CH) Perinatal Psychiatry Program.
Participants: 52 women, ages 18-45, who are 16-29 weeks pregnant and experiencing a depressive episode, and their partners.
Read more
Methods: Women and their identified partners will complete a diagnostic interview, complete measures of depressive symptom severity at baseline, and be randomized to treatment with PA-IPT or TAU. Women randomized to TAU will be treated by UNC physicians according to the UNC-CH Perinatal Psychiatry Program's algorithm for treatment of prenatal MDD (usually one of a number of antidepressant medications, tailored to the individual, although some women may opt against medication altogether and still be eligible to enroll). Women randomized to PA-IPT will participate in 8 therapy sessions with their identified partner over a 12-week period, along with one refresher session at or around 6 weeks postpartum. Women and partners will be assessed for change in depressive symptoms and relationship satisfaction during pregnancy at visits 4 and 8, and postpartum at 6-week and 6-month visits.
Hypothesis: The investigators anticipate notable improvement in both groups similar in magnitude, however it is hypothesized that couples participating in PA-IPT will have higher relationship satisfaction post-treatment (controlling for baseline satisfaction) than those receiving TAU.
- Being tested
- Partner-Assisted Interpersonal Psychotherapy, Treatment as Usual
- Keywords
- Pregnancy, Antenatal, Major Depressive Disorder, Psychotherapy, Antidepressant Medication, Partners, Spouses, Interpersonal Psychotherapy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partner-Assisted Interpersonal PsychotherapyBehavioural
Also called PA-IPT, PAT
Treatment as UsualOther
Also called TAU, Watchful Waiting, Antidepressant Medication
Because treatment(s) are prescribed for subjects by the UNC Perinatal Psychiatry physicians, it is impossible for the investigators to list each potential medication and dosage that might be prescribed to women randomized to this condition. The medication regimens are individual, and some women may opt against medication altogether (and still be eligible to enroll). Women who refuse antidepressant medication will attend visits at the same intervals as those in the study arms for evaluation of safety and symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Partner-Assisted Interpersonal Psychotherapy | Active comparator | Partner-Assisted Interpersonal Psychotherapy is an 8-week series of psychotherapy sessions attended by the patient and her identified partner. Receives: Behavioral: Partner-Assisted Interpersonal Psychotherapy |
| Treatment as Usual | Other | Treatment prescribed for subjects by the UNC Perinatal Psychiatry clinic physicians according to the clinic algorithm. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression-17 item version (HRSD-17)
Change from baseline in symptoms of Major Depressive Disorder
Measured: Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum)
Secondary outcomes (1)
Dyadic Adjustment Scale (DAS)
Change from baseline in relationship satisfaction
Measured: Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Study ended because recruitment goals unmet and further funding unlikely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Partner Assisted Interpersonal PsychotherapyStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation of Hope, North Carolina
- Responsible party
- Sponsor
- Investigators
- Anna R. Brandon, PhD, MSCS, Principal investigator, University of North Carolina, Chapel HillSamantha Meltzer-Brody, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732055
- Sponsor's protocol ID
- 12-0235
- Status last verified
- Jan 2014
- First submitted
- 6 Nov 2012
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Brandon AR, Ceccotti N, Hynan LS, Shivakumar G, Johnson N, Jarrett RB. Proof of concept: Partner-Assisted Interpersonal Psychotherapy for perinatal depression. Arch Womens Ment Health. 2012 Dec;15(6):469-80. doi: 10.1007/s00737-012-0311-1. Epub 2012 Oct 4.
PubMed 23053218
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partner-Assisted Interpersonal Psychotherapy or Antidepressant Medication for Antenatal Depression
- ClinicalTrials.gov ID
- NCT01732055
- Acronym / sponsor ID
- 12-0235
- Keywords
- Pregnancy, Antenatal, Major Depressive Disorder, Psychotherapy, Antidepressant Medication, Partners, Spouses, Interpersonal Psychotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study ended because recruitment goals unmet and further funding unlikely
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Foundation of Hope, North Carolina
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 22 Nov 2012 (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.
Purpose: To compare a novel psychotherapy, Partner-Assisted Interpersonal Psychotherapy (PA-IPT), with treatment as usual (TAU) in a sample of pregnant women seeking treatment for Major Depressive Disorder (MDD) at the University of North Carolina at Chapel Hill (UNC-CH) Perinatal Psychiatry Program.
Participants: 52 women, ages 18-45, who are 16-29 weeks pregnant and experiencing a depressive episode, and their partners.
Methods: Women and their identified partners will complete a diagnostic interview, complete measures of depressive symptom severity at baseline, and be randomized to treatment with PA-IPT or TAU. Women randomized to TAU will be treated by UNC physicians according to the UNC-CH Perinatal Psychiatry Program's algorithm for treatment of prenatal MDD (usually one of a number of antidepressant medications, tailored to the individual, although some women may opt against medication altogether and still be eligible to enroll). Women randomized to PA-IPT will participate in 8 therapy sessions with their identified partner over a 12-week period, along with one refresher session at or around 6 weeks postpartum. Women and partners will be assessed for change in depressive symptoms and relationship satisfaction during pregnancy at visits 4 and 8, and postpartum at 6-week and 6-month visits.
Hypothesis: The investigators anticipate notable improvement in both groups similar in magnitude, however it is hypothesized that couples participating in PA-IPT will have higher relationship satisfaction post-treatment (controlling for baseline satisfaction) than those receiving TAU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partner-Assisted Interpersonal Psychotherapy | Active comparator | Behavioral: Partner-Assisted Interpersonal PsychotherapyPartner-Assisted Interpersonal Psychotherapy is an 8-week series of psychotherapy sessions attended by the patient and her identified partner. |
| Treatment as Usual | Other | Other: Treatment as UsualTreatment prescribed for subjects by the UNC Perinatal Psychiatry clinic physicians according to the clinic algorithm. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Females aged 18-45 years
- 16-29 weeks estimated gestational age
- Able to provide informed consent
- English or Spanish language literacy
- In a committed relationship cohabiting for at least 6 months with a Dyadic Adjustment Scale rating < 90 or with an identified family member or friend residing in the same home
Key exclusion criteria (10 listed)
- No identified primary care, nurse midwife, or obstetrical physician to monitor pregnancy; participant or physician refuses to sign release of information
- By patient report, history of partner verbal, emotional, or physical abuse
- Partner unable or unwilling to participate
- DSM-IV diagnoses of bipolar 1 or 2 or any psychotic episode
- Substance abuse within the last 6 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 |
|---|---|---|
| Partner-Assisted Interpersonal PsychotherapyAlso: PA-IPT, PAT | Behavioural | Partner-Assisted Interpersonal Psychotherapy |
| Treatment as UsualAlso: TAU, Watchful Waiting, Antidepressant MedicationBecause treatment(s) are prescribed for subjects by the UNC Perinatal Psychiatry physicians, it is impossible for the investigators to list each potential medication and dosage that might be prescribed to women randomized to this condition. The medication regimens are individual, and some women may opt against medication altogether (and still be eligible to enroll). Women who refuse antidepressant medication will attend visits at the same intervals as those in the study arms for evaluation of safety and symptoms. | Other | Treatment as Usual |
Primary outcome
Hamilton Rating Scale for Depression-17 item version (HRSD-17)
Time frame: Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum)
Change from baseline in symptoms of Major Depressive Disorder
1 secondary outcome
Dyadic Adjustment Scale (DAS)
Time frame: Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum)
Results and safety
The study was stopped early (reason given: Study ended because recruitment goals unmet and further funding unlikely). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
- Background: PubMed 23053218Brandon AR, Ceccotti N, Hynan LS, Shivakumar G, Johnson N, Jarrett RB. Proof of concept: Partner-Assisted Interpersonal Psychotherapy for perinatal depression. Arch Womens Ment Health. 2012 Dec;15(6):469-80. doi: 10.1007/s00737-012-0311-1. Epub 2012 Oct 4.
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.
Anna R. Brandon, PhD, MSCS principal investigator
University of North Carolina, Chapel Hill
Samantha Meltzer-Brody, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Partner-Assisted Interpersonal Psychotherapy and Treatment as Usual in people with Partner Assisted Interpersonal Psychotherapy and Treatment as Usual, run by University of North Carolina, Chapel Hill 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 8 inclusion and 10 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: stopped early, as of the sponsor's last update on 14 Jan 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study ended because recruitment goals unmet and further funding unlikely). Results are not available in the source record.
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?
Hamilton Rating Scale for Depression-17 item version (HRSD-17) (time frame: Baseline (16-29 weeks pregnancy) until Endpoint (6 months postpartum)). 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 NCT01732055, which also lists 1 linked publication.
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 Jan 2014.