DepressionPhase 4NCT00245193
Motivationally-Enhanced Brief Interpersonal Psychotherapy for Depressed Mothers of Ill Children
A Phase 4 study testing Motivationally-Enhanced Interpersonal Psychotherapy in people with Depression, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study will investigate the effectiveness of motivationally-enhanced brief interpersonal psychotherapy (MI-IPT-B) in treating depression in mothers who bring their children to a child mental health clinic for psychiatric treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Depression
- What is being tested?
- Motivationally-Enhanced Interpersonal Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Mar 2006
- Phase
- Phase 4
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biological or adoptive mother whose child between the ages of 6 and 18 is treated in the Services for Teens at Risk (STAR) Center or the Center for Children and Families (CCF)
- Mother lives with and has custody of the child receiving treatment
- Meets DSM-IV criteria for current unipolar depressive disorder (e.g., dysthymic disorder, depressive disorder, or single or recurrent episodes of major depressive disorder)
- Score of greater than 16 on the Beck Depression Inventory
- Score of greater than 15 on the Hamilton Rating Scale for Depression (17-item)
- Willingness to maintain existing stable dose of antidepressant medication throughout the study if currently on medication and still experiencing symptoms of depression
- Willingness of child (treated in STAR clinic or CCF) to give informed consent
Who cannot join
- Currently receiving antidepressant medication at sub-therapeutic doses or at therapeutic doses but for an inadequate period of time to assess response
- Current dose of medication has not been stable for at least 8 weeks prior to study enrollment
- Suicidal or homicidal
- Requires hospitalization
- At risk for child abuse or neglect and requires intervention
- Simultaneous psychotic disorder or organic mental disorder
Show all 12Show fewer
- History of drug or alcohol abuse within 6 months of study enrollment
- History of a prior manic episode
- Significant medical illness that might explain depressive symptoms (e.g., epilepsy, autoimmune disorders, liver dysfunction, unstable endocrine disease)
- Not fluent in English
- Severe cognitive deficits that would interfere with psychotherapy treatment
- Currently receiving another form of individual psychotherapy or couples therapy (except for participation in a support group, such as Alcoholics Anonymous)
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15231
About this study
Official title: Motivationally-Enhanced Brief Interpersonal Psychotherapy for Depressed Mothers of Ill Children (MI-IPT-B-II)
This study will investigate the effectiveness of motivationally-enhanced brief interpersonal psychotherapy (MI-IPT-B) in treating depression in mothers who bring their children to a child mental health clinic for psychiatric treatment.
Read the detailed description
Depression is a serious illness and is common in mothers who have children facing an illness. Research has shown that these mothers, in particular, need better coping skills and ways to relieve depressive symptoms. Helping mothers of ill children achieve better mental health may also be beneficial to their children. Studies have shown that psychotherapy is an effective treatment for depression, and often results in long-term improvements in depressive symptoms. This study will investigate the effectiveness of MI-IPT-B in treating depression in mothers who bring their children to a child mental health clinic for psychiatric treatment.
Participants in this open label study will be randomly assigned to receive either MI-IPT-B or facilitated referral to treatment as usual (F-TAU). Participants in both groups will undergo the same screening procedures following assignment to an intervention. The MI-IPT-B group will also receive one session of motivational therapy at the time of the initial screening procedures. Participants assigned to receive MI-IPT-B will report to the study site once weekly for therapy. This type of therapy will focus on improving the participants' relationships with their peers and the way that they perceive themselves. The F-TAU group will receive a referral for standard mental health care within the community health system. Both treatments will last 8 weeks. All participants will return to the study site at Week 14 and Month 6 for follow-up assessments of depressive symptoms.
- Conditions
- Depression
- Being tested
- Motivationally-Enhanced Interpersonal Psychotherapy
- Keywords
- Major Depression
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivationally-Enhanced Interpersonal PsychotherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on the Hamilton Rating Scale for Depression; measured at baseline, Week 14, and Month 6
Secondary outcomes (1)
Score on the Beck Depression Inventory; measured at baseline, Week 14, and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2005 (estimated)
- Study startApr 2003
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Investigators
- Holly Swartz, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245193
- Sponsor's protocol ID
- K23MH064518
- Other IDs
- DSIR 8K-RTAT
- Status last verified
- Jun 2013
- First submitted
- 25 Oct 2005
- Last updated
- 25 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivationally-Enhanced Brief Interpersonal Psychotherapy for Depressed Mothers of Ill Children (MI-IPT-B-II)
- ClinicalTrials.gov ID
- NCT00245193
- Acronym / sponsor ID
- K23MH064518
- Conditions
- Depression
- Keywords
- Major Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Apr 2003
- Study completion
- Mar 2006 (actual)
- First posted
- 27 Oct 2005 (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.
This study will investigate the effectiveness of motivationally-enhanced brief interpersonal psychotherapy (MI-IPT-B) in treating depression in mothers who bring their children to a child mental health clinic for psychiatric treatment.
Detailed description
Depression is a serious illness and is common in mothers who have children facing an illness. Research has shown that these mothers, in particular, need better coping skills and ways to relieve depressive symptoms. Helping mothers of ill children achieve better mental health may also be beneficial to their children. Studies have shown that psychotherapy is an effective treatment for depression, and often results in long-term improvements in depressive symptoms. This study will investigate the effectiveness of MI-IPT-B in treating depression in mothers who bring their children to a child mental health clinic for psychiatric treatment.
Participants in this open label study will be randomly assigned to receive either MI-IPT-B or facilitated referral to treatment as usual (F-TAU). Participants in both groups will undergo the same screening procedures following assignment to an intervention. The MI-IPT-B group will also receive one session of motivational therapy at the time of the initial screening procedures. Participants assigned to receive MI-IPT-B will report to the study site once weekly for therapy. This type of therapy will focus on improving the participants' relationships with their peers and the way that they perceive themselves. The F-TAU group will receive a referral for standard mental health care within the community health system. Both treatments will last 8 weeks. All participants will return to the study site at Week 14 and Month 6 for follow-up assessments of depressive symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Biological or adoptive mother whose child between the ages of 6 and 18 is treated in the Services for Teens at Risk (STAR) Center or the Center for Children and Families (CCF)
- Mother lives with and has custody of the child receiving treatment
- Meets DSM-IV criteria for current unipolar depressive disorder (e.g., dysthymic disorder, depressive disorder, or single or recurrent episodes of major depressive disorder)
- Score of greater than 16 on the Beck Depression Inventory
- Score of greater than 15 on the Hamilton Rating Scale for Depression (17-item)
Key exclusion criteria (12 listed)
- Currently receiving antidepressant medication at sub-therapeutic doses or at therapeutic doses but for an inadequate period of time to assess response
- Current dose of medication has not been stable for at least 8 weeks prior to study enrollment
- Suicidal or homicidal
- Requires hospitalization
- At risk for child abuse or neglect and requires intervention
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 |
|---|---|---|
| Motivationally-Enhanced Interpersonal Psychotherapy | Behavioural | – |
Primary outcome
Score on the Hamilton Rating Scale for Depression; measured at baseline, Week 14, and Month 6
1 secondary outcome
Score on the Beck Depression Inventory; measured at baseline, Week 14, and Month 6
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 25 Jun 2013.
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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.
Holly Swartz, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Motivationally-Enhanced Interpersonal Psychotherapy in people with Depression, run by University of Pittsburgh 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 7 inclusion and 12 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 25 Jun 2013. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
Score on the Hamilton Rating Scale for Depression; measured at baseline, Week 14, and Month 6. 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 25 Jun 2013.