DepressionIPT-MOMSNCT00919594
Psychotherapy for Depressed Mothers of Psychiatrically Ill Children
A study testing Interpersonal Psychotherapy for Mothers (IPT-MOMS) and Brief Supportive Psychotherapy in people with Depression, run by University of Pittsburgh at 1 site in United States.
Trial summary
The current proposal is a randomized, controlled, clinical trial to evaluate the intergenerational impact of treating depressed mothers whose children suffer from psychiatric disorders. Read more about this study
- Who is it for?
- Ages 7 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Interpersonal Psychotherapy for Mothers (IPT-MOMS) and Brief Supportive Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Feb 2014
- 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 7 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult female, age 18-65
- Biological or adoptive mother of child, age 7-18, who meets child inclusion criteria (see below)
- Lives with and has custody of the eligible child participant
- Currently in an episode of major depression, as defined by the DSM-IV and documented by the use of the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I)
- Score > or equal to 15 on the 25-item Hamilton Rating Scale for Depression (HRSD-25)
- Ability and willingness to give informed, written consent
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- Willingness to give informed consent for their eligible and assenting child to participate
- Age 7-18
- Currently meets criteria for at least one current depressive or anxiety disorder as defined by the DSM-IV (American Psychiatric Association, 1994) and documented by the Schedule for Affective Disorders and Schizophrenia for School Age Children, Present and Lifetime version (K-SADS-PL)
- Willingness to provide informed consent/assent
Who cannot join
- If a mother subject IS NOT on antidepressants:
- Mothers must be off all antidepressant medications for at least 14 days (30 days for fluoxetine) prior to screening to ensure that pretreatment assessments are not distorted by drug withdrawal or rebound effects). Mother subjects cannot start taking antidepressant medications during the acute treatment phase. If they do start taking antidepressant medication during the acute treatment portion of the study, their participation in the acute phase of the study will be terminated. They will be continued to be followed in the follow-up phase.
- If a mother subject IS on antidepressants:
- Mothers must be on a stable dose of an antidepressant medication (4 consecutive weeks at the same dose) prior to signing consent. The mother subject must agree to stay on the same antidepressant at this current dose throughout the duration of the acute phase of the study. If a participant's dosage of an antidepressant medication is changed or if they cease taking their antidepressant medication during the acute treatment portion of the study, their participation in the acute phase of the study will be terminated. They will be continued to be followed in the follow-up phase.
- Active suicidal ideation or homicidal ideation that in the clinical opinion of the research team as headed by the PI, would require hospitalization
- At serious risk for child abuse or neglect which in the clinical opinion of the research team as headed by the PI, requires intervention
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- Comorbid psychotic disorder, organic mental disorder, current (within prior six months) substance or alcohol abuse, borderline personality disorder, antisocial personality disorder, or history of a prior manic episode (bipolar disorder)
- Significant medical illness that might explain depressive symptoms such as epilepsy, autoimmune disorders, or unstable endocrine disease
- Not fluent in English. The intervention to be tested in this study is psychotherapy. The staff is only trained to deliver these interventions in English. Thus, all subjects must be fluent in English.
- Severe cognitive deficits that would preclude treatment with psychotherapy and/or prevent completion of study questionnaires
- Current receipt of another form of individual psychotherapy; concurrent participation in a support group (such as Alcoholics Anonymous), couples therapy, or family therapy will be permitted
- Currently in an abusive relationship as determined by the domestic violence questionnaire and/or PI's judgment
- Unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations)
- Meets criteria for mental retardation, autistic disorder, schizophrenia, or current (within prior 6 months) substance or alcohol abuse
- Significant cognitive impairment or learning delays that would prevent completion of study questionnaires
- Significant chronic medical illness that might explain depressive or anxiety symptoms such as sickle cell anemia, cystic fibrosis, or leukemia; children with moderate medical illnesses may be included in the study if the PI determines it is of no greater risk to the child's medical illness
- Unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations)
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Psychotherapy for Depressed Mothers of Psychiatrically Ill
The current proposal is a randomized, controlled, clinical trial to evaluate the intergenerational impact of treating depressed mothers whose children suffer from psychiatric disorders.
Read the detailed description
This study will compare a psychotherapy for mothers that targets factors known to be associated with the intergenerational transmission of psychiatric disorders to a nonspecific psychotherapeutic control condition. It will evaluate outcomes in both children and mothers. A modified form of interpersonal psychotherapy for depression, IPT-MOMS, specifically addresses maternal depressive symptoms, maternal interpersonal functioning, and mother-child communication, all factors that contribute to psychiatric illness in youth (Swartz et al., 2006). This application proposes to recruit mother-child dyads, both of whom suffer from psychiatric illness, randomly assign mothers to nine sessions over 3 months of either IPT-MOMS (N=105) or brief supportive psychotherapy (BSP; N=105), and evaluate the impact of acute maternal treatment on child and maternal outcomes at 3, 6, 9, and 12 month follow-up.
- Conditions
- Depression
- Being tested
- Interpersonal Psychotherapy for Mothers (IPT-MOMS), Brief Supportive Psychotherapy
- Keywords
- Interpersonal Psychotherapy, Depression, Mothers
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal Psychotherapy for Mothers (IPT-MOMS)Behavioural
Interventions will be administered during the 3 Month Acute Randomized Phase and will consist of nine individual 45-minute sessions conducted over the course of three months. Treatment cannot exceed nine sessions. In addition to standard IPT techniques, IPT-MOMS includes a specific focus on the challenges associated with managing a child who suffers from psychiatric problems.
Brief Supportive PsychotherapyBehavioural
Interventions will be administered during the 3 Month Acute Randomized Phase and will consist of nine individual 45-minute sessions conducted over the course of three months. Treatment cannot exceed 9 sessions. Brief supportive therapy (BSP) is a manualized form of supportive psychotherapy which emphasizes reflective listening and elicitation of affect (Markowitz et al., 2008). Therapists are instructed to allow patients to determine the focus of each session, pulling for emotion, validating emotions when possible, and offering empathic comments.
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal Psychotherapy for Mothers | Experimental | Interventions will be administered during the 3 Month Acute Randomized Phase and will consist of nine individual 45-minute sessions conducted over the course of three months. Treatment cannot exceed nine sessions. In addition to standard IPT techniques, IPT-MOMS includes a specific focus on the challenges associated with managing a child who suffers from psychiatric problems. Receives: Behavioral: Interpersonal Psychotherapy for Mothers (IPT-MOMS) |
| Brief Supportive Psychotherapy | Active comparator | Interventions will be administered during the 3 Month Acute Randomized Phase and will consist of nine individual 45-minute sessions conducted over the course of three months. Treatment cannot exceed 9 sessions. Brief supportive therapy (BSP) is a manualized form of supportive psychotherapy which emphasizes reflective listening and elicitation of affect (Markowitz et al., 2008). Therapists are instructed to allow patients to determine the focus of each session, pulling for emotion, validating emotions when possible, and offering empathic comments. Receives: Behavioral: Brief Supportive Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
We will compare the effects of two interventions IPT-MOMS and BSP on children outcomes: depressive symptoms (as measured by the CDI), total difficulties (as measured by the SDQ), and psychosocial functioning (as measured by the CIS) over time
Measured: Baseline, Months 3, 6, 9, 12
We will compare the two groups in depressive symptoms (as measured by the HRSD-25) and psychosocial and vocational functioning (as measured by the IIP, ISEL, and WSAS) over time.
Measured: Baseline, Months 3, 6, 9, 12
Secondary outcomes (1)
We will look at major depressive episode criteria for all mothers
Measured: 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startAug 2009
- Primary completionFeb 2014
- Study completionFeb 2014
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Holly Swartz, University of Pittsburgh
- Investigators
- Holly Swartz, M.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919594
- Sponsor's protocol ID
- PRO08100448
- Other IDs
- 5R01MH083647
- Acronym
- IPT-MOMS
- Status last verified
- Jul 2017
- First submitted
- 11 Jun 2009
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Swartz HA, Cyranowski JM, Cheng Y, Zuckoff A, Brent DA, Markowitz JC, Martin S, Amole MC, Ritchey F, Frank E. Brief Psychotherapy for Maternal Depression: Impact on Mothers and Children. J Am Acad Child Adolesc Psychiatry. 2016 Jun;55(6):495-503.e2. doi: 10.1016/j.jaac.2016.04.003. Epub 2016 Apr 7.
PubMed 27238068
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychotherapy for Depressed Mothers of Psychiatrically Ill
- ClinicalTrials.gov ID
- NCT00919594
- Acronym / sponsor ID
- IPT-MOMS / PRO08100448
- Conditions
- Depression
- Keywords
- Interpersonal Psychotherapy, Depression, Mothers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 12 Jun 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.
The current proposal is a randomized, controlled, clinical trial to evaluate the intergenerational impact of treating depressed mothers whose children suffer from psychiatric disorders.
Detailed description
This study will compare a psychotherapy for mothers that targets factors known to be associated with the intergenerational transmission of psychiatric disorders to a nonspecific psychotherapeutic control condition. It will evaluate outcomes in both children and mothers. A modified form of interpersonal psychotherapy for depression, IPT-MOMS, specifically addresses maternal depressive symptoms, maternal interpersonal functioning, and mother-child communication, all factors that contribute to psychiatric illness in youth (Swartz et al., 2006). This application proposes to recruit mother-child dyads, both of whom suffer from psychiatric illness, randomly assign mothers to nine sessions over 3 months of either IPT-MOMS (N=105) or brief supportive psychotherapy (BSP; N=105), and evaluate the impact of acute maternal treatment on child and maternal outcomes at 3, 6, 9, and 12 month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interpersonal Psychotherapy for Mothers | Experimental | Behavioral: Interpersonal Psychotherapy for Mothers (IPT-MOMS)Interventions will be administered during the 3 Month Acute Randomized Phase and will consist of nine individual 45-minute sessions conducted over the course of three months. Treatment cannot exceed nine sessions. In addition to standard IPT techniques, IPT-MOMS includes a specific focus on the challenges associated with managing a child who suffers from psychiatric problems. |
| Brief Supportive Psychotherapy | Active comparator | Behavioral: Brief Supportive PsychotherapyInterventions will be administered during the 3 Month Acute Randomized Phase and will consist of nine individual 45-minute sessions conducted over the course of three months. Treatment cannot exceed 9 sessions. Brief supportive therapy (BSP) is a manualized form of supportive psychotherapy which emphasizes reflective listening and elicitation of affect (Markowitz et al., 2008). Therapists are instructed to allow patients to determine the focus of each session, pulling for emotion, validating emotions when possible, and offering empathic comments. |
Who may qualify
- Ages
- 7 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Adult female, age 18-65
- Biological or adoptive mother of child, age 7-18, who meets child inclusion criteria (see below)
- Lives with and has custody of the eligible child participant
- Currently in an episode of major depression, as defined by the DSM-IV and documented by the use of the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I)
- Score > or equal to 15 on the 25-item Hamilton Rating Scale for Depression (HRSD-25)
Key exclusion criteria (17 listed)
- If a mother subject IS NOT on antidepressants:
- Mothers must be off all antidepressant medications for at least 14 days (30 days for fluoxetine) prior to screening to ensure that pretreatment assessments are not distorted by drug withdrawal or rebound effects). Mother subjects cannot start taking antidepressant medications during the acute treatment phase. If they do start taking antidepressant medication during the acute treatment portion of the study, their participation in the acute phase of the study will be terminated. They will be continued to be followed in the follow-up phase.
- Mothers must be on a stable dose of an antidepressant medication (4 consecutive weeks at the same dose) prior to signing consent. The mother subject must agree to stay on the same antidepressant at this current dose throughout the duration of the acute phase of the study. If a participant's dosage of an antidepressant medication is changed or if they cease taking their antidepressant medication during the acute treatment portion of the study, their participation in the acute phase of the study will be terminated. They will be continued to be followed in the follow-up phase.
- Active suicidal ideation or homicidal ideation that in the clinical opinion of the research team as headed by the PI, would require hospitalization
- At serious risk for child abuse or neglect which in the clinical opinion of the research team as headed by the PI, 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 |
|---|---|---|
| Interpersonal Psychotherapy for Mothers (IPT-MOMS)Interventions will be administered during the 3 Month Acute Randomized Phase and will consist of nine individual 45-minute sessions conducted over the course of three months. Treatment cannot exceed nine sessions. In addition to standard IPT techniques, IPT-MOMS includes a specific focus on the challenges associated with managing a child who suffers from psychiatric problems. | Behavioural | Interpersonal Psychotherapy for Mothers |
| Brief Supportive PsychotherapyInterventions will be administered during the 3 Month Acute Randomized Phase and will consist of nine individual 45-minute sessions conducted over the course of three months. Treatment cannot exceed 9 sessions. Brief supportive therapy (BSP) is a manualized form of supportive psychotherapy which emphasizes reflective listening and elicitation of affect (Markowitz et al., 2008). Therapists are instructed to allow patients to determine the focus of each session, pulling for emotion, validating emotions when possible, and offering empathic comments. | Behavioural | Brief Supportive Psychotherapy |
Primary outcome
We will compare the effects of two interventions IPT-MOMS and BSP on children outcomes: depressive symptoms (as measured by the CDI), total difficulties (as measured by the SDQ), and psychosocial functioning (as measured by the CIS) over time
Time frame: Baseline, Months 3, 6, 9, 12
We will compare the two groups in depressive symptoms (as measured by the HRSD-25) and psychosocial and vocational functioning (as measured by the IIP, ISEL, and WSAS) over time.
Time frame: Baseline, Months 3, 6, 9, 12
1 secondary outcome
We will look at major depressive episode criteria for all mothers
Time frame: 3, 6, 9, and 12 months
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 19 Jul 2017.
- Derived from this study: PubMed 27238068Swartz HA, Cyranowski JM, Cheng Y, Zuckoff A, Brent DA, Markowitz JC, Martin S, Amole MC, Ritchey F, Frank E. Brief Psychotherapy for Maternal Depression: Impact on Mothers and Children. J Am Acad Child Adolesc Psychiatry. 2016 Jun;55(6):495-503.e2. doi: 10.1016/j.jaac.2016.04.003. Epub 2016 Apr 7.
- Individual participant dataSharing planned: No
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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, M.D. 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 study testing Interpersonal Psychotherapy for Mothers (IPT-MOMS) and Brief Supportive 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 10 inclusion and 17 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 19 Jul 2017. 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?
We will compare the effects of two interventions IPT-MOMS and BSP on children outcomes: depressive symptoms (as measured by the CDI), total difficulties (as measured by the SDQ), and psychosocial functioning (as measured by the CIS) over time (time frame: Baseline, Months 3, 6, 9, 12). 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?
On the ClinicalTrials.gov record for NCT00919594, 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 19 Jul 2017.