Psychotherapy for Depressed Mothers of Psychiatrically Ill Children

NCT ID: NCT00919594

Last Updated: 2017-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 348 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2014-02-28

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interpersonal Psychotherapy for Mothers

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.

Group Type: EXPERIMENTAL

Interpersonal Psychotherapy for Mothers (IPT-MOMS)

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Brief Supportive Psychotherapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Brief Supportive Psychotherapy

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Adult female, age 18-65

3. Lives with and has custody of the eligible child participant

4. 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)

5. Score > or equal to 15 on the 25-item Hamilton Rating Scale for Depression (HRSD-25)

6. Ability and willingness to give informed, written consent

7. Willingness to give informed consent for their eligible and assenting child to participate

1. Age 7-18

2. 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)

3. Willingness to provide informed consent/assent

Exclusion Criteria

1. 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.

2. Active suicidal ideation or homicidal ideation that in the clinical opinion of the research team as headed by the PI, would require hospitalization

3. At serious risk for child abuse or neglect which in the clinical opinion of the research team as headed by the PI, requires intervention

4. 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)

5. Significant medical illness that might explain depressive symptoms such as epilepsy, autoimmune disorders, or unstable endocrine disease

6. 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.

7. Severe cognitive deficits that would preclude treatment with psychotherapy and/or prevent completion of study questionnaires

8. 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

9. Currently in an abusive relationship as determined by the domestic violence questionnaire and/or PI's judgment

10. Unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations)

1. Meets criteria for mental retardation, autistic disorder, schizophrenia, or current (within prior 6 months) substance or alcohol abuse

2. Significant cognitive impairment or learning delays that would prevent completion of study questionnaires

3. 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

4. Unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations)

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Holly Swartz

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Holly Swartz, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27238068 (View on PubMed)

Other Identifiers

5R01MH083647

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO08100448

Identifier Type: -

Identifier Source: org_study_id