Mothers Overcoming and Managing Stress (MOMS)
Primary Purpose
Posttraumatic Stress Disorder, PTSD
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Trauma Affect Regulation: Guide for Education and Therapy
Present Centered Therapy (PCT) - psychotherapy
No-treatment "waitlist" group
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring women, posttraumatic stress disorder, PTSD, psychotherapy, clinical trial, emotion regulation
Eligibility Criteria
Inclusion Criteria:
- Female
- Age 18-50 years old (or emancipated minor)
- Primary care-giver of a child aged 0-5 years old
- A history of incarceration, or substance abuse, or exposure to violence
- Mentally able to participate and provide valid consent
- Able to complete the consent process, interviews, self-report measure and treatment/intervention primarily in English
- Willing to consent to be audio and/or videotaped for research purposes in intervention sessions
- Current post-traumatic stress disorder as assessed by study personnel
Exclusion Criteria:
- Imminently suicidal
- Past 30 days inpatient psychiatric treatment
Sites / Locations
- University of Connecticut Health Center
- Burgdorf Clinic/Bank of America Health Center on the Mount Sinai Campus of Saint Francis Hospital and Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Other
Arm Label
1
2
3
Arm Description
12 weekly sessions of one-to-one TARGET (psychotherapy)
12 weekly sessions of one-to-one PCT (psychotherapy)
90-day wait-list group
Outcomes
Primary Outcome Measures
Reduced PTSD symptoms/impairment as evidenced by improvements on the Clinician Administered PTSD Scale (CAPS), Post-Traumatic Cognitions Inventory (PTCI), Traumatic Memories Questionnaire (TMQ), and the Interpretation of PTSD Symptoms Inventory (IPSI).
Secondary Outcome Measures
Improved affect/interpersonal self-regulation as evidenced by improvement on the Negative Mood Regulation Scale, Inventory of Interpersonal Problems, Multiscale Dissociation Inventory, Anxiety Inventory, and Beck Depression Inventory.
Full Information
NCT ID
NCT00751244
First Posted
September 10, 2008
Last Updated
September 24, 2010
Sponsor
UConn Health
Collaborators
U.S. Department of Justice
1. Study Identification
Unique Protocol Identification Number
NCT00751244
Brief Title
Mothers Overcoming and Managing Stress
Acronym
MOMS
Official Title
Breaking the Cycle for Women With Behavioral Problems and Crime
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UConn Health
Collaborators
U.S. Department of Justice
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is a randomized trial of two manualized 12-session one-to-one educational and therapeutic interventions for post-traumatic stress disorder (PTSD), to test and compare their efficacy for reducing PTSD symptoms as a means of prevention of intergenerational victimization by or involvement in criminal activities with at-risk mothers. The two therapies are (1) Trauma Affect Regulation: Guide for Education and Therapy (TARGET) and (2) Present Centered Therapy (PCT). The study also included a wait-list comparison condition in which participants were offered one of the two therapies following completion of baseline and posttest assessments.
Detailed Description
Hypotheses, Objectives and Aims:
The study is a randomized clinical trial comparing two stress management counseling interventions with a wait-list comparison condition to determine their efficacy in addressing behavioral, cognitive, affective, and interpersonal effects of PTSD that often occurs for persons living in adverse socioeconomic circumstances and in violent families and communities. One goal of the study is to reduce the severity of or produce remission from PTSD, in order to reduce impulsivity, aggression, dissociation, and isolation by high-risk or previously incarcerated women. The long-term goal, which will be assessed in subsequent studies over time is to reduce the likelihood of their or their children becoming involved in, or victimized by other persons' involvement in, illegal activities. Children will not be involved in the present study, only women who are the mothers of young children.
Aim #1: To test the efficacy of TARGET and PCT. TARGET (Frisman, L., Ford, J. D., Lin, H., Mallon, S., & Chang, R., 2008) and PCT (McDonagh A, Friedman M, McHugo G, Ford J, Sengupta A, Mueser K, Demment CC, Fournier D, Schnurr PP, Descamps M., 2005) have demonstrated efficacy in randomized trial studies, but have not been tested specifically with mothers of young children. The study will assess outcomes that are of potential importance not only for the well being of the participating women but for their ability to develop secure attachments with their child which are protective against exposure to violence, crime, and victimization and associated with positive psychosocial development by children. Outcome measures reflect self-regulatory capacities compromised by trauma that are essential for effective caregiving by adults.
Aim #2: To compare the efficacy of TARGET and PCT on theory-based differential outcomes. TARGET and PCT use similar but different therapeutic strategies. Each teaches skills for managing negative emotions and critical symptoms (e.g., inhibiting impulsivity). TARGET teaches a skill sequence for affect regulation and social/interoceptive information processing, while PCT teaches a skill sequence for recognizing and solving problems in relationships. We expect that TARGET and PCT will reduce stress-related avoidance and depression and enhance active coping with current stressors. TARGET should be superior to PCT in enhancing the ability to cope with trauma memories, stress reactivity, and anxiety, and therefore the ability to remain free from illegal activities or future or further involvement with criminal justice systems. PCT should be superior to TARGET in enhancing the participant's overall social adjustment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, PTSD
Keywords
women, posttraumatic stress disorder, PTSD, psychotherapy, clinical trial, emotion regulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
147 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
12 weekly sessions of one-to-one TARGET (psychotherapy)
Arm Title
2
Arm Type
Active Comparator
Arm Description
12 weekly sessions of one-to-one PCT (psychotherapy)
Arm Title
3
Arm Type
Other
Arm Description
90-day wait-list group
Intervention Type
Behavioral
Intervention Name(s)
Trauma Affect Regulation: Guide for Education and Therapy
Other Intervention Name(s)
Julian Ford
Intervention Description
Trauma Affect Regulation: Guide for Education and Therapy (TARGET; Ford & Russo, 2006) is a manualized gender-specific treatment for PTSD. TARGET teaches a practical 7-step sequence of skills for processing and managing trauma-related reactions to current stressful experiences, summarized by a mnemonic ("FREEDOM"), e.g., Focusing ("F"), Recognizing current triggers. TARGET also involves creative arts activities, i.e., personalized "lifelines" via collage, drawing, poetry, and writing that may include traumatic experiences but emphasize "life story" narrative reconstruction with no exposure therapy.
Intervention Type
Behavioral
Intervention Name(s)
Present Centered Therapy (PCT) - psychotherapy
Other Intervention Name(s)
McDonagh-Coyle
Intervention Description
Present Centered Therapy (PCT) is a 12-session supportive therapy adapted a 14-session version co-developed by the first author (McDonagh-Coyle et al., 2005). Psychoeducation is provided about the link between traumatic events, PTSD symptoms, and problems in relationships, and social problem solving skills are taught to address the "traumagenic dynamics" of betrayal, stigma, powerlessness, and sexualization (Finkelhor, 1987). PCT focuses on addressing current problems rather than trauma memory-based exposure therapy, and uses a distinctive mnemonic to organize the skill set. PCT has clients keep a journal of relational stressors and responses as between-session homework.
Intervention Type
Other
Intervention Name(s)
No-treatment "waitlist" group
Intervention Description
After a 90 day wait-list period, participants were invited to choose one of the treatment approaches (PCT or TARGET) and engage in 12 sessions of therapy.
Primary Outcome Measure Information:
Title
Reduced PTSD symptoms/impairment as evidenced by improvements on the Clinician Administered PTSD Scale (CAPS), Post-Traumatic Cognitions Inventory (PTCI), Traumatic Memories Questionnaire (TMQ), and the Interpretation of PTSD Symptoms Inventory (IPSI).
Time Frame
post-therapy, 3-month and 6-month follow-ups
Secondary Outcome Measure Information:
Title
Improved affect/interpersonal self-regulation as evidenced by improvement on the Negative Mood Regulation Scale, Inventory of Interpersonal Problems, Multiscale Dissociation Inventory, Anxiety Inventory, and Beck Depression Inventory.
Time Frame
Post-treatment, 3-month and 6-month follow-ups
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female
Age 18-50 years old (or emancipated minor)
Primary care-giver of a child aged 0-5 years old
A history of incarceration, or substance abuse, or exposure to violence
Mentally able to participate and provide valid consent
Able to complete the consent process, interviews, self-report measure and treatment/intervention primarily in English
Willing to consent to be audio and/or videotaped for research purposes in intervention sessions
Current post-traumatic stress disorder as assessed by study personnel
Exclusion Criteria:
Imminently suicidal
Past 30 days inpatient psychiatric treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian Ford, Ph.D.
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joan Levine, M.P.H.
Organizational Affiliation
UConn Health
Official's Role
Study Director
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Burgdorf Clinic/Bank of America Health Center on the Mount Sinai Campus of Saint Francis Hospital and Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06112-1548
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Finkelhor, D. (1987). The trauma of child sexual abuse. Journal of Interpersonal Violence, 2, 348-366.
Results Reference
background
PubMed Identifier
17340945
Citation
Ford JD, Russo E. Trauma-focused, present-centered, emotional self-regulation approach to integrated treatment for posttraumatic stress and addiction: trauma adaptive recovery group education and therapy (TARGET). Am J Psychother. 2006;60(4):335-55. doi: 10.1176/appi.psychotherapy.2006.60.4.335.
Results Reference
background
PubMed Identifier
15982149
Citation
McDonagh A, Friedman M, McHugo G, Ford J, Sengupta A, Mueser K, Demment CC, Fournier D, Schnurr PP, Descamps M. Randomized trial of cognitive-behavioral therapy for chronic posttraumatic stress disorder in adult female survivors of childhood sexual abuse. J Consult Clin Psychol. 2005 Jun;73(3):515-24. doi: 10.1037/0022-006X.73.3.515.
Results Reference
background
Citation
Ford, J. D. (2002). Traumatic victimization in childhood and persistent problems with oppositional-defiance. Journal of Trauma, Maltreatment, and Aggression, 11, 25-58.
Results Reference
background
Citation
Wolpaw, J., Ford, J. D., Newman, E., Davis, J. L., & Briere, J. (2005). Trauma Symptom Checklist for Children: In T. Grisso, G. Vincent & D. Seagrave (Eds.), Mental health screening and assessment in juvenile justice (pp. 152-165). New York: Guilford.
Results Reference
background
Citation
Frisman, L., Ford, J. D., Lin, H., Mallon, S., & Chang, R. (in press). Outcomes of trauma treatment using the TARGET model. Journal of Groups in Addiction and Recovery
Results Reference
background
Links:
URL
http://www.advancedtrauma.com/
Description
Click here for more information about the TARGET treatment model.
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Mothers Overcoming and Managing Stress
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