Mothers Overcoming and Managing Stress

NCT00751244 | Completed Phase 2

• 2 other identifiers: 05-051H-12004-DD-BX-1025
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 2

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.

Conditions

Posttraumatic Stress Disorder; PTSD

Keywords

women; posttraumatic stress disorder; PTSD; psychotherapy; clinical trial; emotion regulation

Outcome Measures

Primary Outcomes (1)

• 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).

  post-therapy, 3-month and 6-month follow-ups

Secondary Outcomes (1)

• 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.

  Post-treatment, 3-month and 6-month follow-ups

Study Arms (3)

1

ACTIVE COMPARATOR

12 weekly sessions of one-to-one TARGET (psychotherapy)

Behavioral: Trauma Affect Regulation: Guide for Education and Therapy

2

ACTIVE COMPARATOR

12 weekly sessions of one-to-one PCT (psychotherapy)

Behavioral: Present Centered Therapy (PCT) - psychotherapy

3

OTHER

90-day wait-list group

Other: No-treatment "waitlist" group

Interventions

Trauma Affect Regulation: Guide for Education and Therapy BEHAVIORAL

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.

Also known as: Julian Ford

1

Present Centered Therapy (PCT) - psychotherapy BEHAVIORAL

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.

Also known as: McDonagh-Coyle

2

No-treatment "waitlist" group OTHER

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.

3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Imminently suicidal
• Past 30 days inpatient psychiatric treatment

Sponsors & Collaborators

• UConn Health: lead
• U.S. Department of Justice: collaborator

Study Sites (2)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Burgdorf Clinic/Bank of America Health Center on the Mount Sinai Campus of Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06112-1548, United States

Location

Related Publications (6)

• Finkelhor, D. (1987). The trauma of child sexual abuse. Journal of Interpersonal Violence, 2, 348-366.

  BACKGROUND

• 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.

  PMID: 17340945 BACKGROUND

• 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.

  PMID: 15982149 BACKGROUND

• Ford, J. D. (2002). Traumatic victimization in childhood and persistent problems with oppositional-defiance. Journal of Trauma, Maltreatment, and Aggression, 11, 25-58.

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Emotional Regulation

Interventions

Educational Status; Therapeutics; Psychotherapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Behavioral Disciplines and Activities

Study Officials

• Julian Ford, Ph.D.

  UConn Health

  PRINCIPAL INVESTIGATOR

• Joan Levine, M.P.H.

  UConn Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 10, 2008
• First Posted: September 11, 2008
• Study Start: January 1, 2005
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: September 27, 2010

Record last verified: 2010-09

Locations

US (2)