Posttraumatic Stress DisorderPhase 2MOMSNCT00751244
Mothers Overcoming and Managing Stress
A Phase 2 study testing Trauma Affect Regulation: Guide for Education and Therapy, Present Centered Therapy (PCT) - psychotherapy and No-treatment "waitlist" group in people with Posttraumatic Stress Disorder and PTSD, run by UConn Health at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Posttraumatic Stress Disorder, PTSD
- What is being tested?
- Trauma Affect Regulation: Guide for Education and Therapy, Present Centered Therapy (PCT) - psychotherapy and No-treatment "waitlist" group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2005to Nov 2007
- Phase
- Phase 2
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Imminently suicidal
- Past 30 days inpatient psychiatric treatment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Connecticut Health Center
Farmington, Connecticut, 06030
Burgdorf Clinic/Bank of America Health Center on the Mount Sinai Campus of Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06112-1548
About this study
Official title: Breaking the Cycle for Women With Behavioral Problems and Crime
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder, PTSD
- Being tested
- Trauma Affect Regulation: Guide for Education and Therapy, Present Centered Therapy (PCT) - psychotherapy, No-treatment "waitlist" group
- Keywords
- women, posttraumatic stress disorder, PTSD, psychotherapy, clinical trial, emotion regulation
- Medical subject headings
- Stress Disorders, Post-Traumatic, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Affect Regulation: Guide for Education and TherapyBehavioural
Also called Julian Ford
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.
Present Centered Therapy (PCT) - psychotherapyBehavioural
Also called McDonagh-Coyle
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.
No-treatment "waitlist" groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 12 weekly sessions of one-to-one TARGET (psychotherapy) Receives: Behavioral: Trauma Affect Regulation: Guide for Education and Therapy |
| 2 | Active comparator | 12 weekly sessions of one-to-one PCT (psychotherapy) Receives: Behavioral: Present Centered Therapy (PCT) - psychotherapy |
| 3 | Other | 90-day wait-list group Receives: Other: No-treatment "waitlist" group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Post-treatment, 3-month and 6-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2008 (estimated)
- Study startJan 2005
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Justice
- Investigators
- Julian Ford, Ph.D., Principal investigator, UConn HealthJoan Levine, M.P.H., Study director, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751244
- Sponsor's protocol ID
- 05-051H-1
- Other IDs
- 2004-DD-BX-1025
- Acronym
- MOMS
- Status last verified
- Sep 2010
- First submitted
- 10 Sep 2008
- Last updated
- 27 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Finkelhor, D. (1987). The trauma of child sexual abuse. Journal of Interpersonal Violence, 2, 348-366.
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.
PubMed 17340945McDonagh 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.
PubMed 15982149Ford, J. D. (2002). Traumatic victimization in childhood and persistent problems with oppositional-defiance. Journal of Trauma, Maltreatment, and Aggression, 11, 25-58.
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.
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breaking the Cycle for Women With Behavioral Problems and Crime
- ClinicalTrials.gov ID
- NCT00751244
- Acronym / sponsor ID
- MOMS / 05-051H-1
- Conditions
- Posttraumatic Stress Disorder, PTSD
- Keywords
- women, posttraumatic stress disorder, PTSD, psychotherapy, clinical trial, emotion regulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- U.S. Department of Justice
- Study start
- Jan 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 11 Sep 2008 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Trauma Affect Regulation: Guide for Education and Therapy12 weekly sessions of one-to-one TARGET (psychotherapy) |
| 2 | Active comparator | Behavioral: Present Centered Therapy (PCT) - psychotherapy12 weekly sessions of one-to-one PCT (psychotherapy) |
| 3 | Other | Other: No-treatment "waitlist" group90-day wait-list group |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Imminently suicidal
- Past 30 days inpatient psychiatric treatment
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 |
|---|---|---|
| Trauma Affect Regulation: Guide for Education and TherapyAlso: Julian FordTrauma 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. | Behavioural | 1 |
| Present Centered Therapy (PCT) - psychotherapyAlso: McDonagh-CoylePresent 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. | Behavioural | 2 |
| No-treatment "waitlist" groupAfter 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. | Other | 3 |
Primary outcome
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
1 secondary outcome
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
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 27 Sep 2010.
- BackgroundFinkelhor, D. (1987). The trauma of child sexual abuse. Journal of Interpersonal Violence, 2, 348-366.
- Background: PubMed 17340945Ford 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.
- Background: PubMed 15982149McDonagh 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.
- BackgroundFord, J. D. (2002). Traumatic victimization in childhood and persistent problems with oppositional-defiance. Journal of Trauma, Maltreatment, and Aggression, 11, 25-58.
- BackgroundWolpaw, 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.
- BackgroundFrisman, 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
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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.
Julian Ford, Ph.D. principal investigator
UConn Health
Joan Levine, M.P.H. study director
UConn Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trauma Affect Regulation: Guide for Education and Therapy, Present Centered Therapy (PCT) - psychotherapy and No-treatment "waitlist" group in people with Posttraumatic Stress Disorder and PTSD, run by UConn Health at 2 sites 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 8 inclusion and 2 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 27 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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). 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 NCT00751244, which also lists 6 linked publications.
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 27 Sep 2010.