Post-Traumatic Stress DisorderNCT01488539
Implementation of an Evidence Based Post-Traumatic Stress Disorder (PTSD) Treatment in Public Sector Settings
A study testing STAIR/NT treatment and Treatment as Usual (TAU) in people with Post-Traumatic Stress Disorder, run by Palo Alto Veterans Institute for Research at 5 sites in United States.
Trial summary
Researchers hope to learn whether a flexibly applied cognitive behavioral treatment for Post-Traumatic Stress Disorder (PTSD) is more effective than the psychotherapy usually provided in the clinic (called Treatment as Usual or TAU). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- STAIR/NT treatment and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Jan 2012to 1 Apr 2017
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A primary diagnosis of PTSD according to DSM-IV criteria with a CAPS score no lower than 40 (cf Weathers, Keane, \& Davidson, 2001)
- PTSD symptoms that are a result of interpersonal violence
- at least one clear trauma memory
- Current age between 18 and 65
- If obtaining other (medication or psychosocial) treatment, must have completed at least a 3 month course of the treatment
Who cannot join
- Substance dependence and severe substance abuse disorders, current psychotic symptoms, unmedicated mania or bipolar disorder
- prominent current suicidal or homicidal ideation (a plan or intent versus a wish) or a suicide attempt within the past three months
- self-injurious behaviors in the last three months requiring medical attention
- Cognitive impairment indicated by chart diagnoses or observable cognitive difficulties
- Current involvement in a violent relationship defined as more than casual contact (e.g. dating or living with an abusive partner)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Grady Health System
Atlanta, Georgia, 30303
Cambridge Health Alliance
Cambridge, Massachusetts, 02139
University of Connecticut Health Center
Farmington, Connecticut, 06030
New York University- Bellevue
New York, New York, 10016
Georgetown University School of Medicine
Washington D.C., District of Columbia, 20057
About this study
Official title: Implementation of an Evidence Based PTSD Treatment in Public Sector Settings
Researchers hope to learn whether a flexibly applied cognitive behavioral treatment for Post-Traumatic Stress Disorder (PTSD) is more effective than the psychotherapy usually provided in the clinic (called Treatment as Usual or TAU). Primary Hypothesis: STAIR/NT will be superior to TAU in improving PTSD symptoms at 28, 36 and 48 weeks post-randomization
Read the detailed description
PTSD among women is a particularly pernicious and chronic disorder associated with significant psychiatric comorbidity, high rates of suicidality, substance abuse, self-injury and multiple traumatization including repeated sexual assault and domestic violence. Public-sector mental health services are the disproportionate recipient of traumatized women with between 62% to 98% of treatment seeking women reporting a history of trauma and of those, up to 40% carry a diagnosis of PTSD with various comorbidities. Over 40 single-site randomized trials of cognitive-behavioral therapy for PTSD have been conducted. However, to date, there are only two large-sample randomized clinical trials which have evaluated the effectiveness of such treatments in the community and both of them concerned military populations. This application proposes to evaluate the effectiveness of an evidence-based PTSD treatment in the context of a collaborative partnership of four public mental health clinics serving diverse populations. The intervention is a two module, sequential treatment (STAIR/NT) in which the first module emphasizes present-focused skills training in affective and interpersonal regulation (STAIR) for day-to-day life difficulties and the second module incorporates past-focused work on the processing of the trauma, using narrative therapy (NT). This cognitive behavioral treatment was specifically designed to treat high risk, multiply traumatized women with chronic PTSD and has been demonstrated to provide significant and clinically substantial relief from PTSD as well as improvement in emotion management and interpersonal functioning.
The investigators will assess the effectiveness of STAIR/NT compared to Treatment as Usual (TAU) in the context of every day clinical care. The study is a randomized, controlled repeated measures intent-to-treat design to assess STAIR/NT as compared to TAU at post-treatment and three and six-month follow-up. Four sites (Western Ontario, Boston, New York and Atlanta), each situated within a large public sector mental health network, will enroll 88 treatment-seeking women with PTSD related to interpersonal violence yielding a total of 352 study participants. The primary outcome will be PTSD symptom severity. Secondary outcomes will be negative mood regulation self-efficacy, interpersonal problems and general level of psychiatric impairment (GAF scores). Exploratory aims include the examination of the relationship between variations in treatment implementation and treatment outcome as well as the influence of patient characteristics and other contextual (therapist and organization) variables likely to impact implementation. The investigators will also introduce web-based technology as a resource intended to strengthen clinical networks and maintain use of study materials after the trial has ended.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- STAIR/NT treatment, Treatment as Usual (TAU)
- Keywords
- Stress Disorders, Post-Traumatic, PTSD, Adult Survivors of Child Abuse, Women, Interpersonal violence, psychological trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic, Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAIR/NT treatmentBehavioural
STAIR/NT is a two module, sequential treatment in which the first module emphasizes present-focused skills training in affective an interpersonal regulation (STAIR) for day-to-day life difficulties and the second module incorporates past-focused work on the processing of the trauma, using narrative therapy (NT). STAIR/NT is a cognitive behavioral treatment that can be flexibly applied allowing treatment tailored to the needs of the individual patient; may be as brief as 16 sessions and as long as 24.
Treatment as Usual (TAU)Behavioural
The Treatment as Usual intervention content varies from site to site and involve some combination of psychotherapy and pharmacotherapy. Treatment duration varies across sites and ranges from 30 to 45 sessions.
| Study group | Role | What they receive |
|---|---|---|
| STAIR/NT | Experimental | Patients will receive STAIR/NT treatment Receives: Behavioral: STAIR/NT treatment |
| Treatment as Usual (TAU) | Other | Patients will receive Treatment as Usual (TAU) Receives: Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Assessed PTSD Symptom Severity
Clinician Adminstered PTSD Scale for DSM-5 (CAPS-5) includes 20 items rated on a 5 point scale from 0 to 4. Possible total scores range from 0 to 80, with higher scores indicating more severe PTSD.
Measured: Baseline, 28, 36, 48 weeks
PTSD Diagnosis
Clinician Adminstered PTSD Scale for DSM-5 (CAPS-5) assess the presence of PTSD diagnosis following the requirements indicated by DSM-5. These include the presence of 5 symtpom clusters that include re-experiencing symptoms, avoidance symptoms, alterations in mood and cognitions and hyperarousal.
Measured: Baseline, 28, 36, 48 weeks
Secondary outcomes (3)
Emotion Regulation Problems
The DERS is a 36 item self-report measure where items are scored from 0 to 4 indicating how frequently the problem occurs. Possible total scores can range from 0 to 144 with higher scores indicating more frequent problems.
Measured: Baseline, 12, 28, 36, 48 weeks
Interpersonal problems
The Inventory of Interpersonal Problems-32 (IIP-32) is a 32 item measure where items are scored from 0 to 4. Possible total scores range from 0 to 128 with higher scores indicating more severe problems.
Measured: Baseline, 12, 28, 36, 48 weeks
Psychosocial Functioning
SF-3 includes 3 items from the SF-36 which assess the impact of emotional problems on daily functioning
Measured: Baseline, 28, 36, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study start1 Jan 2012
- Primary completion1 Apr 2016
- Study completion1 Apr 2017
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 Post-Traumatic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- New York University, Grady Health System, Nathan Kline Institute for Psychiatric Research, Georgetown University, Harvard Medical School (HMS and HSDM), UConn Health, VA New York Harbor Healthcare System, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Marylène Cloitre, Palo Alto Veterans Institute for Research
- Investigators
- Marylene Cloitre, PhD, Principal investigator, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488539
- Sponsor's protocol ID
- CLO0001AGG
- Other IDs
- 1R01MH086611-01A2
- Status last verified
- Aug 2023
- First submitted
- 2 Dec 2011
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cloitre M, Henn-Haase C, Herman JL, Jackson C, Kaslow N, Klein C, Mendelsohn M, Petkova E. A multi-site single-blind clinical study to compare the effects of STAIR Narrative Therapy to treatment as usual among women with PTSD in public sector mental health settings: study protocol for a randomized controlled trial. Trials. 2014 May 29;15:197. doi: 10.1186/1745-6215-15-197.
PubMed 24886235
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an Evidence Based PTSD Treatment in Public Sector Settings
- ClinicalTrials.gov ID
- NCT01488539
- Acronym / sponsor ID
- CLO0001AGG
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Stress Disorders, Post-Traumatic, PTSD, Adult Survivors of Child Abuse, Women, Interpersonal violence, psychological trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- New York University, Grady Health System, Nathan Kline Institute for Psychiatric Research, Georgetown University, Harvard Medical School (HMS and HSDM), UConn Health, VA New York Harbor Healthcare System, National Institute of Mental Health (NIMH)
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 8 Dec 2011 (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.
Researchers hope to learn whether a flexibly applied cognitive behavioral treatment for Post-Traumatic Stress Disorder (PTSD) is more effective than the psychotherapy usually provided in the clinic (called Treatment as Usual or TAU). Primary Hypothesis: STAIR/NT will be superior to TAU in improving PTSD symptoms at 28, 36 and 48 weeks post-randomization
Detailed description
PTSD among women is a particularly pernicious and chronic disorder associated with significant psychiatric comorbidity, high rates of suicidality, substance abuse, self-injury and multiple traumatization including repeated sexual assault and domestic violence. Public-sector mental health services are the disproportionate recipient of traumatized women with between 62% to 98% of treatment seeking women reporting a history of trauma and of those, up to 40% carry a diagnosis of PTSD with various comorbidities. Over 40 single-site randomized trials of cognitive-behavioral therapy for PTSD have been conducted. However, to date, there are only two large-sample randomized clinical trials which have evaluated the effectiveness of such treatments in the community and both of them concerned military populations. This application proposes to evaluate the effectiveness of an evidence-based PTSD treatment in the context of a collaborative partnership of four public mental health clinics serving diverse populations. The intervention is a two module, sequential treatment (STAIR/NT) in which the first module emphasizes present-focused skills training in affective and interpersonal regulation (STAIR) for day-to-day life difficulties and the second module incorporates past-focused work on the processing of the trauma, using narrative therapy (NT). This cognitive behavioral treatment was specifically designed to treat high risk, multiply traumatized women with chronic PTSD and has been demonstrated to provide significant and clinically substantial relief from PTSD as well as improvement in emotion management and interpersonal functioning.
The investigators will assess the effectiveness of STAIR/NT compared to Treatment as Usual (TAU) in the context of every day clinical care. The study is a randomized, controlled repeated measures intent-to-treat design to assess STAIR/NT as compared to TAU at post-treatment and three and six-month follow-up. Four sites (Western Ontario, Boston, New York and Atlanta), each situated within a large public sector mental health network, will enroll 88 treatment-seeking women with PTSD related to interpersonal violence yielding a total of 352 study participants. The primary outcome will be PTSD symptom severity. Secondary outcomes will be negative mood regulation self-efficacy, interpersonal problems and general level of psychiatric impairment (GAF scores). Exploratory aims include the examination of the relationship between variations in treatment implementation and treatment outcome as well as the influence of patient characteristics and other contextual (therapist and organization) variables likely to impact implementation. The investigators will also introduce web-based technology as a resource intended to strengthen clinical networks and maintain use of study materials after the trial has ended.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STAIR/NT | Experimental | Behavioral: STAIR/NT treatmentPatients will receive STAIR/NT treatment |
| Treatment as Usual (TAU) | Other | Behavioral: Treatment as Usual (TAU)Patients will receive Treatment as Usual (TAU) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A primary diagnosis of PTSD according to DSM-IV criteria with a CAPS score no lower than 40 (cf Weathers, Keane, \& Davidson, 2001)
- PTSD symptoms that are a result of interpersonal violence
- at least one clear trauma memory
- Current age between 18 and 65
- If obtaining other (medication or psychosocial) treatment, must have completed at least a 3 month course of the treatment
Key exclusion criteria (5 listed)
- Substance dependence and severe substance abuse disorders, current psychotic symptoms, unmedicated mania or bipolar disorder
- prominent current suicidal or homicidal ideation (a plan or intent versus a wish) or a suicide attempt within the past three months
- self-injurious behaviors in the last three months requiring medical attention
- Cognitive impairment indicated by chart diagnoses or observable cognitive difficulties
- Current involvement in a violent relationship defined as more than casual contact (e.g. dating or living with an abusive partner)
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 |
|---|---|---|
| STAIR/NT treatmentSTAIR/NT is a two module, sequential treatment in which the first module emphasizes present-focused skills training in affective an interpersonal regulation (STAIR) for day-to-day life difficulties and the second module incorporates past-focused work on the processing of the trauma, using narrative therapy (NT). STAIR/NT is a cognitive behavioral treatment that can be flexibly applied allowing treatment tailored to the needs of the individual patient; may be as brief as 16 sessions and as long as 24. | Behavioural | STAIR/NT |
| Treatment as Usual (TAU)The Treatment as Usual intervention content varies from site to site and involve some combination of psychotherapy and pharmacotherapy. Treatment duration varies across sites and ranges from 30 to 45 sessions. | Behavioural | Treatment as Usual (TAU) |
Primary outcome
Clinician Assessed PTSD Symptom Severity
Time frame: Baseline, 28, 36, 48 weeks
Clinician Adminstered PTSD Scale for DSM-5 (CAPS-5) includes 20 items rated on a 5 point scale from 0 to 4. Possible total scores range from 0 to 80, with higher scores indicating more severe PTSD.
PTSD Diagnosis
Time frame: Baseline, 28, 36, 48 weeks
Clinician Adminstered PTSD Scale for DSM-5 (CAPS-5) assess the presence of PTSD diagnosis following the requirements indicated by DSM-5. These include the presence of 5 symtpom clusters that include re-experiencing symptoms, avoidance symptoms, alterations in mood and cognitions and hyperarousal.
3 secondary outcomes
Emotion Regulation Problems
Time frame: Baseline, 12, 28, 36, 48 weeks
Interpersonal problems
Time frame: Baseline, 12, 28, 36, 48 weeks
Psychosocial Functioning
Time frame: Baseline, 28, 36, 48 weeks
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 18 Aug 2023.
- Background: PubMed 24886235Cloitre M, Henn-Haase C, Herman JL, Jackson C, Kaslow N, Klein C, Mendelsohn M, Petkova E. A multi-site single-blind clinical study to compare the effects of STAIR Narrative Therapy to treatment as usual among women with PTSD in public sector mental health settings: study protocol for a randomized controlled trial. Trials. 2014 May 29;15:197. doi: 10.1186/1745-6215-15-197.
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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.
Marylene Cloitre, PhD principal investigator
VA Palo Alto Health Care System
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STAIR/NT treatment and Treatment as Usual (TAU) in people with Post-Traumatic Stress Disorder, run by Palo Alto Veterans Institute for Research at 5 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 5 inclusion and 5 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 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
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?
Clinician Assessed PTSD Symptom Severity (time frame: Baseline, 28, 36, 48 weeks). 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 NCT01488539, 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 18 Aug 2023.