An interventional study of AWARE intervention in Mental Health Disorder, sponsored by Boston University Charles River Campus. Completed. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-12.
Sponsored by Boston University Charles River Campus · Not applicable, Interventional, and Treatment
Our objective for this R34 is to develop gender/culture specific and trauma informed group psychotherapy intervention designed to treat Chinese-, Korean-, and Vietnamese-American young women with histories of interpersonal violence trauma. The intervention is called Asian Women's Action for Resilience and Empowerment (AWARE).
Recent epidemiological studies document two emerging public health problems among Asian-Pacific Islander (API) women in the US:
Our preliminary studies using both quantitative and qualitative methods found strong links between past trauma and poor sexual and mental health outcomes. For API women, reporting a history of forced sex was associated with higher odds of severe depression, substance use, getting pregnant, and HIV risk behaviors compared to API women who did not report a history of forced sex. API women continue to be vulnerable given their lower rates of HIV testing, lower mental health utilization, and premature dropout rates in mental health treatment compared to other racial groups. So far, no existing intervention targets both sexual health and mental health problems among API women. Specifically, this study builds upon data on API women from prior NIMH-funded work as the foundation for our intervention.
1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.
This study's enrollment of 96 is close to the median of 100 across 1,301 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →Boston University Charles River Campus is the lead sponsor of 159 studies on the registry; 33 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 9 (64%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Group psychotherapy intervention for Asian-American women
Behavioral: AWARE intervention
Delayed AWARE intervention for Asian-American women
Behavioral: AWARE intervention
Group psychotherapy for Asian-American women
Change in Sexual Risk Behaviors
AIDS Risk Behavior Assessment (ARBA) was used. Sexual risk behaviors were defined as engaging in unprotected sex, having multiple sex partners, and engaging in anal sex. Engagement in unprotected sex was assessed by asking participants, "Of those times that you had vaginal sex in the past three months, how often did you or your partner use condoms/latex protection?'' Responses were scored 0 for "never used a condom," "some of the time," "half of the time," "more than half of the time" and 1 for "every time." Having multiple sex partners was assessed by the question: "How many female/male sex partners have you had in the past three months?" Responses were coded dichotomously as 0 for none or one sexual partner and 1 for more than one sexual partner. Engagement in anal sex was assessed by the question, "How many times in the past three months did you have anal sex?" Responses were dichotomized as 0 for none, and 1 for one or more times.
Time frame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
Change in Depressive Symptoms
The Center for Epidemiological Studies Depression Scale (CES-D) is a 20-item self-report questionnaire designed to assess depressive symptomatology. For each item, participants reported their status over the past two weeks using a Likert-type scale ranging from rarely or never (0) to most days or always (3). Responses were summed to create a total symptom score ranging from 0 to 60. The CES-D has demonstrated very high internal consistency, reliability and validity. The internal consistency of our sample ranged from .86 to .92.
Time frame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
Change in Substance Use
Addiction Severity Index (ASI) is a self-report questionnaire for patients who present for substance abuse treatment. The instrument gathers information about seven areas of a patients life: medical, employment/support, drug and alcohol use, legal, family history, family/social relationships. The scale has Cronbach's alpha of alcohol section of 0.75 and for Drug section is 0.70. This measure was used in testing SS for women who suffered from substance use and PTSD.
Time frame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
Change in Mental Distress
The General Mental Distress Index (GMDI) is a 21-item scale screening for symptoms of depression, anxiety, suicidal ideation, and other aspects of mental and emotional distress. Each item is scored 1 for "yes" and 0 for "no." A score of 4-6 indicates clinically-significant symptoms, and a score of 7+ indicates acute distress with the possibility of reoccurring mental health problems.
Time frame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
Change in PTSD Symptoms
The PTSD Checklist, Civilian version (PCL-C) is a 17-item self-report measure of PTSD symptom severity. Each item corresponds to a PTSD symptom outlined in the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Participants reported both the frequency and intensity of their experiences of PTSD symptoms over the past three months on a 5-point scale ranging from low to high. Symptom severity was computed by summing the frequency and intensity scores. Total scores ranged from 17 to 85, with a score of 50 used as the cutoff to assess a diagnosis of PTSD.
Time frame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
Change in Safety Outcome
The Columbia-Suicide Severity Rating Scale (C-SSRS) was used to assess history of suicidal ideation and suicidal intent. Participants who reported yes to either one of the following questions were classified as having suicidal ideation--wished to be dead, thought of killing yourself, and thought about how to do this. Suicidal intent was measured with answering yes to either one of having intention of acting on thoughts of killing yourself as well as having worked out the details of how to do it. At baseline (T0), lifetime suicidal outcomes were measured and. For the post intervention evaluations (T1, T2), suicidal outcomes of the past 30 days were measured.
Time frame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
Change in HIV Knowledge
The HIV-Knowledge Questionnaire (HIV-KQ) is a 45-item assessment on knowledge pertaining to HIV. Statements are responded to in a true/false/don't know format, addressing topics of prevention (i.e. safe sex practices), transmission (i.e. sexual transmission and other modes) and consequences (i.e. testing and treatment). The HIV-KQ exhibits a high internal consistency, with Cronbach's alpha = 0.91.
Time frame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
Change in Self-Efficacy Scale
The Self-efficacy Scale for Limiting HIV Risk Behaviors (LHRB) contains 9 statements on self-efficacy pertaining to HIV risk behaviors. Participants are asked to rate how sure they are that they could perform each statement (0= not sure at all to 4=very sure).
Time frame: Outcomes will be measured at: baseline, up to 12 weeks after the baseline, 3 months post intervention
Feasibility Outcome
Participant retention was evaluated using the number of sessions attended. The "completers" of the intervention were defined as those who attended at least 80% of the sessions. Similar definitions have been used in other studies.
Time frame: 8 weeks of treatment
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2013 to primary completion in Jun 2016, 34 months.
Of 666 non-industry interventional studies with no phase under Mental Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's 34 months is above that.
Counting every sponsor, half of 680 studies reached it within 29 months; a quarter within 13 and three quarters within 45.
Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Boston University Charles River Campus →