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The purpose of this study is to develop an innovative, safe, acceptable, feasible, and efficacious integrated CLASP-PE intervention and to Collect pilot data to evaluate the preliminary evidence of the promise of the intervention. We hypothesize that the CLASP-PE intervention will demonstrate safety, acceptability, feasibility, and efficacy in the open trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLASP-PE arm | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLASP-PE arm | Behavioral | Participants will complete 8-16 weekly or twice weekly individual therapy sessions (with total session number determined by clinical need, as is typical in clinical trials of PE for PTSD), 1 therapy session (session 3) with a supportive significant other (SO), consistent with the CLASP protocol, and 11 brief (30 minute) phone calls as possible, with calls occurring every week in between therapy sessions and on a less frequent basis following treatment termination up to 3 months after the final in-person therapy session. In addition, the supportive SOs will complete 11 brief (30 minute) phone calls with the therapist at the same frequency as participants. Participants will sign a release of information prior to involving the supportive significant other in treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with a diagnosis of post-traumatic stress syndrome(PTSD)as assessed by The Clinician Administered PTSD Scale for DSM 5 (CAPS 5) | The CAPS 5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week.The CAPS-5 total score ranges from 0(absent) to 4(extreme/incapacitating) | Baseline |
| Number of participants with a diagnosis of post-traumatic stress syndrome(PTSD)as assessed by The Clinician Administered PTSD Scale for DSM 5 (CAPS 5) | The CAPS 5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week.The CAPS-5 total score ranges from 0(absent) to 4(extreme/incapacitating) | end of treatment (Upto 16 weeks from start of treatment) |
| Number of participants with a diagnosis of post-traumatic stress syndrome(PTSD)as assessed by The Clinician Administered PTSD Scale for DSM 5 (CAPS 5) | The CAPS 5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week.The CPAS-5 total score ranges from 0(absent) to 4(extreme/incapacitating) | 3 months post treatment |
| Number of participants with a diagnosis of post-traumatic stress syndrome(PTSD)as assessed by The Clinician Administered PTSD Scale for DSM 5 (CAPS 5) | The CAPS 5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week.The CPAS-5 total score ranges from 0(absent) to 4(extreme/incapacitating) | 6 months post treatment |
| The extent to which participants have been bothered by PTSD symptoms as assessed by the PTSD Checklist for DSM-5 (PCL-5) assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of potentially traumatic events in a respondent's lifetime as assessed by The Life Events Checklist for DSM-5 (LEC-5). | The LEC-5 assesses exposure to 16 events known to potentially result in PTSD or distress and includes one additional item assessing any other extraordinarily stressful event not captured in the first 16 items. For each potentially traumatic life event, respondents rate their experience of that event on a 6-point nominal scale (1 = happened to me, 2 = witnessed it, 3 = learned about it, 4 = part of my job, 5 = not sure, and 6 = doesn't apply). The LEC-5 does not yield a total score or composite score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Acierno, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D059020 | Suicidal Ideation |
| D003863 | Depression |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D013405 | Suicide |
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The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past month (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely). |
| Baseline |
| The extent to which participants have been bothered by PTSD symptoms as assessed by the PTSD Checklist for DSM-5 (PCL-5) assessment. | The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past month (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely). | before each session(participants will complete 8-16 weekly or twice weekly individual therapy sessions) |
| The extent to which participants have been bothered by PTSD symptoms as assessed by the PTSD Checklist for DSM-5 (PCL-5) assessment. | The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past month (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely). | end of treatment (Upto 16 weeks from start of treatment) |
| The extent to which participants have been bothered by PTSD symptoms as assessed by the PTSD Checklist for DSM-5 (PCL-5) assessment. | The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past month (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely). | 3 months post treatment |
| The extent to which participants have been bothered by PTSD symptoms as assessed by the PTSD Checklist for DSM-5 (PCL-5) assessment. | The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past month (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely). | 6 months post treatment |
| Number of patients with characteristic attitudes and symptoms of depression as measured by the Black depression Inventory (BDI) | The BDI is a 21-item self-report rating inventory that is rated in a 4 point scale from 0-3 based in severity with a maximum score if 63. | Baseline |
| Number of patients with characteristic attitudes and symptoms of depression as measured by the Black depression Inventory (BDI) | The BDI is a 21-item self-report rating inventory that is rated in a 4 point scale from 0-3 based in severity with a maximum score if 63. | before each session(participants will complete 8-16 weekly or twice weekly individual therapy sessions) |
| Number of patients with characteristic attitudes and symptoms of depression as measured by the Black depression Inventory (BDI) | The BDI is a 21-item self-report rating inventory that is rated in a 4 point scale from 0-3 based in severity with a maximum score if 63. | end of treatment(Upto 16 weeks from start of treatment) |
| Number of patients with characteristic attitudes and symptoms of depression as measured by the Black depression Inventory (BDI) | The BDI is a 21-item self-report rating inventory that is rated in a 4 point scale from 0-3 based in severity with a maximum score if 63. | 3 months post treatment |
| Number of patients with characteristic attitudes and symptoms of depression as measured by the Black depression Inventory (BDI) | The BDI is a 21-item self-report rating inventory that is rated in a 4 point scale from 0-3 based in severity with a maximum score if 63. | 6 months post treatment |
| Severity of depression as assessed by the Quick Inventory of Depression Symptomatology (QIDS) The QIDS is a 16-item measure that is scored on a 4 point scale from 0-3 with a higher number indicating more severity of depression. | Baseline |
| Severity of depression as assessed by the Quick Inventory of Depression Symptomatology (QIDS) The QIDS is a 16-item measure that is scored on a 4 point scale from 0-3 with a higher number indicating more severity of depression. | before every session(participants will complete 8-16 weekly or twice weekly individual therapy sessions) |
| Severity of depression as assessed by the Quick Inventory of Depression Symptomatology (QIDS) The QIDS is a 16-item measure that is scored on a 4 point scale from 0-3 with a higher number indicating more severity of depression. | end of treatment (Upto 16 weeks from start of treatment) |
| Severity of depression as assessed by the Quick Inventory of Depression Symptomatology (QIDS) The QIDS is a 16-item measure that is scored on a 4 point scale from 0-3 with a higher number indicating more severity of depression. | 3 months post treatment |
| Severity of depression as assessed by the Quick Inventory of Depression Symptomatology (QIDS) The QIDS is a 16-item measure that is scored on a 4 point scale from 0-3 with a higher number indicating more severity of depression. | 6 months post treatment |
| Intensity of attitudes, behaviors and plans to commit suicide over the prior week as assessed by the Beck Scale for Suicidal ideation(BSSI) | BSSI is a 21-item self-report measure that is scored on a 3 point scale from 0-2 with a higher number indicting a greater suicidal ideation | Baseline |
| Intensity of attitudes, behaviors and plans to commit suicide over the prior week as assessed by the Beck Scale for Suicidal ideation(BSSI) | BSSI is a 21-item self-report measure that is scored on a 3 point scale from 0-2 with a higher number indicting a greater suicidal ideation | end of treatment (Upto 16 weeks from start of treatment) |
| Intensity of attitudes, behaviors and plans to commit suicide over the prior week as assessed by the Beck Scale for Suicidal ideation(BSSI) | BSSI is a 21-item self-report measure that is scored on a 3 point scale from 0-2 with a higher number indicting a greater suicidal ideation | 3 months post treatment |
| Intensity of attitudes, behaviors and plans to commit suicide over the prior week as assessed by the Beck Scale for Suicidal ideation(BSSI) | BSSI is a 21-item self-report measure that is scored on a 3 point scale from 0-2 with a higher number indicting a greater suicidal ideation | 6 months post treatment |
| Measure of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | The severity of ideation subscale is rated on a 5-point ordinal scale: 1 = wish to be dead, 2 = nonspecific active suicidal thoughts, 3 = suicidal thoughts with methods, 4 = suicidal intent, and 5 = suicidal intent with plan. The suicidal behavior subscale is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and nonsuicidal self-injurious behavior. | Baseline |
| Measure of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | The severity of ideation subscale is rated on a 5-point ordinal scale: 1 = wish to be dead, 2 = nonspecific active suicidal thoughts, 3 = suicidal thoughts with methods, 4 = suicidal intent, and 5 = suicidal intent with plan. The suicidal behavior subscale is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and nonsuicidal self-injurious behavior. | end of treatment (Upto 16 weeks from start of treatment) |
| Measure of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | The severity of ideation subscale is rated on a 5-point ordinal scale: 1 = wish to be dead, 2 = nonspecific active suicidal thoughts, 3 = suicidal thoughts with methods, 4 = suicidal intent, and 5 = suicidal intent with plan. The suicidal behavior subscale is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and nonsuicidal self-injurious behavior. | 3 months post-treatment |
| Measure of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | The severity of ideation subscale is rated on a 5-point ordinal scale: 1 = wish to be dead, 2 = nonspecific active suicidal thoughts, 3 = suicidal thoughts with methods, 4 = suicidal intent, and 5 = suicidal intent with plan. The suicidal behavior subscale is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and nonsuicidal self-injurious behavior. | 6 months post-treatment |
| Number of patients with anxiety, mood, psychotic, substance, and eating disorders as assessed by the MINI International Neuropsychiatric Interview (MINI) | Baseline |
| Extent to which client was satisfied with the training as assessed by the Client Satisfaction Questionnaire (CSQ) | The CSQ is an 8-item measure of client satisfaction rated on a 1-4 point Likert scale. A higher score indicates a higher satisfaction. | end of treatment (Upto 16 weeks from start of treatment) |
| Feedback form participants as assessed by the Qualitative interview(QI) which will include a series of open ended questions aimed at eliciting feedback from participants about their perspective on the PE-CLASP Intervention | end of treatment (Upto 16 weeks from start of treatment) |
| Baseline |
| Number of potentially traumatic events in a respondent's lifetime as assessed by The Life Events Checklist for DSM-5 (LEC-5). | The LEC-5 assesses exposure to 16 events known to potentially result in PTSD or distress and includes one additional item assessing any other extraordinarily stressful event not captured in the first 16 items. For each potentially traumatic life event, respondents rate their experience of that event on a 6-point nominal scale (1 = happened to me, 2 = witnessed it, 3 = learned about it, 4 = part of my job, 5 = not sure, and 6 = doesn't apply). The LEC-5 does not yield a total score or composite score. | end of treatment (Upto 16 weeks from start of treatment) |
| Number of potentially traumatic events in a respondent's lifetime as assessed by The Life Events Checklist for DSM-5 (LEC-5). | The LEC-5 assesses exposure to 16 events known to potentially result in PTSD or distress and includes one additional item assessing any other extraordinarily stressful event not captured in the first 16 items. For each potentially traumatic life event, respondents rate their experience of that event on a 6-point nominal scale (1 = happened to me, 2 = witnessed it, 3 = learned about it, 4 = part of my job, 5 = not sure, and 6 = doesn't apply). The LEC-5 does not yield a total score or composite score. | 3 months post treatment |
| Number of potentially traumatic events in a respondent's lifetime as assessed by The Life Events Checklist for DSM-5 (LEC-5). | The LEC-5 assesses exposure to 16 events known to potentially result in PTSD or distress and includes one additional item assessing any other extraordinarily stressful event not captured in the first 16 items. For each potentially traumatic life event, respondents rate their experience of that event on a 6-point nominal scale (1 = happened to me, 2 = witnessed it, 3 = learned about it, 4 = part of my job, 5 = not sure, and 6 = doesn't apply). The LEC-5 does not yield a total score or composite score. | 6 months post treatment |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |