Behavioral Health Technician Delivered Written Exposure Therapy

Browse trials for

• Stress Disorders, Traumatic 1,147
• Stress Disorders, Post-Traumatic 2,239

Keywords

• PTSD
• Post Traumatic Stress Disorder
• Behavioral Health Technician
• Written Exposure Therapy

Stress Disorders, Traumatic

1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.

This study's planned enrollment of 150 is above the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.

Lead sponsor

Palo Alto Veterans Institute for Research is the lead sponsor of 51 studies on the registry; 10 are open to participants now.

Study arms

• Active comparator
  Treatment As Usual (TAU)

  Participants in this arm will receive usually prescribed behavioral health treatment.

  Behavioral: Treatment as Usual (TAU)

• Experimental
  Treatment As Usual (TAU) and Written Exposure Therapy (WET)

  Participants in this arm will receive the usually prescribed behavioral health treatment as well as 5 total sessions of Written Exposure Therapy with a Behavioral Health Technician.

  Behavioral: Written Exposure Therapy · Behavioral: Treatment as Usual (TAU)

Interventions

• BehavioralWritten Exposure Therapy

  Written Exposure Therapy (WET) is a 5-session, trauma-focused intervention in which individuals write about their traumatic experience following scripted instructions.

• BehavioralTreatment as Usual (TAU)

  Treatment as usual (TAU) will be available to all patient participants. Treatment as usual may include various forms of psychotherapy and or medication management.

Primary outcomes

1. Clinician Administered PTSD Scale (CAPS-5)

   The CAPS-5 is a 30-item structured clinical interview that assesses the presence and severity of 20 PTSD symptoms as defined by the DSM-5. It also assess the impact of these symptoms on daily functioning and will be used to evaluate if there is a response to the experimental treatment in this study.

   Time frame: Change from baseline to immediately post treatment

Secondary outcomes

1. Posttraumatic Stress Disorder Checklist (PCL-5)

   The PCL-5 is a 20-item self-report questionnaire designed to assess PTSD symptoms as defined by the DSM-5. This questionnaire will be used to monitor changes before and after treatment, as well as screening patients for PTSD.

   Time frame: Change from baseline through 6 months post treatment

2. Insomnia Severity Index (ISI)

   The ISI is a seven-item questionnaire that is designed as a screening tool to assess the severity of a patient's insomnia using a Likert-type scale.

   Time frame: Change from baseline through 6 months post treatment

3. Generalized Anxiety Disorder 7-Item (GAD-7) Scale

   The GAD-7 is a 7-item self-report measure of the severity from mild to severe of symptoms related to generalized anxiety; items correspond to the diagnostic criteria for generalized anxiety disorder.

   Time frame: Change from baseline through 6 months post treatment

4. Patient Health Questionnaire-9 (PHQ-9)

   The PHQ-9 is a 9-item questionnaire that assesses the severity of affective and somatic symptoms related to depression; items correspond to the diagnostic criteria for major depression disorder.

   Time frame: Change from baseline through 6 months post treatment

5. Life Events Checklist for DSM-5 (LEC-5)

   The LEC-5 includes a list of 16 different potentially traumatic life events that that are commonly associated with PTSD symptoms and was designed to facilitate the diagnosis of PTSD. Therefore, it is used as a self-report measure designed to screen for potentially traumatic events in a respondent's lifetime and is typically administered before the CAP-5.

   Time frame: Baseline

6. Depressive Symptoms Index-Suicidality Subscale (DSI-SS).

   The DSI-SS is a 4-item self-report measure of suicidal ideation that focuses on ideation, plans, perceived control over ideation, and impulses for suicide. Scores on each item range from 0 to 3, with higher scores reflecting greater severity of suicidal ideation.

   Time frame: Change from baseline through 6 months post treatment

7. History of Head Injuries

   The History of Head Injuries form is a 3-item screening questionnaire that assesses a participant's history of a head injuries and altered consciousness to determine the worst head injury sustained while deployed. The form captures the total number of injuries during and outside of deployment.

   Time frame: Baseline

8. Brief Inventory of Psychosocial Functioning (B-IPF).

   The B-IPF is a 7-item measure of functioning in seven life domains: romantic relationship, relationship with children, family relationships, friendships and socializing, work, training and education, and activities of daily living. The B-IPF is an abridged version of the 80-item Inventory of Psychosocial Functioning, a survey that assesses psychosocial functioning but that would be too time-intensive to administer.

   Time frame: Changes from baseline through 6 months post treatment

9. Credibility/Expectancy Questionnaire (CEQ)

   The CEQ is a 6-item measure that was designed to assess treatment expectancy and rationale credibility for use of an experimental treatment in clinical outcomes studies.

   Time frame: Immediately after the first treatment session, and immediately after the final treatment session

10. Net Prompter Score

    The Net Prompter Score is a single item measures of treatment acceptability that asks respondents to rate the likelihood that they would recommend the efficient treatment to a friend or colleague on a scale from 0-10.

    Time frame: Post treatment (~6 months post baseline)

11. Patient Satisfaction Survey

    The Patient Satisfaction Survey is an adapted version of the Therapeutic Alliance and Patient Satisfaction survey. For this study, adaptations were made in order to assess satisfaction with the care received by the BHT (5 items; among patient participants assigned to WET + TAU) and providers separately (5 items; among all patient participants).

    Time frame: Post treatment (~6 months post baseline)

12. Treatment Engagement

    Treatment engagement will be assessed by the BHTs' supervisor at the clinic who will review administrative data to determine the number of behavioral health appointments completed by each enrolled patient participant. Engagement in TAU for patient participant who receive care in the network will be assessed at posttreatment via participant self-report.

    Time frame: Through study completion, an average of 2 years

13. WET Adoption

    Adoption will be assessed by examining the proportion of available BHTs who participate in the WET training and who deliver WET to study participants.

    Time frame: Through study completion, an average of 2 years

14. WET Fidelity

    To assess fidelity to the WET protocol, BHTs will audio record treatment sessions and submit a copy of the written trauma narratives. A random subset of 20% of the WET sessions will be reviewed rated for fidelity. Sessions will be rated using the WET Therapist Adherence and Competence Protocol. Clinicians are rated (yes/no) whether each session task was completed (e.g., "Therapist presented the treatment rationale for writing about traumatic event," "Therapist checked in with participant after writing and inquired how writing session went") and how well the therapist delivered each task (1 = poor to 7 = excellent). An overall competence score is also provided for each session.

    Time frame: Through study completion, an average of 2 years

15. Demographics and Military Service Characteristics Form

    This form will be administered to participants to measure standard demographics (race, gender, age) and military service information (e.g., deployment history, rank).

    Time frame: Baseline.