HIV, Post Traumatic Stress Disorder (PTSD)
Conditions
Keywords
HIV, psychotherapy, trauma
Brief summary
People living with HIV (PLWH) have a higher rate of post-traumatic stress disorder (PTSD) diagnosis than the general population. Comorbid PTSD is also associated with negative HIV-related health outcomes. Unfortunately, little outcome research has examined the usefulness of PTSD treatments for PTSD. This pilot study adapts for PLWH a non-exposure based psychotherapy for PTSD focused on reflecting on one's emotions and relationships and understanding and working through how trauma may have disrupted them. The study team is interested in better understanding the needs of PLWH with PTSD, learning whether PLWH with PTSD find this treatment acceptable and helpful, and beginning to understand the relationship between HIV-related health factors (e.g., inflammation and stress biology) and PTSD, and how these health factors may improve during treatment.
Interventions
This psychotherapy addresses disruptions in the ability to reflect and affective regulation by exploring the psychological meanings of symptoms and their relation to traumatic events. The therapist works to identify intrapsychic conflicts, intense negative affects, and defense mechanisms related to the PTSD syndrome using a psychodynamic formulation that provides a framework for intervention. The transference provides a forum for patients to address feelings of mistrust, difficulties with authority, fears of abuse, angry and guilty feelings, and fantasies. This treatment will be provided in-person or over teletherapy as the public health situation demands.
Sponsors
Montefiore Medical Center
National Institute of Allergy and Infectious Diseases (NIAID)
American Psychoanalytic Association (APsA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of DSM-5 defined PTSD, per the Clinician Administered PTSD Scale \& CAPS-5 total severity score greater than or equal to 25 * HIV diagnosis (by medical records or HIV testing) * Stable psychiatric/psychotropic medication for \>=2 months and ongoing during treatment
Exclusion criteria
* Psychosis * Bipolar I * Acute suicidality * Current substance use disorder * Organic mental syndrome or intellectual disability * Unstable non-HIV medical conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5 | Baseline | Lower scores denote less severe PTSD symptoms; a decline of at least 30% from an individual's baseline CAPS score is defined as a treatment response on the CAPS; diagnostic remission will be defined as achieving response plus failing to meet for DSM-5 defined PTSD per the CAPS after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression Score based on the Hamilton Depression Rating Scale (HDRS) | Baseline, Week 12 (treatment termination) | The HDRS (also known as the Ham-D) scale contains 17 items pertaining to symptoms of depression experienced over the past week. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression, and scores over 24 are indicative of severe depression with the maximum score being 52 on the 17-point scale. |
| Change in Anxiety Score based on the Hamilton Rating Scale for Anxiety (HAM-A) | Baseline, Week 12 (treatment termination) | Severity of anxiety will be assessed using the Hamilton Rating Scale for Anxiety (HAM-A). The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe anxiety. |
| Change in Functional Impairment based on the Sheehan Disability Scale (SDS) | Baseline, Week 6, Week 12 (treatment termination), 3-month post-treatment follow-up | The Sheehan Disability Scale is a composite of three self-rated items designed to measure the extent to which three major domains in the patient's life are functionally impaired by psychiatric or medical symptoms. The SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school (0-10 scoring range), social life (0-10 scoring range), and family life (0-10 scoring range). A composite range of 0-30 is possible. Scores of ≥5 on any of the 3 individual scales and overall higher totals scores are associated with significant functional impairment. |
Countries
United States
Contacts
CONTACTJohn R Keefe, PhD
CONTACTBarbara L Milrod, MD
PRINCIPAL_INVESTIGATORBarbara Milrod, MD
Montefiore Medical Center
Outcome results
None listed