Creative Art Teletherapy for Veterans With PTSD

N/ANot Yet RecruitingNCT07840079

VA Office of Research and Development84 enrolled

Overview

This project focuses on how the investigators can treat post-traumatic stress disorder (PTSD) with a Creative Art Teletherapy, Art-therapy Remote Treatment for Veterans Experiencing Trauma (ART-VET). Treatments for PTSD do not work well enough for many Veterans with PTSD. Many patients do not recover with current treatment methods. A core deficit in PTSD is an inability to feel safe in secure environments, and not to have flight, flight, or freeze behaviors. Unfortunately, many people have trouble with exposure-based psychotherapies and have trouble getting better or learning how to feel safer. Also, many rural Veterans are unable to attend treatment sessions in person. The investigators plan to conduct a clinical trial of ART-VET, a promising 8 session (roughly weekly) teletherapy program, and the investigators will measure how well it works using many clinical and research measures before, during, and after participating in the therapy.

The primary goal of this proposal is to evaluate a promising teletherapy for Veterans with posttraumatic stress disorder, ART-VET. Problem: Current treatments for posttraumatic stress disorder (PTSD) face considerable challenges including high dropout rates and insufficient remission rates. First line pharmacotherapy using selective serotonin reuptake inhibitors (SSRI), serotonin-norepinephrine reuptake inhibitors (SNRI), or psychotherapeutic methods such as prolonged exposure therapy result in remission rates between 20 and 50%, though this estimate is confounded by high dropout rates. Furthermore, gold-standard therapies such as trauma-focused cognitive behavior therapy (CBT), i.e. prolonged exposure and Cognitive Processing Therapy (CPT), face higher dropout rates in Veteran populations than civilian, and the proportion which receive an "adequate dose" of therapy is low due to poor compliance. These factors contribute to the chronicity of PTSD and concomitant declines in health and reduced quality of life for the estimated 23% of Veterans who served in recent conflicts, as well as their families and communities. Furthermore, access to care is restricted, particularly in the rural context. Approximately 4.4 million United States Veterans reside in rural communities, and 61% percent of rural Veterans are enrolled in the VA health care system, significantly higher than the 41% enrollment rate of urban Veterans. Rural health care challenges related to access to specialty care are intensified by combat-related injuries and illnesses such as PTSD. Thus, it is critical that the investigators develop alternative treatments while simultaneously improving our understanding of the mechanistic basis of PTSD. Art-therapy Remote Treatment for Veterans Experiencing Trauma (ART-VET) shows promise as a tool to treat PTSD. ART-VET incorporates elements of other empirically supported psychotherapeutic methods, for example exposure therapy. While art therapy is already in use in the VA, there are fewer than 50 Art Therapists in the Veterans Health Administration (VHA) system, and expanded access is held back in part by the lack of robust clinical trial data. The proposed research builds on a successful pilot study whose results strongly supported further research on ART-VET. Research Design and Methods: This research will determine if Creative Art Teletherapy reduces symptoms of PTSD as assessed by commonly used and validated clinical PTSD scales as well as a broad set of measures of domains frequently impacted by PTSD including sleep, depression, anxiety, and quality of life. Furthermore, the research will expand our understanding of the mechanistic basis of PTSD and the impact of Creative Art Teletherapy on those measures. The overall design is a wait-list control randomized clinical trial with partial cross-over, which allows the assessment of the impact of therapy for all participants as well as estimation of the symptom stability without treatment. The proposed research will also use functional magnetic resonance imaging measures to assess brain activity associated with PTSD symptoms during emotional image viewing and memory tasks. These will be combined to evaluate the relationships, patterns and clustering features of PTSD symptoms, comorbidities, psychosocial wellbeing, sleep quality, self-efficacy, functional brain measures, and quality of life measures as well as patterns of association with qualitative measures of art therapy and patient outcomes including imagery, self-report measures, narrative response themes and features, and clinical notes.

Interventions

Art-therapy Remote Treatment for Veterans Experiencing TraumaBEHAVIORAL

ART-VET consists of 8 telehealth sessions, each approximately 1 hour in duration, scheduled approximately weekly. Sessions balance a well-structured progression with individualization for each participant. Following an initial evaluation and psychoeducation around art therapy and PTSD, sessions follow a progression of established treatment practices that use art to guide the Veteran through stages of trauma treatment that includes establishing safety, sharing one's story, tolerating distress in sharing the trauma experience in order to work towards desired change, processing trauma in order to integrate the experience and regulate emotions, building coping skills, improving relationships with oneself and/or loved ones, integrating prior and current identities, and working towards closure. Sessions incorporate art media and processes, allowing participants to explore these themes visually as well as through verbal processing of the experience and imagery created.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * US Veterans with Post-traumatic stress disorder (PTSD) * Able to operate a pen \& keyboard * Willing to participate in a Creative Art Teletherapy based intervention (including stable internet connection and compatible computing device) * English proficiency (study materials are only available in English; participants must be able to read and write in English) * Willing to provide informed consent. Consistent with ethical principles, all participants must be able to understand the nature of the experiment(s) they are volunteering to participate in, to understand their rights, risks, and potential benefits from their participation * Stable pharmacotherapy Exclusion Criteria: * Major medical illness, in particular psychiatric, neurological or immunological (e.g., schizophrenia, organ failure, type-1 diabetes, significant auto-immune disease, etc.) * Major uncorrectable sensory deficit, such as blindness or hearing loss * Current drug or alcohol dependence or abuse * History of greater than moderate traumatic brain injury (TBI) or have experienced a TBI more recent than 12 months * Pregnancy * Unstable pharmacotherapy * Ongoing or planned psychotherapy. While ART-VET may be effective as an adjuvant to current standard of care psychotherapy, it would not be possible to disentangle the impacts of each in the present study. Potential participants with ongoing or planned psychotherapy will be offered the opportunity to initiate participation 3 months after completion if otherwise still eligible. * Contraindications to participation in intervention or magnetic resonance imaging (MRI) (Disqualification by indication of a contraindication to participation in intervention such as an allergy to materials (unlikely), presence of metal or MRI-unsafe material, claustrophobia or other preclusion to participation in MRI, or disqualification from participation not otherwise subsumed above)

Outcomes

Primary Outcomes

Change from baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score

The CAPS-5 is the gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to make current (past month) and lifetime diagnosis of PTSD and assess PTSD symptoms over the past week. In addition to assessing the 20 DSM-5 PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization). The CAPS-5 total PTSD symptom severity score is calculated by summing the severity ratings (range 0-4) of the 20 DSM-5 PTSD symptoms. Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.

Time frame: Baseline; waitlist pre-ART-VET assessment at approximately 8 weeks after baseline for participants assigned to waitlist; within 3 weeks after ART-VET completion; and approximately 3 months after ART-VET completion.

Secondary Outcomes

Change from baseline in PTSD Checklist for DSM-5 (PCL-5) total score

The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 total score is calculated by summing the severity ratings (range 0-4) of the 20 items. Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.

Change from baseline in Patient Health Questionnaire-9 (PHQ-9) total score

The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report measure of depressive symptoms. Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.

Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) total score

The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report measure of anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.

Change from baseline in Pittsburgh Sleep Quality Index (PSQI) global score

The Pittsburgh Sleep Quality Index (PSQI) is a self-report measure of sleep quality over the past month. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality.

Change from baseline in Van Dream Anxiety Scale (VDAS) total score

The Van Dream Anxiety Scale (VDAS) is a 17-item self-report measure of dream anxiety and nightmare-related distress over the past month. Four questions (7-10) are used for clinical information only and are not used in scoring the VDAS. The remaining 13 questions are rated on a 0 to 4 scale and are summed to calculate the total score which ranges from 0 - 42. Higher scores indicate greater dream anxiety.

Change from baseline in Positive and Negative Affect Schedule (PANAS) Short Form Positive and Negative Affect subscale scores

The Positive and Negative Affect Schedule (PANAS) is a 20-item self-reported measure of positive and negative emotional states over the past week. The PANAS has 20 items scores on a scale of 1 to 5. 10 of these items are summed to calculate the positive affect subscale score and the remaining 10 items are summed to calculate the negative affect subscale score. Both subscale scores range from 10 to 50. Higher positive affect subscale scores represent higher levels of positive affect. Lower negative affect subscale scores represent lower levels of negative affect. These subscale scores use the same units of measure and are included in a single Outcome Measure accordingly.

Change from baseline in Perceived Stress Scale (PSS) total score

The PSS contains 10 items that measure feelings/thoughts regarding stress over the preceding month to assess self-perceived stressfulness of live events/situations. Each item is rated on a scale of 0 to 4. To calculate the total score, the ratings are summed yielding a range of 0 to 40. Higher scores indicate higher levels of self-perceived stress.

Change from baseline in World Health Organization Quality of Life - Brief Version (WHOQOL-BREF) domain scores

WHOQOL-BREF is a 26-item assessment of self-perceived quality of life in the last two weeks. The items are rated on a scale of 1 to 5 and are grouped into four domains: physical health, psychological health, social relationships, and environment. These domains are scores by taking the mean of the item ratings included within them which generates four domain scores with a range of 1 to 5. Higher scores indicate higher self-perceived quality of life.

Change from baseline in Freiburg Mindfulness Inventory (FMI) total score

The Freiburg Mindfulness Inventory (FMI) is a 14-item self-report measure of mindfulness over the past two weeks. Each item is rated 1 to 4 and these ratings are summed to calculate a total score ranging from 14 to 56. Higher scores indicate greater mindfulness.

Working Alliance Inventory - Therapist Version (WAI-T) total score after ART-VET

WAI-T is a 36-item measure assessing therapist/clinician perceptions of their experiences and feelings about their participant/patient. The items are rated on a scale of 1 to 7. The total score is calculated by summing each of the 36 ratings and has a range of 36 - 252. Higher scores indicate a more positive working alliance.

Time frame: Within 3 weeks after ART-VET completion

Working Alliance Inventory - Client Version (WAI-C) total score after ART-VET

WAI-C is a 36-item measure assessing participant/patient perceptions of their experiences and feelings about their therapist/clinician. The items are rated on a scale of 1 to 7. The total score is calculated by summing each of the 36 ratings and has a range of 36 - 252. Higher scores indicate a more positive working alliance.

Time frame: Within 3 weeks after ART-VET completion

Change from pre-ART-VET to post-ART-VET in blood-oxygenation-level-dependent functional magnetic resonance imaging response to trauma-related and non-trauma-related visual stimuli

Blood-oxygenation-level-dependent functional magnetic resonance imaging (BOLD-fMRI) will be used to assess brain functional connectivity during visual and cognitive-emotional tasks. The study will examine association between change from pre-ART-VET to post-ART-VET CAPS-5 total severity scores and task-related BOLD functional connectivity, including responses to trauma-related and comparison stimuli. BOLD-fMRI outcomes are neuroimaging signal metrics and do not have a minimum or maximum clinical scale score; higher or lower values reflect greater or lower task-related correlation in the BOLD signal between different locations in the brain, not inherently better or worse clinical outcome.

Time frame: Pre-ART-VET MRI occurs at baseline for participants assigned to immediate ART-VET and at approximately 8 weeks after baseline for participants assigned to waitlist. Post-ART-VET MRI occurs within 3 weeks after ART-VET completion.