The Efficacy of a Pharmacological Treatment (Reboxetine Plus Ritalin) Versus Dog-Assisted Therapy in PTSD

PTSD, Posttraumatic Stress Disorder

PTSD, Posttraumatic Stress Disorder, Reboxetine, Methylphenidate, Randomized Controlled Trial, Dog-assisted Therapy, Occupational Therapy

Posttraumatic stress disorder (PTSD) is a chronic and often treatment-resistant psychiatric condition that emerges following exposure to trauma and is characterized by intrusive thoughts, emotional dysregulation, and cognitive impairments. In Israel, the prevalence of PTSD has increased significantly in the aftermath of the October 7, 2023 terror attacks, emphasizing the urgent need for more effective, accessible, and personalized interventions. Existing treatments, such as trauma-focused CBT and SSRIs, remain only partially effective, with side effects that reduce adherence and limit long-term recovery. The proposed randomized controlled trial will assess and compare two promising treatment modalities: (i) a new pharmacological combination of reboxetine and methylphenidate, designed to enhance noradrenergic and dopaminergic pathways involved in attention and emotional regulation, and (ii) dog-assisted therapy (DAT), a non-pharmacological, group-based intervention shown to reduce PTSD symptoms and improve functioning. One hundred sixty adults with PTSD will be randomized into four groups: pharmacological treatment, placebo, DAT, or occupational therapy. The study will use validated clinical scales (CAPS-5, GAD-7, CAARS, DLQ, WHOQOLBREF) alongside neurophysiological tools (EEG, EDA, ASAT-based EMG). Data will feed into a machine-learning model to identify predictors of treatment response and support the development of personalized, neurobiologically informed approaches.

Posttraumatic Stress Disorder (PTSD) is a chronic and debilitating psychiatric condition characterized by intrusive memories, avoidance behaviors, hyperarousal, and emotional numbing. It is estimated that it affects 5.3% of the Israeli general population, though following the October 7, 2023 terror attacks, probable PTSD nearly doubled, from 16.2% to 29.8%, highlighting the urgent national need for effective and scalable PTSD interventions. Given its high prevalence and physical and mental consequences, adequate treatment is needed. Current first-line therapies (TF-CBT and EMDR) are effective but are time-intensive, require specialized clinicians, and are not suitable for all patients. Pharmacological interventions, particularly SSRIs yield partial response rates (\ 60%) and often cause adherence-limiting side effects (e.g., major changes in body weight or loss of sexual drive). These limitations underscore the need for novel, tolerable, and mechanistically targeted therapies. Arising evidence suggests a correlation between sensory dysfunction, impaired attention, and PTSD symptoms. The importance of combined treatment specifically targeting these difficulties has been suggested by us. Recent evidence suggests that PTSD involves dysregulation in both noradrenergic and dopaminergic systems, which play critical roles in attention, arousal, and emotional processing. Reboxetine, a norepinephrine reuptake inhibitor (NRI), and methylphenidate, a dopamine-enhancing psychostimulant, are hypothesized to have synergistic effects on PTSD-related cognitive and emotional deficits. Our lab's prior results suggest that this combination is safe, well-tolerated, and effective in reducing both clinician-rated PTSD symptoms, and neurophysiological dysregulations related to sensory gating and attention regulation, sensory processing, participation and quality of life. Animal-assisted therapies, and DAT in particular, are increasingly recognized for their potential to reduce PTSD symptoms and improve emotional regulation. DAT programs for US veterans diagnosed with PTSD were found to be a helpful complementary or alternative treatment option for the veterans, demonstrating signs of meaningful improvements in mental and social health, lower PTSD symptoms severity and higher psychosocial functioning in veterans owning a psychiatric service dog, and positive correlation between Animal-assisted interventions (AAI) and a reduction of posttraumatic symptomatology. DAT programs have also been shown to foster resilience among veterans and their families. A meta-review found that DAT was as effective as traditional psychotherapy in symptom reduction. Our lab conducted a controlled study involving adolescents exposed to interpersonal trauma, showing significant improvement in PTSD symptoms, depression, and attentional regulation after a year-long dog training program (also on the dogs' attention and anxiety-like behavior). Despite growing support for DAT and emerging evidence comparing DAT to psychotherapeutic interventions for PTSD symptomatology, no studies to date have directly compared pharmacological vs. animal-assisted therapy in PTSD. Moreover, there is a lack of objective, physiology-based tools to monitor treatment efficacy and guide individualized care. This study aims to bridge both gaps, combining a novel pharmacological strategy with neurophysiological diagnostics in a rigorously controlled, head-to-head RCT. Therefore, a four-arm randomized controlled trial (RCT) involving 160 adults diagnosed with PTSD, allocated to one of the following groups: 1. Combined pharmacological treatment (reboxetine + methylphenidate) 2. Pharmacological placebo control 3. Dog-assisted therapy (DAT) 4. Active control: Occupational therapy (OT) The pharmacological arm is double-blinded and placebo-controlled, while the DAT/OT arms are open-label, with participant preference and suitability guiding allocation. The study includes repeated measurements at multiple time points, combining subjective and objective outcomes.

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Israel