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

Sponsor
University of Haifa
Study ID
NCT07771530
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • methylphenidate (Ritalin®) — DRUG
    Ritalin 10mg
  • Reboxetine — DRUG
    Reboxetine 4mg
  • Placebo — DRUG
    Placebo matched to Reboxetine
  • Placebo — DRUG
    Placebo matched to Ritalin
  • Dog-Assisted Therapy — BEHAVIORAL
    Dog-Assisted Therapy
  • Occupational Therapy — BEHAVIORAL
    Occupational Therapy

Study Details

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.

Key Dates

First listed
Aug 18, 2026
Start date
Aug 1, 2026
Status verified
Aug 2026
Primary completion
Aug 1, 2028
Completion
Aug 1, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment with Reboxetine and Methylphenidate
    The trial starts with four days of treatment with 2mg of reboxetine every morning at 8 am. For the rest of the first three weeks, the participants will increase their dosage to 4mg every morning. During the fourth week, the participants will continue taking 4mg of reboxetine every morning at 8 am and additionally take 10mg of methylphenidate (or matching placebo) twice daily, i.e., in the morning at 8 am and at noon.
  • Placebo Comparator: Placebo
    The patients will take placebos according to the medication schedule of the treatment group.
  • Experimental: Dog-Assisted Therapy
    . To encompass DAT protocol variability, it will be provided by certified rehabilitation farms in Israel and the US. The twenty-four DAT group therapy weekly sessions, over six months, will be conducted by licensed clinicians trained in occupational therapy, social work, psychology, and counseling, and are certified (diploma) to facilitate group therapy using therapy dogs. The clinicians have, on average, over four years of experience in providing services to people diagnosed with PTSD. Groups will typically have eight to fifteen human participants, depending on the rehabilitation farm. The DAT session's duration will last between fifty to sixty minutes. In generalization, session protocol will include: (i) defining a subject for each of the twenty-four AATx sessions, from which the clinicians will extract the therapeutic messages they would like to convey (e.g. regaining a sense of control, dealing with feelings of anger, guilt or shame, reducing feelings of alienation and distance);
  • Active Comparator: Occupational Therapy
    The occupational therapy schedule will roughly follow the same timeline as the dog-assisted therapy group. Therapy will be provided by licensed occupational therapists.

Primary Outcome Measure

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: Participants will be measured at three time points: (i) Baseline - on the 1st day of the trial before starting the DAT or another OT intervention; (ii) on the twenty-fourth week; and (iii) Follow-up - six weeks after completion of the trial. ]

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