Trial results for a pilot study investigating Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) and Substance Use were posted on ClinicalTrials.gov on 2026-02-27. The study enrolled 65 participants. While the top-level condition for this update is Bipolar Disorder, the trial specifically focused on early psychosis and substance use, which are highly comorbid with and often present in Bipolar Disorder.
Background
Bipolar disorder is a complex mental health condition characterized by significant mood shifts, which can include episodes with psychotic features. Individuals with bipolar disorder also frequently experience co-occurring substance use disorders, complicating treatment and recovery. Early psychosis, often accompanied by substance use, places considerable strain not only on the affected individual but also on their family members. Family-focused interventions, such as Community Reinforcement and Family Training (CRAFT), aim to equip families with strategies to support their loved ones and improve their own wellbeing. This pilot study explored the feasibility and initial efficacy of CRAFT adapted for early psychosis (CRAFT-EP) and substance use, delivered primarily via telehealth, recognizing the critical role of family support in managing these conditions.
Trial design
This completed pilot study, designated as Phase NA, enrolled 65 participants. The trial investigated conditions including Psychosis, Substance Use, Substance Use Disorders, Family, and Cannabis. The intervention evaluated was Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP), delivered exclusively or primarily via telehealth (video conferencing). The study compared the CRAFT-EP intervention combined with Treatment as Usual (CRAFT-EP + TAU) against Treatment as Usual alone.
Key results
The trial reported several key measurements related to family wellbeing:
- Family Wellbeing: Depression (score on a scale):
- For the CRAFT-EP + TAU group, mean scores were 14.19 (Standard Deviation 9.52), 9.76 (Standard Deviation 6.76), and 6.53 (Standard Deviation 7.39).
- For the Treatment as Usual group, mean scores were 10.82 (Standard Deviation 7.36), 11.67 (Standard Deviation 5.88), and 8.64 (Standard Deviation 5.40).
- Family Wellbeing: Anxiety (score on a scale):
- For the CRAFT-EP + TAU group, mean scores were 45.30 (Standard Deviation 15.99), 38.73 (Standard Deviation 11.52), and 32.81 (Standard Deviation 10.08).
- For the Treatment as Usual group, mean scores were 41.82 (Standard Deviation 17.27), 45.24 (Standard Deviation 16.79), and 42.42 (Standard Deviation 16.62).
Key analyses using generalized estimating equations also provided the following results:
- An analysis showed a Mean Difference (Net) of -5.48 (95.0% CI: -10.31 to -0.65) with a p-value of 0.026.
- Another analysis showed a Mean Difference (Net) of -14.31 (95.0% CI: -23.88 to -4.73) with a p-value of 0.003.
- A third analysis showed a Mean Difference (Net) of 1.57 (95.0% CI: -0.25 to 3.38) with a p-value of 0.091.
What this means
The results from this pilot study suggest that Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP), delivered via telehealth, can significantly improve aspects of family wellbeing in the context of early psychosis and substance use. The statistically significant reductions observed in certain measures (p-values of 0.026 and 0.003) indicate a positive impact on family distress. For individuals with Bipolar Disorder, where psychotic features and comorbid substance use are common, family support is a critical component of care. Interventions that reduce family burden and improve their coping skills can indirectly benefit the patient's recovery trajectory. The telehealth delivery method also highlights a potentially accessible approach for families facing geographical or logistical barriers to in-person support. These pilot findings warrant further investigation in larger, more definitive trials.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05380583, titled "Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) and Substance Use: A Pilot Study", were posted on 2026-02-27 on clinicaltrials.gov.