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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating a preventive intervention called Condensed Internet-delivered Prolonged Exposure CIPE for people experiencing symptoms of post-traumatic stress disorder PTSD about one month after a traumatic event. The goal is to test the effectiveness and cost-effectiveness of CIPE when added to usual treatment provided by psychosocial crisis teams in Norwegian municipalities. This study addresses the lack of evidence-based preventive interventions available for victims after crises and disasters in Norway. Participants are randomly assigned to receive either treatment-as-usual TAU alone or TAU plus the CIPE intervention. CIPE is a therapist-supported, internet-based program consisting of four modules delivered over six weeks. Participants are encouraged to engage daily with their therapist through a secure platform and may have phone sessions. The total therapist contact is generally under 60 minutes, while participants work on intervention tasks about six hours weekly. TAU involves proactive support from interdisciplinary crisis teams following national guidelines. Throughout the one-year study period after trauma, participants undergo assessments including the PTSD Checklist for DSM-5 at 10 to 13 weeks, 6 months, and 12 months post-trauma. Other measures include depression, insomnia, grief symptoms, treatment satisfaction, and quality of life. Researchers will monitor use of specialized mental health services and cost-effectiveness. The study aims to understand how CIPE plus usual care compares to usual care alone in reducing PTSD symptoms and improving overall outcomes.
Actively Recruiting
Researchers are evaluating a parent-led, therapist-assisted trauma treatment called Stepping Together for Children after Trauma ST-CT for children aged 7 to 12 who have developed moderate symptoms of posttraumatic stress following trauma. The study aims to compare ST-CT with usual care to see if it more effectively reduces symptoms of posttraumatic stress, depression, and sleep disorders while improving daily functioning for children and their parents. It also examines the cost-effectiveness of ST-CT and its potential to prevent long-term use of healthcare services and prescribed drugs. The study is a randomized controlled trial conducted in Norwegian municipal first-line services with 160 child-parent pairs. Participants are randomly assigned to receive either the ST-CT intervention or usual care. ST-CT involves 11 at-home meetings and workbook tasks over 6-9 weeks, weekly calls, and five therapist sessions. Children who respond well continue to a 6-week maintenance phase. If the workbook is not completed or symptoms persist, care transfers to specialized mental health services. Usual care includes the standard treatments provided by therapists in the municipal services. Participants and their caregivers will be assessed at five time points before treatment, mid-treatment or 9 weeks, post-treatment or 15 weeks, and at 6 and 12 months after baseline. Assessments include post-traumatic stress symptoms, mood, sleep disturbances, trauma-related thoughts, parent-child communication, quality of life, somatic symptoms, anger outbursts, and healthcare service use. Sleep quality is also measured objectively with a sensor. The study tracks symptom changes during treatment and examines family dynamics related to recovery. This comprehensive follow-up lasts up to one year after starting treatment.