CPT-fMRI Study for PTSD

NCT03229915 | Completed

• 1 other identifier: B2017:029
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Posttraumatic stress disorder (PTSD) is prevalent mental illness (\~9% life-time) that results from exposure to trauma. As it is associated with vastly heterogeneous origins, accurate diagnosis and optimal treatment strategies are sometimes very difficult to achieve. No known biomarker exists, which makes it difficult to assess treatment response and functional outcomes. The recent brain imaging studies have suggested that PTSD patients show abnormal brain connectivity measured by functional magnetic resonance imaging (fMRI). The investigators propose that cognitive processing therapy may ameliorate this functional connectivity abnormality which may be related with their symptomatic improvement.

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (1)

• Clinician-Administered PTSD Scale (CAPS) for the DSM-V

  The CAPS is the current gold-standard for psychodiagnostic assessment of PTSD.

  13 weeks

Secondary Outcomes (1)

• functional connectivity

  13 weeks

Study Arms (3)

PTSD

ACTIVE COMPARATOR

Will receive Cognitive Processing Therapy

Behavioral: cognitive processing therapy

Trauma-exponsed control

ACTIVE COMPARATOR

Will receive Cognitive Processing Therapy

Behavioral: cognitive processing therapy

no trauma healthy control

NO INTERVENTION

Scanned twice (13 weeks apart) without any intervention

Interventions

cognitive processing therapy BEHAVIORAL

Group therapy for PTSD patients

PTSD; Trauma-exponsed control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

INCLUSION PTSD 1. Current diagnosis of PTSD as assessed by the Clinician Administered PTSD Scale (CAPS) for the DSM-V \[30\]; CAPS ≥ 15 2. Presence of at least one intrusion symptom, two negative cognition and mood symptoms, and two arousal symptoms. Trauma Exposed Controls 1. experienced a traumatic event (as assessed by criterion A of the CAPS) 2. CAPS \< 15 Health Controls 1\. Not experienced a traumatic event (as assessed by criterion A of the CAPS ≤15) EXCLUSION All 1. substance dependence not in remission for at least three months 2. current uncontrolled bipolar or psychotic disorder, or severe cognitive impairment. 3. Contraindications for MRI (e.g., no metal implants, not pregnant)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Manitoba: lead
• Workers Compensation Board of Manitoba: collaborator

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E 0J9, Canada

Location

Related Publications (1)

• Yakemow G, Kolesar TA, Wright N, Beheshti I, Choi EH, Ryner L, Chaulk S, Patel R, Ko JH. Investigating neural markers of Alzheimer's disease in posttraumatic stress disorder using machine learning algorithms and magnetic resonance imaging. Front Neurol. 2024 Nov 7;15:1470727. doi: 10.3389/fneur.2024.1470727. eCollection 2024.

  PMID: 39574505 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Group 1: PTSD patients Group 2: trauma-exposed control Group 3: no trauma healthy control Group 1 and 2 will undergo CPT.

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 26, 2017
• Study Start: October 1, 2017
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

CA (1)