Effectiveness of Trauma Treatment in the Specialist Health Care Services

NCT06691347 | Recruiting

• 1 other identifier: REK 716204
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

Post-traumatic stress disorder (PTSD) is a common mental illness. Treatments for PTSD are regarded as highly effective, but a large-scale, prospective, longitudinal randomized controlled trial comparing the effectiveness of these treatments has been requested by the research community. This study aims to conduct a comprehensive investigation into the effectiveness of two prominent PTSD therapies, eye movement desensitization and reprocessing (EMDR) and cognitive therapy for PTSD (CT-PTSD), within the Norwegian specialist health care services. The study aims to compare the therapy effectiveness, including their impact on comorbid disorders, complex PTSD symptoms, and functional outcomes post-treatment. Patients will be randomly assigned to EMDR or CT-PTSD and given manualized therapy aligned with their treatment goals. Each arm aims to recruit 135 patients, resulting in a total sample size of 270 patients. The main objective of this study is to examine the growth curves of the two methods and how patient characteristics affect their developments. Secondary short-term aims include (1) investigating the impact of EMDR and CT-PTSD on complex PTSD symptoms, (2) assessing effects on other clinical conditions and functional outcomes, and (3) exploring whether the therapeutic alliance mediates treatment effects. Secondary long-term aims are (1) to assess the long-term effects of EMDR and CT-PTSD on PTSD symptoms and (2) to explore the impact of extended or additional treatments on outcomes.

Conditions

Post Traumatic Stress Disorder PTSD; Quality of Life; Functional Outcome; Complex Post-Traumatic Stress Disorder; Eye Movement Desensitization and Reprocessing; Cognitive Therapy

Outcome Measures

Primary Outcomes (2)

• Changes in PTSD-symptoms

  Changes in PTSD checklist for DSM-V (PCL-5) scores. The PCL-5 consists of 20 items on a 5-point Likert scale ranging from 0-4. Total scores range from 0-80, where a higher score signifies a worse outcome.

  From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months

• Changes in PTSD-symptoms

  The International trauma questionnaire (ITQ) scores. The ITQ consists of 18 items on a 5-point Likert scale ranging from 0-4. Total scores range from 0-72, where a higher score signifies a worse outcome.

  From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months

Secondary Outcomes (7)

• Changes in comorbid illnesses

  From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months

• Changes in comorbid illnesses

  From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months

• Changes in comorbid illnesses

  From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months

• Changes in comorbid illnesses

  From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months

• Changes in comorbid illnesses

  From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months

Other Outcomes (2)

• The impact of therapeutic alliance on treatment effectiveness

  From enrollment to the end of treatment at 24 weeks

• In case of re-referral: number of days until re-referral

  From end of treatment to 12 months afterwards

Study Arms (2)

Eye Movement Desensitization and Reprocessing

EXPERIMENTAL

Patients will receive EMDR as their main treatment method of PTSD. EMDR processes trauma memories while engaging in bilateral stimulation to help rewire the brain's response to trauma and decrease emotional distress.

Behavioral: Eye movement desensitization and reprocessing

Cognitive Therapy for PTSD

EXPERIMENTAL

Patients will receive CT-PTSD as their main treatment method of PTSD. CT-PTSD focuses on techniques such as cognitive restructuring and exposure therapy to help individuals reframe trauma and reduce intrusive memories and emotional distress.

Behavioral: Cognitive therapy for PTSD

Interventions

Eye movement desensitization and reprocessing BEHAVIORAL

Psychotherapy with EMDR. A therapist guides the client in recalling distressing events while simultaneously following a stimulus, like a moving light or tapping. The idea is that this bilateral stimulation helps reduce the intensity of the traumatic memory, allowing clients to gain perspective and lessen emotional distress associated with it. The standard treatment protocol includes up to 24 weekly sessions.

Also known as: EMDR

Eye Movement Desensitization and Reprocessing

Cognitive therapy for PTSD BEHAVIORAL

Psychotherapy with CT-PTSD. A therapist works with the client to understand how they interpret their trauma and identify distorted thinking patterns that fuel their PTSD symptoms. Through guided discussions, written exercises, and sometimes "re-living" the trauma in a controlled way, clients learn to reshape these beliefs, gain a more balanced perspective, and reduce symptoms like hypervigilance, flashbacks, and avoidance behaviors. The standard treatment protocol includes up to 24 weekly sessions.

Also known as: CT-PTSD

Cognitive Therapy for PTSD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18 years
• meeting criteria for PTSD based on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) with a total score ≥23

You may not qualify if:

• insufficient mastery of the Norwegian language
• severe intellectual impairment (estimated IQ of 70 or less)
• comorbid psychiatric illnesses in an acute phase where other types of treatment need to be prioritized (e.g. hospitalization)
• history of EMDR or CT-PTSD treatment

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead
• Norwegian Center for Violence and Traumatic Stress Studies: collaborator

Study Sites (1)

Vestre Viken Health Trust

Drammen, Akershus, 3004, Norway

RECRUITING

MeSH Terms

Conditions

Combat Disorders

Interventions

Eye Movement Desensitization Reprocessing; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Susie Fu, Ph.D, Cand. Psychol.

  Vestre Viken Health trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susie Fu, PhD, Cand. Psychol.

CONTACT

+4790588752; susifu@vestreviken.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The Investigator will be blinded to the random allocation of patients, but will have knowledge of the interventions when treatment begins.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: November 15, 2024
• Study Start: September 26, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)