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NCT Number: NCT06691347

Effectiveness of Trauma Treatment in the Specialist Health Care Services

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.

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Key information

Conditions

Post Traumatic Stress Disorder PTSD Cognitive Therapy Combat Disorders Complex Post-Traumatic Stress Disorder Eye Movement Desensitization and Reprocessing Functional Outcome Mental Disorders Quality of Life Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vestre Viken Health Trust

Drammen, Akershus, 3004, Norway

Location status: Recruiting

Location contact

Susie Fu, Ph.D, Cand. psychol.

CONTACT

[email protected]

+4790588752

About this study

Participants will be recruited from Asker DPS, Bærum DPS, Drammen DPS, and Ringerike DPS. They were referred to DPS for PTSD treatment, either by general practitioners, other primary health care services in their municipality, or psychiatric hospitals. This study is a longitudinal multi-assessment 2-arm RCT and does not include a treatment as usual group. The standard treatment protocol includes up to 24 weekly sessions. Conversely, if no discernible improvement is seen after 10 sessions, it is recommended to terminate treatment. The clinical assessment consists of self-administered questionnaires collected through CheckWare, which is a digital platform developed for healthcare services. They will be asked to report symptoms of PTSD, depression, anxiety, psychosis, alcohol/drug use, functional outcomes, working alliance. Before treatment starts, patients will complete baseline assessments. Throughout the treatment phase, all patients will be requested to fill out self-administered questionnaires after each session.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: EMDR

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.

Other names: CT-PTSD

Primary outcomes

  1. Changes in PTSD-symptoms

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

    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.

  2. Changes in PTSD-symptoms

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

    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.

Secondary outcomes

  1. Changes in comorbid illnesses

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

    Changes in symptoms related to depression as measured with The Beck Depression Inventory-II (BDI). The BDI-II consists of 21 items on a 4-point Likert scale ranging from 0-3. Total scores range from 0-63, where a higher score signifies a worse outcome.

  2. Changes in comorbid illnesses

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

    Changes in symptoms related to anxiety as measured with The Beck Anxiety Inventory (BAI). The BAI consists of 21 items on a 4-point Likert scale ranging from 0-3. Total scores range from 0-63, where a higher score signifies a worse outcome.

  3. Changes in comorbid illnesses

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

    Changes in symptoms related to psychosis as measured with MULVARP. MULVARP consists of Prodromal Questionnaire (PQ-16). It consists of 16 items on a 4-point Likert scale ranging from 0-3. Total scores range from 0-48, where a higher score signifies a worse outcome.

  4. Changes in comorbid illnesses

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

    Changes in symptoms related to alcohol use as measured with Alcohol Use Disorders Identification Test (AUDIT). The AUDIT consists of 10 items on a 5-point Likert scale ranging from 0-4, with the exception of questions 9 and 10 which have possible responses of 0, 2 and 4. Total scores range from 0-40, where a higher score signifies a worse outcome.

  5. Changes in comorbid illnesses

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

    Changes in symptoms related to drug use as measured with Drug Use Disorders Identification Test (DUDIT). The DUDIT consists of 11 items on a 5-point Likert scale ranging from 0-4, with the exception of questions 9 and 10 which have possible responses of 0, 2 and 4. Total scores range from 0-44, where a higher score signifies a worse outcome.

  6. Changes in functional outcomes

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

    Changes in Quality of Life questionnaire (QoL10) scores. The QoL10 consists of 10 items on a 5-point Likert scale ranging from 1-5. Total scores range from 0-50, where a higher score signifies a worse outcome.

  7. Changes in functional outcomes

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

    Changes in Work and Social Functioning (WSAS) scores. The WSAS consists of 5 items on a 9-point Likert scale ranging from 0-8. Total scores range from 0-40, where a higher score signifies a worse outcome.

Other outcomes

  1. The impact of therapeutic alliance on treatment effectiveness

    Time frame: From enrollment to the end of treatment at 24 weeks

    Changes in Working Alliance Inventory scores will be used to evaluate the interventions. The WAI consists of 16 items on a 5-point Likert scale ranging from 1-5. Total scores range from 16-80, where a higher score signifies a better alliance.

  2. In case of re-referral: number of days until re-referral

    Time frame: From end of treatment to 12 months afterwards

    Total number of days from the end of treatment until patients are re-referred to the clinics within the follow-up period

Study contacts

Contact information is provided by the study sponsor or research team.

Susie Fu, PhD, Cand. Psychol.

CONTACT

[email protected]

+4790588752

Sponsors and collaborators

Lead sponsor

Vestre Viken Hospital Trust

Other

Collaborators

  • Norwegian Center for Violence and Traumatic Stress Studies

Registry information

Official study title

Towards Evidence-based PTSD Care in Norwegian Specialist Health Services - A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2028
Study completion
2030
First posted
Nov 15, 2024
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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