Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Norwegian Center for Violence and Traumatic Stress Studies | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in comorbid illnesses | 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. | From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The impact of therapeutic alliance on treatment effectiveness | 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. | From enrollment to the end of treatment at 24 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susie Fu, PhD, Cand. Psychol. | Contact | +4790588752 | susifu@vestreviken.no |
| Name | Affiliation | Role |
|---|---|---|
| Susie Fu, Ph.D, Cand. Psychol. | Vestre Viken Health trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vestre Viken Health Trust | Recruiting | Drammen | Akershus | 3004 | Norway |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Investigator will be blinded to the random allocation of patients, but will have knowledge of the interventions when treatment begins.
Not provided
|
|
| 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. |
|
|
| Changes in comorbid illnesses | 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. | From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months |
| Changes in comorbid illnesses | 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. | From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months |
| Changes in comorbid illnesses | 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. | From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months |
| Changes in comorbid illnesses | 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. | From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months |
| Changes in functional outcomes | 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. | From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months |
| Changes in functional outcomes | 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. | From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months |
| In case of re-referral: number of days until re-referral | Total number of days from the end of treatment until patients are re-referred to the clinics within the follow-up period | From end of treatment to 12 months afterwards |
| ID | Term |
|---|---|
| D003130 | Combat Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D057169 | Eye Movement Desensitization Reprocessing |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided