Clinical trial NCT05598099: Concentrated Exposure Therapy for Post-traumatic Stress Disorder - a Cohort Study
Official title: Concentrated Exposure Therapy for Post-traumatic Stress Disorder - a Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PTSD
Keywords: CBT
CAPS
Group therapy
Psychotherapy
Treatment satisfaction
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2022-10-28
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with PTSD recruited from clinics and popular media referred to Clinic for 4-Day Treatment at Haukeland University Hospital, Bergen, Norway

Brief summary: Post-traumatic stress disorder (PTSD) is a prevalent and disabling condition. Trauma-focused psychotherapy, including cognitive behavioural therapy (CBT), are among the recommended first-line treatment alternatives. However, a substantial proportion of patients decline, drop-out or do not respond to current psychotherapies. Previous research suggests that intensive or concentrated formats of trauma-focused psychotherapy can lead to faster recover and lower attrition, but there are currently few studies of these approaches. The current study will investigate the acceptability. treatment satisfaction and preliminary changes in symptoms after four consecutive days of concentrated CBT for PTSD.

Detailed description: The study will investigate the research questions in three stages. In the first stage four patients will be treated individually. In the second stage two groups of four patients will be treated, with at least a 1:1 ratio between therapists and patients per group. In the third stage 30 patients will be treated in groups of about four patients per group, with at least a 1:1 ratio between therapists and patients per group. The primary outcome measure is changes in PTSD-related symptoms as measured using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Acceptability will be measured as the proportion of patients accepting treatment when offered, while attrition is measured as the proportion of patients that withdraw from treatment after it has started. Several other measures will be collected to measure treatment satisfaction, related symptoms, and functional impairment.

Eligibility criteria: Inclusion Criteria:

* fulfills DSM-5 criteria for PTSD
* One or more single traumas in adolescence or adulthood
* Speaks and writes Norwegian

Exclusion Criteria:

* New or unstable psychopharmacological treatment within last four weeks
* fulfills ICD-11 criteria for complex PTSD
* Ongoing substance abuse
* Ongoing danger of suicide
* Ongoing borderline personality disorder
* Ongoing psychosis
* Intellectual disability

Primary outcomes:
measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: Change in scores from before treatment to one week after treatment
measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: Change in scores from one week after treatment to three months after treatment
measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: Change in scores from three months after treatment to twelve months after treatment
Secondary outcomes:
measure: Client Satisfaction Questionnaire 8 (CSQ-8)
timeFrame: One week after treatment
measure: Client Satisfaction Questionnaire 8 (CSQ-8)
timeFrame: Three months after treatment
measure: Client Satisfaction Questionnaire 8 (CSQ-8)
timeFrame: Twelve months after treatment
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
state: Vestland
Study officials:
affiliation: Haukeland University Hospital
name: Anders L Thorsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: