Post Traumatic Stress Disorder
Conditions
Keywords
Treatment, Brief intervention, Randomized controlled trial, Study Protocol
Brief summary
The purpose of this study is to investigate if a novel brief intervention for Posttraumatic stress disorder (PTSD) is comparable to other traditional clinical interventions for symptom reduction.
Detailed description
Background: Although existing treatment methods are effective in alleviating PTSD symptoms, several barriers to care exist, such as waiting lines, avoidant tendencies, shame and stigma, potentially leading to fewer people seeking therapy or premature dropouts. A potential solution to battling these barriers is Brain Working Recursive Therapy (BWRT), a single-session intervention for PTSD. Although not yet subjected to empirical investigation, clinical experiences suggest an often immediate and long-lasting effect following the intervention related to patient's symptomatology and functional abilities. Methods: The current study protocol outlines a plan to conduct the first non-inferiority randomized controlled trial aimed to explore the efficacy of BWRT compared to treatment as usual (TAU). Eighty-two participants will be allocated at a 1:1 ratio to one of the following treatment conditions: (1) BWRT or (2) treatment as usual. Participants will be compared on several variables, including changes in PTSD symptoms (primary objective), and changes in perceived quality of life, rumination, functional and cognitive ability (secondary objective). Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3). Discussion: Should BWRT prove to be non-inferior to treatment as usual, this brief intervention may be an important contribution to future psychological treatment for PTSD, by making trauma treatment more accessible and battling current barriers to care.
Interventions
BEHAVIORALBrainWorking Recursive Therapy
one session therapy
BEHAVIORALTreatment as usual
evidence-based therapy
Sponsors
University of Bergen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants must have experienced at least one traumatic experience throughout their lifetime * Participants must meet the DSM-5 criteria for PTSD, or subthreshold PTSD * The following DSM-5 criteria must be fulfilled: * A (exposure to traumatic stressor), * in addition to three out of four of the following symptom-clusters; * B (intrusion), * C (avoidance), * D (negative alterations in cognitions and mood), * E (alterations in arousal and reactivity) * A marked decline in functioning and symptom persistence for over a month
Exclusion criteria
* ongoing psychotic disorders, or a history of psychosis, * severe suicidal ideation, * bipolar disorder, * BMI index too low to benefit from psychological interventions, * severe alcohol or substance dependence, * serious somatic illness or brain damage, * participation in concurrent psychotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3). | Changes in PTSD symptoms A total severity score for PTSD symptoms will established based on the summed severity of each symptom, with scores ranging from 0-80. Higher score defines higher severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Satisfaction with Life Scale (SWLS) | Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3). | Changes in perceived quality of life, A 5-item scale designed to measure global cognitive judgments of one's life satisfaction (high scores indicates high satisfaction). Range 5-35 |
| Ruminative Responses Scale (RRS) | Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3). | Rumination. The scale consists of 22 statements related to ruminative tendencies, using a 4-point Likert scale to indicate frequency of different types of ruminative thinking, with responses ranging from 1 (almost never) to 4 (almost always). Range 0-88. High scores indicate high rumination |
| Work and Social Adjustment Scale (WSAS) | Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3). | The WSAS assesses participants' self-reported degree of impairment related to five domains of functioning (ability to work, home management, social leisure activities, private leisure activities, close relationships), consisting of one statement related to each domain, with a response scale indicating perceived impairment on a scale from 0 (not at all) to 8 (very severely) Range 0-40. 0-9= low impairment, 10-19 =moderate impairment, 20-40= severe impairment. |
| Perceived Deficits Questionnaire-Depression, 5-item (PDQ-D5) | Data collection will take place baseline (T1), three weeks post treatment (T2) and at 6-month follow-up (T3). | The PDQ-D5 is a 5-item questionnaire, assessing the presence of problems related to memory, attention and concentration during the past week. The PDQ-D5 uses a 5-point Likert scale, with answers ranging from 0 (never in the past 7 days) to 4 (very often \[more than once a day\]) High scores indicate high impairment in cognitive functioning. Range 0- 20. |
Countries
Norway
Contacts
PRINCIPAL_INVESTIGATORÅsa Hammar, PhD
University of Bergen
Outcome results
None listed