Treatment-resistant post traumatic stress disorder Mental and Behavioural Disorders Post-traumatic stress disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 or over 2. Informed consent 3. Meet DSM529 criteria for combat-related PTSD 4. Treatment resistance, defined as prior receipt of a trauma focused psychological treatment without loss of PTSD diagnosis
Exclusion criteria
Exclusion criteria: 1. Psychosis 2. DSM5 severe major depressive episode 3. Substance dependence 4. Change in psychotropic medication within 1 month 5. Suicidal intent 6. Inability to walk at a normal pace for 30-45 minutes on a treadmill
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms of PTSD, measured using the Clinician Administered PTSD Scale for DSM5 (CAPS5) at baseline, 12 and 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Traumatic stress, measured using the Impact of Event Scale – revised 2. Quality of life/functional impairment, measured using the Work and Social Adjustment Scale 3. Depression, measured using the Patient Health Questionnaire-9 (PHQ-9) 4. Anxiety, measured using General Anxiety Disorder-7 (GAD-7) 5. Alcohol use, measured using AUDIT-O36 6. Changes in sleep, measured using the insomnia severity index (ISI) 7. Perceived social support, measured using the Multidimensional Scale for Perceived Social Support 8. Health-related quality of life, measured using the EQ5D-5L All measured at baseline, 12 and 26 weeks | — |
Countries
United Kingdom, Wales