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A two-arm randomized pilot of standard neurofeedback and a waiting list for patients with treatment resistent PTSD.
This study will be a randomized-controlled pilot and in a later study virtual reality based neurofeedback will be tested. In this study 30 subjects will be randomised into one of two arms of the study. Treatment as usual (TAU) entails both psychotherapy, medication and other interventions.
The 30 participants will be randomized to one arm of the study (15 participants per group). The subjects will be recruited from Psychiatric Outpatient Care at Sahlgrenska University Hospital, Crisis and Trauma Center Gothenburg and Psychiatric Care Center in Tranås, Jönköping.
Participants in the experimental group will have 24 sessions in total, (twice a week. 12 week period) with a trained neurofeedback specialist or trained neurofeedback physician. Before session 1 and after session 24, a clinician will fill in the clinical scales and questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurofeedback | Experimental | 24 sessions of ca 45 minutes neurofeedback using alpha-theta protocol. |
|
| Waiting list | No Intervention | Those assigned to waiting list will be able to pick one of the two interventions at the end of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurofeedback | Device | A device that assists in training patients in relaxing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Administered PTSD Scale (CAPS) | An interview based scale of symptoms of PTSD | Through study completion, an average of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Event Scale - Revised (IES-R) | IES-R is a self-assessment scale that measures the degree to which one has been affected by post-traumatic stress reactions during the last 7 days. | Through study completion, an average of 3 months |
| Impact of Event Scale - Revised (IES-R) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steinn Steingrimsson, PhD | Contact | 0046313421000 | steinn.steingrimsson@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Steinn Steingrimsson, PhD | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Recruiting | Gothenburg | Västra Götaland County | Sweden |
This will be discussed if the occasion arises in order to follow GDPR and ethical rules.
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D058765 | Neurofeedback |
| D001676 | Biofeedback, Psychology |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
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Allocation is to one of two arms
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Statistical analysis will be done seperately
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IES-R is a self-assessment scale that measures the degree to which one has been affected by post-traumatic stress reactions during the last 7 days. |
| 4 weeks after finished intervention for the two intervention arms. |
| Visual Analogue Scale for Wellbeing (VAS-W) | The measurement is a 10 point scale ranging from 1-10 with a visual representation (a sad face at 1 and happy face at 10) asking "How are you feeling right now". | Before and after each session 1-24 for the two intervention arms. |
| Insomnia Severity Index (ISI) | The scale consists of 7 items where participants can score their sleep quality and frequency on a scale from 0-4. 0 being no problems while 4 meaning significant problems. The score ranges from 0-28. | Through study completion, an average of 3 months |
| Insomnia Severity Index (ISI) | The scale consists of 7 items where participants can score their sleep quality and frequency on a scale from 0-4. 0 being no problems while 4 meaning significant problems. The score ranges from 0-28. | 4 weeks after finished intervention for the two intervention arms. |
| Wisconsin Card Sorting Test (WCST) | A cognitive test measuring attention, vigilance and memory. | Through study completion, an average of 3 months |
| Wisconsin Card Sorting Test (WCST) | A cognitive test measuring attention, vigilance and memory. | 4 weeks after finished intervention, an average of 4 months |
| Clinician Administered PTSD Scale (CAPS) | An interview based scale of symptoms of PTSD | For those that have finished the intervention CAPS at one month post treatment |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |