Trial Outcomes & Findings for Management of Chronic Pain and PTSD in Gulf War Veterans With tDCS+Prolonged Exposure (NCT NCT04236284)
NCT ID: NCT04236284
Last Updated: 2023-02-03
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Week 0
Results posted on
2023-02-03
Participant Flow
Participant milestones
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
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Overall Study
STARTED
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21
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Overall Study
Completed tDCS
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16
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Overall Study
Completed Prolonged Exposure Therapy
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14
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Overall Study
COMPLETED
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14
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Overall Study
NOT COMPLETED
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7
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Management of Chronic Pain and PTSD in Gulf War Veterans With tDCS+Prolonged Exposure
Baseline characteristics by cohort
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
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Age, Continuous
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43.3 years
STANDARD_DEVIATION 9.8 • n=5 Participants
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Sex: Female, Male
Female
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2 Participants
n=5 Participants
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Sex: Female, Male
Male
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14 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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4 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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12 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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6 Participants
n=5 Participants
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Race (NIH/OMB)
White
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8 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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2 Participants
n=5 Participants
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Region of Enrollment
United States
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16 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Week 0Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=21 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
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Feasibility of Recruitment as Assessed by Number of Participants Enrolled in the Study
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21 Participants
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PRIMARY outcome
Timeframe: Week 12Population: Data were not collected for this outcome measure due to COVID restrictions.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 12Population: Data were not collected for this outcome measure due to COVID restrictions.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 12Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
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Feasibility of Retention as Assessed by Number of Participants Who Complete at Least 8 Sessions
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16 Participants
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PRIMARY outcome
Timeframe: Week 12Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
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Feasibility of Data Collection as Assessed by Percent of Missing Data
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0 percentage of missing data
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PRIMARY outcome
Timeframe: Week 12The Charleston Psychiatric Outpatient Satisfaction Scale total score ranges from 13 to 65, with a higher score indicating higher satisfaction.
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
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Feasibility as Indicated by Satisfaction as Assessed by the Charleston Psychiatric Outpatient Satisfaction Scale
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42.48 score on a scale
Standard Deviation 4.75
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PRIMARY outcome
Timeframe: Week 12Treatment credibility will be assessed by a scale, with a total score ranging from 0 to 10, with 0 being "not credible, I did not think this treatment would help either my PTSD or Pain symptoms" to 10 being "completely credible, I was very sure this treatment would help both my PTSD and Pain symptoms."
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
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Feasibility as Indicated by Treatment Credibility as Assessed by a Credibility Scale
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8.9 score on a scale
Standard Deviation 0.85
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PRIMARY outcome
Timeframe: Week 12Treatment acceptability will be assessed by a scale, with a total score ranging from 0 to 10, with 0 being "not acceptable, this treatment should not be offered to veterans, those in pain, or those with PTSD" to 10 being "completely acceptable, this treatment is perfectly suited to veterans and others with pain and PTSD symptoms."
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
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Feasibility as Indicated by Treatment Acceptability as Assessed by an Acceptability Scale
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8.9 score on a scale
Standard Deviation 0.85
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PRIMARY outcome
Timeframe: Week 0PROMIS Pain interference 8a assesses self-reported consequences of pain on relevant aspects of one's life in the past 7 days. The measure includes 8-items rating pain from "Not at all" = 1 to "Very much" = 5, therefore the response range is 8-40 with higher scores indicating greater pain interference.
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
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Pain Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale
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31.81 score on a scale
Standard Deviation 4.05
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PRIMARY outcome
Timeframe: Week 6PROMIS Pain interference 8a assesses self-reported consequences of pain on relevant aspects of one's life in the past 7 days. The measure includes 8-items rating pain from "Not at all" = 1 to "Very much" = 5, therefore the response range is 8-40 with higher scores indicating greater pain interference.
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
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Pain Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale
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28.94 score on a scale
Standard Deviation 7.32
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PRIMARY outcome
Timeframe: Week 12PROMIS Pain interference 8a assesses self-reported consequences of pain on relevant aspects of one's life in the past 7 days. The measure includes 8-items rating pain from "Not at all" = 1 to "Very much" = 5, therefore the response range is 8-40 with higher scores indicating greater pain interference.
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
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Pain Interference as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 8a Interference Scale
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25.75 score on a scale
Standard Deviation 8.69
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PRIMARY outcome
Timeframe: Week 0PROMIS Pain intensity 3a is a self-report measure that assesses how much a person hurts (intensity or severity) in the past 7 days. The measure includes three items rating pain from "Had no pain" = 1 to "Very severe" = 5, therefore the response range is 3-15 with higher scores indicating greater pain intensity. Raw scores are reported.
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
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Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale
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11.19 score on a scale
Standard Deviation 1.76
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PRIMARY outcome
Timeframe: Week 6PROMIS Pain intensity 3a is a self-report measure that assesses how much a person hurts (intensity or severity) in the past 7 days. The measure includes three items rating pain from "Had no pain" = 1 to "Very severe" = 5, therefore the response range is 3-15 with higher scores indicating greater pain intensity. Raw scores are reported.
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
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Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale
|
10.50 score on a scale
Standard Deviation 1.86
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PRIMARY outcome
Timeframe: Week 12PROMIS Pain intensity 3a is a self-report measure that assesses how much a person hurts (intensity or severity) in the past 7 days. The measure includes three items rating pain from "Had no pain" = 1 to "Very severe" = 5, therefore the response range is 3-15 with higher scores indicating greater pain intensity. Raw scores are reported.
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
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Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain 3a Intensity Scale
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10.25 score on a scale
Standard Deviation 2.29
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PRIMARY outcome
Timeframe: Week 0Total possible scores on the CAPS-5 scale range from 0 to 80, with a higher score indicating greater PTSD intensity.
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
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PTSD Intensity as Assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5)
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38.88 score on a scale
Standard Deviation 9.01
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PRIMARY outcome
Timeframe: Week 6Total possible scores on the CAPS-5 scale range from 0 to 80, with a higher score indicating greater PTSD intensity.
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
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PTSD Intensity as Assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5)
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33.93 score on a scale
Standard Deviation 11.52
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PRIMARY outcome
Timeframe: Week 12Total possible scores on the CAPS-5 scale range from 0 to 80, with a higher score indicating greater PTSD intensity.
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
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PTSD Intensity as Assessed by the Clinician-Administered PTSD Scale 5 (CAPS-5)
|
28.19 score on a scale
Standard Deviation 14.05
|
SECONDARY outcome
Timeframe: Week 0PCL-5 score ranges from 0 to 80, with a higher score indicating greater PTSD.
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
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PTSD as Assessed by the PTSD Checklist-5 (PCL-5)
|
57.69 score on a scale
Standard Deviation 12.67
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SECONDARY outcome
Timeframe: Week 6PCL-5 score ranges from 0 to 80, with a higher score indicating greater PTSD.
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
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PTSD as Assessed by the PTSD Checklist-5 (PCL-5)
|
51.23 score on a scale
Standard Deviation 14.20
|
SECONDARY outcome
Timeframe: Week 12PCL-5 score ranges from 0 to 80, with a higher score indicating greater PTSD.
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
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|---|---|
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PTSD as Assessed by the PTSD Checklist-5 (PCL-5)
|
38.33 score on a scale
Standard Deviation 20.61
|
SECONDARY outcome
Timeframe: Week 0The PHQ-9 score ranges from 0 to 27, with a higher score indicating greater depression.
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
|
|---|---|
|
Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9)
|
17.75 score on a scale
Standard Deviation 4.77
|
SECONDARY outcome
Timeframe: Week 6The PHQ-9 score ranges from 0 to 27, with a higher score indicating greater depression.
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
|
|---|---|
|
Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9)
|
17.31 score on a scale
Standard Deviation 4.96
|
SECONDARY outcome
Timeframe: Week 12The PHQ-9 score ranges from 0 to 27, with a higher score indicating greater depression.
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
|
|---|---|
|
Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9)
|
13.47 score on a scale
Standard Deviation 6.37
|
SECONDARY outcome
Timeframe: Week 0There are 4 domains on the WHOQOL-BREF, listed below, and for all domains a higher score indicates a greater quality of life. * physical health domain (7 items) - total score ranges from 7 to 35 * psychological health domain (6 items) - total score ranges from 6 to 30 * social relationships domain (3 items) 3 - total score ranges from 3 to 15 * environmental health domain (8 items) - total score ranges 8 to 40
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
|
|---|---|
|
Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)
physical health domain
|
19.25 score on a scale
Standard Deviation 2.67
|
|
Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)
psychological health domain
|
15.33 score on a scale
Standard Deviation 4.29
|
|
Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)
social relationships domain
|
6.50 score on a scale
Standard Deviation 2.91
|
|
Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)
environmental health domain
|
25.18 score on a scale
Standard Deviation 5.47
|
SECONDARY outcome
Timeframe: Week 6Population: Data were not collected for this outcome measure.
There are 4 domains on the WHOQOL-BREF, listed below, and for all domains a higher score indicates a greater quality of life. * physical health domain (7 items) - total score ranges from 7 to 35 * psychological health domain (6 items) - total score ranges from 6 to 30 * social relationships domain (3 items) 3 - total score ranges from 3 to 15 * environmental health domain (8 items) - total score ranges 8 to 40
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12There are 4 domains on the WHOQOL-BREF, listed below, and for all domains a higher score indicates a greater quality of life. * physical health domain (7 items) - total score ranges from 7 to 35 * psychological health domain (6 items) - total score ranges from 6 to 30 * social relationships domain (3 items) 3 - total score ranges from 3 to 15 * environmental health domain (8 items) - total score ranges 8 to 40
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
|
|---|---|
|
Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)
physical health domain
|
20.50 score on a scale
Standard Deviation 3.03
|
|
Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)
psychological health domain
|
16.83 score on a scale
Standard Deviation 3.16
|
|
Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)
social relationships domain
|
8.00 score on a scale
Standard Deviation 3.38
|
|
Quality of Life as Assessed by the World Health Organization Quality of Life - Short Form (WHOQOL-BREF)
environmental health domain
|
27.64 score on a scale
Standard Deviation 5.45
|
SECONDARY outcome
Timeframe: Week 0There are 13 subscales of the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI), with each subscale ranging in score from 0 to 6, with a higher score indicating a greater degree of the domain assessed by the subscale.
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
|
|---|---|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Pain Interference
|
4.73 score on a scale
Standard Deviation 0.80
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Support
|
4.21 score on a scale
Standard Deviation 1.70
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Pain Severity
|
4.54 score on a scale
Standard Deviation 0.83
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Perception of Control
|
3.31 score on a scale
Standard Deviation 1.16
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Affective Distress
|
4.21 score on a scale
Standard Deviation 0.91
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Negative Responses
|
2.50 score on a scale
Standard Deviation 1.34
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Solicitous Responses
|
2.42 score on a scale
Standard Deviation 1.36
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Distracting Responses
|
2.38 score on a scale
Standard Deviation 1.72
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Household Chores
|
3.10 score on a scale
Standard Deviation 1.65
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Outdoor Work
|
2.03 score on a scale
Standard Deviation 1.58
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Activities away from Home
|
2.00 score on a scale
Standard Deviation 0.90
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Social Activities
|
2.13 score on a scale
Standard Deviation 0.99
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
General Activity
|
2.34 score on a scale
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: Week 6Population: Data were not collected for this outcome measure.
There are 13 subscales of the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI), with each subscale ranging in score from 0 to 6, with a higher score indicating a greater degree of the domain assessed by the subscale.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12There are 13 subscales of the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI), with each subscale ranging in score from 0 to 6, with a higher score indicating a greater degree of the domain assessed by the subscale.
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
|
|---|---|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Pain Interference
|
4.09 score on a scale
Standard Deviation 1.34
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Support
|
3.75 score on a scale
Standard Deviation 1.35
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Pain Severity
|
3.75 score on a scale
Standard Deviation 0.94
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Perception of Control
|
3.31 score on a scale
Standard Deviation 1.46
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Affective Distress
|
3.50 score on a scale
Standard Deviation 0.73
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Negative Responses
|
2.81 score on a scale
Standard Deviation 1.27
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Solicitous Responses
|
3.17 score on a scale
Standard Deviation 0.97
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Distracting Responses
|
3.25 score on a scale
Standard Deviation 1.69
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Household Chores
|
2.68 score on a scale
Standard Deviation 1.44
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Outdoor Work
|
2.53 score on a scale
Standard Deviation 1.52
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Activities away from Home
|
2.47 score on a scale
Standard Deviation 1.52
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
Social Activities
|
2.47 score on a scale
Standard Deviation 1.36
|
|
Pain as Assessed by the West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI)
General Activity
|
2.54 score on a scale
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: Week 0Total score ranges from 17 - 68. A score of 17 is the lowest possible score, and indicates no kinesiophobia (that is, fear of pain with movement) or negligible kinesiophobia. A score of 68 is the highest possible score and indicates extreme kinesiophobia.
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
|
|---|---|
|
Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia-Revised (TSK-R)
|
46.64 score on a scale
Standard Deviation 9.43
|
SECONDARY outcome
Timeframe: Week 6Population: Data were not collected for this outcome measure.
Total score ranges from 17 - 68. A score of 17 is the lowest possible score, and indicates no kinesiophobia (that is, fear of pain with movement) or negligible kinesiophobia. A score of 68 is the highest possible score and indicates extreme kinesiophobia.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Total score ranges from 17 - 68. A score of 17 is the lowest possible score, and indicates no kinesiophobia (that is, fear of pain with movement) or negligible kinesiophobia. A score of 68 is the highest possible score and indicates extreme kinesiophobia.
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
|
|---|---|
|
Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia-Revised (TSK-R)
|
46.46 score on a scale
Standard Deviation 11.78
|
SECONDARY outcome
Timeframe: Week 0Total scores ranges from 0 to 52, with a higher score indicating greater Pain Catastrophizing.
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
|
|---|---|
|
Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)
|
33.42 score on a scale
Standard Deviation 11.27
|
SECONDARY outcome
Timeframe: Week 6Population: Data were not collected for this outcome measure.
Total scores ranges from 0 to 52, with a higher score indicating greater Pain Catastrophizing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Total scores ranges from 0 to 52, with a higher score indicating greater Pain Catastrophizing.
Outcome measures
| Measure |
Home-based tDCS + Prolonged Exposure Therapy
n=16 Participants
Home-based tDCS: tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 \_ 7 cm saline-soaked surface sponge electrodes.
Prolonged Exposure Therapy: Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
|
|---|---|
|
Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS)
|
29.42 score on a scale
Standard Deviation 15.03
|
SECONDARY outcome
Timeframe: Week 0Population: Data were not collected for this outcome measure due to COVID restrictions.
Salivary levels of the biomarker panel (cortisol, substance P, DHEA, IL-1, and IL-6) using enzyme-linked immunosorbent assays (ELISA).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 6Population: Data were not collected for this outcome measure due to COVID restrictions.
Salivary levels of the biomarker panel (cortisol, substance P, DHEA, IL-1, and IL-6) using enzyme-linked immunosorbent assays (ELISA).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: Data were not collected for this outcome measure due to COVID restrictions.
Salivary levels of the biomarker panel (cortisol, substance P, DHEA, IL-1, and IL-6) using enzyme-linked immunosorbent assays (ELISA).
Outcome measures
Outcome data not reported
Adverse Events
Home-based tDCS + Prolonged Exposure Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Melba Hernandez Tejada, PhD, DHA
The University of Texas Health Science Center at Houston
Phone: 7134862729
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place