Clinical trial NCT03975075: Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury
Official title: Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Anxiety
Stress
Tetraplegia
Lead sponsor: Craig Hospital
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to test the feasibility of an intervention using biofeedback to treat stress and anxiety among individuals with tetraplegia.

The expected duration of participation in this study is about 5 hours over the course of about 5 weeks. Participants will be randomly assigned to either a biofeedback training intervention or a control group. After completing questionnaires, participants will undergo physiological monitoring for the purpose of measuring heart rate and breathing. Those assigned to the biofeedback group will undergo 20 minutes of physiological monitoring while also participating in biofeedback training twice a week for 4 weeks (8 sessions) from home. Those assigned to the control group will undergo 20 minutes of physiological monitoring twice a week for 4 weeks (8 sessions) from home, but will not receive biofeedback training. Each session is expected to last 30 minutes to allow for completion of questionnaires over the the phone prior to and following each training session.

It is hypothesized that the biofeedback intervention will demonstrate high feasibility and compared to those in the control group, participants who receive the biofeedback intervention will attain greater pre-post reductions in both physiological and self-reported stress.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 65
* Diagnosis of tetraplegia with residual sensory or motor impairments
* Discharged from inpatient rehabilitation and living in the community
* Access to high-speed internet at home
* Willingness to download the videoconferencing software Zoom
* Access to a mobile phone and willingness to download HRV software

Exclusion Criteria:

* Does not speak English
* Scores less than 37 on the STAI
* Unable to travel to Craig for an initial assessment
* History of participating in biofeedback training
* Requires mechanical ventilation
* Dependent on diaphragm pacer for respiration
* Currently in treatment for anxiety (e.g., pharmacologic or psychotherapeutic)
* Associated medical condition for which biofeedback is contraindicated (e.g., psychosis, pacemaker, or other implantable electric device)
* Currently hospitalized for medical/rehabilitation treatment
* Unable to commit to the four-week intervention

Primary outcomes:
measure: Change in physiological stress
timeFrame: Session #1 (week 1) and Session #8 (week 4)
measure: Change in Depression Anxiety Stress Scale-21 (DASS-21) scores
timeFrame: Baseline (week 0) and Session #8 (week 4)
measure: Change in Subjective Units of Distress Scale (SUDS) scores
timeFrame: Baseline (week 0) and Session #8 (week 4)
Secondary outcomes:
measure: Symptom list
timeFrame: After intervention session #1 (week 1), before and after intervention sessions #2-8 (weeks 1 through 4)
measure: State Trait Anxiety Inventory (STAI)
timeFrame: After intervention sessions #1-8 (weeks 1 through 4)
Other outcomes:
measure: Brief Pain Inventory (BPI) - 4 pain severity items
timeFrame: Baseline (week 0) and Session #8 (week 4)
measure: Brief Pain Inventory (BPI) - current pain severity item
timeFrame: Before and after intervention Sessions #1-7 (weeks 1 - 3)
measure: Brief Pain Inventory (BPI) - pain relief item
timeFrame: After each intervention Session #1-8 (weeks 1 - 4)
measure: Impact of study participation
timeFrame: Session #8 (week 4)
Locations:
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
Study officials:
References: