Phase 2
N=126
Telehealth Therapy for Chronic Pain: Comparison of In-person vs. Video-administered ACT for Pain
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT01055639 ↗Enrolled (actual)
126
Serious AEs
0.8%
Results posted
Aug 2016
Primary outcome: Primary: Brief Pain Inventory-interference Subscale — 5.3; 5.8 units on a scale — p=0.12
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- In-Person ACT (Behavioral); Telehealth ACT (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brief Pain Inventory-interference Subscale |
5.3; 5.8 | 0.12 |
| SECONDARY Brief Pain Inventory-severity Subscale |
5.2; 5.7 | 0.04 sig |
| SECONDARY West Haven-Yale Multidimensional Pain Inventory - Activity Subscales |
2.4; 2.2 | 0.88 |
| SECONDARY SF-12 MCS |
41.5; 41.6 | 0.48 |
| SECONDARY SF-12 PCS |
32.6; 30.9 | 0.87 |
| SECONDARY Patient Health Questionnaire-9 |
9.6; 10.2 | 0.29 |
| SECONDARY Pain Anxiety Symptom Scale - 20 |
39.8; 43.5 | 0.19 |
| SECONDARY PTSD Checklist |
42.7; 42.5 | 0.53 |
| SECONDARY Pittsburgh Sleep Quality Index |
11.8; 11.8 | 1.00 |
Summary
The purpose of the study is to test a brief, individual psychosocial in-person or telehealth intervention to reduce interference of pain with daily life, emotional distress, and pain intensity, and improve quality of life and physical activity levels in individuals with chronic pain.
Eligibility Criteria
Inclusion Criteria
- Chronic non-terminal pain condition;
- Pain severity and interference rated > 4/10; and
- Pain most days (> 3/week) for at least 6 months.
Exclusion Criteria
- Current participation in group psychotherapy for pain or any type of individual psychotherapy;
- Previous treatment with ACT;
- Active suicide ideation or history of suicide attempt within 5 years;
- Serious or unstable medical or psychiatric illness or psychosocial instability that could compromise study participation; and
- The following DSM-IV diagnoses or active problems within the past 6 months noted in the patient's Computerized Patient Record System (CPRS) medical record or diagnosed during a structured psychiatric interview:
- schizophrenia;
- other psychotic disorder;
- bipolar disorder;
- organic mental disorder;
- borderline or antisocial personality disorder; or
- alcohol or substance abuse or dependence.
Data sourced from ClinicalTrials.gov (NCT01055639). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.