Demystifying the virtualization process: A call for standard reporting of virtual modifications to evidence-based psychotherapies, using the FRAME model.

The sudden onset of the coronavirus disease led to a rapid expansion of video telehealth to deliver mental healthcare. Although video telehealth was not a new clinical practice, there was limited guidance on how best to modify evidence-based psychotherapies (EBPs) for virtual delivery (a process also referred to as virtualization). The virtualization process for EBPs remains unclear as newly emerging reports on this topic do not consistently report modification decisions. This commentary calls attention to the need to improve documentation practices to allow a greater understanding of modifications needed to maximize the positive effects of EBPs transported to a virtual format. We used the Framework for Reporting Adaptations and Modifications-Expanded (FRAME) to capture details about the nature, process, and outcomes of intervention modifications across a given clinical setting or population. To illustrate the use of the FRAME, we present a case example describing our experiences with transporting a 1-day in-person Acceptance and Commitment Therapy group workshop to a virtual format. Workshop modifications primarily involved changes to the delivery format, administration procedures, and content. The case example walks through how, why, and by whom specific modifications were made as well as the degree to which fidelity was maintained. In the wake of the telemedicine revolution, further investigation into the virtualization process for EBPs is warranted. Improving reporting practices by using the FRAME or a similar adaptation framework will promote a more rigorous study of virtual modifications to EBPs that inform future guidelines and best practices.

Video telehealth rapidly expanded during COVID-19 as a preferred method for delivering mental health treatment. The sudden, unexpected onset of the pandemic left healthcare systems and individual clinicians little time to shift their services to this virtual format. In addition, there was and remains limited information on the most effective ways to modify evidence-based psychotherapies for virtual delivery (a process known as virtualization). To fill this knowledge gap, this commentary calls for improved documentation and evaluation of the virtualization process. We provide a case example demonstrating how to use the Framework for Reporting Adaptations and Modifications-Expanded­a comprehensive system to detail the nature and process of treatment modifications within a given context. Routine use of this or similar adaptation models within the field of behavioral and social sciences will provide a better understanding of changes needed to ensure the continuity and integrity of evidence-based psychotherapies modified for video telehealth delivery.

Item Response Theory Analysis: PROMIS® Anxiety Form and Generalized Anxiety Disorder Scale.

Little research has compared item functioning of the Patient-Reported Outcomes Measurement Information System (PROMIS®) anxiety short form 6a and the generalized anxiety disorder 7-item scale using item response theory models. This was a secondary analysis of self-reported assessments from 67 at-risk U.S. military veterans. The two measures performed comparably well with data fitting adequately to models, acceptable item discriminations, and item and test information curves being unimodal and symmetric. The PROMIS® anxiety short form 6a performed better in that item difficulty estimates had a wider range and distributed more evenly and all response categories had less floor effect, while the third category in most items of the generalized anxiety disorder 7-item scale were rarely used. While both measures may be appropriate, findings provided preliminary information supporting use of the PROMIS® anxiety short form 6a as potentially preferable, especially for veterans with low-to-moderate anxiety. Further testing is needed in larger, more diverse samples.

One-day Acceptance and Commitment Therapy workshop for preventing persistent post-surgical pain and dysfunction in at-risk veterans: A randomized controlled trial protocol.

OBJECTIVE: Persistent post-surgical pain is common among patients undergoing surgery, is detrimental to patients' quality of life, and can precipitate long-term opioid use. The purpose of this randomized controlled trial is to assess the effects of a behavioral intervention offered prior to surgery for patients at risk for poor post-surgical outcomes, including persistent pain and impaired functioning. METHODS: Described herein is an ongoing randomized, patient- and assessor-blind, attention-controlled multisite clinical trial. Four hundred and thirty Veterans indicated for total knee arthroplasty (TKA) with distress and/or pain will be recruited for this study. Participants will be randomly assigned to a one-day (~5 h) Acceptance and Commitment Therapy workshop or one-day education and attention control workshop. Approximately two weeks following their TKA surgery, patients receive an individualized booster session via phone. Following their TKA, patients complete assessments at 1 week, 6 weeks, 3 months, and 6 months. RESULTS: The primary outcomes are pain intensity and knee-specific functioning; secondary outcomes are symptoms of distress and coping skills. Mediation analyses will examine whether changes in symptoms of distress and coping skills have an impact on pain and functioning at 6 months in Veterans receiving ACT. This study is conducted mostly with older Veterans; therefore, results may not generalize to women and younger adults who are underrepresented in this veteran population. CONCLUSIONS: The results of this study will provide the first evidence from a large-scale, patient- and assessor-blind controlled trial on the effectiveness of a brief behavioral intervention for the prevention of persistent post-surgical pain and dysfunction.

Patient-Reported Outcomes Measurement Information System (PROMIS) Instruments: Reliability and Validity in Veterans Following Orthopedic Surgery.

The patient-reported outcomes measurement information system (PROMIS) offers standardized assessment measures of clinically relevant patient-reported outcomes. This study evaluated the reliability and validity of select PROMIS measures with U.S. military veterans following orthopedic surgery. Data for the current study were collected as part of a pilot randomized control trial assessing the efficacy of a 1-day Acceptance and Commitment Therapy workshop on persistent postsurgical pain in at-risk veterans undergoing orthopedic surgery. Sixty-seven participants completed surveys 3 months after surgery. Participants completed the following PROMIS instruments: PROMIS Anxiety Short Form 8a, PROMIS Depression Short Form 8b, and PROMIS Pain Interference Short Form 8a. PROMIS measures were compared to the Generalized Anxiety Disorder 7-Item Scale, the Patient Health Questionnaire 9-Item Scale, and the Brief Pain Inventory Pain Interference subscale, respectively. All three PROMIS measures demonstrated excellent internal consistency (Cronbach's αs ranged from .93 to .96) and each loaded onto a single factor. The PROMIS measures were moderately correlated with their respective comparison measures (r = .69 to .76). The PROMIS anxiety and PROMIS depression measures were highly correlated to one another (r = .91). Findings highlight the potential utility of these PROMIS measures in veterans following orthopedic surgery and the overlap between the PROMIS depression and anxiety measures in this sample.

Transcutaneous Electrical Nerve Stimulation Reduces Movement-Evoked Pain and Fatigue: A Randomized, Controlled Trial.

OBJECTIVE: Fibromyalgia (FM) is characterized by pain and fatigue, particularly during physical activity. Transcutaneous electrical nerve stimulation (TENS) activates endogenous pain inhibitory mechanisms. This study was undertaken to investigate if using TENS during activity would improve movement-evoked pain and other patient-reported outcomes in women with FM. METHODS: Participants were randomly assigned to receive active TENS (n = 103), placebo TENS (n = 99), or no TENS (n = 99) and instructed to use it at home during activity 2 hours each day for 4 weeks. TENS was applied to the lumbar and cervicothoracic regions using a modulated frequency (2-125 Hz) at the highest tolerable intensity. Participants rated movement-evoked pain (primary outcome measure) and fatigue on an 11-point scale before and during application of TENS. The primary outcome measure and secondary patient-reported outcomes were assessed at baseline (time of randomization) and at 4 weeks. RESULTS: After 4 weeks, a greater reduction in movement-evoked pain was reported in the active TENS group versus the placebo TENS group (group mean difference -1.0 [95% confidence interval -1.8, -0.2]; P = 0.008) and versus the no TENS group (group mean difference -1.8 [95% confidence interval -2.6, -1.0]; P < 0.0001). A reduction in movement-evoked fatigue was also reported in the active TENS group versus the placebo TENS group (group mean difference -1.4 [95% confidence interval -2.4, -0.4]; P = 0.001) and versus the no TENS group (group mean difference -1.9 [95% confidence interval -2.9, -0.9]; P = <0.0001). A greater percentage of the patients in the active TENS group reported improvement on the global impression of change compared to the placebo TENS group (70% versus 31%; P < 0.0001) and the no TENS group (9%; P < 0.0001). There were no TENS-related serious adverse events, and <5% of participants experienced minor adverse events from TENS. CONCLUSION: Among women who had FM and were on a stable medication regimen, 4 weeks of active TENS use compared to placebo TENS or no TENS resulted in a significant improvement in movement-evoked pain and other clinical outcomes. Further research is needed to examine effectiveness in a real-world setting to establish the clinical importance of these findings.

Acceptance and Commitment Therapy for Prevention of Chronic Postsurgical Pain and Opioid Use in At-Risk Veterans: A Pilot Randomized Controlled Study.

High levels of pain, significant anxiety, or depressive symptoms before surgery put patients at elevated risk for chronic pain and prolonged opioid use following surgery. The purpose of this preliminary study was to assess the efficacy of a 1-day Acceptance and Commitment Therapy (ACT) workshop in "at-risk" veterans for the prevention of chronic pain and opioid use following orthopedic surgery. In a randomized controlled trial, 88 at-risk veterans undergoing orthopedic surgery were assigned to treatment as usual (TAU; n = 44) or TAU plus a 1-day ACT workshop (n = 44). Pain levels and opioid use were assessed up to 3 months following surgery. Pain acceptance and values-based behavior were assessed at baseline and 3-month follow-up. Participants who completed the ACT workshop reached pain and opioid cessation sooner than those in TAU. Postoperative complications exhibited a moderating effect on these outcomes, such that the effects of ACT were greater in patients without complications. Increases in pain acceptance and values-based behavior, processes targeted in ACT, were related to better outcomes. These promising results merit further investigation in a larger clinical trial. Providing an intervention before surgery for at-risk veterans has the potential to change clinical practice from a focus on management of postoperative pain to prevention of chronic pain in at-risk individuals. PERSPECTIVE: This pilot study compared the effects of a 1-day preventive behavioral intervention (ACT) to TAU in at-risk veterans undergoing orthopedic surgery. Three months following the intervention, veterans receiving ACT exhibited quicker cessation of pain and opioid use. Focusing on preoperative pain management may help prevent chronic postsurgical pain.

Relationships among pain intensity, pain-related distress, and psychological distress in pre-surgical total knee arthroplasty patients: a secondary analysis.

The current study aimed to examine the relationships between movement and resting pain intensity, pain-related distress, and psychological distress in participants scheduled for total knee arthroplasty (TKA). This study examined the impact of anxiety, depression, and pain catastrophizing on the relationship between pain intensity and pain-related distress. Data analyzed for the current study (N = 346) were collected at baseline as part of a larger Randomized Controlled Trial investigating the efficacy of TENS for TKA (TANK Study). Participants provided demographic information, pain intensity and pain-related distress, and completed validated measures of depression, anxiety, and pain catastrophizing. Only 58% of the sample reported resting pain >0 while 92% of the sample reported movement pain >0. Both movement and resting pain intensity correlated significantly with distress (rs = .86, p < .01 and .79, p < .01, respectively). About three quarters to two thirds of the sample (78% for resting pain and 65% for movement pain) reported different pain intensity and pain-related distress. Both pain intensity and pain-related distress demonstrated significant relationships with anxiety, depression, and catastrophizing. Of participants reporting pain, those reporting higher anxiety reported higher levels of distress compared to pain intensity. These findings suggest that anxious patients may be particularly distressed by movement pain preceding TKA. Future research is needed to investigate the utility of brief psychological interventions for pre-surgical TKA patients.

Transcutaneous electrical nerve stimulation for the control of pain during rehabilitation after total knee arthroplasty: A randomized, blinded, placebo-controlled trial.

This study evaluated the efficacy of transcutaneous electrical nerve stimulation (TENS) in reducing pain and hyperalgesia and increasing function after total knee arthroplasty (TKA). We hypothesized that participants using TENS during rehabilitation exercises would report significantly lower pain during range-of-motion (ROM) activity and fast walking but not at rest, would have less hyperalgesia, and would have better function than participants receiving placebo-TENS or standard care. We also hypothesized that change in ROM pain would differ based on psychological characteristics (trait anxiety, pain catastrophizing, and depression) and treatment group. This prospective, randomized study used intent-to-treat analyses in 317 participants after primary, unilateral TKA. Assessors, blinded to treatment allocation, measured pain, function (ROM and gait speed), and hyperalgesia (quantitative sensory tests) postoperatively and 6 weeks after surgery. Analgesic intake, anxiety, depression, and pain catastrophizing were also assessed. TENS participants used it 1 to 2 times per day at 42 mA (on average) and had less pain postoperatively during active knee extension (P=.019) and fast walking (P=.006) than standard care participants. TENS and placebo-TENS were not significantly different. TENS participants who scored low on anxiety and pain catastrophizing had a greater reduction in ROM pain at 6 weeks than those who scored high on these factors (P=.002 and P=.03). Both TENS and placebo-TENS participants had less postoperative mechanical hyperalgesia (P=.03-.01) than standard care participants. Supplementing pharmacologic analgesia with TENS during rehabilitation exercises reduces movement pain postoperatively, but a placebo influence exists and the effect is gone by 6 weeks. Patients with low anxiety and pain catastrophizing may benefit most from TENS.