This single-arm trial funded by the National Institute on Aging/National Institutes of Health (R00AG052642) will examine the feasibility and acceptability of a psychological resilience intervention for 50 older adults (ages >60 years) with cLBP. The intervention will include 7 weekly group sessions (1.5 hours each) targeting content adapted from traditional cognitive-behavioral therapy for pain (CBT), acceptance and commitment therapy (ACT), and positive psychology concepts focused primarily on increasing positive affect, pain acceptance, hope, and self-efficacy. Data will be collected at baseline, on completion of the 7-week treatment, and at 3 months post-treatment. If the trial is found to be feasible, the study findings will inform the design of the full-scale randomized clinical trial. The flow of procedures has been outlined in Figure 1.
The primary aims of this trial are to examine the acceptability of the intervention, the feasibility of recruitment and adherence to the intervention, and preliminary treatment effects. We operationalized the concepts of acceptability, feasibility, and efficacy as follows:
Specific Aim 1:Evaluate the acceptability of the intervention, as indicated by treatment engagement and participant reported treatment credibility and satisfaction.
Specific Aim 2:Assess intervention feasibility, including the ability to meet recruitment and retention metrics, and the feasibility of questionnaire and home activity completion.
Exploratory Aim:Determine the extent to which intervention-related improvements in pain intensity, pain interference, negative mood, and quality of life are predicted by changes in four primary mechanism variables: positive affect, pain acceptance, hope, and pain self-efficacy.
Study setting and recruitment
This single-site study will be conducted at the University of Florida (UF) in Gainesville, FL, USA. Sessions will be held in a large conference room with comfortable seating and access to whiteboards and a computer screen for demonstration of key intervention concepts and activities. Participants will be offered snacks and beverages during sessions and provided a parking voucher upon their departure. Participants will be recruited via a variety of clinic and community-based resources throughout the larger Gainesville, FL community including provider referral, study flyers, radio and newspaper advertisement, and social media. We will also recruit via targeted mailings to individuals in our UF Pain Research and Intervention Center of Excellence (PRICE) registry (i.e., registry of >1,000 adults with pain who have provided consent to be contacted for future pain research) and the UF Clinical and Translational Science Institute (CTSI) HealthStreet registry (i.e., a service that is dedicated to recruiting underserved and minority populations within the Gainesville, FL community).
A sample of 60 participants (to achieve the goal of 50 participants who complete the study; see statistical analysis below), ages 60 and older, will be invited to participate. Study inclusion criteria are as follows: 1) endorsement of pain in the lower back region (i.e., space between the lower posterior margin of the rib cage and the horizontal gluteal fold (35); 2) back pain reported of moderate severity (rating of >3 on a numeric rating scale ranging from 0-10); 3) back pain occurring on at minimum half of the days in the past six months; and 4) back pain moderately interferes with daily activities (rating of >3 on a numeric rating scale ranging from 0-10). In order to generalize results more broadly, study entry will not be restricted to low back pain although participants must identify low back pain as their primary pain complaint.
Participants will be excluded for the following: 1) current participation in another psychological treatment; 2) severe psychiatric illness not adequately controlled by medication (e.g., schizophrenia, bipolar disorder) or other conditions anticipated to impair intervention engagement (e.g., substance abuse/dependence); 3) presence of chronic, malignant pain (e.g., HIV, cancer) or systemic inflammatory disease (e.g., rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, etc.); 4) significant cognitive impairment on the Montreal Cognitive Assessment (36); 5) inability to read and write English; and 6) if currently taking prescription analgesic or psychotropic medication, must be stabilized on these treatments for >4 weeks prior to the baseline assessment. Exclusion criteria were selected to ensure that participants are not at increased risk for discomfort or harm and to protect the integrity of the data due to medical comorbidities that may impact study findings.
Screening and enrollment
All study procedures (Table 1), including screening and enrollment, will be conducted by trained personnel. All interested participants will first undergo a brief screening interview, via telephone or in person, to determine eligibility. Participants will be queried on their self-reported age and health history including the presence of major medical illnesses, recent back-related injuries or surgeries, and low back pain symptoms to ensure that no exclusion criteria are present. If eligible, participants will be invited to participate in a 1.5-hour baseline assessment for a more thorough evaluation of eligibility.
During the baseline assessment, informed consent will be reviewed by the study PI or staff including a description and timing of the study procedures, potential risks and benefits of study involvement, rights to withdraw from the study, and details regarding protections against study risks. All participants will receive a copy of their signed informed consent form. After the consent process, participants will complete a demographic and medical history questionnaire assessing sociodemographic characteristics, reported duration of cLBP, comorbid medical conditions, and current medication use. Participants will also complete psychological and pain-related questionnaires assessing study-relevant outcomes and complete the Montreal Cognitive Assessment (MoCA) as an evaluation of cognitive functioning (36). The MoCA is a widely used screening assessment for detecting cognitive impairment. Participants with scores <26 will be excluded as this could interfere with their engagement in the study intervention. At the completion of the baseline assessment, eligible participants will be scheduled for their first intervention session approximately one week later. Participants will be informed that they may continue to receive their usual medical care.
Participants will be offered seven 1.5-hour group intervention sessions scheduled once weekly for seven weeks. This format was selected based upon the structure of prior clinical trials (37, 38) and evidence that intervention effects on pain and psychological outcomes in older adults are strongest when delivered using group-based approaches (relative to an individual format) (39). To standardize the application of the intervention and to ensure treatment fidelity, the intervention will be manualized and will include interventionist and participant workbooks with materials (e.g., meditation CD) and handouts for discussion and home practice. Study intervention materials and workbooks were written by the study investigators and interventionists and adapted for an older adult population with cLBP (e.g., age-appropriate content and examples specific to cLBP, incorporation of larger font size on written materials). Participant workbooks were printed in color and written at the 6th grade reading level as measured by Flesh-Kinkaid Grade Level estimates. Participants who miss a group visit will be allowed to complete an individual make-up session, with the stipulation that only one missed group session will be permitted (to ensure the benefits of the group dynamic).
A full description of the resilience activities and content in the intervention program are summarized below and in Table 2. The Broaden-and-Build Theory and Social Cognitive Theory contribute to the conceptual framework underlying the intervention, as these theories have applicability to pain management and adaptive health maintenance (14, 40, 41). Intervention content was derived from the PI’s (EJB) preliminary work establishing that positive affect, pain acceptance, hopeful thinking, and pain self-efficacy demonstrated the strongest effects on pain and disability among older adults with cLBP (K99AG052642). Further, responses garnered during a series of focus groups and key informant interviews with the targeted population informed the development of/modifications to the intervention modules and activities. A range of positive psychology, CBT, and ACT techniques will be incorporated to enhance pain resiliency (i.e., pleasant activity scheduling, values-driven behavior, pain acceptance, hopeful thinking and goal-directed behavior, positive events and reappraisal, and pain self-efficacy). All activities were selected due to strong empirical evidence supporting their use (42-45), ease of completion, and applicability to the targeted resilience constructs.
Each session will follow the same format including a review of the previous week’s content (e.g., home activity review), barriers to home activity completion, an overview and discussion of the session objectives including didactic in-session activities, and assignment of home activities. A photocopy of each participant’s home activity will be made at the beginning of each intervention session and will be reviewed by the study PI and intervention facilitators to assess quantity and quality of completion.
Week 1:Introduction and Background. Participants will be provided with instruction on group intervention guidelines (e.g., confidentiality, respect, privacy), an overview of the purpose and structure of the program, education on cLBP etiology and symptoms and the Gate Control Theory of Pain (46), and the rationale for using resilience-enhancing activities for the management of cLBP. A discussion of the Upward and Downward Spirals of Emotions (40, 47) with respect to pain will be provided, as well as the use of character strengths (48) to boost resilience. As a home exercise, participants will be asked to complete the Values in Action (VIA) character strengths online survey to identify individual core virtues and positive attributes (49, 50) and to make note of one occurrence of using a personal strength during the next week.
Week 2: Pleasant Activities. Participants will be given instruction on how to increase the number of pleasant events in their life and will be provided with a list of pleasant activity ideas (51). Education on the benefits of activity pacing will be discussed including ways in which to modify activity engagement to reduce pain flare-ups. The purpose of gratitude will be reviewed, and participants will be asked to identify elements in their life that they are thankful for and appreciate. For their home practice, participants will be encouraged to engage in three pleasant activities over the week and to record events/aspects they are grateful for each day.
Week 3: Pain Acceptance. ACT techniques will be used to help participants identify their personal values and to recognize the importance of living a meaningful and goal-directed life aligned with those values despite pain. A values assessment will be administered during the group session to assist participants in recognizing important values in their life (52). Participants will also receive education and training in mindfulness meditation and will participate in a guided mindfulness exercise (i.e., Leaves on a Stream) (53) during the group session. A CD will be provided for at-home practice and participants will be encouraged to practice mindfulness exercises for a minimum of three times over the course of the week using pre-recorded scripts of Leaves on a Stream and a 5-minute Mindful Breathing exercise (i.e., technique emphasizing focused attention on the breath).
Week 4: Hope and Goal Setting. Based on Snyder’s theory of hope (45), participants will focus on their personal strengths and learn ways in which to create attainable goals (i.e., S.M.A.R.T. Goals) (54) through the development of pathways (i.e., perceived ability to generate routes to goals) and agency (i.e., mobilization of efforts to achieve goals) thinking. A scripted visualization exercise will be conducted during the session whereby participants will imagine themselves successfully reaching their goals. Participants will be asked to develop a goal they would like to achieve over the course of the intervention to facilitate hopeful thinking and goal-directed behavior, and to identify areas in their life that inspire hope (24).
Week 5: Positive Events and Reappraisal. To increase attentional focus on positive events, participants will be given instruction on how to identify negative or unhelpful automatic thoughts, evaluate automatic thoughts for accuracy, and to downregulate negative emotions and thoughts through positive reappraisal (55). Instruction will also be provided on prolonging and enhancing the experience/impact of positive events (e.g., telling someone about the event, replaying the event in your mind). As a home activity, participants will be encouraged to record one positive event that occurred every day and ways in which they strengthened that experience, as well as negative events in which they had to practice positive reappraisal (56).
Week 6: Pain Self-Efficacy. While it is anticipated that self-efficacy will gradually be fostered throughout the course of the intervention (i.e., skills mastery experiences, feedback on progress, social persuasion through group support), this session will complement ongoing training by targeting problem-solving skills and confidence building, as well as empowering participants to promote adaptive pain management behaviors (1, 57). The fear avoidance model of pain (58) will be introduced and education provided on how fear can induce inactivity, thereby facilitating increased pain and disability. As a method of increasing self-efficacy in managing pain, a brief diaphragmatic breathing exercise will be practiced during the group session. Participants will be asked to engage in daily diaphragmatic breathing as a form of relaxation and to record levels of stress and pain before and after their practice (0-10 numeric rating scale).
Week 7: Review of Skills and Wrap-Up: Skills learned in the previous sessions will be reviewed and specific plans for the maintenance of resilience activities will be discussed. Participants will complete post-treatment outcome questionnaires and provide feedback on the intervention program.
Sessions will be administered by postdoctoral clinical psychology fellows who have experience administering psychological treatments for chronic pain. Intervention facilitators will be assigned in pairs to co‑lead the study groups. Interventionists will be trained and supervised by the study investigators (EJB, KTS), each of whom has recognized expertise in delivering psychological interventions for individuals with chronic pain. Interventionists will receive extensive didactic and experiential training from the study PI. During training, interventionists will be assigned reading materials relevant to the study intervention (12, 59-62) and receive didactic and experiential training involving the delivery of each treatment session module in a mock group fashion.
Adherence and fidelity monitoring
Adherence to the intervention protocol and treatment fidelity will be monitored through several methods. First, each group session will be audio recorded (with participant consent) and a random selection of 50% of these recordings will be reviewed by the study Co-I (KTS) to ensure that treatment procedures and content have been followed. Second, interventionists will review a portion of their audio-recorded group sessions for self-evaluation and improvement of skills. Third, interventionist adherence to the treatment protocol, appropriateness of the interventionist’s behavior, and quality of treatment delivery will be assessed using an adapted Cognitive Therapy Adherence and Competence Scale (CTACS) (63) that will be modified to align with the session content. Fourth, interventionists will be provided a structured and manualized therapist treatment manual to deliver the treatment sessions and will participate in weekly group supervision with the study PI involving corrective feedback and discussion of protocol adherence, quality of intervention delivery, and group dynamics. And fifth, interventionists will be provided with a checklist of procedures specific to each session, and each checklist will be reviewed to ensure treatment adherence.
Several strategies will be implemented to maximize retention. At screening, participants will be educated on the importance of attending sessions. Participants will be sent frequent reminders of their appointments per our study contact protocol, and we will contact participants via a variety of modalities, including phone and email to make initial contact, or a mailed letter if unable to reach via phone or email. Participants who fail to attend their scheduled group session will be offered the opportunity to make this session up prior to attending the next session. Financial incentives will also be provided for the completion of study procedures.
For the purposes of monitoring safety, participants’ health status will be reviewed during each session including documentation of any changes in the amount or type of medications that they are currently taking, or the initiation of new therapies or treatments (e.g., counseling, acupuncture, physical therapy) for pain. The study PI will be alerted of any changes and/or adverse events reported by participants and these will be recorded in progress notes and reported to the study physician for review, if necessary. All serious and unexpected adverse events will be reported to the study’s sponsor and the University of Florida IRB within 5 working days. Other types of adverse events will be monitored and reported to the University of Florida IRB in the study’s annual progress review. The investigators will review all reported adverse events and deviations on a weekly basis to minimize the risk to study subjects.
Data handling and storage
Questionnaire data will be collected on paper and then transposed by study staff into a secure internet-based data collection system [i.e., REDCap]. To ensure data accuracy, a secondary staff member will review all data entries and compare them with the source data. Paper and computer records will be anonymized and identified only by subject number. Study records will be stored in locked file cabinets and will only be available to the PI or other project staff. Computer data files will be stored on computer servers with secure passwords and electronic storage devices will be encrypted. Each intervention group session will be audio-recorded for the evaluation of interventionist adherence to the protocol. No identifying information will be transcribed as the purpose of this digital recording will be to assess treatment integrity. Once the audio recordings are reviewed and adherence is discussed with study interventionists, the recordings will be destroyed. Prior to destruction, the recordings will be kept in a locked filing cabinet in the laboratory of the PI.
Assessments and measures
As shown in Table 1, several questionnaires will be administered to assess general health, pain-related symptoms, and psychological functioning. In order to attenuate participant burden, questionnaires administered at intervention completion will be distributed either during the final intervention session or at home between the last two sessions (either via our secure internet-based data collection system (i.e., REDCap) or on paper, depending on the participant’s preference).
Intervention acceptability measures
Session-level engagement. Treatment engagement questions (64) will be adapted for the current study to assess participants’ effort exerted during group activities, completion of homework, and engagement in group discussions. This questionnaire consists of 5 items rated on a 9-point Likert scale ranging from 0 (none) to 8 (a lot), with two additional questions querying on the completion and quality of homework. Items will be completed by the study interventionists upon the completion of every group session for each attendee. A 6-item modified version of this scale will also be completed by each participant at the end of every session to assess their perceptions of engagement and interest in the session content and usefulness of the home activities.
Treatment credibility and expectancy. Treatment credibility questions (65) will be adapted for the current study as a treatment expectancy measure and administered during Visit 1 and Visit 2 consisting of the following 7 items: 1) reasonableness of the intervention, 2) willingness to undergo treatment, 3) confidence in recommending the intervention to others, 4) confidence that the intervention will help with pain coping, 5) confidence that the intervention will decrease pain, 6) confidence that the intervention will eliminate pain, and 7) expectation for improvement in pain symptoms.
Satisfaction with treatment module content. As a treatment evaluation and to better understand their perceptions of the intervention, participants will complete a study-developed questionnaire and be asked to indicate the usefulness of each intervention session module and home activity on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). Approximately one week after the final intervention session, participants will also undergo a 20- to 30-minute qualitative phone interview to obtain their views and experiences of the intervention, including perceived barriers to treatment engagement.
Global treatment satisfaction. The 8-item Client Satisfaction Questionnaire (CSQ-8) (66) will be administered after the intervention as an assessment of treatment satisfaction. Items are rated on a 4-point Likert scale and measure aspects related to the quality of intervention, willingness to recommend the intervention, and general satisfaction with the intervention.
Intervention feasibility measures
We will evaluate feasibility based on the ability to recruit, enroll, and retain participants, as well as adherence and completion of study questionnaires and home activities. Specifically, we will examine: 1) the number of individuals screened for eligibility, who were deemed eligible to participate, and those who were enrolled in study procedures, including any reasons for ineligibility; 2) intervention completion, determined by the number of intervention sessions attended; 3) questionnaire feasibility including completion rates of measures and the degree of missing data present; and 4) feasibility of the home activities.
Home activities evaluation. Participants will complete a 7-item questionnaire that was adapted from Kazantzis and colleagues (67) for the purposes of assessing the utility of the home activities. Items are rated on a 7-point Likert scale ranging from 0 (not at all/none) to 6 (extremely/all). Three questions address feasibility (i.e., degree of home-activity completion, level of understanding regarding home activities, degree of time and effort needed to complete activities) and will be used in the analysis.
Exploratory outcomes and mediator variables
Although this is not a traditional Stage II efficacy study, we will collect data on the following measures to provide preliminary data and to determine the feasibility of examining these constructs in a larger scale evaluation. Exploratory outcomes include pain intensity, pain interference, negative mood (i.e., depression, anxiety), and quality of life. Aligning with the NIH Science of Behavior Change approach (68), we will also evaluate the potential for intervention effects on the proposed resilience targets (i.e., positive affect, pain acceptance, hope, pain self-efficacy) and examine whether treatment-related changes in these variables are associated with improvements in pain outcomes.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity. The 3-item PROMIS Pain Intensity short form (69) evaluates average and worst back pain during the past 7 days, as well as pain at the time of questionnaire completion by providing a 1 (no pain) to 5 (very severe) pain rating. This scale has been used in patients with chronic pain and demonstrates excellent internal consistency (α = 0.91) (70).
PROMIS Pain Interference. The short form of the PROMIS Pain Interference measure (71) includes 8 questions (e.g., “How much did pain interfere with your day to day activities?”) examining pain-related impairment in social, cognitive, emotional, physical, and recreational activities over the past 7 days. Ratings are made from 1 (not at all) to 5 (very much) and higher scores indicate greater interference from pain. The pain interference scale demonstrates convergent validity with related measures and has excellent internal consistency (α = 0.99) (70).
PROMIS Emotional Distress Scales. The 8-item short forms of the PROMIS Depression Scale and the PROMIS Anxiety Scale (72) assess depressive (e.g., “I felt worthless”) and anxiety-related (e.g., “I felt fearful”) symptoms over the past 7 days. Respondents rate the frequency of their experience of each symptom from 1 (never) to 5 (always), with higher scores indicating a greater presence of symptomatology. Cronbach’s alpha demonstrates high internal consistency for both depression (α = 0.98) and anxiety (α = 0.97) scales (70).
World Health Organization Quality of Life–Brief(WHOQol-Bref).The WHOQol-Bref (73) scale consists of 26 items assessing quality of life over the past week in four domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF has good psychometric properties of reliability (α = 0.68 to 0.82 across domains) and performs well in tests of validity (73).
Positive and Negative Affect Schedule (PANAS). The PANAS (74) is a 20-item scale assessing positive affect (PA) and negative affect (NA). Items are rated on a 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely), resulting in scale scores for PA and NA. Research supports the construct validity of the PANAS, with internal consistency estimates found to be high for both subscales: α = 0.89 for PA and 0.85 for NA (75).
Chronic Pain Acceptance Questionnaire (CPAQ). The CPAQ (76) is comprised of 20 items measuring acceptance of pain. This measure has two subscales: activity engagement (i.e., pursuit of life activities regardless of pain) and pain willingness (i.e., disengaging from pain avoidance and control). Items are rated on a 7-point scale ranging from 0 (never true) to 6 (always true). The CPAQ shows moderate to high correlations with measures of avoidance, distress, and daily functioning and has good internal consistency, with alphas of 0.82 for activity engagement and 0.78 for pain willingness (76).
Adult State Hope Scale (ASHS). The ASHS (77) includes 6 questions (e.g., “There are lots of ways around any problem that I am facing now”) that tap into state levels of hope. Two subscale scores assessing agency (i.e., sustained movement towards goals) and pathways (i.e., generation of workable routes to goals) thinking are derived, as well as a total score consisting of a sum of these two scales. Items are rated on an 8-point Likert scale ranging from 1 (definitely false) to 8 (definitely true). The ASHS demonstrates concurrent and discriminant validity, as well as good internal consistency estimates with alphas ranging from 0.82 to 0.95 over a 30-day period (77).
Pain Self-Efficacy Questionnaire (PSEQ). The PSEQ (78) is a 10-item measure that examines pain-related self-efficacy. Scores range from 0 (not at all confident) to 6 (completely confident to undertake an activity), and higher scores indicate a greater level of self-efficacy in the midst of chronic pain. The PSEQ has excellent internal consistency (α = 0.92) and demonstrates significant correlations with measures of pain-related disability and coping (78).
As this is a Stage I pilot feasibility study, a sample size calculation is not appropriate. However, our target sample size of 50 participants is consistent with prior recommendations (79-81) and will provide data on intervention acceptability and feasibility, as well as the potential to influence study outcomes and mechanisms of action. Accounting for a conservative 20% attrition rate, we will recruit an additional 10 participants (total N=60). Because of the potential for high variability and imprecision in outcomes in pilot samples (79, 80, 82), treatment effects will be conducted using descriptive statistics with means, standard deviations, and ranges reported. In addition, 95% confidence intervals (CI) will be developed around each acceptability and feasibility mean. We will evaluate if pre-determined metrics of success for each target fall within this interval. See Table 3 for a description of metrics that will support progression to a fully powered trial. Data collected through post-treatment qualitative interviews will be transcribed verbatim and analyzed with NVivo 12.0 software to assist in the identification and manipulation of text segments. Directed content analysis will guide the analytic approach, which involves the identification of salient themes and concepts that arise from interviews (83). Two research staff from the study team will validate the analysis. To assess enrollment rates, a ratio between participants enrolled versus the number of participants commencing treatment will be calculated. The portion of participants who complete all intervention sessions, including the total mean number of sessions completed, will be estimated as a measurement of participant retention.
Questionnaire feasibility will be measured by analyzing the completion rates of measures including the degree of missing data.
To evaluate potential intervention effects on pain outcomes (i.e., pain intensity, pain interference, negative mood, quality of life), and probable mediators (i.e., positive affect, pain acceptance, hopeful thinking, pain self-efficacy), the mean, standard deviation, and range associated with treatment changes in these outcomes will be determined, and 95% CI’s will be calculated around each mean. For study outcomes and probable mediators, the minimally important change will be 30% of the baseline score, as this metric has been previously defined as a clinically meaningful change in pain-related symptoms (84). Using residualized change scores (i.e., regressing the post-intervention scores on the pre-intervention scores for each measure), Pearson’s correlation coefficients will be computed to examine associations between outcomes and intervention target change scores.