Chronic Pain, Geriatric
Conditions
Brief summary
Fibromyalgia syndrome (FMS) is a chronic musculoskeletal condition characterized by widespread pain and tenderness, and often accompanied by impaired physical functioning, depressed mood, as well as deficits in positive affect (PA).Standard behavioral therapies typically focus on minimizing negative thoughts and emotions associated with pain and yield only modest treatment effects. Efforts are therefore needed to develop more effective psychological treatments for chronic pain by identifying new targets for intervention. The objectives of this Stage I randomized pilot trial are to evaluate the feasibility, acceptability, and the impact of a previously developed online positive affect (PA) skills intervention -LARKSPUR (Lessons in Affect Regulation to Keep Stress and Pain UndeR control)-in a sample of Hispanic, non-Hispanic other, and non-Hispanic African American patients with fibromyalgia syndrome (FMS).
Detailed description
Specific Aims: Aim 1: To maximize relevance and acceptability of content and delivery of LARKSPUR intervention among patients with FMS, a chronic pain population with known deficits in PA. This aim will establish the feasibility (recruitment and retention) and acceptability (helpfulness, satisfaction, and impact) of the multicomponent LARKSPUR intervention in Hispanic, non-Hispanic African American and non-Hispanic other patients with FMS. Aim 2: To conduct a randomized pilot trial to evaluate the impact of the LARKSPUR intervention in FMS pain (primary outcome), as well PA, depressive symptoms, physical functioning, and stress appraisals (secondary outcomes) and Aim 2a: explore racial/ethnic disparities. For Aim 1, the study team will pilot LARKSPUR to examine feasibility and acceptability of the intervention framework by conducting frequency and descriptive statistics for enrollment rates, number of sessions completed, number of weeks required to complete the intervention, and Likert-scale items assessing satisfaction with the intervention and perceived helpfulness. For Aims 2, FMS patients (target N=90) will be randomized to receive the LARKSPUR content online or to complete daily emotion reports online (control). The researchers hypothesize that intervention participants will report more frequent PA, decreased depressive symptoms, enhanced physical functioning, improved stress appraisals, and reduced FMS pain (intensity and interference) immediately following the intervention (approximately 6-8 wks) and at 1-month post-intervention.
Interventions
BEHAVIORALLARKSPUR
This intervention used in our prior research consists of skills training exercises designed to increase the frequency of positive affect. The 6 week intervention (5 weeks of content plus one week of home practice) consists of five components: (1) Positive events and gratitude; (2) mindfulness; (3) reappraisal; (4) strength and goals; and(5) acts of kindness. Participants will have up to 8 weeks to complete this intervention.
Sponsors
National Institute on Aging (NIA)
Cornell University
Wake Forest University
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Access to daily internet * ≥ 50 years of age * Able to read and understand English * Physician diagnosis confirmation of FMS AND/OR Score ≥ 13 on the 6-item, self-report fibromyalgia screening tool * Report having pain for at least the last three months
Exclusion criteria
* Cognitive impairment * Current behavioral treatment for pain * Enrolled in another pain study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Intervention Time as Measured by Number of Weeks to Complete Intervention (Aim 1) | At week 11 (post-intervention) | Length of Intervention time as measured by number of weeks the participant took to complete the LARKSPUR intervention program. |
| Helpfulness, Satisfaction, and Impact as Assessed by Self-Report Participant Feedback Survey (Aim 1) | At week 11 (post-intervention) | The feedback survey collected two Likert-scale questions asking whether the participant recommends the intervention: (1) Would you recommend LARKSPUR to a friend? and (2) Would you recommend LARKSPUR to someone else with chronic pain?. Both questions were measured on an 11-point scale, with 0=Definitely Not to 10=Definitely Yes. Higher scores indicate better outcomes for both questions. The two items were analyzed separately, not combined. |
| Recruitment as Measured by Rates of Enrollment (Aim 1) | At baseline | Percent enrolled of total eligible participants. |
| Retention as Measured by Change in Enrollment | At baseline; at week 11 (post-intervention) | Percentage enrolled at baseline that completed the post-intervention assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Functioning as Measured by PROMIS Fatigue - Short Form 6a (Aim 2) | At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) | Fatigue T-scores measured by PROMIS Fatigue Short Form 6a. This 6-item instrument assesses a patient's a patient's level of fatigue over a 7-day recall period. Respondents report fatigue on a 5-point scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 33.4 to 76.8. Lower T-scores represent better outcomes. |
| Change in Depressive Symptoms as Measured by the Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) (Aim 2) | At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) | The 10-item version of the Center for Epidemiological Studies Depression Scale (CES-D) asks for participants to rate how often over the past week they experienced symptoms associated with depression on a 4-point scale: 0=Rarely or None of the time, 1=Some or Little of the time, 2=Moderately or Much of the time, 3=Most or Almost all the time. CESD-R-10 mean scores range from 0 (rare depressive symptoms) to 4 (depressive symptoms most or almost all the time). |
| Change in Positive Affect as Measured by the Positive and Negative Affect Scale (PANAS-GEN) (Aim 2) | At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) | The 20-item self-report Positive and Negative Affect Scale (PANAS-GEN) asks participants to describe to what extent they feel different feelings and emotions on average. Respondents answer on a five-point scale: 0=Very slightly or not at all, 1=A little, 2=Moderately, 3=Quite a bit, 4=Extremely. PANAS-GEN mean scores range from 0 (very slightly or not at all positive affect) to 4 (extremely positive affect). |
| Change in Stress Appraisal as Measured by the Perceived Stress Scale (Aim 2) | At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) | The 10-item version of the Perceived Stress Scale (PSS) assesses the perception of stress over the previous month. Respondents report how often they have experienced perceived stress on a five-point scale: 0=Never, 1=Almost never, 2=Sometimes, 3=Fairly often, 4=Very often. PSS mean scores range from 0 (experienced no or minimal stress) to 4 (experienced very frequent stress). |
| Change in Positive Affect as Measured by the Modified Differential Emotions Scale (mDES) (Aim 2) | At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) | The modified Differential Emotions Scale (mDES) is a 20-item instrument that measures the extent to which a patient has experienced positive and negative emotions over a chosen time frame; in the version used in this study, we ask for emotions over the past 7 days. Respondents are asked to report the greatest amount of a given emotion on a five-point scale: 0=Not at all, 1=A little bit, 2=Moderately, 3=Quite a bit, 4=Extremely. mDES mean scores range from 0 (not at all experienced positive emotion) to 4 (extremely positive emotion). |
| Change in FMS Pain as Measured by PROMIS Pain Intensity - Short Form 3a (Aim 2) | At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) | Pain intensity T-scores measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity - Short Form 3a. This 3-item instrument assesses how much a person hurts. The first two items assess pain intensity over a 7-day recall period; the last item asks patients to rate their pain intensity right now. Respondents report their pain on a 5-point scale: 1=Had no pain, 2=Mild, 3=Moderate, 4=Severe, 5=Very severe. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 36.3 to 81.8. Lower T-scores represent better outcomes. |
| Change in FMS Pain as Measured by PROMIS Pain Interference - Short Form 6b (Aim 2) | At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) | Pain interference T-scores measured by PROMIS Pain Interference - Short Form 6b. This 6-item instrument measures self-reported impact of pain on a person's life and extent that pain may interfere with engagement with social, cognitive, emotional, physical, and recreational activities over a 7-day recall period. Respondents report pain interference on a 5-point scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, and 5=Very much. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 41.0 to 78.3. Lower T-scores represent better outcomes. |
| Change in Physical Functioning as Measured by PROMIS Physical Functioning Short Form 10a (Aim 2) | At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention) | Physical function T-scores measured by PROMIS Physical Function Short Form 10a. This 10-item instrument assesses a patient's abilities and limitations with respect to everyday physical activities. Respondents report limitations on a 5-point scale: 5=Not at all, ..., 3=Somewhat, ..., 1=Cannot do, and abilities to perform activities on a 5-point scale: 5=Without any difficulty, ..., 3=With some difficulty, ..., 1=Unable to do. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 13.5 to 61.9. Higher T-scores represent better outcomes. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Affective Reactivity to Stress as Measured by the Daily Modified Differential Emotions Scale (mDES) | At baseline, at week 11 (post-intervention); at week 16 (1 month post intervention) | Positive affective reactivity measured by the modified Differential Emotions Scale (mDES). Upon completion of each study assessment, participants completed the mDES daily for one week, for a total of three 7-day-long periods. The mDES is a 20-item instrument that measures the extent to which a patient has experienced positive (10 items) and negative (10 items) emotions over a chosen time frame; in the version used in this survey, we ask for emotions over the past 24 hours. Respondents are asked to report the greatest amount of positive affect on a five-point scale: 0=Not at all, 1=A little bit, 2=Moderately, 3=Quite a bit, 4=Extremely. mDES mean scores were computed over the 10 items, ranging from 0 (not at all positive) to 4 (extremely positive). |
| Change in Affective Reactivity to Stress as Measured by the Daily Inventory of Stressful Events (DISE) | At baseline, at week 11 (post-intervention); at week 16 (1 month post intervention) | Affective reactivity to stress measured by the Daily Inventory of Stressful Events (DISE). Upon completion of each study assessment, patients completed the DISE daily for one week, for a total of three 7-day-long periods. The DISE is a 7-item self-report instrument in which participants report whether stressful events (argument, work or school stress, home stress, discrimination, close friend stress, other stressors) have occurred within the past 24 hours, indicating yes or no accordingly for each item. Item scores are averaged, ranging from 0=no stress to 1=highest stress. Higher scores indicate worse outcomes. |
Countries
United States
Participant flow
Pre-assignment details
142 participants were recruited for the study and assessed for eligibility. Of those 142 participants, n = 22 did not meet eligibility requirements. Of the n = 120 eligible participants, n = 22 declined to participate, n = 2 were excluded by the investigators, and n = 1 was unable to access the online study platform; 95 participants met inclusion criteria and were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| LARKSPUR Intervention Lessons in Affect Regulation to Keep Stress and Pain UndeR control
LARKSPUR: This intervention used in our prior research consists of skills training exercises designed to increase the frequency of positive affect. The 6 week intervention (5 weeks of content plus one week of home practice) consists of five components: (1) Positive events and gratitude; (2) mindfulness; (3) reappraisal; (4) strength and goals; and(5) acts of kindness. Participants will have up to 8 weeks to complete this intervention. | 49 |
| Attention Control Condition Daily emotion reporting/no intervention | 46 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 3 |
Baseline characteristics
| Characteristic | LARKSPUR Intervention | Total | Attention Control Condition |
|---|---|---|---|
| Age, Customized >= 80 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Customized Between 50 and 59 years | 18 Participants | 41 Participants | 23 Participants |
| Age, Customized Between 60 and 69 years | 22 Participants | 41 Participants | 19 Participants |
| Age, Customized Between 70 and 79 years | 8 Participants | 12 Participants | 4 Participants |
| Depressive Symptoms (Center for Epidemiologic Studies Depression Scale Revised, CESD-R-10) | 1.23 units on a scale STANDARD_DEVIATION 0.54 | 1.22 units on a scale STANDARD_DEVIATION 0.54 | 1.22 units on a scale STANDARD_DEVIATION 0.55 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 92 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Positive Affect (modified Differential Emotions Scale, mDES) | 1.68 units on a scale STANDARD_DEVIATION 0.8 | 1.69 units on a scale STANDARD_DEVIATION 0.8 | 1.70 units on a scale STANDARD_DEVIATION 0.8 |
| Positive Affect (Positive and Negative Affect Scale, PANAS-GEN) | 1.89 units on a scale STANDARD_DEVIATION 0.72 | 1.90 units on a scale STANDARD_DEVIATION 0.7 | 1.92 units on a scale STANDARD_DEVIATION 0.69 |
| PROMIS Fatigue - Short Form 6a | 66.20 T-score STANDARD_DEVIATION 7.09 | 64.80 T-score STANDARD_DEVIATION 7.12 | 63.31 T-score STANDARD_DEVIATION 6.92 |
| PROMIS Pain Intensity - Short Form 3a | 63.31 T-score STANDARD_DEVIATION 6.32 | 62.95 T-score STANDARD_DEVIATION 6.04 | 62.57 T-score STANDARD_DEVIATION 5.77 |
| PROMIS Pain Interference - Short Form 6b | 63.16 T-score STANDARD_DEVIATION 5.99 | 62.95 T-score STANDARD_DEVIATION 5.48 | 62.72 T-score STANDARD_DEVIATION 4.94 |
| PROMIS Physical Functioning Short Form 10a | 36.99 T-score STANDARD_DEVIATION 6.03 | 37.11 T-score STANDARD_DEVIATION 5.79 | 37.24 T-score STANDARD_DEVIATION 5.59 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) White | 40 Participants | 77 Participants | 37 Participants |
| Region of Enrollment United States | 49 participants | 95 participants | 46 participants |
| Sex: Female, Male Female | 48 Participants | 90 Participants | 42 Participants |
| Sex: Female, Male Male | 1 Participants | 5 Participants | 4 Participants |
| Stress Appraisal (Perceived Stress Scale) | 1.86 units on a scale STANDARD_DEVIATION 0.71 | 1.77 units on a scale STANDARD_DEVIATION 0.66 | 1.66 units on a scale STANDARD_DEVIATION 0.61 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 46 |
| other Total, other adverse events | 0 / 49 | 0 / 46 |
| serious Total, serious adverse events | 0 / 49 | 0 / 46 |
Outcome results
Primary
Helpfulness, Satisfaction, and Impact as Assessed by Self-Report Participant Feedback Survey (Aim 1)
The feedback survey collected two Likert-scale questions asking whether the participant recommends the intervention: (1) Would you recommend LARKSPUR to a friend? and (2) Would you recommend LARKSPUR to someone else with chronic pain?. Both questions were measured on an 11-point scale, with 0=Definitely Not to 10=Definitely Yes. Higher scores indicate better outcomes for both questions. The two items were analyzed separately, not combined.
Time frame: At week 11 (post-intervention)
Population: For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11. For the Attention Control condition, n = 3 lost to follow-up at Week 11.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Recruited Participants Pre-Randomization | Helpfulness, Satisfaction, and Impact as Assessed by Self-Report Participant Feedback Survey (Aim 1) | Rating of Recommending Intervention to Friend | 8.89 units on a scale | Standard Error 0.27 |
| All Recruited Participants Pre-Randomization | Helpfulness, Satisfaction, and Impact as Assessed by Self-Report Participant Feedback Survey (Aim 1) | Rating of Recommending Intervention to Those with Chronic Pain | 9.14 units on a scale | Standard Error 0.23 |
| Attention Control Condition | Helpfulness, Satisfaction, and Impact as Assessed by Self-Report Participant Feedback Survey (Aim 1) | Rating of Recommending Intervention to Friend | 9.05 units on a scale | Standard Error 0.25 |
| Attention Control Condition | Helpfulness, Satisfaction, and Impact as Assessed by Self-Report Participant Feedback Survey (Aim 1) | Rating of Recommending Intervention to Those with Chronic Pain | 8.59 units on a scale | Standard Error 0.3 |
Primary
Length of Intervention Time as Measured by Number of Weeks to Complete Intervention (Aim 1)
Length of Intervention time as measured by number of weeks the participant took to complete the LARKSPUR intervention program.
Time frame: At week 11 (post-intervention)
Population: For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11. n = 3 participants did not complete all skills in the LARKSPUR intervention and are excluded from analysis. Attention Control group are not analyzed because they did not receive the LARKSPUR intervention.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Recruited Participants Pre-Randomization | Length of Intervention Time as Measured by Number of Weeks to Complete Intervention (Aim 1) | 4.06 weeks |
Primary
Recruitment as Measured by Rates of Enrollment (Aim 1)
Percent enrolled of total eligible participants.
Time frame: At baseline
Population: 120 of 142 participants recruited for the study who met eligibility requirements.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Recruited Participants Pre-Randomization | Recruitment as Measured by Rates of Enrollment (Aim 1) | Unable to Access the Online Study Platform | 1 Participants |
| All Recruited Participants Pre-Randomization | Recruitment as Measured by Rates of Enrollment (Aim 1) | Eligible Participants | 120 Participants |
| All Recruited Participants Pre-Randomization | Recruitment as Measured by Rates of Enrollment (Aim 1) | Enrolled Participants | 95 Participants |
| All Recruited Participants Pre-Randomization | Recruitment as Measured by Rates of Enrollment (Aim 1) | Declined to Participate | 22 Participants |
| All Recruited Participants Pre-Randomization | Recruitment as Measured by Rates of Enrollment (Aim 1) | Excluded by the Investigators | 2 Participants |
Primary
Retention as Measured by Change in Enrollment
Percentage enrolled at baseline that completed the post-intervention assessment.
Time frame: At baseline; at week 11 (post-intervention)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Recruited Participants Pre-Randomization | Retention as Measured by Change in Enrollment | 43 Participants |
| Attention Control Condition | Retention as Measured by Change in Enrollment | 43 Participants |
p-value: 0.68495% CI: [0.13, 3.05]Boschloo Test
Secondary
Change in Depressive Symptoms as Measured by the Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) (Aim 2)
The 10-item version of the Center for Epidemiological Studies Depression Scale (CES-D) asks for participants to rate how often over the past week they experienced symptoms associated with depression on a 4-point scale: 0=Rarely or None of the time, 1=Some or Little of the time, 2=Moderately or Much of the time, 3=Most or Almost all the time. CESD-R-10 mean scores range from 0 (rare depressive symptoms) to 4 (depressive symptoms most or almost all the time).
Time frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Population: For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11, n = 2 lost to follow-up from Week 11 to Week 16. For the Attention Control, n = 3 lost to follow-up at Week 11. Intention-to-treat analyses were conducted for participants completing Baseline and Post-Intervention (n = 43 in LARKSPUR intervention, n = 43 in Attention Control Condition).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| All Recruited Participants Pre-Randomization | Change in Depressive Symptoms as Measured by the Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) (Aim 2) | Week 11 (Post-Intervention) | 1.13 units on a scale |
| All Recruited Participants Pre-Randomization | Change in Depressive Symptoms as Measured by the Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) (Aim 2) | Baseline | 1.26 units on a scale |
| All Recruited Participants Pre-Randomization | Change in Depressive Symptoms as Measured by the Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) (Aim 2) | Week 16 (1 Month Post-Intervention) | 1.39 units on a scale |
| Attention Control Condition | Change in Depressive Symptoms as Measured by the Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) (Aim 2) | Week 11 (Post-Intervention) | 1.07 units on a scale |
| Attention Control Condition | Change in Depressive Symptoms as Measured by the Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) (Aim 2) | Week 16 (1 Month Post-Intervention) | 1.26 units on a scale |
| Attention Control Condition | Change in Depressive Symptoms as Measured by the Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) (Aim 2) | Baseline | 1.19 units on a scale |
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline CESD-R-10 scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.47995% CI: [-0.1, 0.22]Mixed Models Analysis
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline CESD-R-10 scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.12695% CI: [-0.04, 0.29]Mixed Models Analysis
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline CESD-R-10 scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.45795% CI: [-0.12, 0.25]Mixed Models Analysis
Secondary
Change in FMS Pain as Measured by PROMIS Pain Intensity - Short Form 3a (Aim 2)
Pain intensity T-scores measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity - Short Form 3a. This 3-item instrument assesses how much a person hurts. The first two items assess pain intensity over a 7-day recall period; the last item asks patients to rate their pain intensity right now. Respondents report their pain on a 5-point scale: 1=Had no pain, 2=Mild, 3=Moderate, 4=Severe, 5=Very severe. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 36.3 to 81.8. Lower T-scores represent better outcomes.
Time frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Population: For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11, n = 2 lost to follow-up from Week 11 to Week 16. For the Attention Control, n = 3 lost to follow-up at Week 11. Intention-to-treat analyses were conducted for participants completing Baseline and Post-Intervention (n = 43 in LARKSPUR intervention, n = 43 in Attention Control Condition).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| All Recruited Participants Pre-Randomization | Change in FMS Pain as Measured by PROMIS Pain Intensity - Short Form 3a (Aim 2) | Baseline | 63.64 T-score |
| All Recruited Participants Pre-Randomization | Change in FMS Pain as Measured by PROMIS Pain Intensity - Short Form 3a (Aim 2) | Week 11 (Post-Intervention) | 61.22 T-score |
| All Recruited Participants Pre-Randomization | Change in FMS Pain as Measured by PROMIS Pain Intensity - Short Form 3a (Aim 2) | Week 16 (1 month Post-Intervention) | 61.99 T-score |
| Attention Control Condition | Change in FMS Pain as Measured by PROMIS Pain Intensity - Short Form 3a (Aim 2) | Baseline | 62.79 T-score |
| Attention Control Condition | Change in FMS Pain as Measured by PROMIS Pain Intensity - Short Form 3a (Aim 2) | Week 16 (1 month Post-Intervention) | 61.55 T-score |
| Attention Control Condition | Change in FMS Pain as Measured by PROMIS Pain Intensity - Short Form 3a (Aim 2) | Week 11 (Post-Intervention) | 61.49 T-score |
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.83595% CI: [-2.8, 2.27]Mixed Models Analysis
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.73295% CI: [-2.12, 3]Mixed Models Analysis
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.60995% CI: [-2.05, 3.47]Mixed Models Analysis
Secondary
Change in FMS Pain as Measured by PROMIS Pain Interference - Short Form 6b (Aim 2)
Pain interference T-scores measured by PROMIS Pain Interference - Short Form 6b. This 6-item instrument measures self-reported impact of pain on a person's life and extent that pain may interfere with engagement with social, cognitive, emotional, physical, and recreational activities over a 7-day recall period. Respondents report pain interference on a 5-point scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, and 5=Very much. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 41.0 to 78.3. Lower T-scores represent better outcomes.
Time frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Population: For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11, n = 2 lost to follow-up from Week 11 to Week 16. For the Attention Control, n = 3 lost to follow-up at Week 11. Intention-to-treat analyses were conducted for participants completing Baseline and Post-Intervention (n = 43 in LARKSPUR intervention, n = 43 in Attention Control Condition).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| All Recruited Participants Pre-Randomization | Change in FMS Pain as Measured by PROMIS Pain Interference - Short Form 6b (Aim 2) | Week 11 (Post-Intervention) | 61.77 T-score |
| All Recruited Participants Pre-Randomization | Change in FMS Pain as Measured by PROMIS Pain Interference - Short Form 6b (Aim 2) | Baseline | 63.63 T-score |
| All Recruited Participants Pre-Randomization | Change in FMS Pain as Measured by PROMIS Pain Interference - Short Form 6b (Aim 2) | Week 16 (1 Month Post-Intervention) | 62.11 T-score |
| Attention Control Condition | Change in FMS Pain as Measured by PROMIS Pain Interference - Short Form 6b (Aim 2) | Week 16 (1 Month Post-Intervention) | 60.73 T-score |
| Attention Control Condition | Change in FMS Pain as Measured by PROMIS Pain Interference - Short Form 6b (Aim 2) | Baseline | 62.78 T-score |
| Attention Control Condition | Change in FMS Pain as Measured by PROMIS Pain Interference - Short Form 6b (Aim 2) | Week 11 (Post-Intervention) | 62.60 T-score |
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Interference scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.44595% CI: [-2.97, 1.31]Mixed Models Analysis
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Interference scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.20995% CI: [-0.78, 3.54]Mixed Models Analysis
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Interference scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.06395% CI: [-0.12, 4.54]Mixed Models Analysis
Secondary
Change in Physical Functioning as Measured by PROMIS Fatigue - Short Form 6a (Aim 2)
Fatigue T-scores measured by PROMIS Fatigue Short Form 6a. This 6-item instrument assesses a patient's a patient's level of fatigue over a 7-day recall period. Respondents report fatigue on a 5-point scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 33.4 to 76.8. Lower T-scores represent better outcomes.
Time frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Population: For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11, n = 2 lost to follow-up from Week 11 to Week 16. For the Attention Control, n = 3 lost to follow-up at Week 11. Intention-to-treat analyses were conducted for participants completing Baseline and Post-Intervention (n = 43 in LARKSPUR intervention, n = 43 in Attention Control Condition).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| All Recruited Participants Pre-Randomization | Change in Physical Functioning as Measured by PROMIS Fatigue - Short Form 6a (Aim 2) | Baseline | 66.88 T-score |
| All Recruited Participants Pre-Randomization | Change in Physical Functioning as Measured by PROMIS Fatigue - Short Form 6a (Aim 2) | Week 11 (Post-Intervention) | 62.32 T-score |
| All Recruited Participants Pre-Randomization | Change in Physical Functioning as Measured by PROMIS Fatigue - Short Form 6a (Aim 2) | Week 16 (1 Month Post-Intervention) | 61.96 T-score |
| Attention Control Condition | Change in Physical Functioning as Measured by PROMIS Fatigue - Short Form 6a (Aim 2) | Baseline | 62.79 T-score |
| Attention Control Condition | Change in Physical Functioning as Measured by PROMIS Fatigue - Short Form 6a (Aim 2) | Week 11 (Post-Intervention) | 61.55 T-score |
| Attention Control Condition | Change in Physical Functioning as Measured by PROMIS Fatigue - Short Form 6a (Aim 2) | Week 16 (1 Month Post-Intervention) | 63.62 T-score |
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Fatigue scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.60195% CI: [-2.14, 3.69]Mixed Models Analysis
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Fatigue scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.26995% CI: [-4.6, 1.29]Mixed Models Analysis
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Fatigue scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.11695% CI: [-5.47, 0.61]Mixed Models Analysis
Secondary
Change in Physical Functioning as Measured by PROMIS Physical Functioning Short Form 10a (Aim 2)
Physical function T-scores measured by PROMIS Physical Function Short Form 10a. This 10-item instrument assesses a patient's abilities and limitations with respect to everyday physical activities. Respondents report limitations on a 5-point scale: 5=Not at all, ..., 3=Somewhat, ..., 1=Cannot do, and abilities to perform activities on a 5-point scale: 5=Without any difficulty, ..., 3=With some difficulty, ..., 1=Unable to do. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 13.5 to 61.9. Higher T-scores represent better outcomes.
Time frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Population: For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11, n = 2 lost to follow-up from Week 11 to Week 16. For the Attention Control, n = 3 lost to follow-up at Week 11. Intention-to-treat analyses were conducted for participants completing Baseline and Post-Intervention (n = 43 in LARKSPUR intervention, n = 43 in Attention Control Condition).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| All Recruited Participants Pre-Randomization | Change in Physical Functioning as Measured by PROMIS Physical Functioning Short Form 10a (Aim 2) | Baseline | 36.72 T-score |
| All Recruited Participants Pre-Randomization | Change in Physical Functioning as Measured by PROMIS Physical Functioning Short Form 10a (Aim 2) | Week 11 (Post-Intervention) | 38.71 T-score |
| All Recruited Participants Pre-Randomization | Change in Physical Functioning as Measured by PROMIS Physical Functioning Short Form 10a (Aim 2) | Week 16 (1 Month Post-Intervention) | 39.39 T-score |
| Attention Control Condition | Change in Physical Functioning as Measured by PROMIS Physical Functioning Short Form 10a (Aim 2) | Baseline | 36.99 T-score |
| Attention Control Condition | Change in Physical Functioning as Measured by PROMIS Physical Functioning Short Form 10a (Aim 2) | Week 11 (Post-Intervention) | 38.46 T-score |
| Attention Control Condition | Change in Physical Functioning as Measured by PROMIS Physical Functioning Short Form 10a (Aim 2) | Week 16 (1 Month Post-Intervention) | 38.18 T-score |
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Physical Functioning scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.79295% CI: [-1.63, 2.13]Mixed Models Analysis
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Physical Functioning scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.20995% CI: [-0.69, 3.09]Mixed Models Analysis
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.15195% CI: [-0.35, 2.26]Mixed Models Analysis
Secondary
Change in Positive Affect as Measured by the Modified Differential Emotions Scale (mDES) (Aim 2)
The modified Differential Emotions Scale (mDES) is a 20-item instrument that measures the extent to which a patient has experienced positive and negative emotions over a chosen time frame; in the version used in this study, we ask for emotions over the past 7 days. Respondents are asked to report the greatest amount of a given emotion on a five-point scale: 0=Not at all, 1=A little bit, 2=Moderately, 3=Quite a bit, 4=Extremely. mDES mean scores range from 0 (not at all experienced positive emotion) to 4 (extremely positive emotion).
Time frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Population: For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11, n = 2 lost to follow-up from Week 11 to Week 16. For the Attention Control, n = 3 lost to follow-up at Week 11. Intention-to-treat analyses were conducted for participants completing Baseline and Post-Intervention (n = 43 in LARKSPUR intervention, n = 43 in Attention Control Condition).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| All Recruited Participants Pre-Randomization | Change in Positive Affect as Measured by the Modified Differential Emotions Scale (mDES) (Aim 2) | Baseline | 1.94 units on a scale |
| All Recruited Participants Pre-Randomization | Change in Positive Affect as Measured by the Modified Differential Emotions Scale (mDES) (Aim 2) | Week 16 (1 Month Post-Intervention) | 2.49 units on a scale |
| All Recruited Participants Pre-Randomization | Change in Positive Affect as Measured by the Modified Differential Emotions Scale (mDES) (Aim 2) | Week 11 (Post-Intervention) | 2.26 units on a scale |
| Attention Control Condition | Change in Positive Affect as Measured by the Modified Differential Emotions Scale (mDES) (Aim 2) | Week 11 (Post-Intervention) | 2.15 units on a scale |
| Attention Control Condition | Change in Positive Affect as Measured by the Modified Differential Emotions Scale (mDES) (Aim 2) | Baseline | 1.99 units on a scale |
| Attention Control Condition | Change in Positive Affect as Measured by the Modified Differential Emotions Scale (mDES) (Aim 2) | Week 16 (1 Month Post-Intervention) | 2.39 units on a scale |
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline mDES scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.38995% CI: [-0.15, 0.38]Mixed Models Analysis
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline mDES scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.15795% CI: [-0.07, 0.46]Mixed Models Analysis
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline mDES scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.59395% CI: [-0.21, 0.36]Mixed Models Analysis
Secondary
Change in Positive Affect as Measured by the Positive and Negative Affect Scale (PANAS-GEN) (Aim 2)
The 20-item self-report Positive and Negative Affect Scale (PANAS-GEN) asks participants to describe to what extent they feel different feelings and emotions on average. Respondents answer on a five-point scale: 0=Very slightly or not at all, 1=A little, 2=Moderately, 3=Quite a bit, 4=Extremely. PANAS-GEN mean scores range from 0 (very slightly or not at all positive affect) to 4 (extremely positive affect).
Time frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Population: For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11, n = 2 lost to follow-up from Week 11 to Week 16. For the Attention Control, n = 3 lost to follow-up at Week 11. Intention-to-treat analyses were conducted for participants completing Baseline and Post-Intervention (n = 43 in LARKSPUR intervention, n = 43 in Attention Control Condition).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| All Recruited Participants Pre-Randomization | Change in Positive Affect as Measured by the Positive and Negative Affect Scale (PANAS-GEN) (Aim 2) | Week 11 (Post-Intervention) | 1.88 units on a scale |
| All Recruited Participants Pre-Randomization | Change in Positive Affect as Measured by the Positive and Negative Affect Scale (PANAS-GEN) (Aim 2) | Baseline | 1.94 units on a scale |
| All Recruited Participants Pre-Randomization | Change in Positive Affect as Measured by the Positive and Negative Affect Scale (PANAS-GEN) (Aim 2) | Week 16 (1 Month Post-Intervention) | 2.04 units on a scale |
| Attention Control Condition | Change in Positive Affect as Measured by the Positive and Negative Affect Scale (PANAS-GEN) (Aim 2) | Week 11 (Post-Intervention) | 1.90 units on a scale |
| Attention Control Condition | Change in Positive Affect as Measured by the Positive and Negative Affect Scale (PANAS-GEN) (Aim 2) | Baseline | 1.99 units on a scale |
| Attention Control Condition | Change in Positive Affect as Measured by the Positive and Negative Affect Scale (PANAS-GEN) (Aim 2) | Week 16 (1 Month Post-Intervention) | 1.98 units on a scale |
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PANAS-GEN scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.93395% CI: [-0.26, 0.24]Mixed Models Analysis
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PANAS-GEN scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.64295% CI: [-0.19, 0.31]Mixed Models Analysis
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PANAS-GEN scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.57795% CI: [-0.18, 0.32]Mixed Models Analysis
Secondary
Change in Stress Appraisal as Measured by the Perceived Stress Scale (Aim 2)
The 10-item version of the Perceived Stress Scale (PSS) assesses the perception of stress over the previous month. Respondents report how often they have experienced perceived stress on a five-point scale: 0=Never, 1=Almost never, 2=Sometimes, 3=Fairly often, 4=Very often. PSS mean scores range from 0 (experienced no or minimal stress) to 4 (experienced very frequent stress).
Time frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Population: For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11, n = 2 lost to follow-up from Week 11 to Week 16. For the Attention Control, n = 3 lost to follow-up at Week 11. Intention-to-treat analyses were conducted for participants completing Baseline and Post-Intervention (n = 43 in LARKSPUR intervention, n = 43 in Attention Control Condition).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| All Recruited Participants Pre-Randomization | Change in Stress Appraisal as Measured by the Perceived Stress Scale (Aim 2) | Baseline | 1.87 units on a scale |
| All Recruited Participants Pre-Randomization | Change in Stress Appraisal as Measured by the Perceived Stress Scale (Aim 2) | Week 11 (Post-Intervention) | 1.55 units on a scale |
| All Recruited Participants Pre-Randomization | Change in Stress Appraisal as Measured by the Perceived Stress Scale (Aim 2) | Week 16 (1 Month Post-Intervention) | 1.48 units on a scale |
| Attention Control Condition | Change in Stress Appraisal as Measured by the Perceived Stress Scale (Aim 2) | Week 16 (1 Month Post-Intervention) | 1.69 units on a scale |
| Attention Control Condition | Change in Stress Appraisal as Measured by the Perceived Stress Scale (Aim 2) | Baseline | 1.65 units on a scale |
| Attention Control Condition | Change in Stress Appraisal as Measured by the Perceived Stress Scale (Aim 2) | Week 11 (Post-Intervention) | 1.65 units on a scale |
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PSS scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.40395% CI: [-0.32, 0.13]Mixed Models Analysis
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS PSS scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.06295% CI: [-0.44, 0.01]Mixed Models Analysis
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PSS scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.26995% CI: [-0.33, 0.09]Mixed Models Analysis
Other Pre-specified
Change in Affective Reactivity to Stress as Measured by the Daily Inventory of Stressful Events (DISE)
Affective reactivity to stress measured by the Daily Inventory of Stressful Events (DISE). Upon completion of each study assessment, patients completed the DISE daily for one week, for a total of three 7-day-long periods. The DISE is a 7-item self-report instrument in which participants report whether stressful events (argument, work or school stress, home stress, discrimination, close friend stress, other stressors) have occurred within the past 24 hours, indicating yes or no accordingly for each item. Item scores are averaged, ranging from 0=no stress to 1=highest stress. Higher scores indicate worse outcomes.
Time frame: At baseline, at week 11 (post-intervention); at week 16 (1 month post intervention)
Population: For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11, n = 2 lost to follow-up from Week 11 to Week 16. For the Attention Control, n = 3 lost to follow-up at Week 11. Intention-to-treat analyses were conducted for participants completing Baseline and Post-Intervention (n = 43 in LARKSPUR intervention, n = 43 in Attention Control Condition).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| All Recruited Participants Pre-Randomization | Change in Affective Reactivity to Stress as Measured by the Daily Inventory of Stressful Events (DISE) | Baseline | 0.21 units on a scale |
| All Recruited Participants Pre-Randomization | Change in Affective Reactivity to Stress as Measured by the Daily Inventory of Stressful Events (DISE) | Week 11 (Post-Intervention) | 0.21 units on a scale |
| All Recruited Participants Pre-Randomization | Change in Affective Reactivity to Stress as Measured by the Daily Inventory of Stressful Events (DISE) | Week 16 (1 Month Post-Intervention) | 0.19 units on a scale |
| Attention Control Condition | Change in Affective Reactivity to Stress as Measured by the Daily Inventory of Stressful Events (DISE) | Baseline | 0.17 units on a scale |
| Attention Control Condition | Change in Affective Reactivity to Stress as Measured by the Daily Inventory of Stressful Events (DISE) | Week 11 (Post-Intervention) | 0.17 units on a scale |
| Attention Control Condition | Change in Affective Reactivity to Stress as Measured by the Daily Inventory of Stressful Events (DISE) | Week 16 (1 Month Post-Intervention) | 0.16 units on a scale |
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.75895% CI: [-0.03, 0.05]Mixed Models Analysis
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.8895% CI: [-0.04, 0.04]Mixed Models Analysis
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.65295% CI: [-0.05, 0.03]Mixed Models Analysis
Other Pre-specified
Change in Affective Reactivity to Stress as Measured by the Daily Modified Differential Emotions Scale (mDES)
Positive affective reactivity measured by the modified Differential Emotions Scale (mDES). Upon completion of each study assessment, participants completed the mDES daily for one week, for a total of three 7-day-long periods. The mDES is a 20-item instrument that measures the extent to which a patient has experienced positive (10 items) and negative (10 items) emotions over a chosen time frame; in the version used in this survey, we ask for emotions over the past 24 hours. Respondents are asked to report the greatest amount of positive affect on a five-point scale: 0=Not at all, 1=A little bit, 2=Moderately, 3=Quite a bit, 4=Extremely. mDES mean scores were computed over the 10 items, ranging from 0 (not at all positive) to 4 (extremely positive).
Time frame: At baseline, at week 11 (post-intervention); at week 16 (1 month post intervention)
Population: For the LARKSPUR intervention, n = 6 lost to follow-up at Week 11, n = 2 lost to follow-up from Week 11 to Week 16. For the Attention Control, n = 3 lost to follow-up at Week 11. Intention-to-treat analyses were conducted for participants completing Baseline and Post-Intervention (n = 43 in LARKSPUR intervention, n = 43 in Attention Control Condition).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| All Recruited Participants Pre-Randomization | Change in Affective Reactivity to Stress as Measured by the Daily Modified Differential Emotions Scale (mDES) | Week 11 (Post-Intervention) | 1.83 units on a scale |
| All Recruited Participants Pre-Randomization | Change in Affective Reactivity to Stress as Measured by the Daily Modified Differential Emotions Scale (mDES) | Week 16 (1 Month Post-Intervention) | 1.79 units on a scale |
| All Recruited Participants Pre-Randomization | Change in Affective Reactivity to Stress as Measured by the Daily Modified Differential Emotions Scale (mDES) | Baseline | 1.68 units on a scale |
| Attention Control Condition | Change in Affective Reactivity to Stress as Measured by the Daily Modified Differential Emotions Scale (mDES) | Week 16 (1 Month Post-Intervention) | 1.64 units on a scale |
| Attention Control Condition | Change in Affective Reactivity to Stress as Measured by the Daily Modified Differential Emotions Scale (mDES) | Baseline | 1.70 units on a scale |
| Attention Control Condition | Change in Affective Reactivity to Stress as Measured by the Daily Modified Differential Emotions Scale (mDES) | Week 11 (Post-Intervention) | 1.66 units on a scale |
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.00395% CI: [0.07, 0.33]Mixed Models Analysis
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.00695% CI: [0.05, 0.31]Mixed Models Analysis
Comparison: The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.p-value: 0.79695% CI: [-0.15, 0.12]Mixed Models Analysis