Trial Outcomes & Findings for Positive Affect as a Source of Resilience for Adults in Chronic Pain (NCT NCT04869345)

NCT ID: NCT04869345

Last Updated: 2023-05-01

Results Overview

Percent enrolled of total eligible participants.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 95 participants
• Primary outcome timeframe: At baseline
• Results posted on: 2023-05-01

Participant Flow

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.

Participant milestones

Measure	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.	Attention Control Condition Daily emotion reporting/no intervention
Overall Study STARTED	49	46
Overall Study Post-Intervention Week 11	43	43
Overall Study 1 Month Follow-Up Week 16	41	43
Overall Study COMPLETED	41	43
Overall Study NOT COMPLETED	8	3

Reasons for withdrawal

Measure	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.	Attention Control Condition Daily emotion reporting/no intervention
Overall Study Lost to Follow-up	8	3

Baseline Characteristics

Positive Affect as a Source of Resilience for Adults in Chronic Pain

Baseline characteristics by cohort

Measure	LARKSPUR Intervention n=49 Participants 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.	Attention Control Condition n=46 Participants Daily emotion reporting/no intervention	Total n=95 Participants Total of all reporting groups
Age, Customized Between 50 and 59 years	18 Participants n=93 Participants	23 Participants n=4 Participants	41 Participants n=27 Participants
Age, Customized Between 60 and 69 years	22 Participants n=93 Participants	19 Participants n=4 Participants	41 Participants n=27 Participants
Age, Customized Between 70 and 79 years	8 Participants n=93 Participants	4 Participants n=4 Participants	12 Participants n=27 Participants
Age, Customized >= 80 years	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Sex: Female, Male Female	48 Participants n=93 Participants	42 Participants n=4 Participants	90 Participants n=27 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	4 Participants n=4 Participants	5 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=93 Participants	44 Participants n=4 Participants	92 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) White	40 Participants n=93 Participants	37 Participants n=4 Participants	77 Participants n=27 Participants
Race (NIH/OMB) More than one race	3 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants
Region of Enrollment United States	49 participants n=93 Participants	46 participants n=4 Participants	95 participants n=27 Participants
PROMIS Pain Intensity - Short Form 3a	63.31 T-score STANDARD_DEVIATION 6.32 • n=93 Participants	62.57 T-score STANDARD_DEVIATION 5.77 • n=4 Participants	62.95 T-score STANDARD_DEVIATION 6.04 • n=27 Participants
PROMIS Pain Interference - Short Form 6b	63.16 T-score STANDARD_DEVIATION 5.99 • n=93 Participants	62.72 T-score STANDARD_DEVIATION 4.94 • n=4 Participants	62.95 T-score STANDARD_DEVIATION 5.48 • n=27 Participants
PROMIS Physical Functioning Short Form 10a	36.99 T-score STANDARD_DEVIATION 6.03 • n=93 Participants	37.24 T-score STANDARD_DEVIATION 5.59 • n=4 Participants	37.11 T-score STANDARD_DEVIATION 5.79 • n=27 Participants
PROMIS Fatigue - Short Form 6a	66.20 T-score STANDARD_DEVIATION 7.09 • n=93 Participants	63.31 T-score STANDARD_DEVIATION 6.92 • n=4 Participants	64.80 T-score STANDARD_DEVIATION 7.12 • n=27 Participants
Depressive Symptoms (Center for Epidemiologic Studies Depression Scale Revised, CESD-R-10)	1.23 units on a scale STANDARD_DEVIATION 0.54 • n=93 Participants	1.22 units on a scale STANDARD_DEVIATION 0.55 • n=4 Participants	1.22 units on a scale STANDARD_DEVIATION 0.54 • n=27 Participants
Positive Affect (modified Differential Emotions Scale, mDES)	1.68 units on a scale STANDARD_DEVIATION 0.80 • n=93 Participants	1.70 units on a scale STANDARD_DEVIATION 0.80 • n=4 Participants	1.69 units on a scale STANDARD_DEVIATION 0.80 • n=27 Participants
Positive Affect (Positive and Negative Affect Scale, PANAS-GEN)	1.89 units on a scale STANDARD_DEVIATION 0.72 • n=93 Participants	1.92 units on a scale STANDARD_DEVIATION 0.69 • n=4 Participants	1.90 units on a scale STANDARD_DEVIATION 0.70 • n=27 Participants
Stress Appraisal (Perceived Stress Scale)	1.86 units on a scale STANDARD_DEVIATION 0.71 • n=93 Participants	1.66 units on a scale STANDARD_DEVIATION 0.61 • n=4 Participants	1.77 units on a scale STANDARD_DEVIATION 0.66 • n=27 Participants

PRIMARY outcome

Timeframe: At baseline

Population: 120 of 142 participants recruited for the study who met eligibility requirements.

Percent enrolled of total eligible participants.

Outcome measures

Measure	All Recruited Participants Pre-Randomization n=120 Participants All participants recruited into the study screened for eligibility before randomization	Attention Control Condition Daily emotion reporting/no intervention
Recruitment as Measured by Rates of Enrollment (Aim 1) Eligible Participants	120 Participants	—
Recruitment as Measured by Rates of Enrollment (Aim 1) Enrolled Participants	95 Participants	—
Recruitment as Measured by Rates of Enrollment (Aim 1) Declined to Participate	22 Participants	—
Recruitment as Measured by Rates of Enrollment (Aim 1) Excluded by the Investigators	2 Participants	—
Recruitment as Measured by Rates of Enrollment (Aim 1) Unable to Access the Online Study Platform	1 Participants	—

PRIMARY outcome

Timeframe: At baseline; at week 11 (post-intervention)

Percentage enrolled at baseline that completed the post-intervention assessment.

Outcome measures

Measure	All Recruited Participants Pre-Randomization n=49 Participants All participants recruited into the study screened for eligibility before randomization	Attention Control Condition n=46 Participants Daily emotion reporting/no intervention
Retention as Measured by Change in Enrollment	43 Participants	43 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	All Recruited Participants Pre-Randomization n=43 Participants All participants recruited into the study screened for eligibility before randomization	Attention Control Condition n=43 Participants Daily emotion reporting/no intervention
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	9.05 units on a scale Standard Error 0.25
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	8.59 units on a scale Standard Error 0.30

PRIMARY outcome

Timeframe: 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.

Length of Intervention time as measured by number of weeks the participant took to complete the LARKSPUR intervention program.

Outcome measures

Measure	All Recruited Participants Pre-Randomization n=40 Participants All participants recruited into the study screened for eligibility before randomization	Attention Control Condition Daily emotion reporting/no intervention
Length of Intervention Time as Measured by Number of Weeks to Complete Intervention (Aim 1)	4.06 weeks Interval 4.01 to 4.17	—

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	All Recruited Participants Pre-Randomization n=43 Participants All participants recruited into the study screened for eligibility before randomization	Attention Control Condition n=43 Participants Daily emotion reporting/no intervention
Change in FMS Pain as Measured by PROMIS Pain Intensity - Short Form 3a (Aim 2) Baseline	63.64 T-score Interval 61.99 to 65.29	62.79 T-score Interval 61.01 to 64.57
Change in FMS Pain as Measured by PROMIS Pain Intensity - Short Form 3a (Aim 2) Week 11 (Post-Intervention)	61.22 T-score Interval 59.43 to 63.01	61.49 T-score Interval 59.69 to 63.28
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 Interval 60.16 to 63.82	61.55 T-score Interval 59.76 to 63.34

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	All Recruited Participants Pre-Randomization n=43 Participants All participants recruited into the study screened for eligibility before randomization	Attention Control Condition n=43 Participants Daily emotion reporting/no intervention
Change in FMS Pain as Measured by PROMIS Pain Interference - Short Form 6b (Aim 2) Baseline	63.63 T-score Interval 62.02 to 65.25	62.78 T-score Interval 61.24 to 64.32
Change in FMS Pain as Measured by PROMIS Pain Interference - Short Form 6b (Aim 2) Week 11 (Post-Intervention)	61.77 T-score Interval 60.26 to 63.28	62.60 T-score Interval 61.08 to 64.11
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 Interval 60.57 to 63.66	60.73 T-score Interval 59.22 to 62.25

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	All Recruited Participants Pre-Randomization n=43 Participants All participants recruited into the study screened for eligibility before randomization	Attention Control Condition n=43 Participants Daily emotion reporting/no intervention
Change in Physical Functioning as Measured by PROMIS Physical Functioning Short Form 10a (Aim 2) Baseline	36.72 T-score Interval 34.92 to 38.53	36.99 T-score Interval 35.28 to 38.69
Change in Physical Functioning as Measured by PROMIS Physical Functioning Short Form 10a (Aim 2) Week 11 (Post-Intervention)	38.71 T-score Interval 37.39 to 40.04	38.46 T-score Interval 37.14 to 39.79
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 Interval 38.05 to 40.73	38.18 T-score Interval 36.86 to 39.51

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	All Recruited Participants Pre-Randomization n=43 Participants All participants recruited into the study screened for eligibility before randomization	Attention Control Condition n=43 Participants Daily emotion reporting/no intervention
Change in Physical Functioning as Measured by PROMIS Fatigue - Short Form 6a (Aim 2) Baseline	66.88 T-score Interval 65.02 to 68.73	62.79 T-score Interval 60.68 to 64.89
Change in Physical Functioning as Measured by PROMIS Fatigue - Short Form 6a (Aim 2) Week 11 (Post-Intervention)	62.32 T-score Interval 60.25 to 64.4	61.55 T-score Interval 59.5 to 63.6
Change in Physical Functioning as Measured by PROMIS Fatigue - Short Form 6a (Aim 2) Week 16 (1 Month Post-Intervention)	61.96 T-score Interval 59.85 to 64.08	63.62 T-score Interval 61.57 to 65.67

SECONDARY outcome

Timeframe: 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).

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).

Outcome measures

Measure	All Recruited Participants Pre-Randomization n=43 Participants All participants recruited into the study screened for eligibility before randomization	Attention Control Condition n=43 Participants Daily emotion reporting/no intervention
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 Interval 1.09 to 1.43	1.19 units on a scale Interval 1.02 to 1.36
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 Interval 1.02 to 1.25	1.07 units on a scale Interval 0.96 to 1.19
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 Interval 1.27 to 1.51	1.26 units on a scale Interval 1.15 to 1.38

SECONDARY outcome

Timeframe: 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).

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).

Outcome measures

Measure	All Recruited Participants Pre-Randomization n=43 Participants All participants recruited into the study screened for eligibility before randomization	Attention Control Condition n=43 Participants Daily emotion reporting/no intervention
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 Interval 2.08 to 2.45	2.15 units on a scale Interval 1.96 to 2.34
Change in Positive Affect as Measured by the Modified Differential Emotions Scale (mDES) (Aim 2) Baseline	1.94 units on a scale Interval 1.72 to 2.16	1.99 units on a scale Interval 1.79 to 2.19
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 Interval 2.3 to 2.68	2.39 units on a scale Interval 2.12 to 2.48

SECONDARY outcome

Timeframe: 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).

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).

Outcome measures

Measure	All Recruited Participants Pre-Randomization n=43 Participants All participants recruited into the study screened for eligibility before randomization	Attention Control Condition n=43 Participants Daily emotion reporting/no intervention
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 Interval 1.86 to 2.22	1.98 units on a scale Interval 1.8 to 2.16
Change in Positive Affect as Measured by the Positive and Negative Affect Scale (PANAS-GEN) (Aim 2) Baseline	1.94 units on a scale Interval 1.72 to 2.16	1.99 units on a scale Interval 1.79 to 2.19
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 Interval 1.71 to 2.06	1.90 units on a scale Interval 1.72 to 2.07

SECONDARY outcome

Timeframe: 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).

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).

Outcome measures

Measure	All Recruited Participants Pre-Randomization n=43 Participants All participants recruited into the study screened for eligibility before randomization	Attention Control Condition n=43 Participants Daily emotion reporting/no intervention
Change in Stress Appraisal as Measured by the Perceived Stress Scale (Aim 2) Baseline	1.87 units on a scale Interval 1.65 to 2.09	1.65 units on a scale Interval 1.46 to 1.83
Change in Stress Appraisal as Measured by the Perceived Stress Scale (Aim 2) Week 11 (Post-Intervention)	1.55 units on a scale Interval 1.4 to 1.71	1.65 units on a scale Interval 1.49 to 1.81
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 Interval 1.32 to 1.64	1.69 units on a scale Interval 1.54 to 1.85

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

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).

Outcome measures

Measure	All Recruited Participants Pre-Randomization n=43 Participants All participants recruited into the study screened for eligibility before randomization	Attention Control Condition n=43 Participants Daily emotion reporting/no intervention
Change in Affective Reactivity to Stress as Measured by the Daily Modified Differential Emotions Scale (mDES) Baseline	1.68 units on a scale Interval 1.47 to 1.87	1.70 units on a scale Interval 1.5 to 1.9
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 Interval 1.62 to 2.03	1.66 units on a scale Interval 1.46 to 1.86
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 Interval 1.59 to 1.99	1.64 units on a scale Interval 1.44 to 1.84

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

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.

Outcome measures

Measure	All Recruited Participants Pre-Randomization n=43 Participants All participants recruited into the study screened for eligibility before randomization	Attention Control Condition n=43 Participants Daily emotion reporting/no intervention
Change in Affective Reactivity to Stress as Measured by the Daily Inventory of Stressful Events (DISE) Baseline	0.21 units on a scale Interval 0.16 to 0.26	0.17 units on a scale Interval 0.12 to 0.22
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 Interval 0.16 to 0.26	0.17 units on a scale Interval 0.12 to 0.21
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 Interval 0.14 to 0.24	0.16 units on a scale Interval 0.11 to 0.2

Adverse Events

LARKSPUR Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Attention Control Condition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Anthony Ong

Cornell University

Phone: 6072559993

Email: anthony.ong@cornell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place