Trial Outcomes & Findings for Modeling Mood Course to Detect Markers for Effective Adaptive Interventions- Aim 3 (NCT NCT04098497)

Last Updated: 2022-01-03

Results Overview

Feasibility of the microintervention will be evaluated by measuring the average completion of the shortened Young Mania Rating Scale (YMRS) that will be delivered to participants through the mobile app. Number of completed surveys is reported. The Young Mania Rating Scale (YMRS) is a 11-item interview-based measure of manic symptoms. Scores on 3 items range from 0 to 8, whereas scores on the remaining 8 items range from 0 to 4. The total score of the YMRS can range from 0 to 60, with higher scores indicating more severe manic symptoms. The shortened scale used for the app includes three items (tracking the symptoms increased energy, rapid speech, and irritability) from the YMRS. The symptoms are scored on the following 0-3 scale: 0 = absent/normal 1. = mild 2. = moderate 3. = severe

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

30 participants

Primary outcome timeframe

Days 1-43

Results posted on

2022-01-03

Participant Flow

Milestones are not mutually exclusive; e.g., one participant could complete the exit interview, but never set up the Fitbit. All participants were included in at least one component of the analysis. The one participant who did not complete the final interview was not included in the analysis of safety outcomes. The four participants who were never randomized were not included in the analysis of effectiveness outcomes. All participants were included in the analysis of feasibility outcomes.

Participants were recruited from a longitudinal cohort of bipolar disorder, so initial screening was not needed

Participant milestones

Participant milestones
Measure	ACT-based Microintervention Delivered by Mobile App The ACT-based questions were developed by the research team as a unique intervention for the current study. They are based upon core themes of acceptance and commitment therapy: engagement, awareness, and openness. Mobile intervention: The mobile intervention in this study consists of two components: 1) self-monitoring and 2) an ACT-based microintervention. Self-monitoring: twice daily, participants will complete self-reports of mania, depression, medication adherence, and activity through the mobile app Lorevimo. Microintervention: The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action). At each time-point, participants have a 50% chance of receiving a microintervention question along with the daily self-monitoring assessments.
Overall Study STARTED	30
Overall Study Initial Interview	30
Overall Study Set Up Study App	29
Overall Study Logged Symptoms Into Study App at Least Once	26
Overall Study Linked Fitbit to Study Database	27
Overall Study Used Fitbit	24
Overall Study Exit Interview	29
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Modeling Mood Course to Detect Markers for Effective Adaptive Interventions- Aim 3

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ACT-based Microintervention Delivered by Mobile App n=30 Participants The ACT-based questions were developed by the research team as a unique intervention for the current study. They are based upon core themes of acceptance and commitment therapy: engagement, awareness, and openness. Mobile intervention: The mobile intervention in this study consists of two components: 1) self-monitoring and 2) an ACT-based microintervention. Self-monitoring: twice daily, participants will complete self-reports of mania, depression, medication adherence, and activity through the mobile app Lorevimo. Microintervention: The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action). At each time-point, participants have a 50% chance of receiving a microintervention question along with the daily self-monitoring assessments.
Age, Continuous	42.70 years STANDARD_DEVIATION 11.11 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants
Diagnosis Bipolar I	24 Participants n=5 Participants
Diagnosis Bipolar II	6 Participants n=5 Participants
Diagnosis Bipolar NOS	0 Participants n=5 Participants
Baseline HRSD Score	6.20 score on a scale STANDARD_DEVIATION 5.78 • n=5 Participants
Baseline YMRS Score	1.83 score on a scale STANDARD_DEVIATION 3.29 • n=5 Participants

PRIMARY outcome

Timeframe: Days 1-43

Population: All participants were included in the analysis of feasibility outcomes. 30 participants were planned to receive 84 decision points for a total possible number of 2520 surveys delivered.

Outcome measures

Outcome measures
Measure	ACT-based Microintervention Delivered by Mobile App n=2520 surveys delivered The ACT-based questions were developed by the research team as a unique intervention for the current study. They are based upon core themes of acceptance and commitment therapy: engagement, awareness, and openness. Mobile intervention: The mobile intervention in this study consists of two components: 1) self-monitoring and 2) an ACT-based microintervention. Self-monitoring: twice daily, participants will complete self-reports of mania, depression, medication adherence, and activity through the mobile app Lorevimo. Microintervention: The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action). At each time-point, participants have a 50% chance of receiving a microintervention question along with the daily self-monitoring assessments.
Number of Shortened YMRS Surveys Completed	1651 completed surveys

PRIMARY outcome

Timeframe: Days 1-43

Population: All participants were included in the analysis of feasibility outcomes. 30 participants were planned to receive 84 decision points for a total possible number of 2520 surveys delivered.

Feasibility of the microintervention will be evaluated using the average completion of the shortened Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D) that will be delivered to participants through the mobile app. Number of completed surveys is reported. The SIGH-D is a 17-item clinician-rated scale that assesses the severity of depressive symptoms. The total score is obtained by summing the score of each item, 0-4 (symptom is absent, mild, moderate, or severe) or 0-2 (absent, slight or trivial, clearly present). Scores can range from 0 to 54, with higher scores indicating more severe depression. The shortened SIGH-D assessment contains three items that track symptoms of depressed mood, fidgeting, and fatigue. The symptoms are scored on the following 0-3 scale: 0 = absent/normal 1. = mild 2. = moderate 3. = severe

Outcome measures

Outcome measures
Measure	ACT-based Microintervention Delivered by Mobile App n=2520 surveys delivered The ACT-based questions were developed by the research team as a unique intervention for the current study. They are based upon core themes of acceptance and commitment therapy: engagement, awareness, and openness. Mobile intervention: The mobile intervention in this study consists of two components: 1) self-monitoring and 2) an ACT-based microintervention. Self-monitoring: twice daily, participants will complete self-reports of mania, depression, medication adherence, and activity through the mobile app Lorevimo. Microintervention: The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action). At each time-point, participants have a 50% chance of receiving a microintervention question along with the daily self-monitoring assessments.
Number of Shortened SIGHD Surveys Completed	1651 completed surveys

PRIMARY outcome

Timeframe: Day 0, Day 42

Population: One participant did not complete the Exit Interview and therefore safety data is not available.

The safety of the microintervention will be assessed by examining the change in YMRS scores from the beginning of the study (YMRS administered in entrance interview) to the end (YMRS administered again in exit interview). The Young Mania Rating Scale (YMRS) is a 11-item interview-based measure of manic symptoms. Scores on 3 items range from 0 to 8, whereas scores on the remaining 8 items range from 0 to 4. The total score of the YMRS can range from 0 to 56, with higher scores indicating more severe manic symptoms.

Outcome measures

Outcome measures
Measure	ACT-based Microintervention Delivered by Mobile App n=29 Participants The ACT-based questions were developed by the research team as a unique intervention for the current study. They are based upon core themes of acceptance and commitment therapy: engagement, awareness, and openness. Mobile intervention: The mobile intervention in this study consists of two components: 1) self-monitoring and 2) an ACT-based microintervention. Self-monitoring: twice daily, participants will complete self-reports of mania, depression, medication adherence, and activity through the mobile app Lorevimo. Microintervention: The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action). At each time-point, participants have a 50% chance of receiving a microintervention question along with the daily self-monitoring assessments.
Change in YMRS Score	-1.2 score on a scale Standard Deviation 3.75

PRIMARY outcome

Timeframe: Day 0, Day 42

Population: One participant did not complete the Exit Interview and therefore safety data is not available.

The safety of the microintervention will be assessed by examining the change in SIGH-D scores from the beginning of the study (SIGH-D administered in entrance interview) to the end (SIGH-D administered again in exit interview). The SIGH-D is a 17-item clinician-rated scale that assesses the severity of depressive symptoms. The total score is obtained by summing the score of each item, 0-4 (symptom is absent, mild, moderate, or severe) or 0-2 (absent, slight or trivial, clearly present). Scores can range from 0 to 54, with higher scores indicating more severe depression.

Outcome measures

Outcome measures
Measure	ACT-based Microintervention Delivered by Mobile App n=29 Participants The ACT-based questions were developed by the research team as a unique intervention for the current study. They are based upon core themes of acceptance and commitment therapy: engagement, awareness, and openness. Mobile intervention: The mobile intervention in this study consists of two components: 1) self-monitoring and 2) an ACT-based microintervention. Self-monitoring: twice daily, participants will complete self-reports of mania, depression, medication adherence, and activity through the mobile app Lorevimo. Microintervention: The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action). At each time-point, participants have a 50% chance of receiving a microintervention question along with the daily self-monitoring assessments.
Change in SIGH-D Score	2.1 score on a scale Standard Deviation 6.59

SECONDARY outcome

Timeframe: data collected twice daily over 42 days (Days 1-43)

Mood was self-reported using the 6-item digital survey for mood in bipolar disorder (digiPB). This survey is comprised of 3 items (depressed mood, fatigue, fidgeting) measuring common depressive symptoms, two items (increased energy, rapid speech) measuring common manic symptoms, and one item (irritability) measuring a common symptom of both mania and depression. Each item is rated on ordinal scale: 0=absent/normal, 1=mild, 2=moderate, 3=severe. Two scores, d and m, are computed to measure severity of depressive and manic symptoms, respectively. The m score ranges from 0 to 18 with higher scores being most severe symptoms of mania. Self-reported mood was collected twice-daily over 42 days, once in the morning and once in the evening. This leads to a total of 84 decision time points. This outcome looks at the average change in the m score from one decision time point to the next (e.g., from morning to evening or from evening to the next morning) that is attributed to the intervention.

Outcome measures

Outcome measures
Measure	ACT-based Microintervention Delivered by Mobile App n=26 Participants The ACT-based questions were developed by the research team as a unique intervention for the current study. They are based upon core themes of acceptance and commitment therapy: engagement, awareness, and openness. Mobile intervention: The mobile intervention in this study consists of two components: 1) self-monitoring and 2) an ACT-based microintervention. Self-monitoring: twice daily, participants will complete self-reports of mania, depression, medication adherence, and activity through the mobile app Lorevimo. Microintervention: The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action). At each time-point, participants have a 50% chance of receiving a microintervention question along with the daily self-monitoring assessments.
Average Change in m Score on digiBP From One Decision Time Point to the Next Decision Time Point as a Result of the Intervention	0.14 score on a scale Interval -0.04 to 0.32

SECONDARY outcome

Timeframe: data collected twice daily over 42 days (Days 1-43)

Mood was self-reported using the 6-item digital survey for mood in bipolar disorder (digiPB). This survey is comprised of 3 items (depressed mood, fatigue, fidgeting) measuring common depressive symptoms, two items (increased energy, rapid speech) measuring common manic symptoms, and one item (irritability) measuring a common symptom of both mania and depression. Each item is rated on ordinal scale: 0=absent/normal, 1=mild, 2=moderate, 3=severe. Two scores, d and m, are computed to measure severity of depressive and manic symptoms, respectively. D score ranges from 0 to 21, higher scores being most severe symptoms of depression. Self-reported mood was collected twice-daily over 42 days, once in the morning and once in the evening. This leads to a total of 84 decision time points. This outcome looks at the average change in the d score from one decision time point to the next (e.g., from morning to evening or from evening to the next morning) that is attributed to the intervention.

Outcome measures

Outcome measures
Measure	ACT-based Microintervention Delivered by Mobile App n=26 Participants The ACT-based questions were developed by the research team as a unique intervention for the current study. They are based upon core themes of acceptance and commitment therapy: engagement, awareness, and openness. Mobile intervention: The mobile intervention in this study consists of two components: 1) self-monitoring and 2) an ACT-based microintervention. Self-monitoring: twice daily, participants will complete self-reports of mania, depression, medication adherence, and activity through the mobile app Lorevimo. Microintervention: The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action). At each time-point, participants have a 50% chance of receiving a microintervention question along with the daily self-monitoring assessments.
Average Change in d Score on digiBP From One Decision Time Point to the Next Decision Time Point as a Result of the Intervention	0.38 score on a scale Interval 0.11 to 0.65

SECONDARY outcome

Timeframe: data collected twice daily over 42 days (Days 1-43)

The effectiveness of the ACT micro-intervention will be assessed by looking at responses to the activity questionnaire in relation to whether or not a participant received a micro-intervention at the prior time-point. Since you \[woke this morning or last logged your symptoms\], how much energy was consumed by pursuing your values (example: making choices that align with who you want to be or who/what matters)? Questions are answered using a scale of 0-6, where 0 = "none" and 6 = "all of my energy." Self-reported toward energy was collected twice-daily over 42 days, once in the morning and once in the evening. This leads to a total of 84 decision time points. This outcome looks at the average change in toward energy from one decision time point to the next (e.g., from morning to evening or from evening to the next morning) that is attributed to the intervention.

Outcome measures

Outcome measures
Measure	ACT-based Microintervention Delivered by Mobile App n=26 Participants The ACT-based questions were developed by the research team as a unique intervention for the current study. They are based upon core themes of acceptance and commitment therapy: engagement, awareness, and openness. Mobile intervention: The mobile intervention in this study consists of two components: 1) self-monitoring and 2) an ACT-based microintervention. Self-monitoring: twice daily, participants will complete self-reports of mania, depression, medication adherence, and activity through the mobile app Lorevimo. Microintervention: The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action). At each time-point, participants have a 50% chance of receiving a microintervention question along with the daily self-monitoring assessments.
Average Change in Toward Energy Score From One Decision Time Point to the Next Decision Time Point as a Result of the Intervention	0.03 score on a scale Interval -0.07 to 0.14

SECONDARY outcome

Timeframe: data collected twice daily over 42 days (Days 1-43)

The effectiveness of the ACT micro-intervention will be assessed by looking at responses to the activity questionnaire in relation to whether or not a participant received a micro-intervention at the prior time-point. Since you \[woke this morning or last logged your symptoms\], how much energy was consumed by trying to get rid of unwanted feelings, thoughts, or other internal experiences (example: suppressing, distracting, avoiding)? Questions are answered using a scale of 0-6, where 0 = "none" and 6 = "all of my energy." Self-reported away energy was collected twice-daily over 42 days, once in the morning and once in the evening. This leads to a total of 84 decision time points. This outcome looks at the average change in away energy from one decision time point to the next (e.g., from morning to evening or from evening to the next morning) that is attributed to the intervention.

Outcome measures

Outcome measures
Measure	ACT-based Microintervention Delivered by Mobile App n=26 Participants The ACT-based questions were developed by the research team as a unique intervention for the current study. They are based upon core themes of acceptance and commitment therapy: engagement, awareness, and openness. Mobile intervention: The mobile intervention in this study consists of two components: 1) self-monitoring and 2) an ACT-based microintervention. Self-monitoring: twice daily, participants will complete self-reports of mania, depression, medication adherence, and activity through the mobile app Lorevimo. Microintervention: The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action). At each time-point, participants have a 50% chance of receiving a microintervention question along with the daily self-monitoring assessments.
Average Change in Away Energy Score From One Decision Time Point to the Next Decision Time Point as a Result of the Intervention	0.06 score on a scale Interval -0.04 to 0.16

Adverse Events

ACT-based Microintervention Delivered by Mobile App

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ACT-based Microintervention Delivered by Mobile App n=30 participants at risk The ACT-based questions were developed by the research team as a unique intervention for the current study. They are based upon core themes of acceptance and commitment therapy: engagement, awareness, and openness. Mobile intervention: The mobile intervention in this study consists of two components: 1) self-monitoring and 2) an ACT-based microintervention. Self-monitoring: twice daily, participants will complete self-reports of mania, depression, medication adherence, and activity through the mobile app Lorevimo. Microintervention: The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action). At each time-point, participants have a 50% chance of receiving a microintervention question along with the daily self-monitoring assessments.
Nervous system disorders Sensory Processing Disorder	3.3% 1/30 • Number of events 1 • up to day 42 Other Reportable Incidence or Occurrences (ORIOs) are also reported.
Product Issues Fitbit Specific Device Issues	30.0% 9/30 • Number of events 9 • up to day 42 Other Reportable Incidence or Occurrences (ORIOs) are also reported.
Product Issues Technology Issues	16.7% 5/30 • Number of events 5 • up to day 42 Other Reportable Incidence or Occurrences (ORIOs) are also reported.

Additional Information

Amy Cochran

University of Wisconsin - Madison

Phone: (608) 262-0772

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place