Trial Outcomes & Findings for Evaluating Digital Micro-Interventions to Reduce Distress and Increase Wellbeing in Breast Cancer Survivors (NCT NCT07160439)

NCT ID: NCT07160439

Last Updated: 2026-08-13

Results Overview

12 item scale measuring satisfaction and acceptability. Each question is scored on a 0-4 scale with a total raw summed score range of 0-48. Higher scores indicate greater satisfaction and acceptability. Note, this measure could only be administered at post because it requires that participants used the intervention they were assigned, which was provided after they completed the baseline questionnaire battery.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

Post 1 week

Results posted on

2026-08-13

Participant Flow

No significant events occurred between the enrollment and assignment of participants.

Participant milestones

Participant milestones
Measure
Behavioral Activation
Participants are led through an automated process of identifying tasks they can accomplish in their daily lives.
Savoring
Participants are asked to think of a positive and personally meaningful memory to meditate on. They are led through steps to enter their memory, which is then summarized and turned into a meditation practice.
Gratitude
Participants are asked to generate a list of things they are grateful for. They are led through an automated process of selecting a source of gratitude and reflecting on it.
Challenging UnhelpfulThoughts
Participants are taught how to identify unhelpful thoughts, challenge them, and generate more balanced, helpful thoughts through an automated process that leads them step-by-step.
Psychoeducation
Participants receive access to psychoeducation content on mental health, distress, and well-being. They are provided tidbits of information every day to learn from.
Acceptance
Participants are led through an automated process of accepting, rather than actively trying to push away, their distressing emotions or thoughts.
Overall Study
STARTED
20
20
20
20
20
20
Overall Study
COMPLETED
18
18
16
15
16
19
Overall Study
NOT COMPLETED
2
2
4
5
4
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating Digital Micro-Interventions to Reduce Distress and Increase Wellbeing in Breast Cancer Survivors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Savoring
n=18 Participants
Participants are asked to think of a positive and personally meaningful memory to meditate on. They are led through steps to enter their memory, which is then summarized and turned into a meditation practice.
Gratitude
n=17 Participants
Participants are asked to generate a list of things they are grateful for. They are led through an automated process of selecting a source of gratitude and reflecting on it.
Challenging UnhelpfulThoughts
n=16 Participants
Participants are taught how to identify unhelpful thoughts, challenge them, and generate more balanced, helpful thoughts through an automated process that leads them step-by-step.
Psychoeducation
n=16 Participants
Participants receive access to psychoeducation content on mental health, distress, and well-being. They are provided tidbits of information every day to learn from.
Behavioral Activation
n=19 Participants
Participants are led through an automated process of identifying tasks they can accomplish in their daily lives.
Acceptance
n=20 Participants
Participants are led through an automated process of accepting, rather than actively trying to push away, their distressing emotions or thoughts.
Total
n=106 Participants
Total of all reporting groups
Sex: Female, Male
Male
0 Participants
n=1 Participants
0 Participants
n=1 Participants
0 Participants
n=1 Participants
0 Participants
n=2 Participants
0 Participants
0 Participants
n=5 Participants
0 Participants
n=82 Participants
Age, Categorical
<=18 years
0 Participants
n=1 Participants
0 Participants
n=1 Participants
0 Participants
n=1 Participants
0 Participants
n=2 Participants
0 Participants
0 Participants
n=5 Participants
0 Participants
n=82 Participants
Age, Categorical
Between 18 and 65 years
15 Participants
n=1 Participants
17 Participants
n=1 Participants
14 Participants
n=1 Participants
14 Participants
n=2 Participants
17 Participants
17 Participants
n=5 Participants
94 Participants
n=82 Participants
Age, Categorical
>=65 years
3 Participants
n=1 Participants
0 Participants
n=1 Participants
2 Participants
n=1 Participants
2 Participants
n=2 Participants
2 Participants
3 Participants
n=5 Participants
12 Participants
n=82 Participants
Sex: Female, Male
Female
18 Participants
n=1 Participants
17 Participants
n=1 Participants
16 Participants
n=1 Participants
16 Participants
n=2 Participants
19 Participants
20 Participants
n=5 Participants
106 Participants
n=82 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=1 Participants
0 Participants
n=1 Participants
0 Participants
n=1 Participants
1 Participants
n=2 Participants
0 Participants
0 Participants
n=5 Participants
2 Participants
n=82 Participants
Race (NIH/OMB)
Asian
2 Participants
n=1 Participants
1 Participants
n=1 Participants
0 Participants
n=1 Participants
1 Participants
n=2 Participants
0 Participants
1 Participants
n=5 Participants
5 Participants
n=82 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=1 Participants
0 Participants
n=1 Participants
0 Participants
n=1 Participants
0 Participants
n=2 Participants
0 Participants
0 Participants
n=5 Participants
0 Participants
n=82 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=1 Participants
2 Participants
n=1 Participants
0 Participants
n=1 Participants
3 Participants
n=2 Participants
0 Participants
1 Participants
n=5 Participants
7 Participants
n=82 Participants
Race (NIH/OMB)
White
13 Participants
n=1 Participants
11 Participants
n=1 Participants
10 Participants
n=1 Participants
10 Participants
n=2 Participants
14 Participants
17 Participants
n=5 Participants
75 Participants
n=82 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=1 Participants
1 Participants
n=1 Participants
1 Participants
n=1 Participants
0 Participants
n=2 Participants
2 Participants
0 Participants
n=5 Participants
4 Participants
n=82 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=1 Participants
2 Participants
n=1 Participants
5 Participants
n=1 Participants
1 Participants
n=2 Participants
3 Participants
1 Participants
n=5 Participants
13 Participants
n=82 Participants

PRIMARY outcome

Timeframe: Post 1 week

Population: Any differences between the numbers here and the numbers of participants assigned to the groups in the Participant Flow is due to participants choosing to skip this measure.

12 item scale measuring satisfaction and acceptability. Each question is scored on a 0-4 scale with a total raw summed score range of 0-48. Higher scores indicate greater satisfaction and acceptability. Note, this measure could only be administered at post because it requires that participants used the intervention they were assigned, which was provided after they completed the baseline questionnaire battery.

Outcome measures

Outcome measures
Measure
Savoring
n=18 Participants
Participants are asked to think of a positive and personally meaningful memory to meditate on. They are led through steps to enter their memory, which is then summarized and turned into a meditation practice.
Gratitude
n=16 Participants
Participants are asked to generate a list of things they are grateful for. They are led through an automated process of selecting a source of gratitude and reflecting on it.
Challenging UnhelpfulThoughts
n=12 Participants
Participants are taught how to identify unhelpful thoughts, challenge them, and generate more balanced, helpful thoughts through an automated process that leads them step-by-step.
Psychoeducation
n=15 Participants
Participants receive access to psychoeducation content on mental health, distress, and well-being. They are provided tidbits of information every day to learn from.
Behavioral Activation
n=18 Participants
Participants are led through an automated process of identifying tasks they can accomplish in their daily lives.
Acceptance
n=18 Participants
Participants are led through an automated process of accepting, rather than actively trying to push away, their distressing emotions or thoughts.
Evaluation of Digital Micro-Intervention
32.8 score on a scale
Standard Deviation 6.0
33.6 score on a scale
Standard Deviation 4.3
31.6 score on a scale
Standard Deviation 7.9
35.3 score on a scale
Standard Deviation 8.4
31.8 score on a scale
Standard Deviation 9.2
30.6 score on a scale
Standard Deviation 7.4

SECONDARY outcome

Timeframe: Baseline

Population: Any difference between the numbers here and the numbers of participants assigned to the groups in the Participant Flow are due to participants choosing to skip this measure.

24 items that measure various physical and mental health subdomains. Each question is scored on a 1-5 scale. The total raw score for Mental Health is composed of the 2 subdomains of Anxiety and Depression range from 8-40, where higher scores indicate worse overall mental health. The total raw score for Physical Health is composed of the 4 subdomains of Physical Function, Fatigue, Sleep Disturbance, and Ability to Participate in Social Activities, range from 16-80, where higher scores indicate worse overall physical health. The 4-item Pain Interference subscale and an item that assesses pain from 1-10 were omitted from the original PROMIS-29 Profile to limit redundancy with another pain measure.

Outcome measures

Outcome measures
Measure
Savoring
n=18 Participants
Participants are asked to think of a positive and personally meaningful memory to meditate on. They are led through steps to enter their memory, which is then summarized and turned into a meditation practice.
Gratitude
n=17 Participants
Participants are asked to generate a list of things they are grateful for. They are led through an automated process of selecting a source of gratitude and reflecting on it.
Challenging UnhelpfulThoughts
n=16 Participants
Participants are taught how to identify unhelpful thoughts, challenge them, and generate more balanced, helpful thoughts through an automated process that leads them step-by-step.
Psychoeducation
n=16 Participants
Participants receive access to psychoeducation content on mental health, distress, and well-being. They are provided tidbits of information every day to learn from.
Behavioral Activation
n=19 Participants
Participants are led through an automated process of identifying tasks they can accomplish in their daily lives.
Acceptance
n=20 Participants
Participants are led through an automated process of accepting, rather than actively trying to push away, their distressing emotions or thoughts.
PROMIS-29 Profile
Physical Health
35.5 score on a scale
Standard Deviation 7.5
36.5 score on a scale
Standard Deviation 8.7
36.4 score on a scale
Standard Deviation 7.3
36.9 score on a scale
Standard Deviation 6.9
34.1 score on a scale
Standard Deviation 6.0
35.0 score on a scale
Standard Deviation 7.3
PROMIS-29 Profile
Mental Health
24.3 score on a scale
Standard Deviation 5.1
23.9 score on a scale
Standard Deviation 7.4
23.1 score on a scale
Standard Deviation 7.6
20.8 score on a scale
Standard Deviation 5.4
20.7 score on a scale
Standard Deviation 5.8
21.5 score on a scale
Standard Deviation 5.3

SECONDARY outcome

Timeframe: Post 1 week

Population: Any difference between the numbers here and the numbers of participants assigned to the groups in the Participant Flow are due to participants choosing to skip this measure.

24 items that measure various physical and mental health subdomains. Each question is scored on a 1-5 scale. The total raw score for Mental Health is composed of the 2 subdomains of Anxiety and Depression range from 8-40, where higher scores indicate worse overall mental health. The total raw score for Physical Health is composed of the 4 subdomains of Physical Function, Fatigue, Sleep Disturbance, and Ability to Participate in Social Activities, range from 16-80, where higher scores indicate worse overall physical health. The 4-item Pain Interference subscale and an item that assesses pain from 1-10 were omitted from the original PROMIS-29 Profile to limit redundancy with another pain measure.

Outcome measures

Outcome measures
Measure
Savoring
n=18 Participants
Participants are asked to think of a positive and personally meaningful memory to meditate on. They are led through steps to enter their memory, which is then summarized and turned into a meditation practice.
Gratitude
n=16 Participants
Participants are asked to generate a list of things they are grateful for. They are led through an automated process of selecting a source of gratitude and reflecting on it.
Challenging UnhelpfulThoughts
n=15 Participants
Participants are taught how to identify unhelpful thoughts, challenge them, and generate more balanced, helpful thoughts through an automated process that leads them step-by-step.
Psychoeducation
n=16 Participants
Participants receive access to psychoeducation content on mental health, distress, and well-being. They are provided tidbits of information every day to learn from.
Behavioral Activation
n=18 Participants
Participants are led through an automated process of identifying tasks they can accomplish in their daily lives.
Acceptance
n=19 Participants
Participants are led through an automated process of accepting, rather than actively trying to push away, their distressing emotions or thoughts.
PROMIS-29 Profile
Physical Health
31.3 score on a scale
Standard Deviation 8.4
34.9 score on a scale
Standard Deviation 10.1
33.1 score on a scale
Standard Deviation 6.2
33.9 score on a scale
Standard Deviation 6.0
32.9 score on a scale
Standard Deviation 6.6
32.2 score on a scale
Standard Deviation 7.2
PROMIS-29 Profile
Mental Health
16.5 score on a scale
Standard Deviation 12.1
21.4 score on a scale
Standard Deviation 8.2
11.8 score on a scale
Standard Deviation 7.8
17.1 score on a scale
Standard Deviation 4.9
17.8 score on a scale
Standard Deviation 5.3
19.3 score on a scale
Standard Deviation 6.2

SECONDARY outcome

Timeframe: Baseline

Population: Any difference between the numbers here and the numbers of participants assigned to the groups in the Participant Flow are due to participants choosing to skip this measure. Specific to the Savoring group, this measure was initially inadvertently left out of the baseline questionnaire battery and added later during recruitment.

Assesses chronic pain based on 3 items, each one ranging from 0-10. Scores range from 0-30, with higher scores indicating more pain severity and interference.

Outcome measures

Outcome measures
Measure
Savoring
n=4 Participants
Participants are asked to think of a positive and personally meaningful memory to meditate on. They are led through steps to enter their memory, which is then summarized and turned into a meditation practice.
Gratitude
n=17 Participants
Participants are asked to generate a list of things they are grateful for. They are led through an automated process of selecting a source of gratitude and reflecting on it.
Challenging UnhelpfulThoughts
n=15 Participants
Participants are taught how to identify unhelpful thoughts, challenge them, and generate more balanced, helpful thoughts through an automated process that leads them step-by-step.
Psychoeducation
n=16 Participants
Participants receive access to psychoeducation content on mental health, distress, and well-being. They are provided tidbits of information every day to learn from.
Behavioral Activation
n=18 Participants
Participants are led through an automated process of identifying tasks they can accomplish in their daily lives.
Acceptance
n=20 Participants
Participants are led through an automated process of accepting, rather than actively trying to push away, their distressing emotions or thoughts.
Pain, Enjoyment of Life and General Activity (PEG) Scale
15.3 score on a scale
Standard Deviation 8.3
13.0 score on a scale
Standard Deviation 7.6
12.9 score on a scale
Standard Deviation 8.2
14.6 score on a scale
Standard Deviation 6.3
13.7 score on a scale
Standard Deviation 8.2
10.8 score on a scale
Standard Deviation 7.4

SECONDARY outcome

Timeframe: Post 1 week

Population: Any difference between the numbers here and the numbers of participants assigned to the groups in the Participant Flow are due to participants choosing to skip this measure. Specific to the Savoring group, this measure was inadvertently left out of the baseline questionnaire battery and only assessed in 4 participants at baseline, and therefore Post 1 week data from this measure were assessed in those 4 participants.

Assesses chronic pain based on 3 items, each one ranging from 0-10. Scores range from 0-30, with higher scores indicating more pain severity and interference.

Outcome measures

Outcome measures
Measure
Savoring
n=4 Participants
Participants are asked to think of a positive and personally meaningful memory to meditate on. They are led through steps to enter their memory, which is then summarized and turned into a meditation practice.
Gratitude
n=15 Participants
Participants are asked to generate a list of things they are grateful for. They are led through an automated process of selecting a source of gratitude and reflecting on it.
Challenging UnhelpfulThoughts
n=15 Participants
Participants are taught how to identify unhelpful thoughts, challenge them, and generate more balanced, helpful thoughts through an automated process that leads them step-by-step.
Psychoeducation
n=16 Participants
Participants receive access to psychoeducation content on mental health, distress, and well-being. They are provided tidbits of information every day to learn from.
Behavioral Activation
n=18 Participants
Participants are led through an automated process of identifying tasks they can accomplish in their daily lives.
Acceptance
n=19 Participants
Participants are led through an automated process of accepting, rather than actively trying to push away, their distressing emotions or thoughts.
Pain, Enjoyment of Life and General Activity (PEG) Scale
16.5 score on a scale
Standard Deviation 12.1
11.9 score on a scale
Standard Deviation 8.7
11.8 score on a scale
Standard Deviation 7.8
13.6 score on a scale
Standard Deviation 6.8
12.6 score on a scale
Standard Deviation 7.8
10.1 score on a scale
Standard Deviation 7.3

SECONDARY outcome

Timeframe: Baseline

Population: Any difference between the numbers here and the numbers of participants assigned to the groups in the Participant Flow are due to participants choosing to skip this measure.

A 10 item scale to reassess for two emotion regulation strategies: cognitive reappraisal and expressive suppression. Participants rate each item on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree). Scores for each subscale range from 1-7 (after dividing by the number of items), with higher scores indicating a greater tendency to use that particular emotion regulation strategy.

Outcome measures

Outcome measures
Measure
Savoring
n=18 Participants
Participants are asked to think of a positive and personally meaningful memory to meditate on. They are led through steps to enter their memory, which is then summarized and turned into a meditation practice.
Gratitude
n=17 Participants
Participants are asked to generate a list of things they are grateful for. They are led through an automated process of selecting a source of gratitude and reflecting on it.
Challenging UnhelpfulThoughts
n=16 Participants
Participants are taught how to identify unhelpful thoughts, challenge them, and generate more balanced, helpful thoughts through an automated process that leads them step-by-step.
Psychoeducation
n=16 Participants
Participants receive access to psychoeducation content on mental health, distress, and well-being. They are provided tidbits of information every day to learn from.
Behavioral Activation
n=18 Participants
Participants are led through an automated process of identifying tasks they can accomplish in their daily lives.
Acceptance
n=20 Participants
Participants are led through an automated process of accepting, rather than actively trying to push away, their distressing emotions or thoughts.
Emotion Regulation Questionnaire
cognitive reappraisal
4.1 score on a scale
Standard Deviation 1.4
4.5 score on a scale
Standard Deviation 1.2
4.6 score on a scale
Standard Deviation 1.6
4.5 score on a scale
Standard Deviation 0.9
4.1 score on a scale
Standard Deviation 1.3
4.3 score on a scale
Standard Deviation 0.9
Emotion Regulation Questionnaire
expressive suppression
4.3 score on a scale
Standard Deviation 1.2
4.0 score on a scale
Standard Deviation 1.3
3.8 score on a scale
Standard Deviation 1.1
4.6 score on a scale
Standard Deviation 1.4
4.2 score on a scale
Standard Deviation 1.5
3.9 score on a scale
Standard Deviation 1.7

SECONDARY outcome

Timeframe: Post 1 week

Population: Any difference between the numbers here and the numbers of participants assigned to the groups in the Participant Flow are due to participants choosing to skip this measure.

A 10 item scale to reassess for two emotion regulation strategies: cognitive reappraisal and expressive suppression. Participants rate each item on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree). Scores for each subscale range from 1-7 (after dividing by the number of items), with higher scores indicating a greater tendency to use that particular emotion regulation strategy.

Outcome measures

Outcome measures
Measure
Savoring
n=18 Participants
Participants are asked to think of a positive and personally meaningful memory to meditate on. They are led through steps to enter their memory, which is then summarized and turned into a meditation practice.
Gratitude
n=16 Participants
Participants are asked to generate a list of things they are grateful for. They are led through an automated process of selecting a source of gratitude and reflecting on it.
Challenging UnhelpfulThoughts
n=15 Participants
Participants are taught how to identify unhelpful thoughts, challenge them, and generate more balanced, helpful thoughts through an automated process that leads them step-by-step.
Psychoeducation
n=16 Participants
Participants receive access to psychoeducation content on mental health, distress, and well-being. They are provided tidbits of information every day to learn from.
Behavioral Activation
n=18 Participants
Participants are led through an automated process of identifying tasks they can accomplish in their daily lives.
Acceptance
n=18 Participants
Participants are led through an automated process of accepting, rather than actively trying to push away, their distressing emotions or thoughts.
Emotion Regulation Questionnaire
cognitive reappraisal
5.2 score on a scale
Standard Deviation 0.7
4.8 score on a scale
Standard Deviation 1.2
4.9 score on a scale
Standard Deviation 1.1
4.8 score on a scale
Standard Deviation 0.8
4.3 score on a scale
Standard Deviation 1.1
4.7 score on a scale
Standard Deviation 0.9
Emotion Regulation Questionnaire
expressive suppression
4.2 score on a scale
Standard Deviation 1.0
3.7 score on a scale
Standard Deviation 1.0
3.8 score on a scale
Standard Deviation 1.1
4.2 score on a scale
Standard Deviation 1.4
3.8 score on a scale
Standard Deviation 1.4
3.6 score on a scale
Standard Deviation 1.6

SECONDARY outcome

Timeframe: Baseline

Population: Any difference between the numbers here and the numbers of participants assigned to the groups in the Participant Flow are due to participants choosing to skip this measure.

A 7-item measure to evaluate severity of insomnia symptoms. Each item is evaluated on a scale from 0-4. Scores range from 0-28, with higher scores indicating greater severity of insomnia symptoms.

Outcome measures

Outcome measures
Measure
Savoring
n=18 Participants
Participants are asked to think of a positive and personally meaningful memory to meditate on. They are led through steps to enter their memory, which is then summarized and turned into a meditation practice.
Gratitude
n=17 Participants
Participants are asked to generate a list of things they are grateful for. They are led through an automated process of selecting a source of gratitude and reflecting on it.
Challenging UnhelpfulThoughts
n=16 Participants
Participants are taught how to identify unhelpful thoughts, challenge them, and generate more balanced, helpful thoughts through an automated process that leads them step-by-step.
Psychoeducation
n=16 Participants
Participants receive access to psychoeducation content on mental health, distress, and well-being. They are provided tidbits of information every day to learn from.
Behavioral Activation
n=18 Participants
Participants are led through an automated process of identifying tasks they can accomplish in their daily lives.
Acceptance
n=20 Participants
Participants are led through an automated process of accepting, rather than actively trying to push away, their distressing emotions or thoughts.
Insomnia Severity Index
16.4 score on a scale
Standard Deviation 6.0
18.2 score on a scale
Standard Deviation 7.5
17.8 score on a scale
Standard Deviation 3.9
19.7 score on a scale
Standard Deviation 4.1
14.3 score on a scale
Standard Deviation 5.5
14.7 score on a scale
Standard Deviation 4.3

SECONDARY outcome

Timeframe: Post 1 week

Population: Any difference between the numbers here and the numbers of participants assigned to the groups in the Participant Flow are due to participants choosing to skip this measure.

A 7-item measure to evaluate severity of insomnia symptoms. Each item is evaluated on a scale from 0-4. Scores range from 0-28, with higher scores indicating greater severity of insomnia symptoms.

Outcome measures

Outcome measures
Measure
Savoring
n=18 Participants
Participants are asked to think of a positive and personally meaningful memory to meditate on. They are led through steps to enter their memory, which is then summarized and turned into a meditation practice.
Gratitude
n=16 Participants
Participants are asked to generate a list of things they are grateful for. They are led through an automated process of selecting a source of gratitude and reflecting on it.
Challenging UnhelpfulThoughts
n=13 Participants
Participants are taught how to identify unhelpful thoughts, challenge them, and generate more balanced, helpful thoughts through an automated process that leads them step-by-step.
Psychoeducation
n=16 Participants
Participants receive access to psychoeducation content on mental health, distress, and well-being. They are provided tidbits of information every day to learn from.
Behavioral Activation
n=18 Participants
Participants are led through an automated process of identifying tasks they can accomplish in their daily lives.
Acceptance
n=19 Participants
Participants are led through an automated process of accepting, rather than actively trying to push away, their distressing emotions or thoughts.
Insomnia Severity Index
14.8 score on a scale
Standard Deviation 6.5
16.6 score on a scale
Standard Deviation 7.6
13.3 score on a scale
Standard Deviation 4.6
16.4 score on a scale
Standard Deviation 4.4
13.4 score on a scale
Standard Deviation 5.3
13.5 score on a scale
Standard Deviation 5.1

SECONDARY outcome

Timeframe: Baseline

Population: Any difference between the numbers here and the numbers of participants assigned to the groups in the Participant Flow are due to participants choosing to skip this measure.

8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.

Outcome measures

Outcome measures
Measure
Savoring
n=18 Participants
Participants are asked to think of a positive and personally meaningful memory to meditate on. They are led through steps to enter their memory, which is then summarized and turned into a meditation practice.
Gratitude
n=16 Participants
Participants are asked to generate a list of things they are grateful for. They are led through an automated process of selecting a source of gratitude and reflecting on it.
Challenging UnhelpfulThoughts
n=15 Participants
Participants are taught how to identify unhelpful thoughts, challenge them, and generate more balanced, helpful thoughts through an automated process that leads them step-by-step.
Psychoeducation
n=16 Participants
Participants receive access to psychoeducation content on mental health, distress, and well-being. They are provided tidbits of information every day to learn from.
Behavioral Activation
n=19 Participants
Participants are led through an automated process of identifying tasks they can accomplish in their daily lives.
Acceptance
n=20 Participants
Participants are led through an automated process of accepting, rather than actively trying to push away, their distressing emotions or thoughts.
Patient Health Questionnaire-8
13.2 score on a scale
Standard Deviation 4.9
14.6 score on a scale
Standard Deviation 5.6
13.4 score on a scale
Standard Deviation 4.5
13.6 score on a scale
Standard Deviation 4.8
12.7 score on a scale
Standard Deviation 10.6
13.6 score on a scale
Standard Deviation 4.8

SECONDARY outcome

Timeframe: Post 1 week

Population: Any difference between the numbers here and the numbers of participants assigned to the groups in the Participant Flow are due to participants choosing to skip this measure.

8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.

Outcome measures

Outcome measures
Measure
Savoring
n=18 Participants
Participants are asked to think of a positive and personally meaningful memory to meditate on. They are led through steps to enter their memory, which is then summarized and turned into a meditation practice.
Gratitude
n=16 Participants
Participants are asked to generate a list of things they are grateful for. They are led through an automated process of selecting a source of gratitude and reflecting on it.
Challenging UnhelpfulThoughts
n=15 Participants
Participants are taught how to identify unhelpful thoughts, challenge them, and generate more balanced, helpful thoughts through an automated process that leads them step-by-step.
Psychoeducation
n=16 Participants
Participants receive access to psychoeducation content on mental health, distress, and well-being. They are provided tidbits of information every day to learn from.
Behavioral Activation
n=18 Participants
Participants are led through an automated process of identifying tasks they can accomplish in their daily lives.
Acceptance
n=16 Participants
Participants are led through an automated process of accepting, rather than actively trying to push away, their distressing emotions or thoughts.
Patient Health Questionnaire-8
9.8 score on a scale
Standard Deviation 5.3
10.8 score on a scale
Standard Deviation 6.8
8.9 score on a scale
Standard Deviation 5.2
8.8 score on a scale
Standard Deviation 3.2
9.8 score on a scale
Standard Deviation 5.3
8.8 score on a scale
Standard Deviation 3.2

SECONDARY outcome

Timeframe: Baseline

Population: Any difference between the numbers here and the numbers of participants assigned to the groups in the Participant Flow are due to participants choosing to skip this measure.

7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.

Outcome measures

Outcome measures
Measure
Savoring
n=18 Participants
Participants are asked to think of a positive and personally meaningful memory to meditate on. They are led through steps to enter their memory, which is then summarized and turned into a meditation practice.
Gratitude
n=16 Participants
Participants are asked to generate a list of things they are grateful for. They are led through an automated process of selecting a source of gratitude and reflecting on it.
Challenging UnhelpfulThoughts
n=14 Participants
Participants are taught how to identify unhelpful thoughts, challenge them, and generate more balanced, helpful thoughts through an automated process that leads them step-by-step.
Psychoeducation
n=16 Participants
Participants receive access to psychoeducation content on mental health, distress, and well-being. They are provided tidbits of information every day to learn from.
Behavioral Activation
n=18 Participants
Participants are led through an automated process of identifying tasks they can accomplish in their daily lives.
Acceptance
n=20 Participants
Participants are led through an automated process of accepting, rather than actively trying to push away, their distressing emotions or thoughts.
Generalized Anxiety Disorder-7
11.4 score on a scale
Standard Deviation 4.1
13.4 score on a scale
Standard Deviation 4.5
11.4 score on a scale
Standard Deviation 5.2
12.4 score on a scale
Standard Deviation 4.3
10.6 score on a scale
Standard Deviation 3.1
12.2 score on a scale
Standard Deviation 4.1

SECONDARY outcome

Timeframe: Post 1 week

Population: Any difference between the numbers here and the numbers of participants assigned to the groups in the Participant Flow are due to participants choosing to skip this measure.

7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.

Outcome measures

Outcome measures
Measure
Savoring
n=18 Participants
Participants are asked to think of a positive and personally meaningful memory to meditate on. They are led through steps to enter their memory, which is then summarized and turned into a meditation practice.
Gratitude
n=16 Participants
Participants are asked to generate a list of things they are grateful for. They are led through an automated process of selecting a source of gratitude and reflecting on it.
Challenging UnhelpfulThoughts
n=14 Participants
Participants are taught how to identify unhelpful thoughts, challenge them, and generate more balanced, helpful thoughts through an automated process that leads them step-by-step.
Psychoeducation
n=16 Participants
Participants receive access to psychoeducation content on mental health, distress, and well-being. They are provided tidbits of information every day to learn from.
Behavioral Activation
n=18 Participants
Participants are led through an automated process of identifying tasks they can accomplish in their daily lives.
Acceptance
n=19 Participants
Participants are led through an automated process of accepting, rather than actively trying to push away, their distressing emotions or thoughts.
Generalized Anxiety Disorder-7
9.1 score on a scale
Standard Deviation 4.9
9.9 score on a scale
Standard Deviation 6.2
7.8 score on a scale
Standard Deviation 4.8
7.7 score on a scale
Standard Deviation 4.8
6.1 score on a scale
Standard Deviation 2.6
7.2 score on a scale
Standard Deviation 4.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Post 1 week

Population: Any difference between the numbers here and the numbers of participants assigned to the groups in the Participant Flow are due to participants choosing to skip this interview.

Remote interview to assess for participant feedback on usability, obstacles to use, and suggestions for improvement. The count of participants in each group that endorsed each theme is provided.

Outcome measures

Outcome measures
Measure
Savoring
n=15 Participants
Participants are asked to think of a positive and personally meaningful memory to meditate on. They are led through steps to enter their memory, which is then summarized and turned into a meditation practice.
Gratitude
n=14 Participants
Participants are asked to generate a list of things they are grateful for. They are led through an automated process of selecting a source of gratitude and reflecting on it.
Challenging UnhelpfulThoughts
n=9 Participants
Participants are taught how to identify unhelpful thoughts, challenge them, and generate more balanced, helpful thoughts through an automated process that leads them step-by-step.
Psychoeducation
n=12 Participants
Participants receive access to psychoeducation content on mental health, distress, and well-being. They are provided tidbits of information every day to learn from.
Behavioral Activation
n=14 Participants
Participants are led through an automated process of identifying tasks they can accomplish in their daily lives.
Acceptance
n=15 Participants
Participants are led through an automated process of accepting, rather than actively trying to push away, their distressing emotions or thoughts.
Qualitative Interview
Desire for expanding lists
0 Participants
4 Participants
0 Participants
0 Participants
3 Participants
0 Participants
Qualitative Interview
Desire for faster response time from the system
2 Participants
0 Participants
5 Participants
0 Participants
0 Participants
0 Participants
Qualitative Interview
Desire for clearer instructions that lists can be edited
0 Participants
4 Participants
0 Participants
0 Participants
2 Participants
0 Participants
Qualitative Interview
Desire for more even audio files
11 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Qualitative Interview
Desire for interactive quizzes to test knowledge
0 Participants
0 Participants
0 Participants
5 Participants
0 Participants
0 Participants
Qualitative Interview
Desire for stronger connection between values and daily actions
0 Participants
0 Participants
0 Participants
0 Participants
4 Participants
0 Participants
Qualitative Interview
Desire for more metaphor options to choose from
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
9 Participants

Adverse Events

Savoring

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Gratitude

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Challenging UnhelpfulThoughts

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Psychoeducation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Behavioral Activation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Acceptance

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

Philip Chow

University of Virginia

Phone: 4349248082

Results disclosure agreements

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