Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Change in Depressive Symptoms, as Measured by the 9-item Patient Health Questionnaire (PHQ-9). |
The 9-item Patient Health Questionnaire (PHQ-9) has a total score scale range of 0 to 27, with higher values indicating more depressive symptoms. Change in depressive symptoms was calculated as post-intervention minus baseline values. |
Baseline to post-intervention, over a period of 30 days. |
|
Other |
Change in Perceived Stress, as Measured by the 10-item Perceived Stress Scale (PSS) |
The 10-item Perceived Stress Scale (PSS) has a total score scale range of 0 to 40, with higher values indicating higher perceived stress. Change in perceived stress was calculated as post-intervention minus baseline values. |
Baseline to post-intervention, over a period of 30 days. |
|
Other |
Change in Anxiety, as Measured by the 7-item General Anxiety Disorder (GAD-7) Questionnaire |
The 7-item General Anxiety Disorder (GAD-7) questionnaire assesses symptoms of anxiety in the past 2 weeks. The total score scale ranges from 0 to 21, with higher values indicating higher anxiety. Change in anxiety was calculated as post-intervention minus baseline values. |
Baseline to post-intervention, over a period of 30 days. |
|
Primary |
Change in Stressor Demands, as Measured by Ecological Momentary Assessment (EMA) |
Stressor demands were measured by computing a total mean score of "I feel stressed, anxious, overwhelmed" and "I feel strained, upset, overburdened." The total mean score ranges from 1 to 7, with higher scores indicating greater stressor demands. Stressor demands were assessed at notification time points 3 times/day over a 30-day period. At each notification time point, participants completed EMAs of stressor demands immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Change in stressor demands was calculated as post-EMA minus pre-EMA. |
From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days. |
|
Primary |
Change in Negative Affect, as Measured by Ecological Momentary Assessment (EMA) |
Negative affect was measured by computing a total mean score of "I feel sad, downhearted, unhappy" and "I feel angry, irritated, frustrated." The total mean score ranges from 1 to 7, with higher scores indicating greater negative affect. Negative affect was measured at notification time points 3 times/day over a 30-day period. At each notification time point, participants completed EMAs of negative affect immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Change in negative affect was calculated as post-EMA minus pre-EMA. |
From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days. |
|
Secondary |
Change in Coping Resources, as Measured by Ecological Momentary Assessment (EMA) |
Coping resources were measured by computing a total mean score of "I feel in control, coping well, on top of things" and "I feel capable, competent, managing well." The total mean score ranges from 1 to 7, with higher scores indicating greater coping resources. Coping resources were measured at notification time points 3 times/day over a 30-day period. At each notification time point, participants completed EMAs of coping resources immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Change in coping resources was calculated as post-EMA minus pre-EMA. |
From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days. |
|
Secondary |
Change in Positive Affect, as Measured by Ecological Momentary Assessment (EMA) |
Positive affect was measured by computing a total mean score of "I feel joyful, glad, happy", "I feel calm, peaceful, quiet" and "I feel grateful, appreciative, thankful." The total mean score ranges from 1 to 7, with higher scores indicating greater positive affect. Positive affect was assessed at notification time points 3 times/day over a 30-day period. At each notification time point, participants completed EMAs of positive affect immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Changes in positive affect was calculated as post-EMA minus pre-EMA. |
From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days. |
|
Secondary |
Change in Perseverative Cognitions, as Measured by Ecological Momentary Assessment (EMA) |
Perseverative cognitions were measured by computing a total mean score of "I feel worried, concerned, uneasy" and "I dwell, ruminate, brood on my personal problems and feelings." The total mean score ranges from 1 to 7, with higher scores indicating greater perseverative cognitions (greater rumination/worry). Perseverative cognitions were assessed at notification time points 3 times/day over a 30-day period. At each notification time point, participants completed EMAs of perseverative cognitions immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Change in perseverative cognitions was calculated as post-EMA minus pre-EMA. |
From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days. |
|
Secondary |
Change in Self-criticism, as Measured by Ecological Momentary Assessment (EMA) |
Self-criticism were measured by computing a total mean score of "I feel self-critical, self-blaming, self-loathing" and "I feel inadequate, not good enough, unworthy." The total mean score ranges from 1 to 7, with higher scores indicating greater self-criticism. Self-criticism was assessed at notification time points 3 times/day over a 30-day period. At each notification time point, participants completed EMAs of self-criticism immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Change in self-criticism was calculated as post-EMA minus pre-EMA. |
From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days. |
|
Secondary |
Change in Social Connection, as Measured by Ecological Momentary Assessment (EMA) |
Social connection was measured by computing a total mean score of "I feel love, closeness, trust" and "I feel lonely, isolated, disconnected" [reverse coded]). The total mean score ranges from 1 to 7, with higher scores indicating greater social connection. Social connection was assessed at notification time points 3 times/day over a 30-day period. At each notification time point, participants completed EMAs of social connection immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Change in social connection was calculated as post-EMA minus pre-EMA. |
From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days. |
|
Secondary |
Change in Contextualized Stressor Demands, as Measured by Ecological Momentary Assessment (EMA) |
Participants were asked about current stressors ("Is there a stressful situation in your day right now?") using a 7-point scale (1 = "not at all"; 7 = "extremely"). If a response other than "not at all" was endorsed, contextualized stressor demands ("How demanding is it to deal with this situation well right now?") was measured on a 7-point scale (1 = "not at all"; 7 = "extremely") at notification time points 3 times/day over a 30-day period. At each notification time point, participants completed EMAs of contextualized stressor demands immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Change in contextualized stressor demands was calculated as post-EMA minus pre-EMA. |
From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days. |
|
Secondary |
Change in Contextualized Coping Resources, as Measured by Ecological Momentary Assessment (EMA) |
Participants were asked about current stressors ("Is there a stressful situation in your day right now?") using a 7-point scale (1 = "not at all"; 7 = "extremely"). If a response other than "not at all" was endorsed, contextualized coping resources ("Do you feel like you can handle this situation well right now?") were measured on a 7-point scale (1 = "not at all"; 7 = "extremely") at notification time points 3 times/day over a 30-day period. At each notification time point, participants completed EMAs of contextualized coping resources immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Change in contextualized coping resources was calculated as post-EMA minus pre-EMA. |
From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days. |
|
Secondary |
Change in Negative Stressor Impact, as Measured by Ecological Momentary Assessment (EMA) |
Participants were asked about current stressors ("Is there a stressful situation in your day right now?") using a 7-point scale (1 = "not at all"; 7 = "extremely"). If a response other than "not at all" was endorsed, negative stressor impact ["How much does this situation negatively impact you right now (e.g., interferes with your well-being or functioning)?"] was measured on a 7-point scale (1 = "not at all"; 7 = "extremely") at notification time points 3 times/day over a 30-day period. At each notification time point, participants completed EMAs of negative stressor impact immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Change in negative stressor impact was calculated as post-EMA minus pre-EMA. |
From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days. |
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