Trial Outcomes & Findings for Positive Processes and Transition to Health (NCT NCT04678232)
NCT ID: NCT04678232
Last Updated: 2024-10-30
Results Overview
The Affective Updating task (Pe et al., 2013; Pe, Raes, et al., 2013) measures updating of affective information in working memory. The task requires participants to continuously monitor and modify relevant affective information in working memory. Performance is inhibited by rumination. Forty-seven positive and 49 negative words are included. Under high levels of stress, deficits in affective updating predict more depressive symptoms over one year (Pe et al., 2016) and efficiency of reappraisal (Pe et al., 2013). Affective updating in contrast, predicts subjective well-being (Pe et al., 2013). The AUT is scored using the mean proportion of correct responses across 4 types of stimulus sets (positive-positive-positive words, negative-negative-negative, positive-negative-positive, negative-positive-negative). Scores for the AUT range from 0 to 1. Lower scores reflect greater deficits in affecting updating, while higher scores indicate greater abilities with affective updating.
COMPLETED
NA
45 participants
Score at 6 weeks (immediately post treatment)
2024-10-30
Participant Flow
Participant milestones
| Measure |
Receive PATH Therapy
PATH includes six 60-90 min, weekly sessions, with two booster sessions for partial responders. Session 1 provides the PATH rationale and a review of life events (PATH of life: negative and positive). A rationale for an explicit focus on positive events/emotions will be provided. Sessions 2-4 focus on a verbal narrative of the destabilizing life event, reminiscence and processing of a major positive life event, and real-life practice to enact what was taught. Sessions 5 focuses on constructive processing and provides opportunity for integration and consolidation of learning. Session 6 focuses on future negative and positive events to promote application of new learning and resilience. Booster sessions focus on positive and negative life events since the last session and adaptive processes (constructive processing, approach, and reward). All sessions will include cultivation and elaboration of positive emotions to promote engagement and to build on the benefits of positive emotions.
Positive Processes and Transition to Health (PATH): See arm/group description for details regarding this intervention
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Overall Study
STARTED
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45
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Overall Study
COMPLETED
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40
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Overall Study
NOT COMPLETED
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5
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Missing data
Baseline characteristics by cohort
| Measure |
Receive PATH Therapy
n=45 Participants
PATH includes six 60-90 min, weekly sessions, with two booster sessions for partial responders. Session 1 provides the PATH rationale and a review of life events (PATH of life: negative and positive). A rationale for an explicit focus on positive events/emotions will be provided. Sessions 2-4 focus on a verbal narrative of the destabilizing life event, reminiscence and processing of a major positive life event, and real-life practice to enact what was taught. Sessions 5 focuses on constructive processing and provides opportunity for integration and consolidation of learning. Session 6 focuses on future negative and positive events to promote application of new learning and resilience. Booster sessions focus on positive and negative life events since the last session and adaptive processes (constructive processing, approach, and reward). All sessions will include cultivation and elaboration of positive emotions to promote engagement and to build on the benefits of positive emotions.
Positive Processes and Transition to Health (PATH): See arm/group description for details regarding this intervention
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Age, Categorical
<=18 years
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0 Participants
n=45 Participants
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Age, Categorical
Between 18 and 65 years
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45 Participants
n=45 Participants
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Age, Categorical
>=65 years
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0 Participants
n=45 Participants
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Age, Continuous
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35.98 years
STANDARD_DEVIATION 14.06 • n=45 Participants
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Sex: Female, Male
Female
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33 Participants
n=45 Participants
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Sex: Female, Male
Male
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12 Participants
n=45 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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6 Participants
n=45 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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39 Participants
n=45 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=45 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=45 Participants
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Race (NIH/OMB)
Asian
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2 Participants
n=45 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=45 Participants
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Race (NIH/OMB)
Black or African American
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3 Participants
n=45 Participants
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Race (NIH/OMB)
White
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35 Participants
n=45 Participants
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Race (NIH/OMB)
More than one race
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5 Participants
n=45 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=45 Participants
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Region of Enrollment
United States
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45 participants
n=45 Participants
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Affective Updating Task
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0.38 units on a scale
STANDARD_DEVIATION 0.23 • n=45 Participants
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Idiographic Behavioral Approach Task
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55.00 units on a scale
STANDARD_DEVIATION 23.27 • n=45 Participants
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Probabilistic Reward Task
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-0.08 units on a scale
STANDARD_DEVIATION 0.29 • n=45 Participants
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Posttraumatic Cognitions Inventory
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151.03 units on a scale
STANDARD_DEVIATION 42.07 • n=40 Participants • Missing data
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Behavioral Activation for Depression Scale
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71.35 units on a scale
STANDARD_DEVIATION 24.96 • n=40 Participants • Missing data
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Snaith-Hamilton Pleasure Scale
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25.25 units on a scale
STANDARD_DEVIATION 2.29 • n=40 Participants • Missing data
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PRIMARY outcome
Timeframe: Score at 6 weeks (immediately post treatment)The Affective Updating task (Pe et al., 2013; Pe, Raes, et al., 2013) measures updating of affective information in working memory. The task requires participants to continuously monitor and modify relevant affective information in working memory. Performance is inhibited by rumination. Forty-seven positive and 49 negative words are included. Under high levels of stress, deficits in affective updating predict more depressive symptoms over one year (Pe et al., 2016) and efficiency of reappraisal (Pe et al., 2013). Affective updating in contrast, predicts subjective well-being (Pe et al., 2013). The AUT is scored using the mean proportion of correct responses across 4 types of stimulus sets (positive-positive-positive words, negative-negative-negative, positive-negative-positive, negative-positive-negative). Scores for the AUT range from 0 to 1. Lower scores reflect greater deficits in affecting updating, while higher scores indicate greater abilities with affective updating.
Outcome measures
| Measure |
Receive PATH Therapy
n=40 Participants
PATH includes six 60-90 min, weekly sessions, with two booster sessions for partial responders. Session 1 provides the PATH rationale and a review of life events (PATH of life: negative and positive). A rationale for an explicit focus on positive events/emotions will be provided. Sessions 2-4 focus on a verbal narrative of the destabilizing life event, reminiscence and processing of a major positive life event, and real-life practice to enact what was taught. Sessions 5 focuses on constructive processing and provides opportunity for integration and consolidation of learning. Session 6 focuses on future negative and positive events to promote application of new learning and resilience. Booster sessions focus on positive and negative life events since the last session and adaptive processes (constructive processing, approach, and reward). All sessions will include cultivation and elaboration of positive emotions to promote engagement and to build on the benefits of positive emotions.
Positive Processes and Transition to Health (PATH): See arm/group description for details regarding this intervention
|
|---|---|
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Affective Updating Task (Pe et al., 2013; Pe, Raes, et al., 2013)
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0.54 units on a scale
Standard Deviation 0.23
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PRIMARY outcome
Timeframe: Score at 6 weeks (immediately post treatment)The Idiographic Behavioral Approach Task (BAT; Mori \& Aermendariz, 2001; Haynes, 2001) will use in vivo confrontation with feared or avoided stimuli measuring avoidance behavior. Each BAT is unique to each participant (e.g., news/videos of similar events, pictures of loved one). A general list of idiographic stimuli will be developed with participants, who will then approach the stimuli. The task requires participants to rate their subjective units of distress (SUDs) on a scale of 0-100 (0 = no distress, 100 = extreme distress). The primary outcome measured is mean peak SUDs. The mean peak SUDs is calculated by averaging together all of the participant's reported SUDs measured at their highest level of distress. Higher scores indicate a higher average level of distress across all items, and lower scores indicate less distress on average across all items.
Outcome measures
| Measure |
Receive PATH Therapy
n=37 Participants
PATH includes six 60-90 min, weekly sessions, with two booster sessions for partial responders. Session 1 provides the PATH rationale and a review of life events (PATH of life: negative and positive). A rationale for an explicit focus on positive events/emotions will be provided. Sessions 2-4 focus on a verbal narrative of the destabilizing life event, reminiscence and processing of a major positive life event, and real-life practice to enact what was taught. Sessions 5 focuses on constructive processing and provides opportunity for integration and consolidation of learning. Session 6 focuses on future negative and positive events to promote application of new learning and resilience. Booster sessions focus on positive and negative life events since the last session and adaptive processes (constructive processing, approach, and reward). All sessions will include cultivation and elaboration of positive emotions to promote engagement and to build on the benefits of positive emotions.
Positive Processes and Transition to Health (PATH): See arm/group description for details regarding this intervention
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|---|---|
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Idiographic Behavioral Approach Task
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25.65 score on a scale
Standard Deviation 22.47
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PRIMARY outcome
Timeframe: Score at 6 weeks (immediately post treatment)The Probabilistic Reward Task (PRT) assesses reward responsivity (e.g., Der-Avakian et al. 2013; Pizzagalli et al., 2005, 2008, 2008). In each trial, participants choose which of 2 difficult-to-differentiate stimuli was presented. Stimuli are groups of bunnies or dogs (diameter: 25 mm; eyes: 7 mm). Unknown to them, correct identification of the "rich stimulus" is rewarded 3 times more frequently ("Correct! You won 20 cents"). Reward propensity is calculated by increase in response bias during the final block relative to the first. Degree of response bias toward the frequently reinforced alternative is a robust measure of reward sensitivity (Pizzagalli et al., 2005, 2008; Vrieze et al., 2013). The PRT is administered online through Inquisit Lab on Millisecond. PRT scores range between -.75 to .65 (-.75 = lower reward sensitivity, .65 = greater reward sensitivity).
Outcome measures
| Measure |
Receive PATH Therapy
n=40 Participants
PATH includes six 60-90 min, weekly sessions, with two booster sessions for partial responders. Session 1 provides the PATH rationale and a review of life events (PATH of life: negative and positive). A rationale for an explicit focus on positive events/emotions will be provided. Sessions 2-4 focus on a verbal narrative of the destabilizing life event, reminiscence and processing of a major positive life event, and real-life practice to enact what was taught. Sessions 5 focuses on constructive processing and provides opportunity for integration and consolidation of learning. Session 6 focuses on future negative and positive events to promote application of new learning and resilience. Booster sessions focus on positive and negative life events since the last session and adaptive processes (constructive processing, approach, and reward). All sessions will include cultivation and elaboration of positive emotions to promote engagement and to build on the benefits of positive emotions.
Positive Processes and Transition to Health (PATH): See arm/group description for details regarding this intervention
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|---|---|
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Probabilistic Reward Task (Pizzagalli et al., 2005)
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-.03 score on a scale
Standard Deviation .25
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SECONDARY outcome
Timeframe: Score at 6 weeks (immediately post treatment)The Posttraumatic Cognitions Inventory (PTCI; Foa et al., 1999) is a self-report that measures negative posttraumatic stressor-related thoughts that can contribute to the development and maintenance of PTSD. The measure includes 33 items grouped into three subscales. The 21-item Negative Cognitions about Self scale measures negative self-perception since the traumatic event. The 7-item Negative Cognitions about the World subscale evaluates mistrust of others and perceptions of danger. The 5-item Self Blame scale measures self-blame since the traumatic incident. All items are measured on a scale from 1-7 with 1 indicating "totally disagree" and 7 indicating "totally agree." The total score for the PTCI ranges from 33 to 231 and is determined by summing the scores of each subscale. Higher scores reflect more rigid negative cognitions. Total scores were used.
Outcome measures
| Measure |
Receive PATH Therapy
n=38 Participants
PATH includes six 60-90 min, weekly sessions, with two booster sessions for partial responders. Session 1 provides the PATH rationale and a review of life events (PATH of life: negative and positive). A rationale for an explicit focus on positive events/emotions will be provided. Sessions 2-4 focus on a verbal narrative of the destabilizing life event, reminiscence and processing of a major positive life event, and real-life practice to enact what was taught. Sessions 5 focuses on constructive processing and provides opportunity for integration and consolidation of learning. Session 6 focuses on future negative and positive events to promote application of new learning and resilience. Booster sessions focus on positive and negative life events since the last session and adaptive processes (constructive processing, approach, and reward). All sessions will include cultivation and elaboration of positive emotions to promote engagement and to build on the benefits of positive emotions.
Positive Processes and Transition to Health (PATH): See arm/group description for details regarding this intervention
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|---|---|
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Posttraumatic Cognitions Inventory (Foa et al., 1999)
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102.05 score on a scale
Standard Deviation 43.14
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SECONDARY outcome
Timeframe: Score at 6 weeks (immediately post treatment)Behavioral Activation for Depression Scale (Secondary Measure; BADS; Kanter et al., 2006) is a 25- item self-report of approach and avoidance in cognitive and behavioral domains not specific to depression. Items are rated from 0 = Not at all to 6 = Completely. The measure contains four subscales which include Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment. Total scores, which range from 0-150 are calculated by summing the four subscales. A higher score indicates higher behavioral activation and lower scores indicate more depressive symptoms. The BADS has good factor structure, internal consistency, construct, and predictive validity (Kanter et al., 2009; Manos et al, 2011) and sensitivity to change (d =.86; CBT for depression, O'Mahen et al., 2017).
Outcome measures
| Measure |
Receive PATH Therapy
n=38 Participants
PATH includes six 60-90 min, weekly sessions, with two booster sessions for partial responders. Session 1 provides the PATH rationale and a review of life events (PATH of life: negative and positive). A rationale for an explicit focus on positive events/emotions will be provided. Sessions 2-4 focus on a verbal narrative of the destabilizing life event, reminiscence and processing of a major positive life event, and real-life practice to enact what was taught. Sessions 5 focuses on constructive processing and provides opportunity for integration and consolidation of learning. Session 6 focuses on future negative and positive events to promote application of new learning and resilience. Booster sessions focus on positive and negative life events since the last session and adaptive processes (constructive processing, approach, and reward). All sessions will include cultivation and elaboration of positive emotions to promote engagement and to build on the benefits of positive emotions.
Positive Processes and Transition to Health (PATH): See arm/group description for details regarding this intervention
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|---|---|
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Behavioral Activation for Depression Scale (Kanter et al., 2006)
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106.5 score on a scale
Standard Deviation 24.97
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SECONDARY outcome
Timeframe: Score at 6 weeks (immediately post treatment)Snaith-Hamilton Pleasure Scale (SHAPS; Snaith et al., 1995). The SHAPS is a 14- item self-report measuring the capacity to experience pleasure. On a four-point scale (1 = Strongly Agree to 4 = Strongly Disagree), varying statements are rated (e.g., "I would find pleasure in small things"; "I would find pleasure in a telephone call from a friend"). The measure has good convergent and discriminant validity and reflects a unidimensional construct of anhedonia (Leventhal et al., 2006; Nakonezny et al., 2010). Total scores are measured on a scale from 14 to 56 (14 = severe anhedonia, 56 = no anhedonia).
Outcome measures
| Measure |
Receive PATH Therapy
n=38 Participants
PATH includes six 60-90 min, weekly sessions, with two booster sessions for partial responders. Session 1 provides the PATH rationale and a review of life events (PATH of life: negative and positive). A rationale for an explicit focus on positive events/emotions will be provided. Sessions 2-4 focus on a verbal narrative of the destabilizing life event, reminiscence and processing of a major positive life event, and real-life practice to enact what was taught. Sessions 5 focuses on constructive processing and provides opportunity for integration and consolidation of learning. Session 6 focuses on future negative and positive events to promote application of new learning and resilience. Booster sessions focus on positive and negative life events since the last session and adaptive processes (constructive processing, approach, and reward). All sessions will include cultivation and elaboration of positive emotions to promote engagement and to build on the benefits of positive emotions.
Positive Processes and Transition to Health (PATH): See arm/group description for details regarding this intervention
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|---|---|
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Snaith-Hamilton Pleasure Scale (Snaith et al., 1995)
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21.79 score on a scale
Standard Deviation 2.69
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Adverse Events
Receive PATH Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place