Trial Outcomes & Findings for Supplementing Brief Psychotherapy With a Mobile App (NCT NCT05867316)

Results Overview

This is an 11-point scale regarding momentary self-reported intensity of suicidal urges ("Right now, how strongly do you want to kill yourself?". A score of 0 is equivalent to no suicidal thinking at all ("not at all"), a score of 10 is a score of very extreme suicidal thinking ("Extremely). Lower scores equal less severe suicidal thinking (i.e., a better outcome). Scores are averaged across all participants and all instances of survey completion.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

66 participants

Primary outcome timeframe

Assessed immediately before and immediately after each in-app skills-practice exercise, across the 28-day (4-week) post-discharge monitoring period; averaged across exercises within participant.

Results posted on

2026-08-25

Participant Flow

Patients were recruited from an inpatient unit in an open-label study, in which all participants received the same treatment.

Participant milestones

Participant milestones
Measure	Unified Protocol Unified Protocol-based cognitive behavioral therapy comprising three individual sessions with a study therapist, followed by a 28-day ecological momentary assessment (EMA) and ecological momentary intervention (EMI) period post-discharge from the hospital. EMA prompts assessed momentary experiences, and EMI prompts provided opportunities to apply skills learned in therapy in real-world contexts. Overall, the intervention focused on enhancing adaptive responses to negative emotions. Sessions emphasized three core components: (1) developing nonjudgmental awareness of emotional experiences (e.g., physical sensations, thoughts, and urges) to reduce impulsive responding; (2) increasing cognitive flexibility by identifying and reappraising unhelpful thought patterns; and (3) reducing emotion-driven behaviors by replacing avoidant or automatic responses (e.g., isolation, avoidance) with proactive, goal-directed behaviors. The EMI allowed participants an opportunity for guided practice of each of the skills learned in therapy.
Overall Study STARTED	66
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Unified Protocol Unified Protocol-based cognitive behavioral therapy comprising three individual sessions with a study therapist, followed by a 28-day ecological momentary assessment (EMA) and ecological momentary intervention (EMI) period post-discharge from the hospital. EMA prompts assessed momentary experiences, and EMI prompts provided opportunities to apply skills learned in therapy in real-world contexts. Overall, the intervention focused on enhancing adaptive responses to negative emotions. Sessions emphasized three core components: (1) developing nonjudgmental awareness of emotional experiences (e.g., physical sensations, thoughts, and urges) to reduce impulsive responding; (2) increasing cognitive flexibility by identifying and reappraising unhelpful thought patterns; and (3) reducing emotion-driven behaviors by replacing avoidant or automatic responses (e.g., isolation, avoidance) with proactive, goal-directed behaviors. The EMI allowed participants an opportunity for guided practice of each of the skills learned in therapy.
Overall Study Withdrawal by Subject	6

Baseline Characteristics

Supplementing Brief Psychotherapy With a Mobile App

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Unified Protocol n=60 Participants Unified Protocol-based treatment, with three sessions
Age, Continuous	27.8 Years STANDARD_DEVIATION 11.9 • n=31 Participants
Sex: Female, Male Female	33 Participants n=31 Participants
Sex: Female, Male Male	27 Participants n=31 Participants
Race/Ethnicity, Customized Hispanic/Latine	20 Participants n=31 Participants
Race/Ethnicity, Customized Not Hispanic/Latine	39 Participants n=31 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=31 Participants

PRIMARY outcome

Timeframe: Assessed immediately before and immediately after each in-app skills-practice exercise, across the 28-day (4-week) post-discharge monitoring period; averaged across exercises within participant.

Population: This reflects participants who had ecological momentary assessment (EMA) data

This is an 11-point scale regarding momentary self-reported intensity of suicidal urges ("Right now, how strongly do you want to kill yourself?". A score of 0 is equivalent to no suicidal thinking at all ("not at all"), a score of 10 is a score of very extreme suicidal thinking ("Extremely). Lower scores equal less severe suicidal thinking (i.e., a better outcome). Scores are averaged across all participants and all instances of survey completion.

Outcome measures

Outcome measures
Measure	Unified Protocol n=38 Participants Unified Protocol-based treatment, with three sessions
Momentary Suicidal Thinking Before skills practice	0.43 units on a scale Standard Deviation 1.52 • Interval -0.41 to 0.16
Momentary Suicidal Thinking After skills practice	0.36 units on a scale Standard Deviation 0.85

PRIMARY outcome

Timeframe: Beginning of study and end-of-study, approximately four weeks post discharge

Population: Total number of participants with available self-efficacy for managing negative emotion data.

Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) self-efficacy for managing negative emotions scale. The scale is measured with four five-point scale items, summed to a score ranging from 4 to 20 where higher scores are better.

Outcome measures

Outcome measures
Measure	Unified Protocol n=40 Participants Unified Protocol-based treatment, with three sessions
Self-efficacy for Managing Negative Emotion Beginning of study	7.17 Scores on a scale Standard Deviation 3.85
Self-efficacy for Managing Negative Emotion End of study	8.60 Scores on a scale Standard Deviation 3.23

SECONDARY outcome

Timeframe: Assessed immediately before and immediately after each in-app skills-practice exercise, across the 28-day (4-week) post-discharge monitoring period; averaged across exercises within participant.

Negative emotion ("How negative do you feel right now?") on a 0 to 10 scale, where 0 is not at all negative (i.e., better) and 10 is extremely negative. Slopes were extracted for each participant and then those values were averaged over the whole sample.

Outcome measures

Outcome measures
Measure	Unified Protocol n=38 Participants Unified Protocol-based treatment, with three sessions
Negative Emotion Before skills practice	2.88 units on a scale Standard Deviation 2.74 • Interval -0.68 to -0.06
Negative Emotion After skills practice	2.562 units on a scale Standard Deviation 2.563

Adverse Events

Unified Protocol

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

Evan Kleiman

Rutgers, The State University of New Jersey

Phone: 2153596148

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place