Trial Outcomes & Findings for Digital Mental Health Service for Non-Treatment Seeking Young Adults (NCT NCT04948268)

Last Updated: 2026-02-09

Results Overview

10-item self-report measure of transdiagnostic distress, used as outcome measure across diagnostic categories. Higher scores mean greater distress. Minimum score: 10; maximum score: 50

Recruitment status

COMPLETED

Study phase

Target enrollment

120 participants

Primary outcome timeframe

16 weeks

Results posted on

2026-02-09

Participant Flow

Participants were recruited from the Mental Health America (MHA) screening website. Website visitors who completed a depression or anxiety screening form and obtained a score of 10 or higher on either screener were eligible to see an advertisement for our study that contained a link to an informational page and eligibility screening form. Those meeting eligibility criteria were given an option of providing informed consent.

Prior to random assignment, participants who provided affirmative informed consent were required to have completed baseline assessments, confirm their ability to receive text messages as part of the intervention, and complete required payment forms.

Participant milestones

Participant milestones
Measure	Adaptive Digital Mental Health Intervention The adaptive intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content will be delivered via a URL in an SMS message. Machine learning will be used to tailor messages and timing to meet participant preferences.	Non-personalized Digital Mental Health Intervention The non-personalized intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Messages and content will not be tailored based on participants profile or usage.	Adaptive Digital Mental Health Intervention With Coaching The adaptive intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content will be delivered via a URL in an SMS message. Machine learning will be used to tailor messages and timing to meet participant preferences. Coaching will be provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).	Non-personalized Digital Mental Health Intervention With Coaching The non-personalized intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Messages and content will not be tailored based on participants profile or usage. Coaching will be provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).	Active Control The active control condition will provide brief text messages that include a URL link to psychoeducational content, but will not include the interactive messaging component described in experimental arms.
First Randomization STARTED	40	40	0	0	40
First Randomization COMPLETED	40	40	0	0	40
First Randomization NOT COMPLETED	0	0	0	0	0
Second Randomization STARTED	34	30	6	10	40
Second Randomization COMPLETED	34	29	6	10	40
Second Randomization NOT COMPLETED	0	1	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Grouping by initial treatment arm assignment

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 16 weeks

Population: Numbers are lower than participants assigned to groups due to loss to follow-up or incomplete data. Results are grouped per-arm and includes data from all participants with available data.

10-item self-report measure of transdiagnostic distress, used as outcome measure across diagnostic categories. Higher scores mean greater distress. Minimum score: 10; maximum score: 50

Outcome measures

Outcome measures
Measure	Non-personalized Digital Mental Health Intervention Without Coaching n=24 Participants The non-personalized intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Messages and content will not be tailored based on participants profile or usage.	Adaptive Digital Mental Health Intervention Without Coaching n=29 Participants The adaptive intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content will be delivered via a URL in an SMS message. Machine learning will be used to tailor messages and timing to meet participant preferences.	Adaptive Digital Mental Health Intervention With Coaching n=6 Participants The adaptive intervention consists of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content is delivered via a URL in an SMS message. Machine learning is be used to tailor messages and timing to meet participant preferences. Coaching is be provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).	Non-personalized Digital Mental Health Intervention With Coaching n=9 Participants The non-personalized intervention consists of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Messages and content are nottailored based on participants profile or usage. Coaching is provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).	Active Control n=31 Participants The active control condition will provide brief text messages that include a URL link to psychoeducational content, but will not include the interactive messaging component described in experimental arms.
Kessler Psychological Distress Scale	23.54 Score Standard Deviation 7.84	23.52 Score Standard Deviation 5.47	24.50 Score Standard Deviation 8.02	23.78 Score Standard Deviation 5.43	26.58 Score Standard Deviation 8.32

PRIMARY outcome

Timeframe: 62 days

Last message/content rating or click on content URL link received from participant. This measure can include select individuals who exceed 56 days of interaction due to user's ability to temporarily pause receipt of messages, resulting in messages extending beyond 8 weeks (56 days).

Outcome measures

Outcome measures
Measure	Non-personalized Digital Mental Health Intervention Without Coaching n=30 Participants The non-personalized intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Messages and content will not be tailored based on participants profile or usage.	Adaptive Digital Mental Health Intervention Without Coaching n=34 Participants The adaptive intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content will be delivered via a URL in an SMS message. Machine learning will be used to tailor messages and timing to meet participant preferences.	Adaptive Digital Mental Health Intervention With Coaching n=6 Participants The adaptive intervention consists of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content is delivered via a URL in an SMS message. Machine learning is be used to tailor messages and timing to meet participant preferences. Coaching is be provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).	Non-personalized Digital Mental Health Intervention With Coaching n=10 Participants The non-personalized intervention consists of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Messages and content are nottailored based on participants profile or usage. Coaching is provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).	Active Control n=40 Participants The active control condition will provide brief text messages that include a URL link to psychoeducational content, but will not include the interactive messaging component described in experimental arms.
Engagement Length	54.2 Days Standard Deviation 7.27	51.4 Days Standard Deviation 89.4	36.2 Days Standard Deviation 17.3	56.2 Days Standard Deviation 29.7	50.1 Days Standard Deviation 58.2

SECONDARY outcome

Timeframe: 16 weeks

Population: Differences in numbers from those assigned due to loss to follow-up or individuals with incomplete data. Results are grouped per arm and include data from all participants with available data.

10-item self-report measure assessing depression symptom severity. Higher scores mean greater symptom severity. Minimum score: 0; maximum score: 27

Outcome measures

Outcome measures
Measure	Non-personalized Digital Mental Health Intervention Without Coaching n=24 Participants The non-personalized intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Messages and content will not be tailored based on participants profile or usage.	Adaptive Digital Mental Health Intervention Without Coaching n=29 Participants The adaptive intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content will be delivered via a URL in an SMS message. Machine learning will be used to tailor messages and timing to meet participant preferences.	Adaptive Digital Mental Health Intervention With Coaching n=6 Participants The adaptive intervention consists of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content is delivered via a URL in an SMS message. Machine learning is be used to tailor messages and timing to meet participant preferences. Coaching is be provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).	Non-personalized Digital Mental Health Intervention With Coaching n=8 Participants The non-personalized intervention consists of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Messages and content are nottailored based on participants profile or usage. Coaching is provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).	Active Control n=30 Participants The active control condition will provide brief text messages that include a URL link to psychoeducational content, but will not include the interactive messaging component described in experimental arms.
Patient Health Questionnaire-9	8.79 Score Standard Deviation 5.15	9.59 Score Standard Deviation 4.79	9.83 Score Standard Deviation 9.28	9.50 Score Standard Deviation 5.15	11.77 Score Standard Deviation 7.21

SECONDARY outcome

Timeframe: 16 weeks

Population: Numbers are lower than participants assigned to groups due to loss to follow-up or incomplete data. Results are grouped per arm and include data from all participants with available data.

8-item self-report measure assessing generalized anxiety disorder symptom severity Higher scores mean greater symptom severity. Minimum score: 0; maximum score: 21

Outcome measures

Outcome measures
Measure	Non-personalized Digital Mental Health Intervention Without Coaching n=24 Participants The non-personalized intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Messages and content will not be tailored based on participants profile or usage.	Adaptive Digital Mental Health Intervention Without Coaching n=29 Participants The adaptive intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content will be delivered via a URL in an SMS message. Machine learning will be used to tailor messages and timing to meet participant preferences.	Adaptive Digital Mental Health Intervention With Coaching n=6 Participants The adaptive intervention consists of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content is delivered via a URL in an SMS message. Machine learning is be used to tailor messages and timing to meet participant preferences. Coaching is be provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).	Non-personalized Digital Mental Health Intervention With Coaching n=8 Participants The non-personalized intervention consists of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Messages and content are nottailored based on participants profile or usage. Coaching is provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).	Active Control n=30 Participants The active control condition will provide brief text messages that include a URL link to psychoeducational content, but will not include the interactive messaging component described in experimental arms.
Generalized Anxiety Disorder-7	7.54 Score Standard Deviation 5.80	7.93 Score Standard Deviation 3.83	4.67 Score Standard Deviation 4.27	7.37 Score Standard Deviation 4.10	9.47 Score Standard Deviation 5.85

OTHER_PRE_SPECIFIED outcome

Timeframe: 16 weeks

Population: Numbers are lower than participants assigned to groups due to loss to follow-up or incomplete data. Results are grouped per arm and thus include data from all participants with available data.

4-item self-report questionnaire assessing the frequency and intensity of suicidal thoughts over previous two weeks. Higher scores signal greater frequency and severity of suicidal thoughts. Minimum score: 0; maximum score: 12

Outcome measures

Outcome measures
Measure	Non-personalized Digital Mental Health Intervention Without Coaching n=24 Participants The non-personalized intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Messages and content will not be tailored based on participants profile or usage.	Adaptive Digital Mental Health Intervention Without Coaching n=29 Participants The adaptive intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content will be delivered via a URL in an SMS message. Machine learning will be used to tailor messages and timing to meet participant preferences.	Adaptive Digital Mental Health Intervention With Coaching n=6 Participants The adaptive intervention consists of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content is delivered via a URL in an SMS message. Machine learning is be used to tailor messages and timing to meet participant preferences. Coaching is be provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).	Non-personalized Digital Mental Health Intervention With Coaching n=8 Participants The non-personalized intervention consists of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Messages and content are nottailored based on participants profile or usage. Coaching is provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).	Active Control n=30 Participants The active control condition will provide brief text messages that include a URL link to psychoeducational content, but will not include the interactive messaging component described in experimental arms.
Depression Symptom Inventory - Suicidality Subscale	0.17 Score Standard Deviation 0.64	0.34 Score Standard Deviation 1.17	1.00 Score Standard Deviation 1.26	0.75 Score Standard Deviation 1.39	1.13 Score Standard Deviation 1.94

OTHER_PRE_SPECIFIED outcome

Timeframe: 16 weeks

Population: Numbers are lower than participants assigned to groups due to loss to follow-up or incomplete data. Results are grouped per arm and include data from all participants with available data.

9-item self-report measure of behavioral and cognitive coping related skills. Higher scores indicate greater adaptive cognitive and behavioral skills use. Two domains: Frequency of use and usefulness. For each domain, there is a subscale of cognitive (4 items) or behavioral (5 items) coping skills. Frequency rated 0-6 with higher scores being more frequent use. Usefulness is rated 0-6 with higher scores being more useful. Cognitive skill frequency range: 0-24 Cognitive skill usefulness range: 0-24 Behavioral skill frequency range: 0-35 Behavioral skill usefulness range: 0-35

Outcome measures

Outcome measures
Measure	Non-personalized Digital Mental Health Intervention Without Coaching n=25 Participants The non-personalized intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Messages and content will not be tailored based on participants profile or usage.	Adaptive Digital Mental Health Intervention Without Coaching n=29 Participants The adaptive intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content will be delivered via a URL in an SMS message. Machine learning will be used to tailor messages and timing to meet participant preferences.	Adaptive Digital Mental Health Intervention With Coaching n=6 Participants The adaptive intervention consists of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content is delivered via a URL in an SMS message. Machine learning is be used to tailor messages and timing to meet participant preferences. Coaching is be provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).	Non-personalized Digital Mental Health Intervention With Coaching n=8 Participants The non-personalized intervention consists of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Messages and content are nottailored based on participants profile or usage. Coaching is provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).	Active Control n=30 Participants The active control condition will provide brief text messages that include a URL link to psychoeducational content, but will not include the interactive messaging component described in experimental arms.
Cognitive Behavioral Response to Stress Scale Cognitive Skill Frequency	12.37 Score Standard Deviation 4.99	12.76 Score Standard Deviation 4.13	11.00 Score Standard Deviation 6.63	8.75 Score Standard Deviation 9.13	12.40 Score Standard Deviation 4.38
Cognitive Behavioral Response to Stress Scale Cognitive Skill Usefulness	13.90 Score Standard Deviation 5.52	11.04 Score Standard Deviation 4.89	11.60 Score Standard Deviation 6.43	14.50 Score Standard Deviation 7.51	12.52 Score Standard Deviation 4.55
Cognitive Behavioral Response to Stress Scale Behavioral Skill Frequency	16.42 Score Standard Deviation 5.50	15.21 Score Standard Deviation 4.77	13.17 Score Standard Deviation 5.27	10.62 Score Standard Deviation 8.85	14.27 Score Standard Deviation 4.29
Cognitive Behavioral Response to Stress Scale Behavioral Skill Usefulness	21.29 Score Standard Deviation 5.20	18.27 Score Standard Deviation 5.02	17.00 Score Standard Deviation 5.89	21.00 Score Standard Deviation 3.74	18.30 Score Standard Deviation 4.67

OTHER_PRE_SPECIFIED outcome

Timeframe: 62 days

Population: Results are per arm and thus includes data from all participants with available data. This measure can include select individuals who exceed 56 days of interaction due to user's ability to temporarily pause receipt of messages, resulting in messages extending beyond 8 weeks (56 days). Because Active Control is not an interactive medium that contained messages to which participants could respond, there are no participants listed in the active control group.

Number of messages responded to during the active messaging/intervention period.

Outcome measures

Outcome measures
Measure	Non-personalized Digital Mental Health Intervention Without Coaching n=30 Participants The non-personalized intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Messages and content will not be tailored based on participants profile or usage.	Adaptive Digital Mental Health Intervention Without Coaching n=34 Participants The adaptive intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content will be delivered via a URL in an SMS message. Machine learning will be used to tailor messages and timing to meet participant preferences.	Adaptive Digital Mental Health Intervention With Coaching n=6 Participants The adaptive intervention consists of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content is delivered via a URL in an SMS message. Machine learning is be used to tailor messages and timing to meet participant preferences. Coaching is be provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).	Non-personalized Digital Mental Health Intervention With Coaching n=10 Participants The non-personalized intervention consists of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Messages and content are nottailored based on participants profile or usage. Coaching is provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).	Active Control The active control condition will provide brief text messages that include a URL link to psychoeducational content, but will not include the interactive messaging component described in experimental arms.
Objective Engagement Markers: Percent of Messages Responded to	60.2 Percent of messages responded to Standard Deviation 25.2	53.7 Percent of messages responded to Standard Deviation 20.6	18.7 Percent of messages responded to Standard Deviation 12.8	32.5 Percent of messages responded to Standard Deviation 18.6	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 62 days

Population: Results are grouped per arm. Means and standard deviations include only individuals with \>0 link clicks. This measure can include select individuals who clicked on links beyond 56 days of interaction due to user's ability to temporarily pause receipt of messages.

Number of URL clicks during the study.