Trial Outcomes & Findings for Horyzons: Implementation in Clinical Practice (NCT NCT04673851)

Last Updated: 2024-08-15

Results Overview

The UCLA Loneliness scale is a 20 item scale. Answers are on a 4 point scale with options "I often feel this way," "I sometimes feel this way," "I rarely feel this way," and "I never feel this way." Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness). The UCLA Loneliness Scale is a part of the PhenX Toolkit. The UCLA Loneliness Scale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

Recruitment status

COMPLETED

Study phase

Target enrollment

85 participants

Primary outcome timeframe

Cohort 1: Baseline, Mid-treatment (single assessment between Month 1-2), and Post-treatment (up to 3 months); Cohort 2: Baseline, Mid-treatment (single assessment between Month 2-4), and Post-treatment (up to 6 months)

Results posted on

2024-08-15

Participant Flow

Participant milestones

Participant milestones
Measure	FEP Clients (Cohort 1) Participants with first episode psychosis (FEP) recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE). Participants will use the online platform Horyzons for 3 months. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.	FEP Clients (Cohort 2) Participants with first episode psychosis (FEP) recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE). Participants will use the online platform Horyzons for 6 months. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.	FEP Clinicians (Cohort 1) Providers (clinicians and peer support specialists) affiliated with First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE) will participate in a focus group discussing the implementation and integration of Horyzons into their care routine with clients who participated in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.	FEP Clinicians (Cohort 2) Providers (clinicians and peer support specialists) affiliated with First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE) will participate in a focus group discussing the implementation and integration of Horyzons into their care routine with clients who participated in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.
Overall Study STARTED	25	37	12	11
Overall Study COMPLETED	20	27	12	11
Overall Study NOT COMPLETED	5	10	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Number analyzed in row differs from overall due to missing data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FEP Clients (Cohort 1) n=25 Participants Participants with first episode psychosis (FEP) recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE). Participants will use the online platform Horyzons for 3 months as a part of their care plan. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.	FEP Clients (Cohort 2) n=37 Participants Participants with first episode psychosis (FEP) recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE). Participants will use the online platform Horyzons for 6 months as a part of their care plan. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.	FEP Clinicians (Cohort 1) n=12 Participants Providers (clinicians and peer support specialists) affiliated with First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE) will participate in a focus group discussing the implementation and integration of Horyzons into their care routine with clients who participated in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.	FEP Clinicians (Cohort 2) n=11 Participants Providers (clinicians and peer support specialists) affiliated with First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE) will participate in a focus group discussing the implementation and integration of Horyzons into their care routine with clients who participated in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.	Total n=85 Participants Total of all reporting groups
Age, Continuous	24.88 years STANDARD_DEVIATION 4.58 • n=25 Participants • Number analyzed in row differs from overall due to missing data.	22.76 years STANDARD_DEVIATION 4.56 • n=37 Participants • Number analyzed in row differs from overall due to missing data.	41.75 years STANDARD_DEVIATION 15.00 • n=12 Participants • Number analyzed in row differs from overall due to missing data.	40.67 years STANDARD_DEVIATION 15.06 • n=9 Participants • Number analyzed in row differs from overall due to missing data.	28.08 years STANDARD_DEVIATION 11.32 • n=83 Participants • Number analyzed in row differs from overall due to missing data.
Sex/Gender, Customized Female	6 Participants n=25 Participants • Number analyzed in row differs from overall due to missing data.	12 Participants n=37 Participants • Number analyzed in row differs from overall due to missing data.	8 Participants n=12 Participants • Number analyzed in row differs from overall due to missing data.	8 Participants n=10 Participants • Number analyzed in row differs from overall due to missing data.	34 Participants n=84 Participants • Number analyzed in row differs from overall due to missing data.
Sex/Gender, Customized Male	19 Participants n=25 Participants • Number analyzed in row differs from overall due to missing data.	24 Participants n=37 Participants • Number analyzed in row differs from overall due to missing data.	3 Participants n=12 Participants • Number analyzed in row differs from overall due to missing data.	1 Participants n=10 Participants • Number analyzed in row differs from overall due to missing data.	47 Participants n=84 Participants • Number analyzed in row differs from overall due to missing data.
Sex/Gender, Customized Non-Binary	0 Participants n=25 Participants • Number analyzed in row differs from overall due to missing data.	1 Participants n=37 Participants • Number analyzed in row differs from overall due to missing data.	1 Participants n=12 Participants • Number analyzed in row differs from overall due to missing data.	1 Participants n=10 Participants • Number analyzed in row differs from overall due to missing data.	3 Participants n=84 Participants • Number analyzed in row differs from overall due to missing data.
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=25 Participants • Number analyzed in row differs from overall due to missing data.	2 Participants n=37 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=12 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=10 Participants • Number analyzed in row differs from overall due to missing data.	5 Participants n=84 Participants • Number analyzed in row differs from overall due to missing data.
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=25 Participants • Number analyzed in row differs from overall due to missing data.	35 Participants n=37 Participants • Number analyzed in row differs from overall due to missing data.	12 Participants n=12 Participants • Number analyzed in row differs from overall due to missing data.	9 Participants n=10 Participants • Number analyzed in row differs from overall due to missing data.	78 Participants n=84 Participants • Number analyzed in row differs from overall due to missing data.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=37 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=12 Participants • Number analyzed in row differs from overall due to missing data.	1 Participants n=10 Participants • Number analyzed in row differs from overall due to missing data.	1 Participants n=84 Participants • Number analyzed in row differs from overall due to missing data.
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=25 Participants • Number analyzed in row differs from overall due to missing data.	1 Participants n=37 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=12 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=10 Participants • Number analyzed in row differs from overall due to missing data.	2 Participants n=84 Participants • Number analyzed in row differs from overall due to missing data.
Race (NIH/OMB) Asian	1 Participants n=25 Participants • Number analyzed in row differs from overall due to missing data.	3 Participants n=37 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=12 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=10 Participants • Number analyzed in row differs from overall due to missing data.	4 Participants n=84 Participants • Number analyzed in row differs from overall due to missing data.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=37 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=12 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=10 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=84 Participants • Number analyzed in row differs from overall due to missing data.
Race (NIH/OMB) Black or African American	6 Participants n=25 Participants • Number analyzed in row differs from overall due to missing data.	11 Participants n=37 Participants • Number analyzed in row differs from overall due to missing data.	3 Participants n=12 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=10 Participants • Number analyzed in row differs from overall due to missing data.	20 Participants n=84 Participants • Number analyzed in row differs from overall due to missing data.
Race (NIH/OMB) White	16 Participants n=25 Participants • Number analyzed in row differs from overall due to missing data.	15 Participants n=37 Participants • Number analyzed in row differs from overall due to missing data.	9 Participants n=12 Participants • Number analyzed in row differs from overall due to missing data.	9 Participants n=10 Participants • Number analyzed in row differs from overall due to missing data.	49 Participants n=84 Participants • Number analyzed in row differs from overall due to missing data.
Race (NIH/OMB) More than one race	0 Participants n=25 Participants • Number analyzed in row differs from overall due to missing data.	7 Participants n=37 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=12 Participants • Number analyzed in row differs from overall due to missing data.	1 Participants n=10 Participants • Number analyzed in row differs from overall due to missing data.	8 Participants n=84 Participants • Number analyzed in row differs from overall due to missing data.
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=25 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=37 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=12 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=10 Participants • Number analyzed in row differs from overall due to missing data.	1 Participants n=84 Participants • Number analyzed in row differs from overall due to missing data.
Region of Enrollment United States	25 Participants n=25 Participants	37 Participants n=37 Participants	12 Participants n=12 Participants	11 Participants n=11 Participants	85 Participants n=85 Participants
Participant Education Level Middle school or less	0 Participants n=25 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=37 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=12 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=10 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=84 Participants • Number analyzed in row differs from overall due to missing data.
Participant Education Level Some high school	2 Participants n=25 Participants • Number analyzed in row differs from overall due to missing data.	3 Participants n=37 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=12 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=10 Participants • Number analyzed in row differs from overall due to missing data.	5 Participants n=84 Participants • Number analyzed in row differs from overall due to missing data.
Participant Education Level High school diploma or equivalent	4 Participants n=25 Participants • Number analyzed in row differs from overall due to missing data.	12 Participants n=37 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=12 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=10 Participants • Number analyzed in row differs from overall due to missing data.	16 Participants n=84 Participants • Number analyzed in row differs from overall due to missing data.
Participant Education Level Some college	12 Participants n=25 Participants • Number analyzed in row differs from overall due to missing data.	14 Participants n=37 Participants • Number analyzed in row differs from overall due to missing data.	1 Participants n=12 Participants • Number analyzed in row differs from overall due to missing data.	1 Participants n=10 Participants • Number analyzed in row differs from overall due to missing data.	28 Participants n=84 Participants • Number analyzed in row differs from overall due to missing data.
Participant Education Level College degree	6 Participants n=25 Participants • Number analyzed in row differs from overall due to missing data.	7 Participants n=37 Participants • Number analyzed in row differs from overall due to missing data.	1 Participants n=12 Participants • Number analyzed in row differs from overall due to missing data.	0 Participants n=10 Participants • Number analyzed in row differs from overall due to missing data.	14 Participants n=84 Participants • Number analyzed in row differs from overall due to missing data.
Participant Education Level Higher than college	1 Participants n=25 Participants • Number analyzed in row differs from overall due to missing data.	1 Participants n=37 Participants • Number analyzed in row differs from overall due to missing data.	10 Participants n=12 Participants • Number analyzed in row differs from overall due to missing data.	9 Participants n=10 Participants • Number analyzed in row differs from overall due to missing data.	21 Participants n=84 Participants • Number analyzed in row differs from overall due to missing data.
Years of Education	14.16 years STANDARD_DEVIATION 2.89 • n=25 Participants • Number analyzed in row differs from overall due to missing data.	13.49 years STANDARD_DEVIATION 1.86 • n=37 Participants • Number analyzed in row differs from overall due to missing data.	19.75 years STANDARD_DEVIATION 2.98 • n=12 Participants • Number analyzed in row differs from overall due to missing data.	20 years STANDARD_DEVIATION 2.92 • n=5 Participants • Number analyzed in row differs from overall due to missing data.	15.06 years STANDARD_DEVIATION 3.50 • n=79 Participants • Number analyzed in row differs from overall due to missing data.
Diagnosis Schizophrenia	9 Participants n=25 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.	18 Participants n=37 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.	—	—	27 Participants n=62 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.
Diagnosis Schizoaffective disorder	7 Participants n=25 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.	6 Participants n=37 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.	—	—	13 Participants n=62 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.
Diagnosis Schizophreniform disorder	1 Participants n=25 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.	1 Participants n=37 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.	—	—	2 Participants n=62 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.
Diagnosis Brief psychotic disorder	0 Participants n=25 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.	1 Participants n=37 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.	—	—	1 Participants n=62 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.
Diagnosis Schizotypal personality disorder	1 Participants n=25 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.	0 Participants n=37 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.	—	—	1 Participants n=62 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.
Diagnosis Bipolar disorder with psychotic features	1 Participants n=25 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.	4 Participants n=37 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.	—	—	5 Participants n=62 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.
Diagnosis Major depressive disorder with psychotic features	0 Participants n=25 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.	1 Participants n=37 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.	—	—	1 Participants n=62 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.
Diagnosis Substance-induced psychotic disorder	1 Participants n=25 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.	0 Participants n=37 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.	—	—	1 Participants n=62 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.
Diagnosis Unspecified psychotic disorder	5 Participants n=25 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.	6 Participants n=37 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.	—	—	11 Participants n=62 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.
Diagnosis Unknown/Not Reported	0 Participants n=25 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.	0 Participants n=37 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.	—	—	0 Participants n=62 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group.
Age at Diagnosis of Psychotic Illness	21.24 years STANDARD_DEVIATION 3.52 • n=25 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group. Number analyzed in row differs from overall due to missing data.	19.68 years STANDARD_DEVIATION 4.57 • n=34 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group. Number analyzed in row differs from overall due to missing data.	—	—	20.34 years STANDARD_DEVIATION 4.20 • n=59 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group. Number analyzed in row differs from overall due to missing data.
Duration of Psychotic Illness Prior to Study Entry	4.20 years STANDARD_DEVIATION 2.81 • n=25 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group. Number analyzed in row differs from overall due to missing data.	3.24 years STANDARD_DEVIATION 3.05 • n=34 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group. Number analyzed in row differs from overall due to missing data.	—	—	3.64 years STANDARD_DEVIATION 2.96 • n=59 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group. Number analyzed in row differs from overall due to missing data.
Duration of Untreated Psychotic Illness Prior to Study Entry	0.38 years STANDARD_DEVIATION 0.66 • n=24 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group. Number analyzed in row differs from overall due to missing data.	0.49 years STANDARD_DEVIATION 0.67 • n=34 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group. Number analyzed in row differs from overall due to missing data.	—	—	0.45 years STANDARD_DEVIATION 0.66 • n=58 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group. Number analyzed in row differs from overall due to missing data.
Number of Lifetime Hospitalizations Prior to Study Entry	2 hospitalizations n=25 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group. Number analyzed in row differs from overall due to missing data.	1 hospitalizations n=36 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group. Number analyzed in row differs from overall due to missing data.	—	—	2 hospitalizations n=61 Participants • Data not applicable to FEP Clinicians and therefore not collected for this group. Number analyzed in row differs from overall due to missing data.

PRIMARY outcome

Timeframe: Cohort 1: Baseline, Mid-treatment (single assessment between Month 1-2), and Post-treatment (up to 3 months); Cohort 2: Baseline, Mid-treatment (single assessment between Month 2-4), and Post-treatment (up to 6 months)

Population: This outcome only applies to FEP Clients. Mid- and post-treatment data were unavailable for participants who withdrew or were lost to follow-up (Mid-treatment: n = 4 in cohort 1, n = 7 in cohort 2; Post-treatment: n = 5 in cohort 1; n = 10 in cohort 2).

Outcome measures

Outcome measures
Measure	FEP Clients (Cohort 1) n=25 Participants Participants with first episode psychosis (FEP) recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE). Participants will use the online platform Horyzons for 3 months as a part of their care plan. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.	FEP Clients (Cohort 2) n=37 Participants Participants with first episode psychosis (FEP) recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE). Participants will use the online platform Horyzons for 6 months as a part of their care plan. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.
Mean Change in UCLA Loneliness Scale Score (Both Cohorts) Mid-treatment	41.95 score on a scale Standard Deviation 12.84	42.47 score on a scale Standard Deviation 10.75
Mean Change in UCLA Loneliness Scale Score (Both Cohorts) Post-treatment	39.70 score on a scale Standard Deviation 13.70	40.78 score on a scale Standard Deviation 12.67
Mean Change in UCLA Loneliness Scale Score (Both Cohorts) Baseline	42.96 score on a scale Standard Deviation 11.64	45.08 score on a scale Standard Deviation 11.53

PRIMARY outcome

Population: This outcome only applies to FEP Clients. Mid- and post-treatment data were not available for participants who withdrew or were lost to follow-up (Mid-treatment: n = 4 in cohort 1, n = 7 in cohort 2; Post-treatment: n = 5 in cohort 1; n = 10 in cohort 2).

The MOS Social Support Survey is a 19 item scale. Answers are on a 5 point scale with options "none of the time", "a little of the time", "some of the time", "most of the time", and "all of the time". Possible scores range from 19 to 95. Higher scores reflect higher feelings of social support (more perceived social support). The MOS Social Support Survey is a part of the PhenX Toolkit. The MOS Social Support Survey is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

Outcome measures

Outcome measures
Measure	FEP Clients (Cohort 1) n=25 Participants Participants with first episode psychosis (FEP) recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE). Participants will use the online platform Horyzons for 3 months as a part of their care plan. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.	FEP Clients (Cohort 2) n=37 Participants Participants with first episode psychosis (FEP) recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE). Participants will use the online platform Horyzons for 6 months as a part of their care plan. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Total Score (Both Cohorts) Baseline	77.28 score on a scale Standard Deviation 12.36	73.24 score on a scale Standard Deviation 15.22
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Total Score (Both Cohorts) Mid-treatment	76.19 score on a scale Standard Deviation 12.29	74.90 score on a scale Standard Deviation 14.16
Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Total Score (Both Cohorts) Post-treatment	79.45 score on a scale Standard Deviation 9.68	76.59 score on a scale Standard Deviation 14.45

SECONDARY outcome

The Social Interaction Anxiety Scale (SIAS) is a 20 item scale. Answers are on a 5-point scale starting at 0 with options "none at all", "slightly", "moderately", "very", and "extremely". Possible scores range from 0 to 80. Higher scores reflect higher levels of social anxiety. Scoring a 43 or higher may indicate a diagnosis of social anxiety, and scores between 34 and 42 may indicate social phobia(s). The SIAS is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

Outcome measures

Outcome measures
Measure	FEP Clients (Cohort 1) n=25 Participants Participants with first episode psychosis (FEP) recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE). Participants will use the online platform Horyzons for 3 months as a part of their care plan. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.	FEP Clients (Cohort 2) n=37 Participants Participants with first episode psychosis (FEP) recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE). Participants will use the online platform Horyzons for 6 months as a part of their care plan. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.
Mean Change in Social Interaction Anxiety Scale (SIAS) Score (Both Cohorts) Mid-treatment	26.90 score on a scale Standard Deviation 13.58	28.90 score on a scale Standard Deviation 18.61
Mean Change in Social Interaction Anxiety Scale (SIAS) Score (Both Cohorts) Baseline	26.24 score on a scale Standard Deviation 11.23	27.54 score on a scale Standard Deviation 15.97
Mean Change in Social Interaction Anxiety Scale (SIAS) Score (Both Cohorts) Post-treatment	23.85 score on a scale Standard Deviation 13.97	26.85 score on a scale Standard Deviation 18.65

SECONDARY outcome

The Psychological Wellbeing Scale (Short Form) is an 18 item scale. Answers are on a 6 point scale with options "strongly disagree", "moderately disagree", "slightly disagree", "slightly agree", "moderately agree", and "strongly agree". Possible scores range from 18 to 108. Higher scores reflect higher levels of psychological wellbeing. The Psychological Wellbeing Scale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

Outcome measures

Outcome measures
Measure	FEP Clients (Cohort 1) n=25 Participants Participants with first episode psychosis (FEP) recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE). Participants will use the online platform Horyzons for 3 months as a part of their care plan. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.	FEP Clients (Cohort 2) n=37 Participants Participants with first episode psychosis (FEP) recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE). Participants will use the online platform Horyzons for 6 months as a part of their care plan. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.
Mean Change in Psychological Wellbeing Scale Short Form - Total Score (Both Cohorts) Baseline	83.80 score on a scale Standard Deviation 14.54	78.38 score on a scale Standard Deviation 14.80
Mean Change in Psychological Wellbeing Scale Short Form - Total Score (Both Cohorts) Mid-treatment	84.57 score on a scale Standard Deviation 14.68	81.87 score on a scale Standard Deviation 14.95
Mean Change in Psychological Wellbeing Scale Short Form - Total Score (Both Cohorts) Post-treatment	88.20 score on a scale Standard Deviation 15.94	86.41 score on a scale Standard Deviation 15.33

OTHER_PRE_SPECIFIED outcome

Timeframe: Cohort 1: Mid-treatment (between Month 1-2), Post-treatment (up to 3 months); Cohort 2: 1.5 months (between Month 1-2), Mid-treatment (between Month 2-4), 4.5 months (between Month 4-5), Post-treatment (up to 6 months)

Population: This outcome only applies to FEP Clients. Data were not available for participants who withdrew or were lost to follow-up (1.5-month assessment \[cohort 2 only\]: n = 5; Mid-treatment: n = 4 in cohort 1, n = 7 in cohort 2; 4.5-month assessment \[cohort 2 only\]: n = 10; Post-treatment: n = 5 in cohort 1; n = 10 in cohort 2). As per protocol, the 1.5 and 4.5 month assessments were not performed for Cohort 1.

The Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Total Score is a 12-item scale. Answers are on a 5-point scale with options "seldom", "sometimes", "fairly often", "very often", and "always". Possible scores range from 12 to 60 (summed). Higher scores reflect greater therapeutic alliance. The WAI-I is administered in both cohort 1 (Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (1.5 Months, Mid-treatment, 4.5 Months, Post-treatment, up to 6 months).

Outcome measures

Outcome measures
Measure	FEP Clients (Cohort 1) n=21 Participants Participants with first episode psychosis (FEP) recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE). Participants will use the online platform Horyzons for 3 months as a part of their care plan. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.	FEP Clients (Cohort 2) n=32 Participants Participants with first episode psychosis (FEP) recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE). Participants will use the online platform Horyzons for 6 months as a part of their care plan. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.
Mean Change in Working Alliance Inventory for Guided Internet Interventions - Total Score (Both Cohorts) 1.5 months	—	49.75 score on a scale Standard Deviation 7.36
Mean Change in Working Alliance Inventory for Guided Internet Interventions - Total Score (Both Cohorts) Mid-treatment	45.81 score on a scale Standard Deviation 8.26	50.33 score on a scale Standard Deviation 9.09
Mean Change in Working Alliance Inventory for Guided Internet Interventions - Total Score (Both Cohorts) Post-treatment	49.80 score on a scale Standard Deviation 7.88	46.41 score on a scale Standard Deviation 9.75
Mean Change in Working Alliance Inventory for Guided Internet Interventions - Total Score (Both Cohorts) 4.5 months	—	49.15 score on a scale Standard Deviation 7.44

OTHER_PRE_SPECIFIED outcome

The Working Alliance Inventory for Guided Internet Interventions - Bond subscale score is a 4-item scale. Answers are on a 5-point scale with options "seldom", "sometimes", "fairly often", "very often", and "always". Possible scores range from 4 to 20 (summed). Higher scores reflect greater bond with a clinician. The WAI-I - Bond subscale is administered in both cohort 1 (Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (1.5 Months, Mid-treatment, 4.5 Months, Post-treatment, up to 6 months).

Outcome measures

Outcome measures
Measure	FEP Clients (Cohort 1) n=21 Participants Participants with first episode psychosis (FEP) recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE). Participants will use the online platform Horyzons for 3 months as a part of their care plan. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.	FEP Clients (Cohort 2) n=32 Participants Participants with first episode psychosis (FEP) recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE). Participants will use the online platform Horyzons for 6 months as a part of their care plan. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.
Mean Change in Working Alliance Inventory for Guided Internet Interventions - Bond Subscale Score (Both Cohorts) 1.5 months	—	18.56 score on a scale Standard Deviation 2.05
Mean Change in Working Alliance Inventory for Guided Internet Interventions - Bond Subscale Score (Both Cohorts) Mid-treatment	16.86 score on a scale Standard Deviation 4.05	18.50 score on a scale Standard Deviation 2.81
Mean Change in Working Alliance Inventory for Guided Internet Interventions - Bond Subscale Score (Both Cohorts) 4.5 months	—	18.00 score on a scale Standard Deviation 2.56
Mean Change in Working Alliance Inventory for Guided Internet Interventions - Bond Subscale Score (Both Cohorts) Post-treatment	18.50 score on a scale Standard Deviation 2.12	17.93 score on a scale Standard Deviation 2.63

OTHER_PRE_SPECIFIED outcome

The Working Alliance Inventory for Guided Internet Interventions - Goal/Task Score is an 8-item scale. Answers are on a 5-point scale with options "seldom", "sometimes", "fairly often", "very often", and "always". Possible scores range from 8 to 40 (summed). Higher scores reflect greater shared goals and tasks with a clinician. The WAI-I - Goal/Task subscale is administered in both cohort 1 (Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (1.5 Months, Mid-treatment, 4.5 Months, Post-treatment, up to 6 months).

Outcome measures

Outcome measures
Measure	FEP Clients (Cohort 1) n=21 Participants Participants with first episode psychosis (FEP) recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE). Participants will use the online platform Horyzons for 3 months as a part of their care plan. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.	FEP Clients (Cohort 2) n=32 Participants Participants with first episode psychosis (FEP) recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE). Participants will use the online platform Horyzons for 6 months as a part of their care plan. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.
Mean Change in Working Alliance Inventory for Guided Internet Interventions - Goal/Task Subscale Score (Both Cohorts) 1.5 months	—	31.19 score on a scale Standard Deviation 6.03
Mean Change in Working Alliance Inventory for Guided Internet Interventions - Goal/Task Subscale Score (Both Cohorts) Mid-treatment	28.95 score on a scale Standard Deviation 5.50	31.83 score on a scale Standard Deviation 6.86
Mean Change in Working Alliance Inventory for Guided Internet Interventions - Goal/Task Subscale Score (Both Cohorts) 4.5 months	—	31.15 score on a scale Standard Deviation 5.78
Mean Change in Working Alliance Inventory for Guided Internet Interventions - Goal/Task Subscale Score (Both Cohorts) Post-treatment	31.30 score on a scale Standard Deviation 6.33	28.48 score on a scale Standard Deviation 7.93

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

The MOS Social Support Survey - Emotional/informational support subscale is an 8 item subscale. Answers are on a 5 point scale with options "none of the time", "a little of the time", "some of the time", "most of the time", and "all of the time". Possible scores range from 8 to 40. Higher scores reflect higher feelings of emotional and informational social support (more perceived emotional and informational social support). The MOS Social Support Survey - Emotional/informational support subscale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

The MOS Social Support Survey - Tangible support subscale is a 4 item subscale. Answers are on a 5 point scale with options "none of the time", "a little of the time", "some of the time", "most of the time", and "all of the time". Possible scores range from 4 to 20. Higher scores reflect higher feelings of tangible social support (more perceived tangible social support). The MOS Social Support Survey - Tangible support subscale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

The MOS Social Support Survey - Affectionate support subscale is a 3 item subscale. Answers are on a 5 point scale with options "none of the time", "a little of the time", "some of the time", "most of the time", and "all of the time". Possible scores range from 3 to 15. Higher scores reflect higher feelings of affectionate social support (more perceived affectionate social support). The MOS Social Support Survey - Affectionate support subscale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

The MOS Social Support Survey - Positive social interaction subscale is a 3 item subscale. Answers are on a 5 point scale with options "none of the time", "a little of the time", "some of the time", "most of the time", and "all of the time". Possible scores range from 3 to 15. Higher scores reflect higher feelings of positive social interaction (more perceived positive social interaction). The MOS Social Support Survey - Positive social interaction subscale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

The Psychological Wellbeing Scale (Short Form) - Environmental Mastery Subscale is a 3 item scale. Answers are on a 6 point scale with options "strongly disagree", "moderately disagree", "slightly disagree", "slightly agree", "moderately agree", and "strongly agree". Possible scores range from 3 to 18. Higher scores reflect higher levels of environmental mastery. The MOS Social Support Survey - Environmental Mastery subscale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

The Psychological Wellbeing Scale (Short Form) - Personal Growth subscale is a 3 item scale. Answers are on a 6 point scale with options "strongly disagree", "moderately disagree", "slightly disagree", "slightly agree", "moderately agree", and "strongly agree". Possible scores range from 3 to 18. Higher scores reflect higher levels of personal growth. The Psychological Wellbeing Scale - Personal Growth subscale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

The Psychological Wellbeing Scale (Short Form) - Self-Acceptance subscale is a 3 item scale. Answers are on a 6 point scale with options "strongly disagree", "moderately disagree", "slightly disagree", "slightly agree", "moderately agree", and "strongly agree". Possible scores range from 3 to 18. Higher scores reflect higher feelings of self-acceptance. The Psychological Wellbeing Scale - Self-Acceptance subscale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

The Psychological Wellbeing Scale (Short Form) - Autonomy Subscale is a 3 item scale. Answers are on a 6 point scale with options "strongly disagree", "moderately disagree", "slightly disagree", "slightly agree", "moderately agree", and "strongly agree". Possible scores range from 3 to 18. Higher scores reflect higher levels of autonomy. The Psychological Wellbeing Scale - Autonomy subscale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

The Psychological Wellbeing Scale (Short Form) - Purpose in Life subscale is a 3 item scale. Answers are on a 6 point scale with options "strongly disagree", "moderately disagree", "slightly disagree", "slightly agree", "moderately agree", and "strongly agree". Possible scores range from 3 to 18. Higher scores reflect higher feelings of purpose in life. The Psychological Wellbeing Scale - Purpose in Life subscale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

The Psychological Wellbeing Scale (Short Form) - Positive Relationships subscale is a 3 item scale. Answers are on a 6 point scale with options "strongly disagree", "moderately disagree", "slightly disagree", "slightly agree", "moderately agree", and "strongly agree". Possible scores range from 3 to 18. Higher scores reflect higher levels of positive relationships. The Psychological Wellbeing Scale - Positive Relationships subscale is administered in both cohort 1 (Baseline, Mid-treatment, Post-treatment, up to 3 months) and cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

This qualitative data will be collected post-treatment from clients and clinicians. Focus groups and individual interviews will discuss usage of the platform and any feedback participants may have. Feedback from participants will be summarized to include common themes regarding likes and dislikes of the platform, implementation within the clinical setting, and participant ideas for future directions. Feedback is elicited at post-treatment in both cohort 1 (Month 3) and cohort 2 (Month 6).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

This quantitative data will be collected post-treatment from clients and clinicians. Feedback forms will prompt participants to answer questions regarding their experience with the platform on a scale of 1 to 5, with higher scores reflecting a more positive experience. Frequency counts will be included here. Feedback is elicited at post-treatment in both cohort 1 (Month 3) and cohort 2 (Month 6).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

The Questionnaire about the Process of Recovery (QPR) - Total Score is a 15-item scale. Answers are rated on a 5-point scale with options "disagree strongly", "disagree", "neither agree nor disagree", "agree", and "agree strongly. Possible scores range from 0 to 60. Higher scores are indicative of recovery. The QPR is administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

The Modified Colorado Symptom Index - Total Score is a 14-item scale. Answers are rated on a 4-point scale with options "not at all", "once during the month", "several times during the month", "several times a week", and "at least every day". Possible scores range from 0 to 56. Higher scores indicate greater emotional distress. The Modified Colorado Symptom Index is administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

The Social Anxiety Scale for Social Media Users (SAS-SMU) - Total Score is a 21-item scale. Answers are rated on a 5-point scale with options "never", "rarely", "sometimes", "often", and "always". Possible scores range from 21 to 105. Higher scores reflect greater anxiety related to social media usage. The SAS-SMU is administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

The Social Anxiety Scale for Social Media Users (SAS-SMU) - Shared Content Anxiety subscale is a 7-item scale. Answers are rated on a 5-point scale with options "never", "rarely", "sometimes", "often", and "always". Possible scores range from 7 to 35. Higher scores reflect greater anxiety related to sharing or creating content on social media. The SAS-SMU - Shared Content Anxiety subscale is administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

The Social Anxiety Scale for Social Media Users (SAS-SMU) - Privacy Concern Anxiety subscale is a 5-item scale. Answers are rated on a 5-point scale with options "never", "rarely", "sometimes", "often", and "always". Possible scores range from 5 to 25. Higher scores reflect greater anxiety related to privacy concerns on social media. The SAS-SMU - Privacy Concern Anxiety subscale is administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

The Social Anxiety Scale for Social Media Users (SAS-SMU) - Interaction Anxiety subscale is a 6-item scale. Answers are rated on a 5-point scale with options "never", "rarely", "sometimes", "often", and "always". Possible scores range from 6 to 30. Higher scores reflect greater anxiety related to social interactions over social media. The SAS-SMU - Interaction Anxiety subscale is administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

The Social Anxiety Scale for Social Media Users (SAS-SMU) - Self-Evaluation Anxiety subscale is a 3-item scale. Answers are rated on a 5-point scale with options "never", "rarely", "sometimes", "often", and "always". Possible scores range from 3 to 15. Higher scores reflect greater anxiety related to negative self-evaluation. The SAS-SMU - Self-Evaluation Anxiety subscale is administered in only cohort 2 (Baseline, Mid-treatment, Post-treatment, up to 6 months).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 20 weeks

The Perceived Autonomy Support Scale - Total Score is a 6-item scale. Answer are on a 7-point scale with options "strongly disagree", "moderately disagree", "slightly disagree", "neutral", "slightly agree", "moderately agree", and "strongly agree". Possible scores range from 6 to 42. Higher scores reflect greater perceived autonomy support. The Perceived Autonomy Support Scale is administered in both cohort 1 (Mid-treatment, Post-treatment, up to 6 weeks) and cohort 2 (1.5 Months, Mid-treatment, 4.5 Months, Post-treatment, up to 20 weeks).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months

The Twente Engagement with E-health Technologies Scale - Total Score is a 9-item scale. Answers are on a 5-point scale with options "strongly disagree", "disagree", "neutral", "agree", and "strongly agree". Possible scores range from 0 to 36. Higher scores reflect greater engagement. The Twente Engagement with E-health Technologies Scale is administered in only cohort 2 (Baseline, 1.5 Months, Mid-treatment, 4.5 Months, Post-treatment, up to 6 months).

Outcome measures

Outcome data not reported

Adverse Events

FEP Clients (Cohort 1)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

FEP Clients (Cohort 2)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	FEP Clients (Cohort 1) n=25 participants at risk Participants with first episode psychosis (FEP) recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE). Participants will use the online platform Horyzons for 3 months as a part of their care plan. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.	FEP Clients (Cohort 2) n=37 participants at risk Participants with first episode psychosis (FEP) recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE). Participants will use the online platform Horyzons for 6 months (cohort 2) as a part of their care plan. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.
Psychiatric disorders Hospitalization for substance abuse	4.0% 1/25 • Number of events 1 • From the time of signing informed consent through the end of post treatment, approximately 3 months for Cohort 1 and 6 months for Cohort 2. Since FEP Clinicians were not exposed to the study intervention, adverse events were not collected for this group.	0.00% 0/37 • From the time of signing informed consent through the end of post treatment, approximately 3 months for Cohort 1 and 6 months for Cohort 2. Since FEP Clinicians were not exposed to the study intervention, adverse events were not collected for this group.

Other adverse events

Adverse event data not reported

Additional Information

Bryan Stiles, MA

University of North Carolina at Chapel Hill

Phone: 919-590-5811

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place