DepressionT2CNCT04560075
Text 2 Connect- Texting Intervention for Mental Health Treatment Utilization
A study testing Text2Connect and Psychoeducational Videos (PE) Only in people with Depression and Suicidal Ideation, run by University of Pittsburgh at 3 sites in United States.
Trial summary
Text2Connect (T2C) proposes to test a text-based intervention designed to improve engagement with mental health treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Suicidal Ideation
- What is being tested?
- Text2Connect and Psychoeducational Videos (PE) Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2020to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant engaged in treatment at CC Waterdam, STAR or CABS clinic
- Participants have a current psychiatric diagnosis documented in their electronic medical record and/or be in receipt of mental health services within 3 months per self-/ parent- or clinician- report
- At least 18 years of age
- Recently graduated high school
- Planning to attend college or higher education program within 6 weeks
- Own a text-capable phone
- Be willing and able to provide informed consent
Who cannot join
- Participants will be excluded if they have conditions that might impair their ability to effectively engage in Text2Connect
- Under the age of 18yo
- Non-English speakers
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Community Pediatrics (CCP- Waterdam) of Children's Hospital of Pittsburgh UPMC
McMurray, Pennsylvania, 15317
Child and Adolescent Bipolar Spectrum Services (CABS) Center
Pittsburgh, Pennsylvania, 15213
STAR Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: ETUDES Center- Text2Connect - Phase 2
Text2Connect (T2C) proposes to test a text-based intervention designed to improve engagement with mental health treatment.
Read the detailed description
To enhance outcomes for transition-age youth with mental health disorders during the vulnerable period that occurs during their first several months of college, the investigators propose an automated TM intervention, "Text to Connect" (T2C), that aims to increase mental health self-efficacy through psychoeducation, self-monitoring of symptoms and stressors, and cues to action for college-bound youth.
Assignment of Interventions:
The study will utilize block randomization whereby 2/3 of participants will be randomly assigned to receive T2C, and 1/3 to receive PE. Blocks will balance the groups on site (CCP versus STAR/CABS). A 2:1 randomization scheme will randomize 50 youth to either receive T2C (n=30) or a link to brief psychoeducational videos about mental health (PE; n=20). All participants will then complete a brief battery of self-report assessments online at baseline and again monthly through month 4. Youth randomized to receive PE will receive a text message with the link to the webpage with the psychoeducational videos. Youth randomized to receive T2C will be onboarded and initiate the TM intervention that sends automated prompts at minimum monthly through month 4.
Hypothesis:
Aim 1. To examine the feasibility of T2C for transition-age youth with psychiatric disorders (n=3 clinics, 50 adolescents). Youth randomized to receive T2C will:
Hypothesis 1a. engage with T2C at high rates (>70% response rate to SMS prompts).
Hypothesis 1b. report high levels of satisfaction (>70% satisfaction) and usability with T2C.
Aim 2. To examine the impact of T2C versus PE on mental health self-efficacy, symptoms and functioning, and treatment engagement. Over 4 months, youth who receive T2C, as compared with youth who receive PE, will report:
Hypothesis 2a (Primary). Greater mental health self-efficacy Hypothesis 2b (Secondary). Lower symptom severity and greater psychosocial functioning Hypothesis 2c (Secondary). Higher rates of follow-through with mental health services
- Conditions
- Depression, Suicidal Ideation
- Being tested
- Text2Connect, Psychoeducational Videos (PE) Only
- Keywords
- depression, suicidal ideation, treatment, mental health, text message intervention
- Medical subject headings
- Depression, Suicidal Ideation, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text2ConnectBehavioural
The T2C intervention aims to increase mental health self-efficacy though psychoeducation, self-monitoring of symptoms and stressors, and cues to action for college-bound youth.
Psychoeducational Videos (PE) OnlyBehavioural
Participants in this group will receive psychoeducation through the PE video library.
| Study group | Role | What they receive |
|---|---|---|
| Text2Connect | Experimental | Participants receiving Text2Connect (T2C) personalized messages will receive a monthly check-in text prompt. Based on their response, the participants then receive either general psychoeducational videos and prompts to continue to monitor mental health or are then prompted to endorse stressors and symptoms they are experiencing to prompt awareness of treatment targets in daily life. Receives: Behavioral: Text2Connect |
| Psychoeducational Videos (PE) Only | Active comparator | Participants will receive a web link to a library of 4 PE videos. These brief 2-minute videos include general information about self-care during college. Receives: Behavioral: Psychoeducational Videos (PE) Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement With Intervention: Text Message Check-ins
Participant's engagement with the T2C intervention will be assessed via their response rate to SMS prompts, as the primary outcome of Text2Connect Phase 2. "High" engagement with T2C will be rated as >70% response rate.
All Intervention participants (n=34) received text-message check-ins with question: "How would you rate your emotional health this past week?" on a likert scale of: 1=excellent; 2=very good; 3=good;4=fair; 5=poor. Participants who did not respond to this message initially were sent a reminder with the same content each week of the intervention.
Measured: Over 3 months after baseline
Engagement With Intervention: Web-based Check Ins
Participant's engagement with the T2C intervention will be assessed via their response rate to prompts, as the primary outcome of Text2Connect Phase 2. "High" engagement with T2C will be rated as >70% response rate.
Participants received 1 text "How would you rate our emotional health this last week" on a likert scale of: 1 (excellent), 2 Very good, 3 good 4 fair 5 poor. If respondents answered "fair" or "Poor" they were routed to a website with psychoeducational videos and additional questions called a "web-based check in." The questions inquired what type of stressors the participant experienced contributing to the "Fair" or "Poor" ratings, what types of symptoms the participants noticed as a result of the indicated stressor and if participants felt they could manage their stress.
Measured: Over 3 months after baseline
Engagement With Intervention: Drop Out Rate
Participant's engagement with the T2C intervention will be assessed via their response rate to prompts, as the primary outcome of Text2Connect Phase 2. "High" engagement with T2C will be rated as >70% response rate. Participants are considered "dropped out" if they requested to be removed from the T2C intervention and all texts to be stopped.
Measured: Over 3 months after baseline
Usability & Satisfaction-PSSUQ
Satisfaction with the technical components of interventions will be assessed through the certain questions from the Post System Satisfaction and Usability Questionnaire (PSSUQ), as the primary outcome of Text2Connect Phase 2. The PSSUQ utilize 16 items w/ response options ranging from 1-7 where 1=strongly disagree and 7=strongly agree. The PSSUQ has sub-scores derived from subsets of the questions which reflect system usefulness, information quality, and interface quality. Scores are added and range from 16-112, with higher score indicating less satisfaction. Questions 1 to 16 result in the Overall score; Questions 1 to 6 result in System Usefulness score; Questions 7 to 12 result in Information Quality score; Questions 13 to 16 result in Interface Quality.
Measured: 3 month follow up timepoint
Usability & Satisfaction-CSQ
Satisfaction with the technical components of interventions will be assessed through the certain questions from the Client Satisfaction Questionnaire (CSQ8). 8 items are scored on a likert scale of 1 to 4. Item 1 (reverse scored): scale 1(excellent)-4 (poor); Item 2: 1(definitely not)-4(definitely); item 3(reverse scored): 1(none of needs met)-4(all needs met); item 4: 1(definitely not)-4(definitely); item 5: 1(quite dissatisfied)-4(very satisfied); item 6(reverse scored): 1(made things worse)-4(helped a great deal); item 7 (reverse scored): 1(quite dissatisfied)-4(very satisfied); item 8: 1(definitely not)-4(definitely). Higher scores=higher satisfaction (score sum range is 8-32).
Measured: 3 month follow up timepoint
Mental Health Self-Efficacy
Mental health self-efficacy will be assessed via the Mental Health Self-Efficacy Scale (MHSES), as the primary outcome of Text2Connect Phase 2. The MHSES contains 6 items that are scored on a 10-point Likert Scale. Scores range from 6-60 with higher scores indicating greater confidence in participant's mental health self-efficacy.
Measured: 1 month timepoint
Mental Health Self-Efficacy
Mental health self-efficacy will be assessed via the Mental Health Self-Efficacy Scale (MHSES), as the primary outcome of Text2Connect Phase 2. The MHSES contains 6 items that are scored on a 10-point Likert Scale. Scores range from 6-60 with higher scores indicating greater confidence in participant's mental health self-efficacy.
Measured: 3 month timepoint
Mental Health Self-Efficacy
Mental health self-efficacy will be assessed via the Mental Health Self-Efficacy Scale (MHSES), as the primary outcome of Text2Connect Phase 2. The MHSES contains 6 items that are scored on a 10-point Likert Scale. Scores range from 6-60 with higher scores indicating greater confidence in participant's mental health self-efficacy.
Measured: 2 month timepoint
General Self-Efficacy
Mental health self-efficacy will be assessed via the General Self-Efficacy Scale (GSE), as the primary outcome of Text2Connect Phase 2. The GSE contains 10 items scored on a 4-point Likert Scale, with scores ranging from 10-40. Higher scores indicate greater self-efficacy.
Measured: 1 month Timepoint
General Self-Efficacy
Mental health self-efficacy will be assessed via the General Self-Efficacy Scale (GSE), as the primary outcome of Text2Connect Phase 2. The GSE contains 10 items scored on a 4-point Likert Scale, with scores ranging from 10-40. Higher scores indicate greater self-efficacy.
Measured: 2 month Timepoint
General Self-Efficacy
Mental health self-efficacy will be assessed via the General Self-Efficacy Scale (GSE), as the primary outcome of Text2Connect Phase 2. The GSE contains 10 items scored on a 4-point Likert Scale, with scores ranging from 10-40. Higher scores indicate greater self-efficacy.
Measured: 3 month Timepoint
Secondary outcomes (9)
Psychosocial Functioning
Psychosocial functioning will be assessed via the College Adjustment Questionnaire (CAQ) The CAQ contains 14 questions \& 3 subscales (Educational, Relational, \& Psychological functioning) embedded within. Each subscale is scored on 1(very inaccurate)-5 (very accurate) likert scale. Educational Functioning items include: 1, 5, 7, 12, 13; Relational Functioning items include: 2, 4, 9, 10, 14; Psychological Functioning items include: 3, 6, 8, 11. Items 2 \& 9 from Relational subscale, 13 from Educational subscale, \& 8 \& 11 from Psychological subscale are reversed scored on 5 (very inaccurate)-1(very accurate) likert scale.
The Educational functioning subscale score can be summed range from 5-25; the Relational functioning subscale score can be summed range from 5-25; the Psychological subscale can be summed range from 4-20. Total scores across all 3 subscales can be summed \& range from 14-70. Higher scores indicate better functioning on each scale and across the total measure.
Measured: 1 month timepoint
Psychosocial Functioning
Psychosocial functioning will be assessed via the College Adjustment Questionnaire (CAQ) The CAQ contains 14 questions \& 3 subscales (Educational, Relational, \& Psychological functioning) embedded within. Each subscale is scored on 1(very inaccurate)-5 (very accurate) likert scale. Educational Functioning items include: 1, 5, 7, 12, 13; Relational Functioning items include: 2, 4, 9, 10, 14; Psychological Functioning items include: 3, 6, 8, 11. Items 2 \& 9 from Relational subscale, 13 from Educational subscale, \& 8 \& 11 from Psychological subscale are reversed scored on 5 (very inaccurate)-1(very accurate) likert scale.
The Educational functioning subscale score can be summed range from 5-25; the Relational functioning subscale score can be summed range from 5-25; the Psychological subscale can be summed range from 4-20. Total scores across all 3 subscales can be summed \& range from 14-70. Higher scores indicate better functioning on each scale and across the total measure.
Measured: 2 month timepoint
Psychosocial Functioning
Psychosocial functioning will be assessed via the College Adjustment Questionnaire (CAQ) The CAQ contains 14 questions \& 3 subscales (Educational, Relational, \& Psychological functioning) embedded within. Each subscale is scored on 1(very inaccurate)-5 (very accurate) likert scale. Educational Functioning items include: 1, 5, 7, 12, 13; Relational Functioning items include: 2, 4, 9, 10, 14; Psychological Functioning items include: 3, 6, 8, 11. Items 2 \& 9 from Relational subscale, 13 from Educational subscale, \& 8 \& 11 from Psychological subscale are reversed scored on 5 (very inaccurate)-1(very accurate) likert scale.
The Educational functioning subscale score can be summed range from 5-25; the Relational functioning subscale score can be summed range from 5-25; the Psychological subscale can be summed range from 4-20. Total scores across all 3 subscales can be summed \& range from 14-70. Higher scores indicate better functioning on each scale and across the total measure.
Measured: 3 month timepoint
Symptom Severity
Symptom severity will be assessed via the CCAPS Mental Health Symptoms. The CCAPS is a 62-item instrument with 8 subscales (depression, general anxiety, social anxiety, academic distress, eating concerns, family distress, hostility, substance abuse) related to psychological symptoms \& distress in college students. Scores are on a 5 point likert scale for each subscale: 0 (not at all like me), 1,2,3,4 (Extremely like me). Lower scores indicate greater severity of symptoms. Some items are reverse-scored. To score, average the items scores for each subscale to create the subscale raw score.
Measured: 1 month timepoint
Symptom Severity
Symptom severity will be assessed via the CCAPS Mental Health Symptoms. The CCAPS is a 62-item instrument with 8 subscales (depression, general anxiety, social anxiety, academic distress, eating concerns, family distress, hostility, substance abuse) related to psychological symptoms \& distress in college students. Scores are on a 5 point likert scale for each subscale: 0 (not at all like me), 1,2,3,4 (Extremely like me). Lower scores indicate greater severity of symptoms. Some items are reverse-scored. To score, average the items scores for each subscale to create the subscale raw score.
Measured: 2 month timepoint
Symptom Severity
Symptom severity will be assessed via the CCAPS Mental Health Symptoms. The CCAPS is a 62-item instrument with 8 subscales (depression, general anxiety, social anxiety, academic distress, eating concerns, family distress, hostility, substance abuse) related to psychological symptoms \& distress in college students. Scores are on a 5 point likert scale for each subscale: 0 (not at all like me), 1,2,3,4 (Extremely like me). Lower scores indicate greater severity of symptoms. Some items are reverse-scored. To score, average the items scores for each subscale to create the subscale raw score.
Measured: 3 month timepoint
Mental Health Service Follow-through
Mental health service follow-through will be assessed via the Client Service Receipt Inventory (CSRI). Ratings of 4 questions are Yes or No indicating if participants received the type of service. Scores described below are count of participants indicating "Yes" on the scale.
Measured: 1 month timepoint
Mental Health Service Follow-through
Mental health service follow-through will be assessed via the Client Service Receipt Inventory (CSRI). Ratings of 4 questions are Yes or No indicating if participants received the type of service. Scores described below are count of participants indicating "Yes" on the scale.
Measured: 2 month timepoint
Mental Health Service Follow-through
Mental health service follow-through will be assessed via the Client Service Receipt Inventory (CSRI). Ratings of 4 questions are Yes or No indicating if participants received the type of service. Scores described below are count of participants indicating "Yes" on the scale.
Measured: 3 month timepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Oct 2020
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will use a parallel study design, where participants are randomized into two intervention groups (T2C and PE) and will receive interventions in parallel.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Foundation Research Institute, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Tina R Goldstein, University of Pittsburgh
- Investigators
- Tina Goldstein, PhD, Principal investigator, University of PittsburghBrian Suffoletto, MD, Study director, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560075
- Sponsor's protocol ID
- STUDY20060206
- Other IDs
- P50MH115838-02
- Acronym
- T2C
- Status last verified
- May 2023
- First submitted
- 10 Sep 2020
- Last updated
- 19 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All requests for study data will follow NIMH's data sharing and data use policies. The final completely de-identified dataset(s) will include demographic and clinical data at baseline, and primary and secondary outcomes for all studies, including those funded by the innovation contests. These analytic datasets may also include derived variables with documentation. Our form datasets will include original case report forms, a detailed codebook of variable names, value labels, and programming formats and all study documentation including the protocol and manual of procedures. For descriptive/raw data, study investigators/study staff will upload to NIMH's National Database for Clinical Trials Related to Mental Health Illness (NDCT) on a semi-annual basis all analyzed data being uploaded prior to primary paper publication.
Publications
Suffoletto B, Goldstein T, Gotkiewicz D, Gotkiewicz E, George B, Brent D. Acceptability, Engagement, and Effects of a Mobile Digital Intervention to Support Mental Health for Young Adults Transitioning to College: Pilot Randomized Controlled Trial. JMIR Form Res. 2021 Oct 14;5(10):e32271. doi: 10.2196/32271.
PubMed 34647893
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ETUDES Center- Text2Connect - Phase 2
- ClinicalTrials.gov ID
- NCT04560075
- Acronym / sponsor ID
- T2C / STUDY20060206
- Conditions
- Depression, Suicidal Ideation
- Keywords
- depression, suicidal ideation, treatment, mental health, text message intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Kaiser Foundation Research Institute, National Institute of Mental Health (NIMH)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Posted 19 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Text2Connect (T2C) proposes to test a text-based intervention designed to improve engagement with mental health treatment.
Detailed description
To enhance outcomes for transition-age youth with mental health disorders during the vulnerable period that occurs during their first several months of college, the investigators propose an automated TM intervention, "Text to Connect" (T2C), that aims to increase mental health self-efficacy through psychoeducation, self-monitoring of symptoms and stressors, and cues to action for college-bound youth.
Assignment of Interventions:
The study will utilize block randomization whereby 2/3 of participants will be randomly assigned to receive T2C, and 1/3 to receive PE. Blocks will balance the groups on site (CCP versus STAR/CABS). A 2:1 randomization scheme will randomize 50 youth to either receive T2C (n=30) or a link to brief psychoeducational videos about mental health (PE; n=20). All participants will then complete a brief battery of self-report assessments online at baseline and again monthly through month 4. Youth randomized to receive PE will receive a text message with the link to the webpage with the psychoeducational videos. Youth randomized to receive T2C will be onboarded and initiate the TM intervention that sends automated prompts at minimum monthly through month 4.
Hypothesis:
Aim 1. To examine the feasibility of T2C for transition-age youth with psychiatric disorders (n=3 clinics, 50 adolescents). Youth randomized to receive T2C will:
Hypothesis 1a. engage with T2C at high rates (>70% response rate to SMS prompts).
Hypothesis 1b. report high levels of satisfaction (>70% satisfaction) and usability with T2C.
Aim 2. To examine the impact of T2C versus PE on mental health self-efficacy, symptoms and functioning, and treatment engagement. Over 4 months, youth who receive T2C, as compared with youth who receive PE, will report:
Hypothesis 2a (Primary). Greater mental health self-efficacy Hypothesis 2b (Secondary). Lower symptom severity and greater psychosocial functioning Hypothesis 2c (Secondary). Higher rates of follow-through with mental health services
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study will use a parallel study design, where participants are randomized into two intervention groups (T2C and PE) and will receive interventions in parallel.
| Arm | Type | Receives |
|---|---|---|
| Text2Connect | Experimental | Behavioral: Text2ConnectParticipants receiving Text2Connect (T2C) personalized messages will receive a monthly check-in text prompt. Based on their response, the participants then receive either general psychoeducational videos and prompts to continue to monitor mental health or are then prompted to endorse stressors and symptoms they are experiencing to prompt awareness of treatment targets in daily life. |
| Psychoeducational Videos (PE) Only | Active comparator | Behavioral: Psychoeducational Videos (PE) OnlyParticipants will receive a web link to a library of 4 PE videos. These brief 2-minute videos include general information about self-care during college. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant engaged in treatment at CC Waterdam, STAR or CABS clinic
- Participants have a current psychiatric diagnosis documented in their electronic medical record and/or be in receipt of mental health services within 3 months per self-/ parent- or clinician- report
- At least 18 years of age
- Recently graduated high school
- Planning to attend college or higher education program within 6 weeks
Key exclusion criteria (3 listed)
- Participants will be excluded if they have conditions that might impair their ability to effectively engage in Text2Connect
- Under the age of 18yo
- Non-English speakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text2ConnectThe T2C intervention aims to increase mental health self-efficacy though psychoeducation, self-monitoring of symptoms and stressors, and cues to action for college-bound youth. | Behavioural | Text2Connect |
| Psychoeducational Videos (PE) OnlyParticipants in this group will receive psychoeducation through the PE video library. | Behavioural | Psychoeducational Videos (PE) Only |
Primary outcome
Engagement With Intervention: Text Message Check-ins
Time frame: Over 3 months after baseline
Participant's engagement with the T2C intervention will be assessed via their response rate to SMS prompts, as the primary outcome of Text2Connect Phase 2. "High" engagement with T2C will be rated as >70% response rate. All Intervention participants (n=34) received text-message check-ins with question: "How would you rate your emotional health this past week?" on a likert scale of: 1=excellent; 2=very good; 3=good;4=fair; 5=poor. Participants who did not respond to this message initially were sent a reminder with the same content each week of the intervention.
Engagement With Intervention: Web-based Check Ins
Time frame: Over 3 months after baseline
Participant's engagement with the T2C intervention will be assessed via their response rate to prompts, as the primary outcome of Text2Connect Phase 2. "High" engagement with T2C will be rated as >70% response rate. Participants received 1 text "How would you rate our emotional health this last week" on a likert scale of: 1 (excellent), 2 Very good, 3 good 4 fair 5 poor. If respondents answered "fair" or "Poor" they were routed to a website with psychoeducational videos and additional questions called a "web-based check in." The questions inquired what type of stressors the participant experienced contributing to the "Fair" or "Poor" ratings, what types of symptoms the participants noticed as a result of the indicated stressor and if participants felt they could manage their stress.
Engagement With Intervention: Drop Out Rate
Time frame: Over 3 months after baseline
Participant's engagement with the T2C intervention will be assessed via their response rate to prompts, as the primary outcome of Text2Connect Phase 2. "High" engagement with T2C will be rated as >70% response rate. Participants are considered "dropped out" if they requested to be removed from the T2C intervention and all texts to be stopped.
Usability & Satisfaction-PSSUQ
Time frame: 3 month follow up timepoint
Satisfaction with the technical components of interventions will be assessed through the certain questions from the Post System Satisfaction and Usability Questionnaire (PSSUQ), as the primary outcome of Text2Connect Phase 2. The PSSUQ utilize 16 items w/ response options ranging from 1-7 where 1=strongly disagree and 7=strongly agree. The PSSUQ has sub-scores derived from subsets of the questions which reflect system usefulness, information quality, and interface quality. Scores are added and range from 16-112, with higher score indicating less satisfaction. Questions 1 to 16 result in the Overall score; Questions 1 to 6 result in System Usefulness score; Questions 7 to 12 result in Information Quality score; Questions 13 to 16 result in Interface Quality.
Usability & Satisfaction-CSQ
Time frame: 3 month follow up timepoint
Satisfaction with the technical components of interventions will be assessed through the certain questions from the Client Satisfaction Questionnaire (CSQ8). 8 items are scored on a likert scale of 1 to 4. Item 1 (reverse scored): scale 1(excellent)-4 (poor); Item 2: 1(definitely not)-4(definitely); item 3(reverse scored): 1(none of needs met)-4(all needs met); item 4: 1(definitely not)-4(definitely); item 5: 1(quite dissatisfied)-4(very satisfied); item 6(reverse scored): 1(made things worse)-4(helped a great deal); item 7 (reverse scored): 1(quite dissatisfied)-4(very satisfied); item 8: 1(definitely not)-4(definitely). Higher scores=higher satisfaction (score sum range is 8-32).
Mental Health Self-Efficacy
Time frame: 1 month timepoint
Mental health self-efficacy will be assessed via the Mental Health Self-Efficacy Scale (MHSES), as the primary outcome of Text2Connect Phase 2. The MHSES contains 6 items that are scored on a 10-point Likert Scale. Scores range from 6-60 with higher scores indicating greater confidence in participant's mental health self-efficacy.
Mental Health Self-Efficacy
Time frame: 3 month timepoint
Mental health self-efficacy will be assessed via the Mental Health Self-Efficacy Scale (MHSES), as the primary outcome of Text2Connect Phase 2. The MHSES contains 6 items that are scored on a 10-point Likert Scale. Scores range from 6-60 with higher scores indicating greater confidence in participant's mental health self-efficacy.
Mental Health Self-Efficacy
Time frame: 2 month timepoint
Mental health self-efficacy will be assessed via the Mental Health Self-Efficacy Scale (MHSES), as the primary outcome of Text2Connect Phase 2. The MHSES contains 6 items that are scored on a 10-point Likert Scale. Scores range from 6-60 with higher scores indicating greater confidence in participant's mental health self-efficacy.
General Self-Efficacy
Time frame: 1 month Timepoint
Mental health self-efficacy will be assessed via the General Self-Efficacy Scale (GSE), as the primary outcome of Text2Connect Phase 2. The GSE contains 10 items scored on a 4-point Likert Scale, with scores ranging from 10-40. Higher scores indicate greater self-efficacy.
General Self-Efficacy
Time frame: 2 month Timepoint
Mental health self-efficacy will be assessed via the General Self-Efficacy Scale (GSE), as the primary outcome of Text2Connect Phase 2. The GSE contains 10 items scored on a 4-point Likert Scale, with scores ranging from 10-40. Higher scores indicate greater self-efficacy.
General Self-Efficacy
Time frame: 3 month Timepoint
Mental health self-efficacy will be assessed via the General Self-Efficacy Scale (GSE), as the primary outcome of Text2Connect Phase 2. The GSE contains 10 items scored on a 4-point Likert Scale, with scores ranging from 10-40. Higher scores indicate greater self-efficacy.
9 secondary outcomes
Psychosocial Functioning
Time frame: 1 month timepoint
Psychosocial Functioning
Time frame: 2 month timepoint
Psychosocial Functioning
Time frame: 3 month timepoint
Symptom Severity
Time frame: 1 month timepoint
Symptom Severity
Time frame: 2 month timepoint
Symptom Severity
Time frame: 3 month timepoint
Mental Health Service Follow-through
Time frame: 1 month timepoint
Mental Health Service Follow-through
Time frame: 2 month timepoint
Mental Health Service Follow-through
Time frame: 3 month timepoint
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34647893Suffoletto B, Goldstein T, Gotkiewicz D, Gotkiewicz E, George B, Brent D. Acceptability, Engagement, and Effects of a Mobile Digital Intervention to Support Mental Health for Young Adults Transitioning to College: Pilot Randomized Controlled Trial. JMIR Form Res. 2021 Oct 14;5(10):e32271. doi: 10.2196/32271.
- Individual participant dataSharing planned: Yes. All requests for study data will follow NIMH's data sharing and data use policies. The final completely de-identified dataset(s) will include demographic and clinical data at baseline, and primary and secondary outcomes for all studies, including those funded by the innovation contests. These analytic datasets may also include derived variables with documentation. Our form datasets will include original case report forms, a detailed codebook of variable names, value labels, and programming formats and all study documentation including the protocol and manual of procedures. For descriptive/raw data, study investigators/study staff will upload to NIMH's National Database for Clinical Trials Related to Mental Health Illness (NDCT) on a semi-annual basis all analyzed data being uploaded prior to primary paper publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tina Goldstein, PhD principal investigator
University of Pittsburgh
Brian Suffoletto, MD study director
University of Pittsburgh Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text2Connect and Psychoeducational Videos (PE) Only in people with Depression and Suicidal Ideation, run by University of Pittsburgh at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement With Intervention: Text Message Check-ins (time frame: Over 3 months after baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04560075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023; AzTrials last refreshed its copy on 1 Nov 2026.