NCT04560075

Brief Summary

Text2Connect (T2C) proposes to test a text-based intervention designed to improve engagement with mental health treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

May 19, 2023

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

September 10, 2020

Results QC Date

August 30, 2022

Last Update Submit

May 10, 2023

Conditions

Keywords

depressionsuicidal ideationtreatmentmental healthtext message intervention

Outcome Measures

Primary Outcomes (11)

  • 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.

    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.

    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.

    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.

    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).

    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.

    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.

    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.

    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.

    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.

    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.

    3 month Timepoint

Secondary Outcomes (9)

  • Psychosocial Functioning

    1 month timepoint

  • Psychosocial Functioning

    2 month timepoint

  • Psychosocial Functioning

    3 month timepoint

  • Symptom Severity

    1 month timepoint

  • Symptom Severity

    2 month timepoint

  • +4 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Psychoeducational Videos (PE) Only

Interventions

Text2ConnectBEHAVIORAL

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.

Text2Connect

Participants in this group will receive psychoeducation through the PE video library.

Psychoeducational Videos (PE) Only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Children's Community Pediatrics (CCP- Waterdam) of Children's Hospital of Pittsburgh UPMC

McMurray, Pennsylvania, 15317, United States

Location

Child and Adolescent Bipolar Spectrum Services (CABS) Center

Pittsburgh, Pennsylvania, 15213, United States

Location

STAR Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DepressionSuicidal IdeationPsychological Well-Being

Interventions

Single Person

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSuicideSelf-Injurious BehaviorPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Marital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic Factors

Limitations and Caveats

Findings may not be valid in men or racial or ethnic minorities due to makeup of sample. This study may have a limited understanding of durability, prolonged engagement, and typical experiences and stresses related to college transition due to only following participants for 3 months during COVID pandemic.

Results Point of Contact

Title
Dr. Tina Goldstein
Organization
University of Pittsburgh

Study Officials

  • Tina Goldstein, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR
  • Brian Suffoletto, MD

    University of Pittsburgh Medical Center

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessors will be masked to the intervention condition at follow-up assessment time points.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry and Psychology

Study Record Dates

First Submitted

September 10, 2020

First Posted

September 23, 2020

Study Start

October 1, 2020

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

May 19, 2023

Results First Posted

May 19, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

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.

Time Frame
These data will be released to the NDCT soon after each project's "main outcomes" manuscript is accepted for publication
Access Criteria
In addition to public access to the NDCT, data can also be accessed by contacting ETUDES Center investigators.

Locations