NCT03712267

Brief Summary

This randomized control trial aims to establish whether viewing and discussing patients' electronic communication (texts, emails, Facebook direct messaging, etc) impacts clinical care and decision making across the lifespan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 13, 2018

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

November 5, 2025

Status Verified

November 1, 2025

Enrollment Period

4.7 years

First QC Date

October 12, 2018

Last Update Submit

November 4, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Improvement in Mental Health Related Quality of Life/Functioning

    Investigators will use the Short Form Health - 36 Item Survey (SF-36) to assess whether use of electronic media will lead to participants reporting improved functioning/quality of life. The SF-36 is a patient-administered scale and focuses on 8 domains including social functioning, perceptions of health, emotional well-being, role limitations due to physical or emotional concerns, and physical functioning.

    After final visit

  • Therapeutic Alliance

    Investigators will use the Working Alliance Inventory - Short Revised (WAI-SR) scale to assess whether use of electronic media will lead to participants reporting an enhanced working alliance. The working alliance inventory is a 12 item measure of the client's/patient's perception of how comfortable they believe their alliance with their therapist is. Each item is rated on a scale of 1-5, and measures how frequently participants believe criteria has been achieved. A score of 1 typically represents that the specific item has been achieved least frequently and a sore of 5 indicates that the specific item is achieved at every session. The items are then summed up to compute a total score.

    After final visit

Secondary Outcomes (2)

  • Clinical Outcome - Improvement in scores of depression

    Every 4 visits, up to 13 visits

  • Clinical Outcome - Improvement in scores of anxiety

    Every 4 visits, up to 13 visits

Study Arms (2)

Electronic Media Enhanced

EXPERIMENTAL

Research assistants will collect information on participants' electronic messaging behavior and content and provide that for use to participants' clinicians.

Behavioral: Electronic Media Enhanced

Treatment As Usual

PLACEBO COMPARATOR

Participants will not have their electronic messaging reviewed prior to their typically scheduled clinical appointments.

Behavioral: Treatment as Usual

Interventions

Research assistants will provide participants' therapists with information from participants' electronic messaging prior to typically scheduled clinical appointments.

Electronic Media Enhanced

Research assistants will not review or provide participants' therapists with information from participants' electronic media and will compare with the Electronic Media Enhanced cohort to see if there was a difference in therapy outcomes.

Treatment As Usual

Eligibility Criteria

Age14 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Are currently receiving psychotherapy at McLean and have had at least 4 visits with their current therapy provider in outpatient clinics or 2 sessions with their therapy provider in partial hospitalization or residential settings
  • Age 18-85, and fluent in English
  • Have a primary diagnosis of anxiety or depression (as determined by self-report and review of medical records, which should list a primary depression or anxiety spectrum diagnosis). Symptomatology can be active or in remission.
  • Are actively using at least 1 platform for text messaging (i.e. they should have an account on each platform and have produced content within the month prior to beginning the study). This will be based on self report.
  • Use a mobile device for text messaging
  • Able to provide informed consent.

You may not qualify if:

  • Probable or diagnosed dementia or cognitive impairment, or neurodevelopmental disorder (such as an autism spectrum disorder) based on self report and review of medical records.
  • \- Individuals with Attention-Deficit/Hyperactivity Disorder (ADHD) or Attention-Deficit Disorder (ADD) may be eligible provided symptoms have been stable for at least 6 months.
  • Active psychotic symptoms
  • \- History of psychosis is allowable only if the patient has not had symptoms for at least a year
  • Are actively receiving ECT treatment
  • Current alcohol or drug abuse problem (based on self report and review of medical records)
  • \- History of substance use is fine, provided there has been no relapse or withdrawal symptoms in the month leading up to enrollment
  • Are involuntarily admitted to McLean Hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Ipsit Vahia, MD

    Mclean Hospital

    PRINCIPAL INVESTIGATOR
  • Kerry Ressler, MD; PhD

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Study participants will be randomized to either the intervention group or the control group through an online computer randomizing generator. This is not a blinded randomized control trial.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, Geriatric Psychiatry Outpatient Programs

Study Record Dates

First Submitted

October 12, 2018

First Posted

October 19, 2018

Study Start

December 13, 2018

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

November 5, 2025

Record last verified: 2025-11

Locations