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Electronic Media and Its Application in Psychotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03712267
Recruitment Status : Not yet recruiting
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
The Once Upon a Time Foundation
Information provided by (Responsible Party):
Ipsit Vihang Vahia, Mclean Hospital

Brief Summary:
This study 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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Depression Electronic Media Behavioral: Electronic Media Enhanced Not Applicable

Detailed Description:
This study explores the usefulness and effectiveness of including electronic communication as part of standard clinical care. Participants will provide information and content from their electronic media to research assistants during in person interviews. Research assistants will then give clinicians the information collected, so the clinicians can incorporate the data into the session as they see fit. Therapists will retain full clinical discretion of how they continue to conduct their therapy sessions, and the investigators will measure whether clinicians and patients believed use of electronic communication impacted the session content and procedure.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Electronic Media and Its Application in Psychotherapy
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Electronic Media Enhanced
Research assistants will collect information on participants' activity on messaging applications.
Behavioral: Electronic Media Enhanced
Research assistants will provide participants' therapists with information from participants' electronic media, to see if that has any impact on their therapy.

Primary Outcome Measures :
  1. Therapeutic Alliance [ Time Frame: After 3 months ]
    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.

  2. Clinical Outcome - Improvement in scores of depression [ Time Frame: Every 4 weeks, for 3 months ]
    Investigators will use the Patient Health Questionnaire-9 (OHQ-9) to assess changes in patient's/client's symptoms of depression. The Patient Health Questionnaire-9 is a 9 item questionnaire used to screen for symptoms of major depression. It is self-administered by participants. Items are scored on a scale of 0-3 with total scores ranging from 0-27. Higher scores indicate more severe depressive symptoms.

  3. Clinical Outcome - Improvement in scores of anxiety [ Time Frame: Every 4 weeks, for 3 months ]
    Investigators will use the General Anxiety Disorder Scale (GAD-7) to assess changes in patient's/client's symptoms of anxiety. The Generalized Anxiety Disorder Scale is a 7-item questionnaire used to screen symptoms of anxiety disorders. It is self-administered by the participant. The 7 items are scored on a 0-3 scale, and total scores range from 0-21. Higher scores indicate more severe anxiety symptoms.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Are currently receiving outpatient psychotherapy at McLean and have had at least 4 visits with their current therapy provider
  • 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.

Exclusion Criteria:

  • Probable or diagnosed psychosis, bipolar disorder, dementia, or neurodevelopmental disorder (such as an autism spectrum disorder) based on self report and review of medical records.
  • Are actively receiving ECT treatment
  • Have a known alcohol or drug abuse problem (based on self report and review of medical records)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03712267

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Contact: Praise Owoyemi, BA 617-855 ext 2499
Contact: Katherine Hobbs, BA 617-855 ext 2589

Sponsors and Collaborators
Mclean Hospital
The Once Upon a Time Foundation
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Principal Investigator: Ipsit Vahia, MD Mclean Hospital
Principal Investigator: Kerry Ressler, MD; PhD Mclean Hospital
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Responsible Party: Ipsit Vihang Vahia, Medical Director, Geriatric Psychiatry Outpatient Programs, Mclean Hospital Identifier: NCT03712267    
Other Study ID Numbers: 2018P002179
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders