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Electronic Media and Its Application in Psychotherapy

Primary Purpose

Anxiety Disorders, Depression, Electronic Media

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electronic Media Enhanced
Treatment as Usual
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety Disorders

Eligibility Criteria

14 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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
  2. Age 18-85, and fluent in English
  3. 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.
  4. 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.
  5. Use a mobile device for text messaging
  6. Able to provide informed consent.

Exclusion Criteria:

  1. 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.

  2. Active psychotic symptoms

    - History of psychosis is allowable only if the patient has not had symptoms for at least a year

  3. Are actively receiving ECT treatment

  4. 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

  5. Are involuntarily admitted to McLean Hospital

Sites / Locations

  • McLean HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Electronic Media Enhanced

Treatment As Usual

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Clinical Outcome - Improvement in scores of depression
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.
Clinical Outcome - Improvement in scores of anxiety
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.

Full Information

First Posted
October 12, 2018
Last Updated
December 21, 2021
Sponsor
Mclean Hospital
Collaborators
Once Upon a Time Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03712267
Brief Title
Electronic Media and Its Application in Psychotherapy
Official Title
Electronic Media and Its Application in Psychotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2018 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
Collaborators
Once Upon a Time Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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 if they are in the intervention group. 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. The investigators will compare the impact of receiving this electronic enhancement intervention versus only receiving treatment as usual care on mental health related functioning and therapeutic alliance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Depression, Electronic Media

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
115 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electronic Media Enhanced
Arm Type
Experimental
Arm Description
Research assistants will collect information on participants' electronic messaging behavior and content and provide that for use to participants' clinicians.
Arm Title
Treatment As Usual
Arm Type
Placebo Comparator
Arm Description
Participants will not have their electronic messaging reviewed prior to their typically scheduled clinical appointments.
Intervention Type
Behavioral
Intervention Name(s)
Electronic Media Enhanced
Intervention Description
Research assistants will provide participants' therapists with information from participants' electronic messaging prior to typically scheduled clinical appointments.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in Mental Health Related Quality of Life/Functioning
Description
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.
Time Frame
After final visit
Title
Therapeutic Alliance
Description
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.
Time Frame
After final visit
Secondary Outcome Measure Information:
Title
Clinical Outcome - Improvement in scores of depression
Description
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.
Time Frame
Every 4 visits, up to 13 visits
Title
Clinical Outcome - Improvement in scores of anxiety
Description
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.
Time Frame
Every 4 visits, up to 13 visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Dickinson, BA
Phone
617-855
Ext
2511
Email
rdickinson@mclean.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hailey Cray, BA
Phone
617-855
Ext
3688
Email
hcray@mclean.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsit Vahia, MD
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kerry Ressler, MD; PhD
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heejung Kim, BA
Phone
617-855-2511
Email
jkim199@mclean.harvard.edu
First Name & Middle Initial & Last Name & Degree
Praise Owoyemi, BA
Phone
617-855-2499
Email
powoyemi@mclean.harvard.edu

12. IPD Sharing Statement

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Electronic Media and Its Application in Psychotherapy

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