Electronic Media and Its Application in Psychotherapy

Depression Clinical Trial

Official title:

Electronic Media and Its Application in Psychotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03712267
• Other study ID #: 2018P002179
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2018
• Est. completion date: November 2022

Study information

• Verified date: December 2021
• Source: Mclean Hospital
• Contact: Rebecca Dickinson, BA
• Phone: 617-855
• Email: rdickinson[@]mclean.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 115
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Electronic Media

Intervention

Behavioral:
• Electronic Media Enhanced
Research assistants will provide participants' therapists with information from participants' electronic messaging prior to typically scheduled clinical appointments.
• Treatment as Usual
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.

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	Once Upon a Time Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Every 4 visits, up to 13 visits
Secondary	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.	Every 4 visits, up to 13 visits