Clinical trial NCT03712267: Electronic Media and Its Application in Psychotherapy
Official title: Electronic Media and Its Application in Psychotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Disorders
Depression
Electronic Media
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: Once Upon a Time Foundation
First posted: 2018-10-19
Enrollment: 115
Sex: ALL
Minimum age (years): 14
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in Mental Health Related Quality of Life/Functioning
timeFrame: After final visit
measure: Therapeutic Alliance
timeFrame: After final visit
Secondary outcomes:
measure: Clinical Outcome - Improvement in scores of depression
timeFrame: Every 4 visits, up to 13 visits
measure: Clinical Outcome - Improvement in scores of anxiety
timeFrame: Every 4 visits, up to 13 visits
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Ipsit Vahia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mclean Hospital
name: Kerry Ressler, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References: