Anxiety DisordersNCT03712267
Electronic Media and Its Application in Psychotherapy
A study testing Electronic Media Enhanced and Treatment as Usual in people with Anxiety Disorders and Depression, run by Mclean Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 85 years
- Conditions the study is for
- Anxiety Disorders, Depression, Electronic Media
- What is being tested?
- Electronic Media Enhanced and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2018to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anxiety Disorders, Depression, Electronic Media
- Being tested
- Electronic Media Enhanced, Treatment as Usual
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Media EnhancedBehavioural
Research assistants will provide participants' therapists with information from participants' electronic messaging prior to typically scheduled clinical appointments.
Treatment as UsualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Electronic Media Enhanced | Experimental | Research assistants will collect information on participants' electronic messaging behavior and content and provide that for use to participants' clinicians. Receives: Behavioral: Electronic Media Enhanced |
| Treatment As Usual | Placebo comparator | Participants will not have their electronic messaging reviewed prior to their typically scheduled clinical appointments. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After final visit
Secondary outcomes (2)
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.
Measured: Every 4 visits, up to 13 visits
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.
Measured: Every 4 visits, up to 13 visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start13 Dec 2018
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Once Upon a Time Foundation
- Responsible party
- Principal investigator, Ipsit Vihang Vahia, Mclean Hospital
- Investigators
- Ipsit Vahia, MD, Principal investigator, Mclean HospitalKerry Ressler, MD; PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712267
- Sponsor's protocol ID
- 2018P002179
- Status last verified
- Nov 2025
- First submitted
- 12 Oct 2018
- Last updated
- 5 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Connolly Gibbons MB, Zandi PP, Miller L, Vahia IV, Gallop R, Chiu RY, Kodkany N, Liow Y, Crits-Christoph P. Who benefits from electronic communications data in psychotherapy? Predictors of outcome and alliance in a pooled randomized trial database. Psychother Res. 2026 Sep 17:1-15. doi: 10.1080/10503307.2026.2734089. Online ahead of print.
PubMed 42755118
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Media and Its Application in Psychotherapy
- ClinicalTrials.gov ID
- NCT03712267
- Acronym / sponsor ID
- 2018P002179
- Conditions
- Anxiety Disorders, Depression, Electronic Media
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- Once Upon a Time Foundation
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic Media Enhanced | Experimental | Behavioral: Electronic Media EnhancedResearch assistants will collect information on participants' electronic messaging behavior and content and provide that for use to participants' clinicians. |
| Treatment As Usual | Placebo comparator | Behavioral: Treatment as UsualParticipants will not have their electronic messaging reviewed prior to their typically scheduled clinical appointments. |
Who may qualify
- Ages
- 14 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
- Active psychotic symptoms
- Are actively receiving ECT treatment
- Current alcohol or drug abuse problem (based on self report and review of medical records)
- Are involuntarily admitted to McLean Hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Media EnhancedResearch assistants will provide participants' therapists with information from participants' electronic messaging prior to typically scheduled clinical appointments. | Behavioural | Electronic Media Enhanced |
| Treatment as UsualResearch 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. | Behavioural | Treatment As Usual |
Primary outcome
Improvement in Mental Health Related Quality of Life/Functioning
Time frame: After final visit
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
Time frame: After final visit
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 secondary outcomes
Clinical Outcome - Improvement in scores of depression
Time frame: Every 4 visits, up to 13 visits
Clinical Outcome - Improvement in scores of anxiety
Time frame: Every 4 visits, up to 13 visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Derived from this study: PubMed 42755118Connolly Gibbons MB, Zandi PP, Miller L, Vahia IV, Gallop R, Chiu RY, Kodkany N, Liow Y, Crits-Christoph P. Who benefits from electronic communications data in psychotherapy? Predictors of outcome and alliance in a pooled randomized trial database. Psychother Res. 2026 Sep 17:1-15. doi: 10.1080/10503307.2026.2734089. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsit Vahia, MD principal investigator
Mclean Hospital
Kerry Ressler, MD; PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Media Enhanced and Treatment as Usual in people with Anxiety Disorders and Depression, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Mental Health Related Quality of Life/Functioning (time frame: After final visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03712267, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.