NCT04011540

Digital Data in Mental Health Therapy

Completed NA Results posted Last updated 28 May 2024

What this trial tests

NA trial testing Digital data in Depressive Symptoms in 115 participants. Completed in 31 December 2021.

Timeline

21 September 2020

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	University of Pennsylvania
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	115
Start date	21 September 2020
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	1 location across United States

Drugs / interventions tested

• Digital data

Conditions studied

• Depressive Symptoms — all drugs for Depressive Symptoms →
• Anxiety Generalized — all drugs for Anxiety Generalized →

Sponsor

University of Pennsylvania

Who can join

Adults 18 to 80, any sex, with Depressive Symptoms or Anxiety Generalized. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Health-related Quality of Life (HRQoL), RAND 36-Item Health Survey Changed Value (Baseline to 2 Months) Primary · 2 months

The RAND 36-Item Health Survey is a set of generic, coherent, and easily administered health-related quality of life (HRQoL) measures. It explores eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Each item is scored on a 0 to 100 range. The lowest and highest possible scores are 0 and 100, respectively.

Group	Value	95% CI
Intervention	-0.89	-5.55 – 3.77
Usual Care	-1.85	-5.73 – 2.04

Depressive Symptoms, Patient Health Questionnaire-8 (PHQ-8) Change Value Secondary · 2 months

Patient health questionnaire-8 (PHQ-8) (Kroenke, Spitzer, \& Williams, 2001) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-8 incorporates DSM-IV depression diagnostic criteria. Each question is rated on a scale of 0 to 3, minimum score is 0 and maximum score is 24. A total of 8 questions are administered. Lower scores indicate minimal depression (better outcome) and higher scores indicate severe depression (worse outcome).

Group	Value	95% CI
Intervention	-1.20	-2.31 – -0.08
Usual Care	-0.44	-1.65 – 0.77

Anxiety Symptoms, Generalized Anxiety Disorder-7 (GAD-7) Change Value Secondary · 2 months

GAD-7 is a 7-item anxiety scale. It has good reliability, as well as criterion, construct, factorial, and procedural validity. Each item is rated according to the frequency of the described problem. The responses are scored as follows: 0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day with a maximum score of 21 Scores are interpreted as 5 to 9, mild anxiety; 10 to 14, moderate anxiety; and 15 and above, severe anxiety. Lower scores represent mild anxiety (better outcome) while higher scores represent severe anxiety (worse outcome).

Group	Value	95% CI
Intervention	-0.90	-2.10 – 0.30
Usual Care	-1.14	-2.38 – 0.10

Therapeutic Relationship, Working Alliance Inventory (WAI) Change Value Secondary · 2 months

Working Alliance Inventory (WAI) (Horvath and Greenberg 1986) is used to measure the service user-psychiatrist relationship from the service user perspective. The Working Alliance Inventory-Short Version (WAI-S) is based upon Bordins three-factor conceptualization of the provider and client relationship: collaboration on tasks, collaboration on goals and the bond between the client and therapist. Participants rate items on a 5-point Likert scale anchored at each end with 'rarely or never' (1) and 'always' (5). The total score is simply the sum of all the scores with the appropriate negative it

Group	Value	95% CI
Intervention	0.36	-1.52 – 2.25
Usual Care	-0.65	-2.26 – 0.95

Sponsor's own description

The Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment intends to better understand how digital data, social media, and electronic communication can be used in mental health therapy.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of Integrating Patient-Generated Digital Data Into Mental Health Therapy: A Randomized Controlled Trial.
   Merchant RM, Southwick L, Beidas RS, Mandell DS, et al · · 2023 · cited 5× · PMID 36545773 · DOI 10.1176/appi.ps.20220272
2. Integrating Patient-Generated Digital Data Into Mental Health Therapy: Mixed Methods Analysis of User Experience.
   Southwick L, Sharma M, Rai S, Beidas RS, et al · · 2024 · PMID 39696769 · DOI 10.2196/59785