Clinical trial NCT04316572: Mental Health Specialist Video Consultations for Primary Care Patients
Official title: ImPROving Cross-sectoral Collaboration Between Primary and Psychosocial Care: A Randomised Controlled Superiority Trial to Compare the Effectiveness of a Mental Health Specialist VIDEo Consultations Model Versus Treatment as Usual in Patients With Depression or Anxiety Disorders in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety Disorder
Keywords: primary care
mental health
telemedicine
video consultations
effectiveness
health services research
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Heinrich-Heine University, Duesseldorf
First posted: 2020-03-20
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Even in Western health care systems, most people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP). Notably, the accessibility of mental health specialist care is mainly complicated by (a) long waiting times for specialists, (b) long travel distances to specialists, particularly in rural and remote areas, (c) patients' reservations about mental health specialist care (including fear of being stigmatised by seeking such care). To mitigate those barriers, technology-based integrated care models have been proposed. The purpose of this study is to measure the effectiveness of a mental health specialist video consultations model versus treatment as usual in patients with depression or anxiety disorders in primary care. In an individually randomized, prospective, two-arm superiority study with parallel group design, N = 320 patients with anxiety and/or depressive disorder will be recruited in GP practices.

Detailed description: The purpose of this study is to measure the effectiveness of a mental health specialist video consultations model versus treatment as usual in patients with depression or anxiety disorders in primary care. In total, the investigators plan to enrol 320 patients who will be randomly allocated to the experimental condition (mental health specialist video consultations) or the control condition (treatment as usual from their GP) in a 1:1 ratio. General practitioners will recruit patients during their regular clinic hours. If the patient is interested in participation, the patient will receive the informed consent form and the baseline questionnaire from the GP. The practice team will send the patient's contact details to the study team who will screen the patient with respect to the eligibility criteria.

Patients will be randomly allocated to one of the two study conditions (video consultation model vs. treatment-as-usual, TAU) in a 1:1 ratio by central randomisation.

The evaluation of the primary outcome will be performed according to the intention-to-treat principle.

The health economic evaluation will be carried out from the perspective of society. A cost-effectiveness and a cost-utility analysis will be carried out.

Eligibility criteria: Inclusion Criteria:

* at least one of the following psychological conditions i) at least moderately severe depression, defined as a PHQ-9 score of 10 or greater with either item one and/or two being endorsed, ii) at least moderately general anxiety disorder, defined as a Generalized Anxiety Disorder (GAD)-7 score of 10 or greater, or iii) exceeding the cut off of 11 points of the combined anxiety and depression score (PHQ-ADS)
* currently no or as yet insufficient treatment (psychotherapy, psychopharmacotherapy, or both) or difficulty with adherence
* capable of giving consent
* written informed consent

Exclusion Criteria:

* substance abuse/dependence that is likely to compromise intervention adherence
* risk of endangerment to others and/or risk of self-endangerment
* need for emergency medical treatment
* acute psychotic symptoms
* severe cognitive impairment or dementia
* significant hearing and/or visual impairment
* pregnancy in the ≥ 2nd Trimester
* prior experience with video consultations as part of the feasibility trial
* insufficient German language proficiency

Primary outcomes:
measure: The Patient Health Questionnaire Depression and Anxiety Scale (PHQ-ADS)
timeFrame: 6 months after inclusion
Secondary outcomes:
measure: The Patient Health Questionnaire Depression and Anxiety Scale (PHQ-ADS)
timeFrame: 12 months after inclusion
measure: The Patient Health Questionnaire (PHQ-9)
timeFrame: 6 months after inclusion, 12 months after inclusion
measure: Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: 6 months after inclusion, 12 months after inclusion
measure: Short-Form Health Survey 12 (SF-12)
timeFrame: 6 months after inclusion, 12 months after inclusion
measure: Recovery Assessment Scale (RAS-G)
timeFrame: 6 months after inclusion, 12 months after inclusion
measure: Somatic Symptom Disorder-B Criteria Scale (SSD-12)
timeFrame: 6 months after inclusion, 12 months after inclusion
measure: Patient Assessment of Chronic Illness Care (PACIC)
timeFrame: 6 months after inclusion, 12 months after inclusion
measure: EQ-5D
timeFrame: 6 months after inclusion, 12 months after inclusion
measure: Questionnaire for the Assessment of Medical and non Medical Resource Utilisation in Mental Disorders (FIMPsy)
timeFrame: 6 months after inclusion, 12 months after inclusion
Other outcomes:
measure: Assessment of Negative Effects of Psychotherapy (INEP)
timeFrame: 6 months after inclusion, 12 months after inclusion (not measured at baseline, patients in control condition fill in adapted version)
measure: Normalisation MeAsure Development questionnaire (NoMAD)
timeFrame: 6 months after inclusion, 12 months after inclusion (measured in GPs and study therapists only)
Locations:
city: Heidelberg
country: Germany
facility: Heidelberg University
state: Baden-Wuerttemberg
Study officials:
affiliation: Department of General Internal Medicine and Psychosomatics, Heidelberg University
name: Markus W Haun, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haun MW, Tonnies J, Krisam R, Kronsteiner D, Wensing M, Szecsenyi J, Vomhof M, Icks A, Wild B, Hartmann M, Friederich HC. Mental health specialist video consultations versus treatment as usual in patients with depression or anxiety disorders in primary care: study protocol for an individually randomised superiority trial (the PROVIDE-C trial). Trials. 2021 May 5;22(1):327. doi: 10.1186/s13063-021-05289-3.