Mental Health Specialist Video Consultations for Primary Care Patients

Depression Clinical Trial

— PROVIDE-C  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04316572
• Other study ID #: S-923/2019
• Status: Completed
• Phase: N/A
• Start date: March 24, 2020
• Est. completion date: November 18, 2022

Study information

• Verified date: July 2023
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: November 18, 2022
• Est. primary completion date: May 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Depression

Intervention

Behavioral:
• mental health specialist video consultation
The consultations will be based on a psychodynamic understanding with a solution-oriented stance and will follow a manual: Session 1: Getting familiar with the telemental health setting, building a working alliance and deepening diagnostics. Session 2: Clarification of the task/objective, focus building, motivational interviewing if necessary. Session 3-4: Focused brief interventions e.g. psychoeducation, promotion of social resources, activation of health-promoting lifestyles (sleep hygiene, eating diary, relaxation etc.), work on personal problems and, if necessary, initiation of further specialised treatment. Session 5: Ending the intervention, stabilisation, subsequent treatment plan and communicating a case summary to the general practitioner

Locations

Country	Name	City	State
Germany	Heidelberg University	Heidelberg	Baden-Wuerttemberg

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of Negative Effects of Psychotherapy (INEP)	unintended/adverse effects of the intervention	6 months after inclusion, 12 months after inclusion (not measured at baseline, patients in control condition fill in adapted version)
Other	Normalisation MeAsure Development questionnaire (NoMAD)	measurement of acceptance of newly introduced treatment models, 4 dimensions, range:1-5, lower score indicates greater acceptance of the intervention	6 months after inclusion, 12 months after inclusion (measured in GPs and study therapists only)
Primary	The Patient Health Questionnaire Depression and Anxiety Scale (PHQ-ADS)	composite measure of depression and anxiety (range: 0-48 Points, higher score indicates more severly depressed/anxious)	6 months after inclusion
Secondary	The Patient Health Questionnaire Depression and Anxiety Scale (PHQ-ADS)	composite measure of depression and anxiety (range: 0-48 Points, higher score indicates more severly depressed/anxious)	12 months after inclusion
Secondary	The Patient Health Questionnaire (PHQ-9)	depressive symptom severity (range: 0-27 Points, higher score indicates more severly depressed)	6 months after inclusion, 12 months after inclusion
Secondary	Generalized Anxiety Disorder Scale (GAD-7)	anxiety symptom severity, range: 0-21, higher score indicates worse outcome	6 months after inclusion, 12 months after inclusion
Secondary	Short-Form Health Survey 12 (SF-12)	health related quality of life (two dimensions: physical and mental quality of life, ranges: 0-100, higher score indicates higher quality of life	6 months after inclusion, 12 months after inclusion
Secondary	Recovery Assessment Scale (RAS-G)	self-reported mental health recovery, five dimension: 1) Goal and success orientation, 2) No domination by Symptoms, 3) Personal confidence and hope, 4) Reliance on others, 5) Willingness to ask others for help, ranges 1-5, higher score indicates better outcome	6 months after inclusion, 12 months after inclusion
Secondary	Somatic Symptom Disorder-B Criteria Scale (SSD-12)	self-reported somatisation, range: 0-48, higher score indicates worse outcome	6 months after inclusion, 12 months after inclusion
Secondary	Patient Assessment of Chronic Illness Care (PACIC)	patients' satisfaction with the care of their chronic disease, range: 1-5, higher score indicates higher satisfaction	6 months after inclusion, 12 months after inclusion
Secondary	EQ-5D	health related quality of life for health economic Evaluations, 5 dimensions: 1) Mobility, 2) Self-Care, 3) Usual Activities, 4) Pain/Discomfort, 5)Anxiety/Depression	6 months after inclusion, 12 months after inclusion
Secondary	Questionnaire for the Assessment of Medical and non Medical Resource Utilisation in Mental Disorders (FIMPsy)	self reported use of medical and psychosocial services for health-economic evaluation	6 months after inclusion, 12 months after inclusion