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Completed

NCT Number: NCT04316572

Mental Health Specialist Video Consultations for Primary Care Patients

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.

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Key information

Conditions

Depression Anxiety Disorder Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heidelberg University

Heidelberg, Baden-Wurttemberg, D-69120, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mental health specialist video consultation

Behavioral

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

Primary outcomes

  1. The Patient Health Questionnaire Depression and Anxiety Scale (PHQ-ADS)

    Time frame: 6 months after inclusion

    composite measure of depression and anxiety (range: 0-48 Points, higher score indicates more severly depressed/anxious)

Secondary outcomes

  1. The Patient Health Questionnaire Depression and Anxiety Scale (PHQ-ADS)

    Time frame: 12 months after inclusion

    composite measure of depression and anxiety (range: 0-48 Points, higher score indicates more severly depressed/anxious)

  2. The Patient Health Questionnaire (PHQ-9)

    Time frame: 6 months after inclusion, 12 months after inclusion

    depressive symptom severity (range: 0-27 Points, higher score indicates more severly depressed)

  3. Generalized Anxiety Disorder Scale (GAD-7)

    Time frame: 6 months after inclusion, 12 months after inclusion

    anxiety symptom severity, range: 0-21, higher score indicates worse outcome

  4. Short-Form Health Survey 12 (SF-12)

    Time frame: 6 months after inclusion, 12 months after inclusion

    health related quality of life (two dimensions: physical and mental quality of life, ranges: 0-100, higher score indicates higher quality of life

  5. Recovery Assessment Scale (RAS-G)

    Time frame: 6 months after inclusion, 12 months after inclusion

    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. Somatic Symptom Disorder-B Criteria Scale (SSD-12)

    Time frame: 6 months after inclusion, 12 months after inclusion

    self-reported somatisation, range: 0-48, higher score indicates worse outcome

  7. Patient Assessment of Chronic Illness Care (PACIC)

    Time frame: 6 months after inclusion, 12 months after inclusion

    patients' satisfaction with the care of their chronic disease, range: 1-5, higher score indicates higher satisfaction

  8. EQ-5D

    Time frame: 6 months after inclusion, 12 months after inclusion

    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

  9. Questionnaire for the Assessment of Medical and non Medical Resource Utilisation in Mental Disorders (FIMPsy)

    Time frame: 6 months after inclusion, 12 months after inclusion

    self reported use of medical and psychosocial services for health-economic evaluation

Other outcomes

  1. Assessment of Negative Effects of Psychotherapy (INEP)

    Time frame: 6 months after inclusion, 12 months after inclusion (not measured at baseline, patients in control condition fill in adapted version)

    unintended/adverse effects of the intervention

  2. Normalisation MeAsure Development questionnaire (NoMAD)

    Time frame: 6 months after inclusion, 12 months after inclusion (measured in GPs and study therapists only)

    measurement of acceptance of newly introduced treatment models, 4 dimensions, range:1-5, lower score indicates greater acceptance of the intervention

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Collaborators

  • Heinrich-Heine University, Duesseldorf

Registry information

Official study 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

Acronym: PROVIDE-C

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 20, 2020
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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