DepressionPROVIDE-CNCT04316572
Mental Health Specialist Video Consultations for Primary Care Patients
A study testing mental health specialist video consultation in people with Depression and Anxiety Disorder, run by Heidelberg University at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety Disorder
- What is being tested?
- mental health specialist video consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteGermany
- Study dates
- 24 Mar 2020to 18 Nov 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- pregnancy in the ≥ 2nd Trimester
- prior experience with video consultations as part of the feasibility trial
- insufficient German language proficiency
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Depression, Anxiety Disorder
- Being tested
- mental health specialist video consultation
- Keywords
- primary care, mental health, telemedicine, video consultations, effectiveness, health services research
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mental health specialist video consultationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| mental health specialist video consultation | Experimental | The intervention group will receive five video consultations with psychotherapists directly in the GP's practice.
The consultations will be carried out via the web portal of a certified video service provider (arztkonsultation ak GmbH). The patient will be located in the GP's practice and the psychotherapist in his practice or another suitable room. Patients are scheduled for five sessions of 50 minutes. Receives: Behavioral: mental health specialist video consultation |
| treatment as usual by the GP | No intervention | Routine treatment by the GP, which may or may not include conversations about psychosocial problems and/or referral to specialised services (e.g., inpatient therapy, counseling, self-help). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months after inclusion
Secondary outcomes (9)
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)
Measured: 12 months after inclusion
The Patient Health Questionnaire (PHQ-9)
depressive symptom severity (range: 0-27 Points, higher score indicates more severly depressed)
Measured: 6 months after inclusion, 12 months after inclusion
Generalized Anxiety Disorder Scale (GAD-7)
anxiety symptom severity, range: 0-21, higher score indicates worse outcome
Measured: 6 months after inclusion, 12 months after inclusion
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
Measured: 6 months after inclusion, 12 months after inclusion
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
Measured: 6 months after inclusion, 12 months after inclusion
Somatic Symptom Disorder-B Criteria Scale (SSD-12)
self-reported somatisation, range: 0-48, higher score indicates worse outcome
Measured: 6 months after inclusion, 12 months after inclusion
Patient Assessment of Chronic Illness Care (PACIC)
patients' satisfaction with the care of their chronic disease, range: 1-5, higher score indicates higher satisfaction
Measured: 6 months after inclusion, 12 months after inclusion
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
Measured: 6 months after inclusion, 12 months after inclusion
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
Measured: 6 months after inclusion, 12 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start24 Mar 2020
- Primary completion24 May 2022
- Study completion18 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Heinrich-Heine University, Duesseldorf
- Responsible party
- Principal investigator, Markus Haun, Heidelberg University
- Investigators
- Markus W Haun, MD, MSc, Principal investigator, Department of General Internal Medicine and Psychosomatics, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316572
- Sponsor's protocol ID
- S-923/2019
- Acronym
- PROVIDE-C
- Status last verified
- Jul 2023
- First submitted
- 18 Mar 2020
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Muller S, Gagelmann L, Tonnies J, Wildenauer A, Wensing M, Friederich HC, Haun MW. Primary Care Physicians' Experiences with Integrated Mental Health Specialist Video Consultations-A Normalization Process Theory-Based Mixed-Methods Evaluation. J Gen Intern Med. 2026 Feb 12. doi: 10.1007/s11606-025-10109-4. Online ahead of print.
PubMed 41680544Muller S, Ritter-von Kramer A, Tonnies J, Wildenauer A, Wensing M, Friederich HC, Haun MW. Engaging underrepresented patient groups in specialised treatment - qualitative results from the PROVIDE-C randomised trial on integrated mental health video consultations for depression and anxiety. BMC Public Health. 2025 Nov 6;25(1):3817. doi: 10.1186/s12889-025-25235-1.
PubMed 41199204van Eickels D, Henning K, Wensing M, Friederich HC, Haun MW. Psychometric validation of the German version of the somatic symptom disorder - B criteria scale (SSD-12) in a primary care population with depression and anxiety: A COSMIN-guided analysis. Gen Hosp Psychiatry. 2025 Nov-Dec;97:3-10. doi: 10.1016/j.genhosppsych.2025.09.001. Epub 2025 Sep 4.
PubMed 40939424Haun MW, Tonnies J, Hartmann M, Wildenauer A, Wensing M, Szecsenyi J, Feisst M, Pohl M, Vomhof M, Icks A, Friederich HC. Model of integrated mental health video consultations for people with depression or anxiety in primary care (PROVIDE-C): assessor masked, multicentre, randomised controlled trial. BMJ. 2024 Sep 25;386:e079921. doi: 10.1136/bmj-2024-079921.
PubMed 39322237Haun 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.
PubMed 33952313
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04316572
- Acronym / sponsor ID
- PROVIDE-C / S-923/2019
- Conditions
- Depression, Anxiety Disorder
- Keywords
- primary care, mental health, telemedicine, video consultations, effectiveness, health services research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Heinrich-Heine University, Duesseldorf
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 18 Nov 2022 (actual)
- First posted
- 20 Mar 2020 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mental health specialist video consultation | Experimental | Behavioral: mental health specialist video consultationThe intervention group will receive five video consultations with psychotherapists directly in the GP's practice. The consultations will be carried out via the web portal of a certified video service provider (arztkonsultation ak GmbH). The patient will be located in the GP's practice and the psychotherapist in his practice or another suitable room. Patients are scheduled for five sessions of 50 minutes. |
| treatment as usual by the GP | No intervention | –Routine treatment by the GP, which may or may not include conversations about psychosocial problems and/or referral to specialised services (e.g., inpatient therapy, counseling, self-help). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| mental health specialist video consultationThe 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 | Behavioural | mental health specialist video consultation |
Primary outcome
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)
9 secondary outcomes
The Patient Health Questionnaire Depression and Anxiety Scale (PHQ-ADS)
Time frame: 12 months after inclusion
The Patient Health Questionnaire (PHQ-9)
Time frame: 6 months after inclusion, 12 months after inclusion
Generalized Anxiety Disorder Scale (GAD-7)
Time frame: 6 months after inclusion, 12 months after inclusion
Short-Form Health Survey 12 (SF-12)
Time frame: 6 months after inclusion, 12 months after inclusion
Recovery Assessment Scale (RAS-G)
Time frame: 6 months after inclusion, 12 months after inclusion
Somatic Symptom Disorder-B Criteria Scale (SSD-12)
Time frame: 6 months after inclusion, 12 months after inclusion
Patient Assessment of Chronic Illness Care (PACIC)
Time frame: 6 months after inclusion, 12 months after inclusion
EQ-5D
Time frame: 6 months after inclusion, 12 months after inclusion
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
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 1 Aug 2023.
- Derived from this study: PubMed 41680544Muller S, Gagelmann L, Tonnies J, Wildenauer A, Wensing M, Friederich HC, Haun MW. Primary Care Physicians' Experiences with Integrated Mental Health Specialist Video Consultations-A Normalization Process Theory-Based Mixed-Methods Evaluation. J Gen Intern Med. 2026 Feb 12. doi: 10.1007/s11606-025-10109-4. Online ahead of print.
- Derived from this study: PubMed 41199204Muller S, Ritter-von Kramer A, Tonnies J, Wildenauer A, Wensing M, Friederich HC, Haun MW. Engaging underrepresented patient groups in specialised treatment - qualitative results from the PROVIDE-C randomised trial on integrated mental health video consultations for depression and anxiety. BMC Public Health. 2025 Nov 6;25(1):3817. doi: 10.1186/s12889-025-25235-1.
- Derived from this study: PubMed 40939424van Eickels D, Henning K, Wensing M, Friederich HC, Haun MW. Psychometric validation of the German version of the somatic symptom disorder - B criteria scale (SSD-12) in a primary care population with depression and anxiety: A COSMIN-guided analysis. Gen Hosp Psychiatry. 2025 Nov-Dec;97:3-10. doi: 10.1016/j.genhosppsych.2025.09.001. Epub 2025 Sep 4.
- Derived from this study: PubMed 39322237Haun MW, Tonnies J, Hartmann M, Wildenauer A, Wensing M, Szecsenyi J, Feisst M, Pohl M, Vomhof M, Icks A, Friederich HC. Model of integrated mental health video consultations for people with depression or anxiety in primary care (PROVIDE-C): assessor masked, multicentre, randomised controlled trial. BMJ. 2024 Sep 25;386:e079921. doi: 10.1136/bmj-2024-079921.
- Derived from this study: PubMed 33952313Haun 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.
- Individual participant dataSharing planned: Yes
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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.
Markus W Haun, MD, MSc principal investigator
Department of General Internal Medicine and Psychosomatics, Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mental health specialist video consultation in people with Depression and Anxiety Disorder, run by Heidelberg University at 1 site in Germany.
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 4 inclusion and 9 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 1 Aug 2023. 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 Germany. 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. 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?
The Patient Health Questionnaire Depression and Anxiety Scale (PHQ-ADS) (time frame: 6 months after inclusion). 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 NCT04316572, which also lists 5 linked publications.
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 1 Aug 2023.