Depression in AdolescenceINNOV5-MHNCT07258095
INNOV5-MH-MAROC: Integrated Mental Health Care for Adolescents and Adults in Primary Care Centers and Schools in Morocco
A study testing INNOV5 Integrated Mental Health Program and Enhanced Treatment as Usual (TAU+) in people with Depression in Adolescence and Depression in Adults, run by Swiss Medical Academy Maroc at 1 site in Switzerland.
Trial summary
Depression and anxiety are highly prevalent among adolescents and adults in Morocco, while access to evidence-based care in primary care centers and schools remains limited. This multicenter pragmatic randomized controlled trial evaluates an integrated mental health program inspired by WHO priorities. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Depression in Adolescence, Depression in Adults, Anxiety
- What is being tested?
- INNOV5 Integrated Mental Health Program and Enhanced Treatment as Usual (TAU+)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2028to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adolescents (12-17 years) and adults (≥18 years) attending participating primary care centres or high schools in Morocco.
- Clinically significant depressive and/or anxiety symptoms identified by screening (PHQ-9 and/or GAD-7) according to study thresholds.
- Able to understand study procedures and provide informed consent (or parental consent and adolescent assent for minors).
- Planning to remain in the study area for at least 12 months.
Who cannot join
- Acute psychiatric emergency requiring immediate specialised care (e.g. psychosis, high-risk suicidal crisis, severe substance use disorder).
- Cognitive impairment or severe medical condition preventing participation in the intervention or assessments.
- Current participation in another interventional mental health trial.
- Any other situation judged by the investigator to make participation unsafe or inappropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Swiss Medical Academy Maroc
Sion, 1950
Younes Moudar, MPH, +41764429310, y.moudar@ardevaz.com
0764429310
About this study
Official title: INNOV5-MH-MAROC: Multicenter Pragmatic Randomized Controlled Trial Evaluating an Integrated Program of Five WHO Innovations in Mental Health in Morocco
Depression and anxiety are highly prevalent among adolescents and adults in Morocco, while access to evidence-based care in primary care centers and schools remains limited. This multicenter pragmatic randomized controlled trial evaluates an integrated mental health program inspired by WHO priorities. The INNOV5 intervention combines: (1) a collaborative care model in primary care; (2) mhGAP-based task-shifting and stepped care; (3) validated digital mental health interventions; (4) virtual reality exposure therapy for selected anxiety- or trauma-related cases; and (5) a school-based mental health promotion component in participating high schools. The primary objective is to compare the change in depressive symptoms (PHQ-9) at 6 months between INNOV5 and enhanced treatment as usual (TAU+). Secondary objectives include effects on anxiety (GAD-7), quality of life (WHOQOL-BREF), suicidal ideation and behavior (C-SSRS), functioning, school attendance, and feasibility and acceptability of the program.
- Conditions
- Depression in Adolescence, Depression in Adults, Anxiety, Mental and Behavioural Disorders
- Being tested
- INNOV5 Integrated Mental Health Program, Enhanced Treatment as Usual (TAU+)
- Keywords
- Depression, Anxiety, Adolescent mental health, Primary care, School-based mental health, Digital mental health, Virtual reality exposure, mhGAP, Task-shifting, Morocco
- Medical subject headings
- Anxiety Disorders, Mental Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INNOV5 Integrated Mental Health ProgramBehavioural
Integrated multicomponent mental health program combining: (1) a collaborative care model in primary care; (2) mhGAP-based task-shifting and stepped care; (3) validated digital mental health interventions (apps and online tools); (4) virtual reality exposure therapy for selected anxiety- or trauma-related cases; and (5) a school-based mental health promotion component in participating high schools.
Enhanced Treatment as Usual (TAU+)Behavioural
Usual mental health care and referrals available at participating primary care centers and schools, with minimal enhancements such as WHO mhGAP materials and basic information and referral resources, but without access to the INNOV5 integrated program components.
| Study group | Role | What they receive |
|---|---|---|
| INNOV5 Integrated Program | Experimental | Participants receive the INNOV5 integrated mental health program combining: (1) a collaborative care model in primary care; (2) mhGAP-based task-shifting and stepped care; (3) validated digital mental health interventions (apps and online tools); (4) virtual reality exposure therapy for selected anxiety- or trauma-related cases; and (5) a school-based mental health promotion component in participating high schools. Receives: Behavioral: INNOV5 Integrated Mental Health Program; Behavioral: Enhanced Treatment as Usual (TAU+) |
| Enhanced Treatment as Usual (TAU+) | Active comparator | Participants receive enhanced treatment as usual in participating primary care centers and schools. TAU+ consists of routine mental health care and referrals available at each site, plus minimal enhancements such as access to WHO mhGAP materials and basic information and referral resources. Participants do not receive the specific INNOV5 program components. Receives: Behavioral: INNOV5 Integrated Mental Health Program; Behavioral: Enhanced Treatment as Usual (TAU+) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms (PHQ-9)
Mean change in Patient Health Questionnaire-9 (PHQ-9) total score from baseline to 6 months comparing INNOV5 versus enhanced treatment as usual (TAU+). The PHQ-9 is a 9-item self-report scale of depressive symptoms; total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Measured: Baseline to 6 months
Secondary outcomes (1)
Change in anxiety symptoms (GAD-7)
Mean change in Generalized Anxiety Disorder-7 (GAD-7) total score from baseline to 6 months between participants allocated to the INNOV5 integrated mental health program and those allocated to enhanced treatment as usual (TAU+). The GAD-7 is a 7-item self-report measure of anxiety symptoms; total scores range from 0 to 21, with higher scores indicating more severe anxiety.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Mar 2028 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in AdolescenceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized 1:1 to either the INNOV5 integrated mental health program or enhanced treatment as usual (TAU+) in a two-arm parallel-group pragmatic trial conducted in Moroccan primary care centers and high schools.
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Medical Academy Maroc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258095
- Sponsor's protocol ID
- SMA-INNOV5-MH-MAROC-01
- Other IDs
- SMA-INNOV5-MH-MAROC-01
- Acronym
- INNOV5-MH
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the primary and secondary outcome analyses will be made available to qualified researchers upon reasonable request, after completion of the trial and publication of the main results. Data sharing will comply with Moroccan data protection law (Loi 09-08), CNDP authorization and institutional policies. A data sharing agreement will be required.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INNOV5-MH-MAROC: Multicenter Pragmatic Randomized Controlled Trial Evaluating an Integrated Program of Five WHO Innovations in Mental Health in Morocco
- ClinicalTrials.gov ID
- NCT07258095
- Acronym / sponsor ID
- INNOV5-MH / SMA-INNOV5-MH-MAROC-01
- Conditions
- Depression in Adolescence, Depression in Adults, Anxiety, Mental and Behavioural Disorders
- Keywords
- Depression, Anxiety, Adolescent mental health, Primary care, School-based mental health, Digital mental health, Virtual reality exposure, mhGAP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Swiss Medical Academy MarocUniversity, hospital or other
- Study start
- 1 Mar 2028 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Dec 2025 (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.
Depression and anxiety are highly prevalent among adolescents and adults in Morocco, while access to evidence-based care in primary care centers and schools remains limited. This multicenter pragmatic randomized controlled trial evaluates an integrated mental health program inspired by WHO priorities. The INNOV5 intervention combines: (1) a collaborative care model in primary care; (2) mhGAP-based task-shifting and stepped care; (3) validated digital mental health interventions; (4) virtual reality exposure therapy for selected anxiety- or trauma-related cases; and (5) a school-based mental health promotion component in participating high schools. The primary objective is to compare the change in depressive symptoms (PHQ-9) at 6 months between INNOV5 and enhanced treatment as usual (TAU+). Secondary objectives include effects on anxiety (GAD-7), quality of life (WHOQOL-BREF), suicidal ideation and behavior (C-SSRS), functioning, school attendance, and feasibility and acceptability of the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 to either the INNOV5 integrated mental health program or enhanced treatment as usual (TAU+) in a two-arm parallel-group pragmatic trial conducted in Moroccan primary care centers and high schools.
| Arm | Type | Receives |
|---|---|---|
| INNOV5 Integrated Program | Experimental | Behavioral: INNOV5 Integrated Mental Health Program, Behavioral: Enhanced Treatment as Usual (TAU+)Participants receive the INNOV5 integrated mental health program combining: (1) a collaborative care model in primary care; (2) mhGAP-based task-shifting and stepped care; (3) validated digital mental health interventions (apps and online tools); (4) virtual reality exposure therapy for selected anxiety- or trauma-related cases; and (5) a school-based mental health promotion component in participating high schools. |
| Enhanced Treatment as Usual (TAU+) | Active comparator | Behavioral: INNOV5 Integrated Mental Health Program, Behavioral: Enhanced Treatment as Usual (TAU+)Participants receive enhanced treatment as usual in participating primary care centers and schools. TAU+ consists of routine mental health care and referrals available at each site, plus minimal enhancements such as access to WHO mhGAP materials and basic information and referral resources. Participants do not receive the specific INNOV5 program components. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adolescents (12-17 years) and adults (≥18 years) attending participating primary care centres or high schools in Morocco.
- Clinically significant depressive and/or anxiety symptoms identified by screening (PHQ-9 and/or GAD-7) according to study thresholds.
- Able to understand study procedures and provide informed consent (or parental consent and adolescent assent for minors).
- Planning to remain in the study area for at least 12 months.
Key exclusion criteria (4 listed)
- Acute psychiatric emergency requiring immediate specialised care (e.g. psychosis, high-risk suicidal crisis, severe substance use disorder).
- Cognitive impairment or severe medical condition preventing participation in the intervention or assessments.
- Current participation in another interventional mental health trial.
- Any other situation judged by the investigator to make participation unsafe or inappropriate.
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 |
|---|---|---|
| INNOV5 Integrated Mental Health ProgramIntegrated multicomponent mental health program combining: (1) a collaborative care model in primary care; (2) mhGAP-based task-shifting and stepped care; (3) validated digital mental health interventions (apps and online tools); (4) virtual reality exposure therapy for selected anxiety- or trauma-related cases; and (5) a school-based mental health promotion component in participating high schools. | Behavioural | Enhanced Treatment as Usual (TAU+), INNOV5 Integrated Program |
| Enhanced Treatment as Usual (TAU+)Usual mental health care and referrals available at participating primary care centers and schools, with minimal enhancements such as WHO mhGAP materials and basic information and referral resources, but without access to the INNOV5 integrated program components. | Behavioural | Enhanced Treatment as Usual (TAU+), INNOV5 Integrated Program |
Primary outcome
Change in depressive symptoms (PHQ-9)
Time frame: Baseline to 6 months
Mean change in Patient Health Questionnaire-9 (PHQ-9) total score from baseline to 6 months comparing INNOV5 versus enhanced treatment as usual (TAU+). The PHQ-9 is a 9-item self-report scale of depressive symptoms; total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
1 secondary outcome
Change in anxiety symptoms (GAD-7)
Time frame: Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the primary and secondary outcome analyses will be made available to qualified researchers upon reasonable request, after completion of the trial and publication of the main results. Data sharing will comply with Moroccan data protection law (Loi 09-08), CNDP authorization and institutional policies. A data sharing agreement will be required.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INNOV5 Integrated Mental Health Program and Enhanced Treatment as Usual (TAU+) in people with Depression in Adolescence and Depression in Adults, run by Swiss Medical Academy Maroc at 1 site in Switzerland.
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 4 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: opening soon, as of the sponsor's last update on 2 Dec 2025. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Younes MOUDAR, MPH (+41764429310, y.moudar@ardevaz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptoms (PHQ-9) (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2025.