Affective DisordersMEHIRANCT03109028
Mental Health in Refugees and Asylum Seekers
A study testing Peer-to-Peer-Groupintervention, Smartphone-based-Intervention and Gendersensitive-Groupintervention in people with Affective Disorders, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The objective of this study is to investigate a stepped and collaborative care model (SCCM) for adolescent and adult refugees suffering from depression living in Germany. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Affective Disorders
- What is being tested?
- Peer-to-Peer-Groupintervention, Smartphone-based-Intervention and Gendersensitive-Groupintervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 584 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2018to 1 Mar 2020
- 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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Obtained a statutory health insurance
- Approved residence status as a refugee, asylum seeker or asylee
- Mother tongue in Arabic or Farsi/Urdu or speaks English or German fluently
- Age between 16-65 years
- Participants shows relevant depressive symptoms measured by the PHQ-9 or PHQ-A
Who cannot join
- An existing schizophrenia or degenerative disorder
- Missing informed consent
- Possible suicidality
- Uncertain residence status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stepped Care Model Supporting Mental Health in Refugees and Asylum Seekers
The objective of this study is to investigate a stepped and collaborative care model (SCCM) for adolescent and adult refugees suffering from depression living in Germany.
Read the detailed description
A prospective, cluster-randomized intervention study, conducted in seven German cities and comprising a total of 476 patients, should compare effectiveness and efficiency of this SCCM as compared to a 'Treatment as Usual' (TAU) condition. The fundamental principle of the examined care model is to provide patients with mild and moderate depression with accessible and affordable treatments, which are located outside the usual psychiatric-psychotherapeutic institutions (e.g. peer-to-peer-approaches or smartphone based interventions).
The acquired insights from the stepped care model, as well as concerning the individual low barrier interventions for adolescents and adults, can be used immediately for benefitting the provision of care of refugees but also for improving care of other communities with lacking access to health care systems. The generated disease figures from the nationwide screening process can be utilized directly to manage the provision of mental health fostering offers for refugees by federal institutions and social health insurance companies.
In both treatment arms (SCCM and TAU) and independent of intervention form participants will be assessed at four time periods after the initial screening process: Baseline (T1), after week 12 (T1), after week 24 (T2), after week 48 (T3).
Following clinical measurement tools will be used at all time periods:
- Refugee Health Screener (RHS-15)
- Patient Health Questionnaire (PHQ-9)
- Patient Health Questionnaire-Adapted (PHQ-A) *
- Montgomery-Åsberg Depression Scale (MÅDRS)
- Mannheimer Modul Ressourcenverbrauch (MRV)
- Brief Resilience Scale (BRS)
- General Self-Efficacy Scale (GSE)
- World Health Organization Quality of Life (WHOQOL-BREF)
- Child \& Adolescent Trauma Screening (CATS)*
Following clinical measurement tools will be used at Baseline (T1):
- Demographics / Migration Questionnaires
- M.I.N.I. International Neuropsychiatric Interview
- M.I.N.I. KID International Neuropsychiatric Interview*
- Harvard Trauma Questionnaire (HTQ)
Following clinical measurement tools will be used at Baseline (T0) and after Post-Intervention (T1):
- Cultural Differences Subscale
- Credibility / Expectancy Questionnaire
Following clinical measurement tools will be used at Baseline (T0), after Post-Intervention (T1) and Follow-Up 1 (T3):
- Strengths and Difficulties Questionnaire (SDQ)
*Adolescents only
- Conditions
- Affective Disorders
- Being tested
- Peer-to-Peer-Groupintervention, Smartphone-based-Intervention, Gendersensitive-Groupintervention, Empowerment-Groupintervention, Adolescent-Groupintervention
- Medical subject headings
- Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-to-Peer-GroupinterventionBehavioural
Target group: Adult participants with mild to moderate depressive symptoms who prefer therapists with the same cultural background.
Therapists: Recruitment of psychosocial counselors within refugee community who have sufficient German or English language knowledge. Counselors will be trained for a time period of two months.
Content: Vulnerability and resilience factors; Self-efficacy strategies; Causes and consequences of stress; Possibilities on accelerating the integration process; Strategies preventing violence and radicalization Form of therapy: Group-based intervention for a time period of three months; Two times per week with each session enduring 90 minutes; Group size between 8-10 participants; Headed by two psychosocial counselors.
Smartphone-based-InterventionBehavioural
Target group: Participants with moderate depressive symptoms who prefer an internet-based intervention.
Content: Five modules with 20 exercises elaborating on psycho-education, treatment options, self-management and diagnostics.
Form of therapy: Participants receive regular emails and sms to encourage steady participation via the internet-based smartphone-application. Weekly questionnaires ascertain the degree of participants symptomatology.
Gendersensitive-GroupinterventionBehavioural
Target group: Vulnerable group of adult women while taking cultural characteristics into account Therapists: Recruitment of psychosocial counselors (similar to Peer-to-Peer-Intervention); Training and supervision of gender-specific aspects.
Content: Focus on psycho-education which consider women specific topics such as gender-differences in symptoms and prevalence in psychic stress related and trauma disorders; physical, psychic and psychosocial consequences of traumatic and violent experiences; gender-specific risk and safety factors; stress and emotional self-regulation Form of therapy: Group-based intervention for a time period of three months; Two times per week with each session enduring 90 minutes; Group size between 8-10 participants; Headed by two female psychosocial counselors.
Empowerment-GroupinterventionBehavioural
Target group: Gender-sensitive group with mild to moderate depressive symptoms. Therapists: Psychologists and doctors in psychotherapeutic advanced training; The therapist-training lasts for three months with continued supervision during the intervention.
Content: Low-threshold intervention based on the treatment of depression; psycho-education about psychic burdens, trauma, stress and grief as well as vulnerability and resilience factors; Problem solving and self-actualization strategies.
Form of therapy: Group-based intervention for a time period of two months; Two times per week with each session enduring 90 minutes; Group size between 8-10 participants;
Adolescent-GroupinterventionBehavioural
Target group: Adolescent participants with moderate depressive symptoms. Therapists: Two child and adolescent psychiatrists with translators or two native speaking child and adolescent psychotherapists.
Content: Elements which are based on the START-Manual13 teaching emotion recognition and emotion regulation; Foundations are based on Dialetical behavior therapy; Specific focus lies on the use of mindfulness; Additionally the social network of the participants will receive psycho-education; Professional helpers in facilities will acquire E-learning elements of the SHELTER-program (Safety and Help for Early Adverse Life events and Traumatic Experiences in minor refugees)
Treatment as UsusalOther
Participants will receive the currently conducted routine and standard psychiatric health care. This involves ambulatory and stationary treatment by board certificated psychiatrists and psychotherapists.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | Active comparator | Regular standard psychiatric health care including all feasible interventions including medication, psychotherapy and social work. Receives: Other: Treatment as Ususal |
| Stepped and Collaborative Care Modell | Experimental | A stepped and collaborative treatment model with varying stepped psychotherapeutic interventions for adult and adolescent refugees. Receives: Behavioral: Peer-to-Peer-Groupintervention; Behavioral: Smartphone-based-Intervention; Behavioral: Gendersensitive-Groupintervention; Behavioral: Empowerment-Groupintervention; Behavioral: Adolescent-Groupintervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression severity measured by the Patient Health Questionnaire - 9 (PHQ-9)
Significant reduction in depression severity as measured by the Patient Health Questionnaire - 9 (PHQ-9) from baseline to post intervention in the experimental condition (SCCM) compared to the active control condition (TAU)
Measured: Baseline,12, 24 and 48 weeks after randomization
Secondary outcomes (2)
Response and remission rates measured by the Mannheimer Modul Ressourcenverbrauch (MRV)
Exploreing the superiority of broader effectiveness parameters, such as response and remission rates measured by the MRV between the SCCM and TAU condition.
Measured: Baseline, 12, 24 and 48 weeks after randomization
Traumatic events measured by the Child and Adoleszent Trauma Screening (CATS)
Significant reduction in emotional stress experienced by traumatic experiences as measured by the Child and Adoleszent Trauma Screening (CATS) in adolescents refugees from baseline to post intervention in the experimental condition (SCCM) compared to the active control condition (TAU)
Measured: Baseline, 12, 24 and 48 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 Mar 2018
- Primary completion31 Dec 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Affective DisordersStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 584 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Zentralinstitut für Seelische Gesundheit Mannheim, University of Potsdam, University of Ulm, Philipps University Marburg, RWTH Aachen University, Ludwig-Maximilians - University of Munich
- Responsible party
- Principal investigator, Malek Bajbouj, Charite University, Berlin, Germany
- Investigators
- Malek Bajbouj, Prof. Dr. med., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109028
- Sponsor's protocol ID
- 01VSF16061
- Acronym
- MEHIRA
- Status last verified
- Feb 2022
- First submitted
- 6 Apr 2017
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kemna S, Bringmann M, Karnouk C, Hoell A, Tschorn M, Kamp-Becker I, Padberg F, Ubleis A, Hasan A, Falkai P, Salize HJ, Meyer-Lindenberg A, Banaschewski T, Schneider F, Habel U, Plener P, Hahn E, Wiechers M, Strupf M, Jobst A, Millenet S, Hoehne E, Sukale T, Schuster M, Dinauer R, Mehran N, Kaiser F, Lieb K, Heinz A, Rapp M, Bajbouj M, Boge K. Characterizing of dropouts in the mental health of refugees and asylum seekers (MEHIRA) study examining the effects of a stepped and collaborative care model - a multicentered rater-blinded randomized controlled trial. Psychol Med. 2024 Dec;54(16):4868-4877. doi: 10.1017/S0033291724003179. Epub 2025 Jan 8.
PubMed 39773258Strupf M, Hoell A, Bajbouj M, Boge K, Wiechers M, Karnouk C, Kamp-Becker I, Banaschewski T, Meyer-Lindenberg A, Rapp M, Hasan A, Falkai P, Habel U, Heinz A, Plener P, Kaiser F, Weigold S, Mehran N, Ubleis A, Padberg F. Shared sorrow, shared costs: cost-effectiveness analysis of the Empowerment group therapy approach to treat affective disorders in refugee populations. BJPsych Open. 2023 Jun 22;9(4):e113. doi: 10.1192/bjo.2023.504.
PubMed 37345544Boge K, Karnouk C, Hoell A, Tschorn M, Kamp-Becker I, Padberg F, Ubleis A, Hasan A, Falkai P, Salize HJ, Meyer-Lindenberg A, Banaschewski T, Schneider F, Habel U, Plener P, Hahn E, Wiechers M, Strupf M, Jobst A, Millenet S, Hoehne E, Sukale T, Dinauer R, Schuster M, Mehran N, Kaiser F, Brocheler S, Lieb K, Heinz A, Rapp M, Bajbouj M. Effectiveness and cost-effectiveness for the treatment of depressive symptoms in refugees and asylum seekers: A multi-centred randomized controlled trial. Lancet Reg Health Eur. 2022 Jun 6;19:100413. doi: 10.1016/j.lanepe.2022.100413. eCollection 2022 Aug.
PubMed 35694653
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Care Model Supporting Mental Health in Refugees and Asylum Seekers
- ClinicalTrials.gov ID
- NCT03109028
- Acronym / sponsor ID
- MEHIRA / 01VSF16061
- Conditions
- Affective Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 584 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Zentralinstitut für Seelische Gesundheit Mannheim, University of Potsdam, University of Ulm, Philipps University Marburg, RWTH Aachen University, Ludwig-Maximilians - University of Munich
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 11 Apr 2017 (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.
The objective of this study is to investigate a stepped and collaborative care model (SCCM) for adolescent and adult refugees suffering from depression living in Germany.
Detailed description
A prospective, cluster-randomized intervention study, conducted in seven German cities and comprising a total of 476 patients, should compare effectiveness and efficiency of this SCCM as compared to a 'Treatment as Usual' (TAU) condition. The fundamental principle of the examined care model is to provide patients with mild and moderate depression with accessible and affordable treatments, which are located outside the usual psychiatric-psychotherapeutic institutions (e.g. peer-to-peer-approaches or smartphone based interventions).
The acquired insights from the stepped care model, as well as concerning the individual low barrier interventions for adolescents and adults, can be used immediately for benefitting the provision of care of refugees but also for improving care of other communities with lacking access to health care systems. The generated disease figures from the nationwide screening process can be utilized directly to manage the provision of mental health fostering offers for refugees by federal institutions and social health insurance companies.
In both treatment arms (SCCM and TAU) and independent of intervention form participants will be assessed at four time periods after the initial screening process: Baseline (T1), after week 12 (T1), after week 24 (T2), after week 48 (T3).
Following clinical measurement tools will be used at all time periods:
- Refugee Health Screener (RHS-15)
- Patient Health Questionnaire (PHQ-9)
- Patient Health Questionnaire-Adapted (PHQ-A) *
- Montgomery-Åsberg Depression Scale (MÅDRS)
- Mannheimer Modul Ressourcenverbrauch (MRV)
- Brief Resilience Scale (BRS)
- General Self-Efficacy Scale (GSE)
- World Health Organization Quality of Life (WHOQOL-BREF)
- Child \& Adolescent Trauma Screening (CATS)*
Following clinical measurement tools will be used at Baseline (T1):
- Demographics / Migration Questionnaires
- M.I.N.I. International Neuropsychiatric Interview
- M.I.N.I. KID International Neuropsychiatric Interview*
- Harvard Trauma Questionnaire (HTQ)
Following clinical measurement tools will be used at Baseline (T0) and after Post-Intervention (T1):
- Cultural Differences Subscale
- Credibility / Expectancy Questionnaire
Following clinical measurement tools will be used at Baseline (T0), after Post-Intervention (T1) and Follow-Up 1 (T3):
- Strengths and Difficulties Questionnaire (SDQ)
*Adolescents only
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | Active comparator | Other: Treatment as UsusalRegular standard psychiatric health care including all feasible interventions including medication, psychotherapy and social work. |
| Stepped and Collaborative Care Modell | Experimental | Behavioral: Peer-to-Peer-Groupintervention, Behavioral: Smartphone-based-Intervention, Behavioral: Gendersensitive-Groupintervention, Behavioral: Empowerment-Groupintervention, Behavioral: Adolescent-GroupinterventionA stepped and collaborative treatment model with varying stepped psychotherapeutic interventions for adult and adolescent refugees. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Obtained a statutory health insurance
- Approved residence status as a refugee, asylum seeker or asylee
- Mother tongue in Arabic or Farsi/Urdu or speaks English or German fluently
- Age between 16-65 years
- Participants shows relevant depressive symptoms measured by the PHQ-9 or PHQ-A
Key exclusion criteria (4 listed)
- An existing schizophrenia or degenerative disorder
- Missing informed consent
- Possible suicidality
- Uncertain residence status
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 |
|---|---|---|
| Peer-to-Peer-GroupinterventionTarget group: Adult participants with mild to moderate depressive symptoms who prefer therapists with the same cultural background. Therapists: Recruitment of psychosocial counselors within refugee community who have sufficient German or English language knowledge. Counselors will be trained for a time period of two months. Content: Vulnerability and resilience factors; Self-efficacy strategies; Causes and consequences of stress; Possibilities on accelerating the integration process; Strategies preventing violence and radicalization Form of therapy: Group-based intervention for a time period of three months; Two times per week with each session enduring 90 minutes; Group size between 8-10 participants; Headed by two psychosocial counselors. | Behavioural | Stepped and Collaborative Care Modell |
| Smartphone-based-InterventionTarget group: Participants with moderate depressive symptoms who prefer an internet-based intervention. Content: Five modules with 20 exercises elaborating on psycho-education, treatment options, self-management and diagnostics. Form of therapy: Participants receive regular emails and sms to encourage steady participation via the internet-based smartphone-application. Weekly questionnaires ascertain the degree of participants symptomatology. | Behavioural | Stepped and Collaborative Care Modell |
| Gendersensitive-GroupinterventionTarget group: Vulnerable group of adult women while taking cultural characteristics into account Therapists: Recruitment of psychosocial counselors (similar to Peer-to-Peer-Intervention); Training and supervision of gender-specific aspects. Content: Focus on psycho-education which consider women specific topics such as gender-differences in symptoms and prevalence in psychic stress related and trauma disorders; physical, psychic and psychosocial consequences of traumatic and violent experiences; gender-specific risk and safety factors; stress and emotional self-regulation Form of therapy: Group-based intervention for a time period of three months; Two times per week with each session enduring 90 minutes; Group size between 8-10 participants; Headed by two female psychosocial counselors. | Behavioural | Stepped and Collaborative Care Modell |
| Empowerment-GroupinterventionTarget group: Gender-sensitive group with mild to moderate depressive symptoms. Therapists: Psychologists and doctors in psychotherapeutic advanced training; The therapist-training lasts for three months with continued supervision during the intervention. Content: Low-threshold intervention based on the treatment of depression; psycho-education about psychic burdens, trauma, stress and grief as well as vulnerability and resilience factors; Problem solving and self-actualization strategies. Form of therapy: Group-based intervention for a time period of two months; Two times per week with each session enduring 90 minutes; Group size between 8-10 participants; | Behavioural | Stepped and Collaborative Care Modell |
| Adolescent-GroupinterventionTarget group: Adolescent participants with moderate depressive symptoms. Therapists: Two child and adolescent psychiatrists with translators or two native speaking child and adolescent psychotherapists. Content: Elements which are based on the START-Manual13 teaching emotion recognition and emotion regulation; Foundations are based on Dialetical behavior therapy; Specific focus lies on the use of mindfulness; Additionally the social network of the participants will receive psycho-education; Professional helpers in facilities will acquire E-learning elements of the SHELTER-program (Safety and Help for Early Adverse Life events and Traumatic Experiences in minor refugees) | Behavioural | Stepped and Collaborative Care Modell |
| Treatment as UsusalParticipants will receive the currently conducted routine and standard psychiatric health care. This involves ambulatory and stationary treatment by board certificated psychiatrists and psychotherapists. | Other | Treatment as Usual |
Primary outcome
Depression severity measured by the Patient Health Questionnaire - 9 (PHQ-9)
Time frame: Baseline,12, 24 and 48 weeks after randomization
Significant reduction in depression severity as measured by the Patient Health Questionnaire - 9 (PHQ-9) from baseline to post intervention in the experimental condition (SCCM) compared to the active control condition (TAU)
2 secondary outcomes
Response and remission rates measured by the Mannheimer Modul Ressourcenverbrauch (MRV)
Time frame: Baseline, 12, 24 and 48 weeks after randomization
Traumatic events measured by the Child and Adoleszent Trauma Screening (CATS)
Time frame: Baseline, 12, 24 and 48 weeks after randomization
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 18 Feb 2022.
- Derived from this study: PubMed 39773258Kemna S, Bringmann M, Karnouk C, Hoell A, Tschorn M, Kamp-Becker I, Padberg F, Ubleis A, Hasan A, Falkai P, Salize HJ, Meyer-Lindenberg A, Banaschewski T, Schneider F, Habel U, Plener P, Hahn E, Wiechers M, Strupf M, Jobst A, Millenet S, Hoehne E, Sukale T, Schuster M, Dinauer R, Mehran N, Kaiser F, Lieb K, Heinz A, Rapp M, Bajbouj M, Boge K. Characterizing of dropouts in the mental health of refugees and asylum seekers (MEHIRA) study examining the effects of a stepped and collaborative care model - a multicentered rater-blinded randomized controlled trial. Psychol Med. 2024 Dec;54(16):4868-4877. doi: 10.1017/S0033291724003179. Epub 2025 Jan 8.
- Derived from this study: PubMed 37345544Strupf M, Hoell A, Bajbouj M, Boge K, Wiechers M, Karnouk C, Kamp-Becker I, Banaschewski T, Meyer-Lindenberg A, Rapp M, Hasan A, Falkai P, Habel U, Heinz A, Plener P, Kaiser F, Weigold S, Mehran N, Ubleis A, Padberg F. Shared sorrow, shared costs: cost-effectiveness analysis of the Empowerment group therapy approach to treat affective disorders in refugee populations. BJPsych Open. 2023 Jun 22;9(4):e113. doi: 10.1192/bjo.2023.504.
- Derived from this study: PubMed 35694653Boge K, Karnouk C, Hoell A, Tschorn M, Kamp-Becker I, Padberg F, Ubleis A, Hasan A, Falkai P, Salize HJ, Meyer-Lindenberg A, Banaschewski T, Schneider F, Habel U, Plener P, Hahn E, Wiechers M, Strupf M, Jobst A, Millenet S, Hoehne E, Sukale T, Dinauer R, Schuster M, Mehran N, Kaiser F, Brocheler S, Lieb K, Heinz A, Rapp M, Bajbouj M. Effectiveness and cost-effectiveness for the treatment of depressive symptoms in refugees and asylum seekers: A multi-centred randomized controlled trial. Lancet Reg Health Eur. 2022 Jun 6;19:100413. doi: 10.1016/j.lanepe.2022.100413. eCollection 2022 Aug.
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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.
Malek Bajbouj, Prof. Dr. med. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-to-Peer-Groupintervention, Smartphone-based-Intervention and Gendersensitive-Groupintervention in people with Affective Disorders, run by Charite University, Berlin, Germany 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 5 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: finished, as of the sponsor's last update on 18 Feb 2022. 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?
Depression severity measured by the Patient Health Questionnaire - 9 (PHQ-9) (time frame: Baseline,12, 24 and 48 weeks after randomization). 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 NCT03109028, which also lists 3 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 18 Feb 2022.