Anxiety DisordersNCT06988332
Problem Management Plus (PM+) in Chile: a Pilot Randomized Controlled Trial of a Psychological Transdiagnostic Intervention Delivered in Primary Health Care
A study testing Problem Management Plus (PM+) in people with Anxiety Disorders and Depressive Disorder, run by University of Chile at 1 site in Chile.
Trial summary
This study aims to evaluate the implementation outcomes of a pilot randomized controlled trial and to assess the preliminary efficacy of Problem Management Plus (PM+) in reducing symptoms of depression and anxiety among users at a Primary Health Care center in Chile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Depressive Disorder
- What is being tested?
- Problem Management Plus (PM+)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChile
- Study dates
- 9 May 2025to 12 Oct 2025
- 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
- Individuals over 18 years old.
- Diagnosed with or presenting depressive and/or anxiety symptoms (through screening).
- Residents of the selected study region.
- Part of the population enrolled and validated in the pilot primary health care facilities.
Who cannot join
- Suicidal risk requiring immediate or urgent referral to care services.
- Suffering from severe psychiatric disorders or substance use disorders.
- Being in situations of declared risk that require protection (e.g., domestic violence).
- Moderate or severe disability.
- Incapacitating medical illnesses.
- Receiving other mental health treatments that could lead to over-intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot, Single-blind, Randomized Controlled Trial Evaluating the Implementation Outcomes and Preliminary Efficacy of Problem Management Plus (PM+) Versus Treatment as Usual in Adult Primary Care Users With Symptoms of Depression and/or Anxiety
This study aims to evaluate the implementation outcomes of a pilot randomized controlled trial and to assess the preliminary efficacy of Problem Management Plus (PM+) in reducing symptoms of depression and anxiety among users at a Primary Health Care center in Chile.
Two intervention groups will be compared: PM+ versus care as usual (CAU). The process will include an evaluation of the feasibility of the study procedures, as well as the acceptability and fidelity of the PM+ intervention.
Read the detailed description
In Chile, only 19% of the population with mental health conditions has access to primary care services, highlighting the urgent need to expand mental health care availability. Training more healthcare professionals to deliver low-intensity psychological interventions could be a valuable approach to addressing this disparity.
The World Health Organization's Problem Management Plus (PM+) is a low-intensity, transdiagnostic, peer-delivered intervention designed for implementation in resource-limited settings to address common mental health disorders. In this context, PM+ serves as an evidence-based strategy that can help reduce gaps in healthcare services, particularly regarding availability and accessibility.
This study aims to evaluate the implementation outcomes of a pilot randomized clinical trial, including feasibility, acceptability and fidelity and to assess the preliminary efficacy of PM+ in reducing mental health symptoms among users at a primary healthcare center in Chile.
The study design is a single-blind pilot randomized controlled trial with a 1:1 allocation ratio, assessing two intervention arms for participants with depressive and/or anxiety symptoms over five weeks.
The study population consists of adults of 18 years or above with mild to moderate depressive and/or anxiety symptoms, living in the selected study region and enrolled in the primary health care center chosen to conduct the trial.
Two groups will be compared. The treatment group will receive five sessions of PM+. The control group will receive care as usual (CAU), which includes the regular mental health services provided at the primary health care center selected for the study.
Implementation outcomes of PM+ will be assessed, focusing mainly on feasibility, acceptability and fidelity. Additionally, preliminary efficacy outcomes of depression, anxiety and self-identified problems will be evaluated.
- Conditions
- Anxiety Disorders, Depressive Disorder
- Being tested
- Problem Management Plus (PM+)
- Keywords
- Common mental health disorders, Common mental health problems, Depressive disorder, Anxiety disorders, Pilot Randomised Controlled Trial, Pilot RCT, PM+, Problem Management Plus
- Medical subject headings
- Anxiety Disorders, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Management Plus (PM+)Behavioural
Problem Management Plus (PM+) will be delivered according to the Spanish version of the WHO protocol (OMS, 2016).
PM+ is a low-intensity, transdiagnostic psychological intervention based on Cognitive Behavioral Therapy (CBT). The protocol incorporates evidence-based strategies, including problem-solving, stress management, behavioral activation, and accessing social support.
The intervention consists of five individual 90-minute sessions provided by healthcare professionals without previous expertise in mental health care (WHO, 2018). PM+ helpers will be supervised by master trainers specifically trained for Chile.
Two systematic reviews have demonstrated the effectiveness of PM+ in reducing symptoms of common mental disorders, such as depression and anxiety (Schäfer et al., 2023) and specific symptoms of post-traumatic stress (Akhtar et al., 2022).
| Study group | Role | What they receive |
|---|---|---|
| Problem Management Plus (PM+) | Experimental | PM+ is delivered in five individual sessions conducted by trained healthcare professionals without previous expertise in mental health care. Receives: Behavioral: Problem Management Plus (PM+) |
| Care as Usual (CAU) | No intervention | Care as usual comprises the mental health services currently provided to Primary Health Care users in Chile. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation outcome: Feasibility
Measured through components A and B. A. Percentage of participant recruitment: defined as the proportion of participants who consented to enroll in the trial and were subsequently recruited.
- Participant adherence to PM+: defined as the average number of PM+ sessions attended by each participant.
Measured: Feasibility outcome component A will be collected once recruitment is completed. Component B will be collected at week 6, starting from the first intervention week.
Implementation outcome: Acceptability
Indicators of PM+ acceptability among users and trained facilitators, assessed with quantitative scales. For users, an adapted version of the Abbreviated Acceptability Rating Profile (AARP) will be administered. The AARP consists of 8 Likert-scale items, yielding total scores ranging from 8 to 48, with higher scores indicating greater acceptability. For facilitators, an adapted version of the Acceptability of Intervention Measure (AIM) will be used. The AIM comprises 5 Likert-scale items, producing scores ranging from 4 to 20, where higher scores reflect greater acceptability. For both measures, descriptive statistics will be reported using median and interquartile range (IQR), as well as mean and standard deviation (x̄ [SD]).
Measured: Acceptability outcomes will be collected during the post-intervention assessment at week 6, starting from the first intervention week.
Implementation Outcome: Fidelity
Indicators of PM+ fidelity will be assessed with a study-specific rubric developed based on expert judgement. The rubric consists of 5 items, each reflecting a component of proper PM+ delivery. Items range from 1 ("low fidelity") to 4 ("high fidelity"), with higher scores indicating greater fidelity. The reported statistics will include the median and interquartile range (IQR) for each item, and the mean and standard deviation (x̄ [SD]) for the overall fidelity score per assessed PM+ session.
Measured: Fidelity outcomes will be collected throughout the intervention period, from the first to the final intervention week (week 5).
Secondary outcomes (3)
Preliminary pre-to-post effect of PM+ on depressive symptoms.
Measured using the Patient Health Questionnaire - 9 items (PHQ-9), with scores ranging from 0 to 27. Higher scores indicate increased symptom severity.
Measured: Measured through baseline at week 0 and post-intervention assessment at week 6, starting from the first intervention week.
Preliminary pre-to-post effect of PM+ on anxiety symptoms.
Measured using the Generalized Anxiety Disorder - 7 item (GAD-7), with scores ranging from 0 to 21. Higher scores indicate increased symptom severity.
Measured: Measured through baseline at week 0 and post-intervention assessment at week 6, starting from the first intervention week.
Preliminary pre-to-post effect of PM+ on self-identified problems.
Measured using the Psychological Outcome Profiles (PSYCHLOPS), with scores ranging from 0 to 20. Higher scores indicate increased self-identified problem severity.
Measured: Measured through baseline at week 0 and post-intervention assessment at week 6, starting from the first intervention week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start9 May 2025
- Primary completion12 Sep 2025
- Study completion12 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Pan American Health Organization
- Responsible party
- Sponsor
- Investigators
- Camila A. Solís, MSc., Study chair, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988332
- Sponsor's protocol ID
- 390
- Status last verified
- Oct 2025
- First submitted
- 24 Apr 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will only be shared when required by regulatory institutions. In order to protect privacy and ensure the confidentiality of information, all data shared with research staff members without direct access to the case file will identify participants solely by their enrollment number and will be transmitted using depersonalized forms, such as the CRF. In the case it becomes necessary to share IPD with regulatory institutions, such as ethics committees or governmental agencies, the depersonalized enrollment number will be used to maintain the confidentiality of personal information. Personal information will only be shared with public health care services or as required under Chilean legislation.
Publications
Schafer SK, Thomas LM, Lindner S, Lieb K. World Health Organization's low-intensity psychosocial interventions: a systematic review and meta-analysis of the effects of Problem Management Plus and Step-by-Step. World Psychiatry. 2023 Oct;22(3):449-462. doi: 10.1002/wps.21129.
PubMed 37713578Akhtar A, Koyiet P, Rahman A, Schafer A, Hamdani SU, Cuijpers P, Sijbrandij M, Bryant RA. Residual posttraumatic stress disorder symptoms after provision of brief behavioral intervention in low- and middle-income countries: An individual-patient data meta-analysis. Depress Anxiety. 2022 Jan;39(1):71-82. doi: 10.1002/da.23221. Epub 2021 Nov 9.
PubMed 34752690
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Single-blind, Randomized Controlled Trial Evaluating the Implementation Outcomes and Preliminary Efficacy of Problem Management Plus (PM+) Versus Treatment as Usual in Adult Primary Care Users With Symptoms of Depression and/or Anxiety
- ClinicalTrials.gov ID
- NCT06988332
- Acronym / sponsor ID
- 390
- Conditions
- Anxiety Disorders, Depressive Disorder
- Keywords
- Common mental health disorders, Common mental health problems, Depressive disorder, Anxiety disorders, Pilot Randomised Controlled Trial, Pilot RCT, PM+, Problem Management Plus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Pan American Health Organization
- Study start
- 9 May 2025 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- 12 Oct 2025 (actual)
- First posted
- 23 May 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.
This study aims to evaluate the implementation outcomes of a pilot randomized controlled trial and to assess the preliminary efficacy of Problem Management Plus (PM+) in reducing symptoms of depression and anxiety among users at a Primary Health Care center in Chile.
Two intervention groups will be compared: PM+ versus care as usual (CAU). The process will include an evaluation of the feasibility of the study procedures, as well as the acceptability and fidelity of the PM+ intervention.
Detailed description
In Chile, only 19% of the population with mental health conditions has access to primary care services, highlighting the urgent need to expand mental health care availability. Training more healthcare professionals to deliver low-intensity psychological interventions could be a valuable approach to addressing this disparity.
The World Health Organization's Problem Management Plus (PM+) is a low-intensity, transdiagnostic, peer-delivered intervention designed for implementation in resource-limited settings to address common mental health disorders. In this context, PM+ serves as an evidence-based strategy that can help reduce gaps in healthcare services, particularly regarding availability and accessibility.
This study aims to evaluate the implementation outcomes of a pilot randomized clinical trial, including feasibility, acceptability and fidelity and to assess the preliminary efficacy of PM+ in reducing mental health symptoms among users at a primary healthcare center in Chile.
The study design is a single-blind pilot randomized controlled trial with a 1:1 allocation ratio, assessing two intervention arms for participants with depressive and/or anxiety symptoms over five weeks.
The study population consists of adults of 18 years or above with mild to moderate depressive and/or anxiety symptoms, living in the selected study region and enrolled in the primary health care center chosen to conduct the trial.
Two groups will be compared. The treatment group will receive five sessions of PM+. The control group will receive care as usual (CAU), which includes the regular mental health services provided at the primary health care center selected for the study.
Implementation outcomes of PM+ will be assessed, focusing mainly on feasibility, acceptability and fidelity. Additionally, preliminary efficacy outcomes of depression, anxiety and self-identified problems will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Problem Management Plus (PM+) | Experimental | Behavioral: Problem Management Plus (PM+)PM+ is delivered in five individual sessions conducted by trained healthcare professionals without previous expertise in mental health care. |
| Care as Usual (CAU) | No intervention | –Care as usual comprises the mental health services currently provided to Primary Health Care users in Chile. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals over 18 years old.
- Diagnosed with or presenting depressive and/or anxiety symptoms (through screening).
- Residents of the selected study region.
- Part of the population enrolled and validated in the pilot primary health care facilities.
Key exclusion criteria (6 listed)
- Suicidal risk requiring immediate or urgent referral to care services.
- Suffering from severe psychiatric disorders or substance use disorders.
- Being in situations of declared risk that require protection (e.g., domestic violence).
- Moderate or severe disability.
- Incapacitating medical illnesses.
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 |
|---|---|---|
| Problem Management Plus (PM+)Problem Management Plus (PM+) will be delivered according to the Spanish version of the WHO protocol (OMS, 2016). PM+ is a low-intensity, transdiagnostic psychological intervention based on Cognitive Behavioral Therapy (CBT). The protocol incorporates evidence-based strategies, including problem-solving, stress management, behavioral activation, and accessing social support. The intervention consists of five individual 90-minute sessions provided by healthcare professionals without previous expertise in mental health care (WHO, 2018). PM+ helpers will be supervised by master trainers specifically trained for Chile. Two systematic reviews have demonstrated the effectiveness of PM+ in reducing symptoms of common mental disorders, such as depression and anxiety (Schäfer et al., 2023) and specific symptoms of post-traumatic stress (Akhtar et al., 2022). | Behavioural | Problem Management Plus (PM+) |
Primary outcome
Implementation outcome: Feasibility
Time frame: Feasibility outcome component A will be collected once recruitment is completed. Component B will be collected at week 6, starting from the first intervention week.
Measured through components A and B. A. Percentage of participant recruitment: defined as the proportion of participants who consented to enroll in the trial and were subsequently recruited. B. Participant adherence to PM+: defined as the average number of PM+ sessions attended by each participant.
Implementation outcome: Acceptability
Time frame: Acceptability outcomes will be collected during the post-intervention assessment at week 6, starting from the first intervention week.
Indicators of PM+ acceptability among users and trained facilitators, assessed with quantitative scales. For users, an adapted version of the Abbreviated Acceptability Rating Profile (AARP) will be administered. The AARP consists of 8 Likert-scale items, yielding total scores ranging from 8 to 48, with higher scores indicating greater acceptability. For facilitators, an adapted version of the Acceptability of Intervention Measure (AIM) will be used. The AIM comprises 5 Likert-scale items, producing scores ranging from 4 to 20, where higher scores reflect greater acceptability. For both measures, descriptive statistics will be reported using median and interquartile range (IQR), as well as mean and standard deviation (x̄ [SD]).
Implementation Outcome: Fidelity
Time frame: Fidelity outcomes will be collected throughout the intervention period, from the first to the final intervention week (week 5).
Indicators of PM+ fidelity will be assessed with a study-specific rubric developed based on expert judgement. The rubric consists of 5 items, each reflecting a component of proper PM+ delivery. Items range from 1 ("low fidelity") to 4 ("high fidelity"), with higher scores indicating greater fidelity. The reported statistics will include the median and interquartile range (IQR) for each item, and the mean and standard deviation (x̄ [SD]) for the overall fidelity score per assessed PM+ session.
3 secondary outcomes
Preliminary pre-to-post effect of PM+ on depressive symptoms.
Time frame: Measured through baseline at week 0 and post-intervention assessment at week 6, starting from the first intervention week.
Preliminary pre-to-post effect of PM+ on anxiety symptoms.
Time frame: Measured through baseline at week 0 and post-intervention assessment at week 6, starting from the first intervention week.
Preliminary pre-to-post effect of PM+ on self-identified problems.
Time frame: Measured through baseline at week 0 and post-intervention assessment at week 6, starting from the first intervention week.
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 20 Nov 2025.
- Results publication: PubMed 37713578Schafer SK, Thomas LM, Lindner S, Lieb K. World Health Organization's low-intensity psychosocial interventions: a systematic review and meta-analysis of the effects of Problem Management Plus and Step-by-Step. World Psychiatry. 2023 Oct;22(3):449-462. doi: 10.1002/wps.21129.
- Results publication: PubMed 34752690Akhtar A, Koyiet P, Rahman A, Schafer A, Hamdani SU, Cuijpers P, Sijbrandij M, Bryant RA. Residual posttraumatic stress disorder symptoms after provision of brief behavioral intervention in low- and middle-income countries: An individual-patient data meta-analysis. Depress Anxiety. 2022 Jan;39(1):71-82. doi: 10.1002/da.23221. Epub 2021 Nov 9.
- Link to the Spanish version of the WHO Problem Management Plus (PM+) protocol.Link provided by the sponsor.
- Link to the English version of the WHO Problem Management Plus (PM+) protocol.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will only be shared when required by regulatory institutions. In order to protect privacy and ensure the confidentiality of information, all data shared with research staff members without direct access to the case file will identify participants solely by their enrollment number and will be transmitted using depersonalized forms, such as the CRF. In the case it becomes necessary to share IPD with regulatory institutions, such as ethics committees or governmental agencies, the depersonalized enrollment number will be used to maintain the confidentiality of personal information. Personal information will only be shared with public health care services or as required under Chilean legislation.
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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.
Camila A. Solís, MSc. study chair
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem Management Plus (PM+) in people with Anxiety Disorders and Depressive Disorder, run by University of Chile at 1 site in Chile.
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 6 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 20 Nov 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 Chile. 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?
Implementation outcome: Feasibility (time frame: Feasibility outcome component A will be collected once recruitment is completed. Component B will be collected at week 6, starting from the first intervention week.). The study lists 3 primary outcomes in all. 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 NCT06988332, which also lists 2 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 20 Nov 2025.