Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622000989741
Ethics application status
Approved
Date submitted
20/06/2022
Date registered
14/07/2022
Date last updated
14/07/2022
Date data sharing statement initially provided
14/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
mPareshan: Addressing symptoms of anxiety and depression through an mHealth application delivered by frontline health workers at community doorsteps
Scientific title
mPareshan: A community-based implementation research to address symptoms of anxiety and depression through an mHealth application delivered by frontline workers: protocol for a non-randomized feasibility study
Secondary ID [1] 307361 0
None
Universal Trial Number (UTN)
Trial acronym
mPareshan
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 326670 0
Depression
326671 0
Condition category
Condition code
Mental Health 323909 323909 0 0
Anxiety
Mental Health 323910 323910 0 0
Depression
Public Health 323911 323911 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The main intervention of the study is a digital app customized to the cultural context of rural Sind Pakistan to address symptoms of anxiety and depression amongst community participants who screen positive (SP) for symptoms through a baseline survey. The survey will use two psychometric scales; PHQ-9 and GAD-7 to establish point prevalence of anxiety and depression and will be conducted by trained field data collectors before intervention.

The intervention will be delivered at the community doorsteps (District Badin Sind) by the Lady health Workers (LHWs) of Pakistan's Lady Health Worker Programme (LHW-P) under supervision of her assigned Lady Health supervisors (LHSs) during their routine monthly visits to households in their catchment. During these visits in addition to her LHW-P mandated maternal and child health services, the LHW will additionally provide 25-30 minutes to deliver the mPareshan intervention if there is a confirmed SP in that household (as identified through the baseline survey) .

The intervention app will have three distinct segments (a) tracking (b) counselling and (c) referral. The tracking segment records information on participant recruitment/retention and consent. Counselling segment (comprises of 6 sessions delivered at an interval of 15 days) has features of psychoeducation through audio and video clips, breathing exercises and imparts SP skills to cope with anxiety and depression by engaging in pleasant activities and socializing with friends and family. Based on a two-week recall, the referral segment identifies danger signs related to suicidal ideation, self-harm and harm to others and then suggests appropriate referrals to the nearest mental health facility.

The one year feasibility study is divided into following phases

1. Preintervention Phase : Baseline Quantitative and Qualitative assessments-3 months
2 Intervention Phase : 3 months App design and 3 months for Intervention roll out (6 counselling sessions)
3 Post Intervention Phase : 3 months end line Quantitative and Qualitative Assessments
Intervention code [1] 323790 0
Behaviour
Intervention code [2] 323791 0
Early detection / Screening
Intervention code [3] 323896 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331720 0
Feasibility outcomes 1 :
-% SP consent , recruitment, retention
-% SP retention ,
-number of counselling sessions completed for each SP
Timepoint [1] 331720 0
Feasibility outcomes 1 :
-Continuous tracking during intervention roll out
- Post-intervention, After completion of all 6 counselling sessions
data will be collected through app dashboard
Primary outcome [2] 331721 0
The effect of mPareshan intervention on screen positive participants (SP’s) mean symptomatic scores of anxiety
Timepoint [2] 331721 0
-Post-intervention, at endline (after completion of 6 counselling sessions) assessing change in SPs baseline anxiety scores through GAD-7
Primary outcome [3] 331722 0
The effect of mPareshan intervention on screen positive participants (SP’s) mean symptomatic scores of depression .
Timepoint [3] 331722 0

-Post-intervention, at endline (after completion of 6 counselling sessions) assessing change in SPs baseline depression scores through PHQ-9.
Secondary outcome [1] 410864 0
Effect on mental health literacy (knowledge) of LHWs and LHSs to be assessed by using a 10-item questionnaire adapted for this study from WHO mHGAP-Intervention guide 2.0”
Timepoint [1] 410864 0
within 6 months of pre intervention phase following a modified mhGAP training using pretest post test to assess CHWs knowledge and skills related to mental health,
Secondary outcome [2] 411546 0
Effect on mental health skills (counselling & communication) of LHWs and LHSs to be assessed by using a 10-item questionnaire adapted for this study from WHO mHGAP-Intervention guide 2.0
Timepoint [2] 411546 0
within 6-months of pre intervention phase following a modified mhGAP training using pretest post test to assess CHWs knowledge and skills related to mental health,
Secondary outcome [3] 411549 0
Feasibility Outcome 2:

-Willingness of CHWs and Community Participants to use a digital app to address symptoms of anxiety and depression
Timepoint [3] 411549 0
-Pre-intervention, formative phase, within 6-months before starting the intervention : Assessing stakeholder (CHWS, Community and LHW-P) perceptions through focus group discussions and key informant interviews of usefulness and acceptability of using a mHealth based application by LHWs at community doorsteps

- Post-intervention, after completion of 6 counselling sessions to assess CHWs and end user perceptions about willingness of using mPareshan app (the intervention) in addressing symptoms of anxiety and depression through focus group discussions and key informant interviews
Secondary outcome [4] 411862 0
Feasibility outcome 3:

-Acceptability of CHWs and Community Participants to use a digital app to address symptoms of anxiety and depression
Timepoint [4] 411862 0
-Pre-intervention, formative phase, within 6-months before starting the intervention : Assessing stakeholder (CHWS, Community and LHW-P) perceptions through focus group discussions and key informant interviews of acceptability of using a mHealth based application by LHWs at community doorsteps

- Post-intervention, after completion of 6 counselling sessions to assess CHWs and end user perceptions about acceptability of using mPareshan app (the intervention) for addressing symptoms of anxiety and depression through focus group discussions and key informant interviews

Eligibility
Key inclusion criteria
Eligibility criteria for participant enrollment in Intervention:
- Aged 18 years or older
- Showing “mild” or “moderate” symptoms of anxiety or depression according to GAD-7 and PHQ-9 tools
- Willing to participate and able to give consent
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Age less than 18 year or greater than 60 years
- Undergoing any therapy/pharmacological treatment for mental health issues
- Cases of minimal, moderately severe, and severe anxiety and depression according to GAD-7 and PHQ-9

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
non-randomized, pretest-posttest, feasibility trial
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Qualitative data: : Primary Outcome 1
COnsolidated criteria for REporting Qualitative research (COREQ) guidelines will be used to analyze the data. All interviews will be transcribed in English. Using QSR NVivo, content analysis will be conducted on all interview and FGD transcripts, and codes will be organized into either emergent or predetermined categories by the researchers. Commonalities and differences across the data will be identified and clustered around thematic sections. Verbatim quotes will be added to complement the themes.

Quantitative data: Primary Outcome 2,3 and Secondary Outcome
Data collected from SP respondents will be exported from REDCap to Statistical Package for the Social Sciences (SPSS) Version 21 (IBM Corp). Data will be cleaned, coded, and analyzed using SPSS software. A descriptive analysis will be performed, and results will be tabulated as numbers (percentages) for qualitative variables and mean (±standard deviation) for quantitative variables.
Quantitative variables will first be assessed for normality through the Shapiro-Wilk test. Variables like the mean PHQ-9, and GAD-7, scores will be assessed if the normality assumption is fulfilled. Pearson Chi-Square test will be used to compare categorical data, such as normal versus abnormal PHQ-9 and GAD-7 scores, with demographic data. Paired t-test will be used to assess pre- and post-intervention change in mean difference of GAD-7, PHQ-9, and UCLA SF10 scores.
Linear regression analysis will be used to further examine the association of symptoms of anxiety and depression, adjusted for participant age, number of children, household income, and other independent variables which appear significant. All predictors will be entered using a stepwise approach to adjust for the effect of confounding. The results of the multivariable analysis will be reported as adjusted OR with 95% CI. A two-sided level of significance will be used and any association with a p-value less than 0.05 will be considered statistically significant.

Paired t test will be used to assess the change in knowledge and skills scores of CHWs before and after the mhGAP training to enhance their mental health literacy

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/07/2022
Actual
Date of last participant enrolment
Anticipated
15/10/2022
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
124
Accrual to date
Final
Recruitment outside Australia
Country [1] 24839 0
Pakistan
State/province [1] 24839 0
Sindh

Funding & Sponsors
Funding source category [1] 311645 0
University
Name [1] 311645 0
Brain and Mind Institute, Aga Khan University
Country [1] 311645 0
Kenya
Primary sponsor type
University
Name
Brain and Mind Institute, Aga Khan University
Address
Aga Khan University Centre,
3rd Parklands Ave. off Limuru Road, Nairobi
Country
Kenya
Secondary sponsor category [1] 313089 0
None
Name [1] 313089 0
Address [1] 313089 0
Country [1] 313089 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311100 0
Aga Khan University, Ethical Review Committee
Ethics committee address [1] 311100 0
Stadium Road, P. O. Box 3500
Karachi 74800, Pakistan
Ethics committee country [1] 311100 0
Pakistan
Date submitted for ethics approval [1] 311100 0
Approval date [1] 311100 0
06/12/2021
Ethics approval number [1] 311100 0
2021-6570-20015

Summary
Brief summary
The purpose of this feasibility trial is to assess the effect of mPareshan digital intervention on screened positive participants’ mean symptomatic scores of anxiety and depression.

It is hypothesized that the mPareshan application will be feasible to be delivered at community doorsteps by front line health workers.

The mPareshan digital app is the main intervention for this study.

There are six sessions in the app, designed to create awareness about mental health, provide psycho-social counselling through audio clips/ videos reinforcing positive thinking and making appropriate referrals for those exhibiting danger signs like self- harm, harm to others and suicidal ideation.

Each session imparts psychoeducation counselling through contextually relevant audio and video clips, breathing exercises and promotes coping skills by engaging participants in pleasant activities and encouraging socialization.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119946 0
Prof Fauziah Rabbani
Address 119946 0
Department of Community Health Sciences, The Aga Khan University, Stadium Road, Karachi 74800, Sindh province.
Country 119946 0
Pakistan
Phone 119946 0
+92 21 3486 4864
Fax 119946 0
Email 119946 0
[email protected]
Contact person for public queries
Name 119947 0
Prof Fauziah Rabbani
Address 119947 0
Department of Community Health Sciences, The Aga Khan University, Stadium Road, Karachi 74800, Sindh province.
Country 119947 0
Pakistan
Phone 119947 0
+92 21 3486 4864
Fax 119947 0
Email 119947 0
[email protected]
Contact person for scientific queries
Name 119948 0
Prof Fauziah Rabbani
Address 119948 0
Department of Community Health Sciences, The Aga Khan University, Stadium Road, Karachi 74800, Sindh province.
Country 119948 0
Pakistan
Phone 119948 0
+92 21 3486 4864
Fax 119948 0
Email 119948 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 384222-(Uploaded-16-06-2022-16-44-47)-Basic results summary.docx
Plain language summaryNo N/A

Documents added automatically
No additional documents have been identified.