Evaluating the effectiveness of an Islamic-faith based mental health support programme to reduce psychological distress and improve wellbeing among individuals in Somalia

ISRCTN	ISRCTN12696185
DOI	https://doi.org/10.1186/ISRCTN12696185
Sponsors	Trinity College Dublin, World Vision Ireland
Funders	Research Ireland, Irish Aid

Submission date: 04/11/2026
Registration date: 04/11/2026
Last edited: 04/11/2026

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Over the past four decades, Somalia has been experiencing a prolonged humanitarian crisis characterised by ongoing violence, recurring drought, poverty, and overall instability. These conditions have had profound mental health consequences for Somalis, including in Puntland - a state in Northwest Somalia - where an estimated one-third of the populations has reported experiencing significant mental distress. However, access to effective MHPSS in Puntland remains critically limited. This is, in part, due to the fact that Somalia is a Muslim nation, where the influence of faith on perceptions of mental health and help-seeking behaviours leads many individuals in Puntland to avoid availing of existing evidence-based mental health and psychosocial (MHPSS) support programmes. There is, therefore, an urgent need for culturally relevant, faith-aligned, and evidence-informed MHPSS initiatives in the Puntland region.
This study aims to evaluate the implementation of a novel MHPSS approach co-developed together with communities in Puntland. The approach is called Healing and Empowering - Achieving Resilience through Spiritual Nurture (HEARTS). Drawing from insights shared by community members in Puntland, HEARTS is a manualised MHPSS approach that combines practices, teachings, and principles from Islam with components from existing psychological interventions that are known to be effective in improving mental wellbeing. This study aims to achieve the following:
1. To assess preliminary evidence of HEARTS’ effectiveness in improving the following primary outcomes: psychological distress, somatic symptoms, functional impairment, and subjective wellbeing
2. To assess preliminary evidence of HEARTS' effectiveness in improving the following secondary outcomes: social connectedness, positive and negative emotions, meaning in life, sources of support (including Islam), performance of Islamic duties, and positive Islamic coping
3. To identify the extent to which any changes in the secondary outcomes explain any changes observed in the primary outcomes
4. To identify HEARTS participants' levels of satisfaction with HEARTS following their participation using quantitative methods
5. To identify the impact of the HEARTS facilitator training in improving facilitators’ knowledge, attitudes, and practices related to mental health, as well as their competencies to facilitate HEARTS
6. To identify reception to HEARTS among HEARTS participants and HEARTS facilitators, as well as recommendations for how HEARTS could be improved for future implementation in their community and other Muslim contexts using qualitative methods

Who can participate?
Members of the community in Puntland where HEARTS is being piloted, aged 18 years and over, who self-report psychological distress can be screened for participation in HEARTS

What does the study involve?
Participants are put into groups (clusters) based on gender, and each cluster is randomly allocated to either receive HEARTS immediately (weeks 1-6) or to wait to receive HEARTS (weeks 7-12). Facilitators have been paired up and assigned to facilitate one HEARTS group per study arm (immediate or waitlist). Participants and facilitators complete data collection at multiple timepoints throughout the 12 weeks to identify if HEARTS is effective in improving wellbeing and how it could be improved.

What are the possible benefits and risks of participating?
The possible benefits of participating are experiencing improvements in any of the outcomes listed above, while also being provided with a space to come together with other community members of the same gender to discuss similar experiences and support each other. Participants are also provided a small allowance in the amount of $10 USD per session for attending HEARTS sessions. Facilitators are provided with a stipend in the amount of $100 USD per month for 3 months. The possible risks of participating include experiencing distress during the HEARTS sessions, potential breach of confidentiality by fellow participants and/or session facilitators, as well as experiencing stigma from other group members and/or the community at large.

Where is the study run from?
This study is run from both Somalia and Ireland. Somalia is the site of initial the co-design workshops for HEARTS, participant recruitment and HEARTS implementation, while Ireland is the site of overall study design and oversight.

When is the study starting and how long is it expected to run for?
August 2026 to December 2026

Who is funding the study?
This study is funded by Taighde Éireann - Research Ireland under grant number EPSPG/2025/3113, and by Irish Aid within Ireland's Civil Society Partnership programme.

Who is the main contact?
Charles (Chad) Zemp, zempc@tcd.ie

Contact information

Mr Charles Zemp
Scientific, Principal investigator, Public

Trinity Centre for Global Health, Trinity College Dublin, Phoenix House, 7-9 Leinster St S.
Dublin
D02K104
Ireland

ORCID ID	0009-0007-3837-3186
Phone	+353 (0)18964395
Email	zempc@tcd.ie

Prof Frédérique Vallières
Scientific, Principal investigator

Trinity Centre for Global Health, Trinity College Dublin, Phoenix House, 7-9 Leinster St S.
Dublin
D02K104
Ireland

ORCID ID	0000-0001-6315-3029
Phone	+353 (0)18964395
Email	fvallier@tcd.ie

Dr Kristin Hadfield
Scientific

Trinity Centre for Global Health, Trinity College Dublin, Phoenix House, 7-9 Leinster St S.
Dublin
D02K104
Ireland

ORCID ID	0000-0003-0234-0829
Phone	+353 (0)18964395
Email	Kristin.Hadfield@tcd.ie

Ms Esperanza Escorza
Public

The Mews, Garland House, Rathmines Park, Dublin 6
Dublin
D06 C6K4
Ireland

Phone	+353 (0)1 498 0800
Email	esperanza.escorza@worldvision.ie

Mr Maurice Sadlier
Public

The Mews, Garland House, Rathmines Park, Dublin 6
Dublin
D06 C6K4
Ireland

Phone	+353 (0)1 498 0800
Email	maurice.sadlier@worldvision.ie

Ms Laurène Barlet
Scientific, Public

The Mews, Garland House, Rathmines Park, Dublin 6
Dublin
D06 C6K4
Ireland

Phone	+353 (0)1 498 0800
Email	laurene.barlet@worldvision.ie

Mr Abdinajib Hirsi
Public, Scientific

Aven Premier International, Halane, Mogadishu
Garowe
-
Somalia

Phone	+252 (0)613 700 032
Email	Abdinajib_Hirsi@wvi.org

Mr Mohamed Isse
Scientific, Public

Aven Premier International, Halane, Mogadishu
Garowe
-
Somalia

Phone	+252 (0)613 700 032
Email	mohamed_isse@wvi.org

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Uncontrolled
Assignment	Parallel
Purpose	Health services research, Supportive care, Treatment
Participant information sheet	50591_PIS_HEARTS Facilitators (English).pdf
Scientific title	Healing and Empowering - Achieving Resilience through Spiritual Nurture (HEARTS): evaluating the impact of an Islamic faith-based, community-led, mental health and psychosocial support approach to reduce psychological distress and improve wellbeing among individuals in Somalia: a pilot cluster randomised controlled trial
Study acronym	HEARTS
Study objectives
Ethics approval(s)	1. Approved 16/06/2026, Research Ethics Committee of the School of Psychology, Trinity College Dublin (Áras an Phiarsaigh, Trinity College Dublin, Dublin 2, Dublin, D02 PN40, Ireland; +353 (0)1 896 1886; psych.ethics@tcd.ie), ref: 6289 2. Approved 11/04/2026, Non-communicable Diseases Program of the Ministry of Health of the Puntland State Government of Somalia (CF45+C8G, Wadada Wasaaraddaha (Ministries Road), Garowe, N/A, Somalia; N/A; info@moh.pl.so), ref: MOH/NCD/ERC/2026/001
Health condition(s) or problem(s) studied	Psychological distress, subjective wellbeing, functional impairment, somatic symptoms, social connectedness, positive and negative emotions, meaning in life, positive Islamic coping
Intervention	HEARTS is a community-led, Islamic faith-based mental health and psychosocial support (MHPSS) intervention aimed at improving psychological distress and wellbeing. HEARTS combines practices, teachings, and principles of Islam with components from evidence-based psychological interventions that are known to be effective in reducing distress and improving wellbeing. HEARTS is a manualised intervention, meaning that facilitators use a HEARTS facilitator manual to guide their facilitation of each session. Facilitators of HEARTS are community members who have been trained to facilitate the HEARTS intervention using the HEARTS facilitator manual. HEARTS sessions occur for 2 hours once a week for 6 consecutive weeks. This cluster RCT has a total duration of 12 weeks.Participants are allocated to study arm via stratified (by gender) cluster randomisation. The immediate treatment study arm participates in HEARTS for the first 6 weeks. The waitlist control study arm participants in HEARTS for the second 6 weeks.
Intervention type	Behavioural
Primary outcome measure(s)	Psychological distress (HEARTS participants) measured using the Kessler-10 Questionnaire at baseline, 3 weeks, 6 weeks, 12 weeks Psychological distress (HEARTS participants) measured using the Somali Distress and Resilience Scale at baseline, 3 weeks, 6 weeks, 12 weeks Psychological distress (HEARTS participants) measured using changes in welwel and murug (local idioms of distress) at baseline, 3 weeks, 6 weeks, 12 weeks Subjective well-being (HEARTS participants) measured using the WHO-5 Questionnaire at baseline, 3 weeks, 6 weeks, 12 weeks Functional impairment (HEARTS participants) measured using the WHO-DAS 2.0 questionnaire at baseline, 3 weeks, 6 weeks, 12 weeks Somatic symptoms (HEARTS participants) measured using the Somatic Symptoms Scale-8 at baseline, 3 weeks, 6 weeks, 12 weeks
Key secondary outcome measure(s)	Social connectedness (HEARTS participants) measured using the Oslo Social Support Scale-3 at baseline, 3 weeks, 6 weeks, 12 weeks Social connectedness (HEARTS participants) measured using the Somali Distress and Resilience Scale at baseline, 3 weeks, 6 weeks, 12 weeks Positive and negative emotions (HEARTS participants) measured using the Positive and Negative Affect Schedule (PANAS-10) questionnaire at baseline, 3 weeks, 6 weeks, 12 weeks Meaning in life (HEARTS participants) measured using the Meaning in Life questionnaire at baseline, 3 weeks, 6 weeks, 12 weeks Sources of support (HEARTS participants) measured using one item from the Somali Distress and Resilience Scale; the following two items: "I feel close to Allah" and "I draw support from God" at baseline, 3 weeks, 6 weeks, 12 weeks Frequency of performing Islamic duties (HEARTS participants and facilitators) measured using the Islamic duty subscale from the Psychological Measure of Islamic Religiousness at baseline, 3 weeks, 6 weeks, 12 weeks Positive Islamic coping (HEARTS participants and facilitators) measured using the Positive Islamic Coping subscale from the Psychological Measure of Islamic Religiousness at baseline, 3 weeks, 6 weeks, 12 weeks Knowledge, attitudes, and practices regarding mental health (HEARTS facilitators) measured using a questionnaire developed by the study team at baseline, pre-facilitator training, post-facilitator training, 6 weeks, 12 weeks Competencies to facilitate HEARTS (HEARTS facilitators) measured using a questionnaire developed by the study team at baseline, pre-facilitator training, post-facilitator training, 6 weeks, 12 weeks Qualitative reception to HEARTS (HEARTS participants and facilitators) measured using a semi-structured interview schedule developed by the study team at 12 weeks Ideas for how HEARTS could be improved (HEARTS participants and facilitators) measured using a semi-structured interview schedule developed by the study team at 12 weeks Ideas for how HEARTS could be sustained in the community (HEARTS participants and facilitators) measured using a semi-structured interview schedule developed by the study team at 12 weeks Feedback on each HEARTS session (HEARTS participants and facilitators) measured using a feedback form used during each HEARTS session to capture anonymous feedback at weekly over the 12-week duration of the HEARTS RCT
Completion date	31/12/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	100
Key inclusion criteria	HEARTS participants: 1. 18+ years of age 2. Islamic faith 3. Self-report of psychological distress HEARTS facilitators: 1. 18+ years of age 2. Islamic faith 3. Knowledge of the Qur'an 4. Able to read and write in Somali 5. Willingness to train others in the HEARTS approach 6. Passionate about supporting people and their wellbeing
Key exclusion criteria	Identified as at high risk for suicide
Date of first enrolment	05/08/2026
Date of final enrolment	07/08/2026

Locations

Countries of recruitment

Somalia

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan	The anonymous datasets generated during and/or analysed during the current study will be stored in a publicly available repository (Zenodo)

Study outputs

Output type	Date added	Peer reviewed?	Patient-facing?
Other files	04/11/2026	No	No
Other files	04/11/2026	No	No
Participant information sheet	04/11/2026	No	Yes
Participant information sheet	04/11/2026	No	Yes
Participant information sheet	04/11/2026	No	Yes
Participant information sheet	04/11/2026	No	Yes
Protocol file	04/11/2026	No	No

Additional files

50591_PROTOCOL.pdf: Protocol file
50591_HEARTS Participants (Somali).pdf: Participant information sheet
50591_PIS_HEARTS Participants (English).pdf: Participant information sheet
50591_PIS_HEARTS Facilitators (Somali).pdf: Participant information sheet
50591_PIS_HEARTS Facilitators (English).pdf: Participant information sheet
50591_PIS_HEARTS Consent Form (Somali).pdf: Other files
50591_HEARTS Consent Form (English).pdf: Other files

Editorial Notes

04/11/2026: Study's existence confirmed by the Research Ethics Committee of the School of Psychology, Trinity College Dublin.