Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202507903096871 Date of Registration: 17/07/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Cluster RCT of a Blended Intervention for Emotion Regulation
Official scientific title Efficacy and Acceptability of a Blended Intervention for Emotion Regulation (MAISHA) among Adolescents in Kenya: Study Protocol for a Cluster RCT
Brief summary describing the background and objectives of the trial Youth and adolescents often face emotional challenges that can affect their mental health, especially in settings where mental health services are hard to access. This study tests a new program called MAISHA, which was developed together with young people in Kenya to help them manage their emotions and feel better. MAISHA combines two parts: a smartphone app and group sessions. The app supports young people in their daily lives by checking in on their mood and stress levels and offering short exercises like breathing techniques, calming imagery, or journaling, all based on compassion-focused strategies. The group sessions are led by trained lay providers and focus on helping participants build a growth mindset, practice gratitude, and reflect on their values. The study includes 666 young people aged 13–25 who will be randomly assigned to different combinations of the app, the group sessions, or standard care. The study will assess how effective and acceptable the program is - and which parts work best in daily life.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MAISHA
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 01/09/2025
Actual trial start date
Anticipated date of last follow up 30/04/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 666
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Digital Intervention Element Participants receive 6 prompts per day (4 random EMA prompts, 1 morning, 1 evening) with the 4 random prompts triggering tailored emotion regulation exercises based on affect and stress ratings. In addition, participants are encouraged to complete 1–2 self-scheduled emotion regulation exercises per day and may also initiate exercises on demand at any time. 28 days The digital intervention is an ecological momentary intervention (EMI) delivered via a smartphone app (movisensXS, version 1.6.2 or higher). It provides mood check-ins throughout the day and offers brief, tailored exercises - such as breathing, imagery, and journaling—based on users’ real-time stress and affect levels. The content, grounded in compassion-focused therapy, was adapted from the German AI4U and EMIcompass programs. Participants use their own Android smartphones when available or receive a study device with offline functionality and secure data upload. 166
Experimental Group Face to face Intervention Element Weekly group sessions, each 1 hour, delivered over 4 weeks in groups of 6–7 young people. 28 days The face-to-face intervention consists of four weekly group sessions, each lasting one hour, delivered by trained lay providers from the local community. The sessions focus on growth mindset, gratitude, and value affirmation, and are based on WISE intervention principles that promote adaptive meaning-making through simple psychological insights. This component builds on the Shamiri Intervention, a tiered caregiving model previously shown to reduce symptoms of depression and anxiety in Kenyan youth and adolescents. Groups of 6–7 young people will be guided by young adult lay providers, trained in facilitation, counseling techniques, and safety protocols under the supervision of a clinical psychologist. 166
Experimental Group Blended Intervention as described for digital and face-to-face element respectively: Digital: Participants receive 6 prompts per day (4 random EMA prompts, 1 morning, 1 evening) with the 4 random prompts triggering tailored emotion regulation exercises based on affect and stress ratings. In addition, participants are encouraged to complete 1-2 self-scheduled emotion regulation exercises per day and may also initiate exercises on demand at any time. Face-to-face: Weekly group sessions, each 1 hour, delivered over 4 weeks in groups of 6-7 young people. 28 days The blended intervention combines the digital and face-to-face elements of MAISHA. Participants take part in weekly group sessions (1 hour each, over four weeks) in groups of 6 to 7, and simultaneously use the MAISHA app throughout the same period. Lay providers introduce the app at the end of the first session and offer basic support - such as guidance on exercises or technical issues - via an integrated chat feature. 166
Control Group Care as Usual 28 days The Care as Usual (CAU) group receives standard health care services as available through the Kenyan primary health care system. This may include mental health promotion, prevention, and treatment in line with national policy, but no structured intervention is delivered through the study. After the trial, participants in this group will be offered access to an adjusted version of the digital MAISHA app. 166 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Voluntary enrollment into the study (written consent) • Fulfillment of criteria for increased psychological distress or early symptoms of emotional dysregulation, that is • Difficulties in emotion regulation assessed with the DERS-SF • None of the participants fulfills the criteria for a severe mental illness (including psychosis, severe major depression, severe anxiety disorder, mania or hypomania, severe borderline personality disorder), measured with established measures. • Persons with a severe mental or physical illness that impedes the use of the training (i.e., mental disorder of stage 2 or above; severe physical disability like total blindness) • Current suicidal ideation, assessed with the Community Quick Screening Tool (QST) and a mental health professional • Consumption of alcohol or other psychotropic substances on the day of the assessment (self-report, QST) • Evidence that symptoms of psychological distress are precipitated by an organic disease, i.e. epilepsy, brain tumor, or other significant neurological diseases • Insufficient command of the local language (i.e., English or Swahili) • Participants refusing or withdrawing informed assent or consent Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s) 13 Year(s) 25 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/06/2025 Ethics Committee of the Medical Faculty University Heidelberg
Ethics Committee Address
Street address City Postal code Country
Alte Glockengiesserei 11 Heidelberg 69115 Germany
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/06/2025 Kenyatta University Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
P.O. Box 43844 Nairobi 00100 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/07/2025 The National Commission for Science Technology and Innovation
Ethics Committee Address
Street address City Postal code Country
Off Waiyaki Way, Upper Kabete, P. O. Box 30623 Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Emotion regulation difficulties at post-intervention, assessed using the short form of the Difficulties in Emotion Regulation Scale (DERS-SF, 18-item self-report, 6 subscales, rated on a Likert scale from 1–5). Primary analysis will compare total sum scores between the blended intervention and the control condition. Time Frame: Baseline to post-intervention comparison (4-6 weeks after baseline) Baseline, post-intervention
Secondary Outcome Momentary data will be collected 6 times per day (4 random EMA prompts, 1 morning, 1 evening) throughout the 28-day intervention. Outcomes include momentary affect, event-related stress, stress reactivity, emotion regulation, and social context. Affect is assessed with bipolar items and emotion facets; stress reactivity is calculated based on affect-stress associations. Emotion regulation is measured using a 4-item short version of the State Difficulties in Emotion Regulation Scale (S-DERS) and two additional perceived emotion regulation capacity items. All items are rated on a 0–100 visual analogue scale. Throughout the intervention phase
Secondary Outcome Secondary outcomes at post-intervention include positive and negative affect (Positive and Negative Affect Schedule), symptoms of depression, anxiety, and stress (Depression Anxiety Stress Scale – 21 item version), emotional reactivity (Perth Emotional Reactivity Scale – short form), emotion beliefs (Emotion Beliefs Questionnaire), emotion regulation strategies (Emotion Regulation Questionnaire), and interpersonal emotion regulation (Interpersonal Emotion Regulation Questionnaire). Average or sum scores per scale/subscale will be used for analysis. DERS-SF subscale scores will also be analyzed as secondary outcomes. Baseline, post-intervention
Secondary Outcome Process evaluation. Implementation outcomes include reach, fidelity, dose, adherence, and participant engagement. Data sources include attendance logs, app use data, session observations, facilitator surveys, and interviews with adolescents and lay providers. Fidelity is assessed through independent ratings and provider feedback. Engagement is explored through surveys, in-depth interviews, and focus group discussions. Throughout and post-intervention
Secondary Outcome Acceptability, usability, and safety: Acceptability and usability are assessed post-intervention using validated questionnaires, e.g. the mHealth App Usability Questionnaire (MAUQ). About 30 participants will provide qualitative feedback in interviews. Safety is monitored through documentation and reporting of serious adverse events (SAEs) in line with ethics protocols. Post-intervention
Secondary Outcome Other measures: Additional variables include sociodemographic characteristics and equity indicators. Baseline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Shamiri Institute 13th Floor, Pioneer Point, Chania Avenue Nairobi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Health and Life Science Alliance Heidelberg Mannheim Berliner Strasse 47 Heidelberg 69120 Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Heidelberg Institute of Global Health HIGH University Clinic Heidelberg Im Neuenheimer Feld 130.3 Heidelberg 69120 Germany Hospital
COLLABORATORS
Name Street address City Postal code Country
Department of Public Mental Health Central Institute of Mental Health CIMH J5 Mannheim 68159 Germany
Shamiri Institute 13th Floor, Pioneer Point, Chania Avenue Nairobi Kenya
African Academy of Public Health AAPH 82A Light Industrial Area, Mikocheni P.O. Box 32273 Dar es Salaam Tanzania
Department of Mental Health and Psychiatry University of Dodoma UDOM P.O.Box 259 Dodoma Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shannon McMahon mcmahon@uni-heidelberg.de +496221338220 Im Neuenheimer Feld 130.3
City Postal code Country Position/Affiliation
Heidelberg 69120 Germany PD and Research group leader at Heidelberg Institute of Global Health HIGH
Role Name Email Phone Street address
Scientific Enquiries Annika Stefanie Reinhold annikastefanie.reinhold@zi-mannheim.de +4962117031937 J5
City Postal code Country Position/Affiliation
Mannheim 68159 Germany Doctoral candidate in the Department Public Mental Health at the Central Institute of Mental Health CIMH
Role Name Email Phone Street address
Public Enquiries Tom Osborn osborn@shamiri.institute +254112540760 13th Floor, Pioneer Point, Chania Avenue
City Postal code Country Position/Affiliation
Nairobi Kenya CEO of Shamiri
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data (IPD) will be pseudonymized and stored securely in compliance with GDPR, Kenya’s Data Protection Act, and institutional policies. IPD will not be made publicly available, but summary results will be submitted to the registry within 12 months of study completion. Upon reasonable request, de-identified data may be shared with qualified researchers after ethics approval and a data access agreement. Informed Consent Form,Study Protocol 12 months after study completion Qualified researchers may request access to de-identified data for secondary analyses upon submission of a data access request, ethics approval, and a signed data sharing agreement. Requests will be reviewed by the study investigators.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 11/07/2025 Request from reviewer (sorry - before it was only allowed for me by the plattform to put in numbers into this field for some reason) Primary Outcome, Emotion regulation difficulties at post-intervention, assessed using the short form of the Difficulties in Emotion Regulation Scale (DERS-SF, 18-item self-report, 6 subscales, rated on a Likert scale from 1–5). Primary analysis will compare total sum scores between the blended intervention and the control condition. Time Frame: Baseline to post-intervention comparison (4-6 weeks after baseline), 0, 1 Primary Outcome, Emotion regulation difficulties at post-intervention, assessed using the short form of the Difficulties in Emotion Regulation Scale (DERS-SF, 18-item self-report, 6 subscales, rated on a Likert scale from 1–5). Primary analysis will compare total sum scores between the blended intervention and the control condition. Time Frame: Baseline to post-intervention comparison (4-6 weeks after baseline), Baseline, post-intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 11/07/2025 Request from reviewer (see above) Secondary Outcome, Momentary data will be collected 6 times per day (4 random EMA prompts, 1 morning, 1 evening) throughout the 28-day intervention. Outcomes include momentary affect, event-related stress, stress reactivity, emotion regulation, and social context. Affect is assessed with bipolar items and emotion facets; stress reactivity is calculated based on affect-stress associations. Emotion regulation is measured using a 4-item short version of the State Difficulties in Emotion Regulation Scale (S-DERS) and two additional perceived emotion regulation capacity items. All items are rated on a 0–100 visual analogue scale., 0, 1 Secondary Outcome, Momentary data will be collected 6 times per day (4 random EMA prompts, 1 morning, 1 evening) throughout the 28-day intervention. Outcomes include momentary affect, event-related stress, stress reactivity, emotion regulation, and social context. Affect is assessed with bipolar items and emotion facets; stress reactivity is calculated based on affect-stress associations. Emotion regulation is measured using a 4-item short version of the State Difficulties in Emotion Regulation Scale (S-DERS) and two additional perceived emotion regulation capacity items. All items are rated on a 0–100 visual analogue scale., Baseline, post-intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 11/07/2025 Request from reviewer (see above) Secondary Outcome, Momentary data will be collected 6 times per day (4 random EMA prompts, 1 morning, 1 evening) throughout the 28-day intervention. Outcomes include momentary affect, event-related stress, stress reactivity, emotion regulation, and social context. Affect is assessed with bipolar items and emotion facets; stress reactivity is calculated based on affect-stress associations. Emotion regulation is measured using a 4-item short version of the State Difficulties in Emotion Regulation Scale (S-DERS) and two additional perceived emotion regulation capacity items. All items are rated on a 0–100 visual analogue scale., Baseline, post-intervention Secondary Outcome, Momentary data will be collected 6 times per day (4 random EMA prompts, 1 morning, 1 evening) throughout the 28-day intervention. Outcomes include momentary affect, event-related stress, stress reactivity, emotion regulation, and social context. Affect is assessed with bipolar items and emotion facets; stress reactivity is calculated based on affect-stress associations. Emotion regulation is measured using a 4-item short version of the State Difficulties in Emotion Regulation Scale (S-DERS) and two additional perceived emotion regulation capacity items. All items are rated on a 0–100 visual analogue scale., Throughout the intervention phase
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 11/07/2025 Request from reviewer (see above) Secondary Outcome, Secondary outcomes at post-intervention include positive and negative affect (Positive and Negative Affect Schedule), symptoms of depression, anxiety, and stress (Depression Anxiety Stress Scale – 21 item version), emotional reactivity (Perth Emotional Reactivity Scale – short form), emotion beliefs (Emotion Beliefs Questionnaire), emotion regulation strategies (Emotion Regulation Questionnaire), and interpersonal emotion regulation (Interpersonal Emotion Regulation Questionnaire). Average or sum scores per scale/subscale will be used for analysis. DERS-SF subscale scores will also be analyzed as secondary outcomes., 0, 1 Secondary Outcome, Secondary outcomes at post-intervention include positive and negative affect (Positive and Negative Affect Schedule), symptoms of depression, anxiety, and stress (Depression Anxiety Stress Scale – 21 item version), emotional reactivity (Perth Emotional Reactivity Scale – short form), emotion beliefs (Emotion Beliefs Questionnaire), emotion regulation strategies (Emotion Regulation Questionnaire), and interpersonal emotion regulation (Interpersonal Emotion Regulation Questionnaire). Average or sum scores per scale/subscale will be used for analysis. DERS-SF subscale scores will also be analyzed as secondary outcomes., Baseline, post-intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 11/07/2025 Request from reviewer (see above) Secondary Outcome, Process evaluation. Implementation outcomes include reach, fidelity, dose, adherence, and participant engagement. Data sources include attendance logs, app use data, session observations, facilitator surveys, and interviews with adolescents and lay providers. Fidelity is assessed through independent ratings and provider feedback. Engagement is explored through surveys, in-depth interviews, and focus group discussions., 1 Secondary Outcome, Process evaluation. Implementation outcomes include reach, fidelity, dose, adherence, and participant engagement. Data sources include attendance logs, app use data, session observations, facilitator surveys, and interviews with adolescents and lay providers. Fidelity is assessed through independent ratings and provider feedback. Engagement is explored through surveys, in-depth interviews, and focus group discussions., Throughout and post-intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 11/07/2025 Request from reviewer (see above) Secondary Outcome, Acceptability, usability, and safety: Acceptability and usability are assessed post-intervention using validated questionnaires, e.g. the mHealth App Usability Questionnaire (MAUQ). About 30 participants will provide qualitative feedback in interviews. Safety is monitored through documentation and reporting of serious adverse events (SAEs) in line with ethics protocols., 1 Secondary Outcome, Acceptability, usability, and safety: Acceptability and usability are assessed post-intervention using validated questionnaires, e.g. the mHealth App Usability Questionnaire (MAUQ). About 30 participants will provide qualitative feedback in interviews. Safety is monitored through documentation and reporting of serious adverse events (SAEs) in line with ethics protocols., Post-intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 11/07/2025 Request from reviewer (see above) Secondary Outcome, Other measures: Additional variables include sociodemographic characteristics and equity indicators., 0 Secondary Outcome, Other measures: Additional variables include sociodemographic characteristics and equity indicators., Baseline