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.: PACTR202607628909375 Date of Registration: 07/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluating the Integration of Anxiety Screening and Basic Anxiety-Management Techniques into Interpersonal Group Psychotherapy (IPT-G): A Quasi-Experimental Pilot Study in Luwero, Uganda
Official scientific title Evaluating the Integration of Anxiety Screening and Basic Anxiety-Management Techniques into Interpersonal Group Psychotherapy (IPT-G): A Quasi-Experimental Pilot Study in Luwero, Uganda
Brief summary describing the background and objectives of the trial This quasi-experimental pilot trial evaluates whether integrating anxiety screening and basic anxiety-management techniques into StrongMinds’ standard Interpersonal Group Psychotherapy (IPT-G) model improves outcomes for people receiving community-based mental health care in Luwero District, Uganda. Depression and anxiety commonly co-occur, and untreated anxiety may reduce engagement with therapy, prolong distress, and limit gains from depression-focused care. While StrongMinds’ IPT-G model has been used to address depression in low-resource community settings, it does not routinely include systematic anxiety screening or structured anxiety-specific support. This study therefore tests an enhanced IPT-G model that incorporates screening with the Generalized Anxiety Disorder-7 (GAD-7) and brief ACT-informed anxiety-management strategies, including grounding, acceptance, and values-based coping, alongside the standard 6-week IPT-G programme. The main objective is to assess whether the enhanced IPT-G model leads to greater reductions in anxiety symptoms compared with standard IPT-G. Secondary objectives are to assess whether the integrated model also improves depressive symptoms, psychological well-being, functioning, life satisfaction, perceived control, and social support, and to generate practical evidence on the feasibility and value of incorporating anxiety care into scalable community-based psychotherapy delivery. Findings will inform future programme refinement, scale-up decisions, and possible further evaluation.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
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 27/04/2026
Actual trial start date
Anticipated date of last follow up 08/09/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 400
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
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard interpersonal group therapy Each session lasts about 90–120 minutes Delivered face-to-face in community settings Six weekly group sessions Participants in the control arm will receive the routine StrongMinds 6-week IPT-G programme delivered face-to-face in community settings, consisting of six weekly group sessions. The intervention focuses on reducing depressive symptoms by addressing key interpersonal problem areas, including grief, role disputes, role transitions, and social isolation. Facilitators will deliver the intervention according to the existing StrongMinds IPT-G manual and routine supervision procedures, without adding anxiety-specific psychoeducation or ACT-informed anxiety-management techniques. Participants may still undergo anxiety screening using the GAD-7 for study assessment purposes, but no structured anxiety-focused treatment components will be provided in this arm. 200 Active-Treatment of Control Group
Experimental Group Enhanced Interpersonal Group Psychotherapy Six weekly group sessions About 90–120 minutes per session Delivered face-to-face in community settings Six weeks Participants will receive the standard StrongMinds 6-week IPT-G programme delivered face-to-face in community settings, consisting of six weekly group sessions of approximately 90–120 minutes each, with the addition of structured anxiety screening and brief anxiety-management techniques. The enhanced model includes screening using the Generalized Anxiety Disorder-7 (GAD-7) and integration of ACT-informed anxiety-management strategies, including grounding, acceptance of internal experiences, values-based coping, reduction of reassurance-seeking behaviours, and practical distress-management skills. These components are incorporated into the existing IPT-G framework alongside standard interpersonal strategies such as communication analysis, role play, problem-area work, strengthening social support, and relapse prevention. The intervention is delivered by trained lay facilitators using adapted training materials and job aids developed for the enhanced model. 200
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults aged 18 years and above. Residents of the selected sub-counties in Luwero District where the study is being conducted. Enrolled in StrongMinds Interpersonal Group Psychotherapy (IPT-G) groups during the study period. Screen positive for depressive and/or anxiety symptoms, defined as a score of 10 or above on the PHQ-9 and/or GAD-7. Able and willing to provide written informed consent to participate in the study. Available to participate in the 6-week IPT-G intervention period and follow-up assessments. Presence of severe mental illness requiring specialized psychiatric care, such as active psychosis or severe bipolar disorder. Identified as being at high risk of suicide, requiring immediate clinical intervention beyond the scope of community-based IPT-G, according to StrongMinds risk assessment procedures. Severe cognitive impairment or intellectual disability that would prevent meaningful participation in group psychotherapy sessions. Current intoxication or severe substance use disorder that would interfere with the ability to participate in group therapy sessions. 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 120 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 08/04/2026 Mildmay Uganda Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Entebbe Rd, Lweeza Entebbe 24985 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in depressive symptom scores from baseline to 2-week and 3-month follow-up, measured using the PHQ-9. Outcomes will be measured at baseline, at 2 weeks post-implementation and at 3 months post-implementation.
Primary Outcome Change in anxiety symptom scores from baseline to 2-week and 3-month follow-up, measured using the GAD-7. Outcomes will be measured at baseline, at 2 weeks post-implementation and at 3 months post-implementation.
Secondary Outcome Psychological well-being, measured using the WHO-5 Well-Being Index. Outcomes will be measured at baseline, at 2 weeks post-implementation and at 3 months post-implementation.
Secondary Outcome Life satisfaction, measured using the Cantril Self-Anchoring Ladder. Outcomes will be measured at baseline, at 2 weeks post-implementation and at 3 months post-implementation.
Secondary Outcome Perceived control over life circumstances, measured using a single-item autonomy scale. Outcomes will be measured at baseline, at 2 weeks post-implementation and at 3 months post-implementation.
Secondary Outcome Functional impairment/disability, measured using WHODAS 2.0. Outcomes will be measured at baseline, at 2 weeks post-implementation and at 3 months post-implementation.
Secondary Outcome Perceived social support, measured using the Multidimensional Scale of Perceived Social Support . Outcomes will be measured at baseline, at 2 weeks post-implementation and at 3 months post-implementation.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
StrongMinds Uganda 32 Luthuli Rise Kampala Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
StrongMinds 4a Katalima Bend Kampala Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor StrongMinds Plot 4a Katalima bend Kampala Uganda Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Roscoe Kasujja roscoe.kasujja@strongminds.org +256752507050 4a Katalima bend
City Postal code Country Position/Affiliation
Kampala Uganda Technical Advisor
Role Name Email Phone Street address
Scientific Enquiries Elly Atuhumuza elly.atuhumuza@strongminds.org +256785686879 4a Katalima bend
City Postal code Country Position/Affiliation
Kampala Uganda Research Director
Role Name Email Phone Street address
Public Enquiries Christine Nanyondo cnanyondo@strongminds.org +256700346102 4a Katalima bend
City Postal code Country Position/Affiliation
Kampala Uganda Programs Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data underlying the reported results will be made available, including baseline and follow-up data on depression, anxiety, psychological well-being, life satisfaction, perceived control, functioning, social support, and key sociodemographic variables. Supporting documents may include the study protocol, data dictionary, and statistical analysis plan. Data will be shared in a de-identified form to protect participant confidentiality and only in accordance with applicable ethical and regulatory requirements. Study Protocol Beginning 12 months after study completion and ending 5 years after publication of the primary results. De-identified individual participant data will be made available to qualified researchers upon reasonable request. Requests must include a methodologically sound research proposal, a data use plan, and evidence of relevant ethical approval where applicable. Data access will be subject to review and approval by the study investigators and/or sponsoring institution, and a signed data access or data sharing agreement will be required. Data will only be shared in ways that protect participant confidentiality and comply with applicable ethical and regulatory requirements.
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 19/06/2026 To improve clarity as requested by the reviewer. Primary Outcome, Change in depressive symptom scores from baseline to 2-week and 3-month follow-up, measured using the PHQ-9. , 2 weeks and 3 months Primary Outcome, Change in depressive symptom scores from baseline to 2-week and 3-month follow-up, measured using the PHQ-9. , Outcomes will be measured at baseline, at 2 weeks post-implementation and at 3 months post-implementation.
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 19/06/2026 To improve clarify, as per reviewer comment. Primary Outcome, Change in anxiety symptom scores from baseline to 2-week and 3-month follow-up, measured using the GAD-7. , 2 week and 3 months Primary Outcome, Change in anxiety symptom scores from baseline to 2-week and 3-month follow-up, measured using the GAD-7. , Outcomes will be measured at baseline, at 2 weeks post-implementation and at 3 months post-implementation.
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 19/06/2026 To improve clarity, as per reviewer comment. Secondary Outcome, Psychological well-being, measured using the WHO-5 Well-Being Index. , 2 week and 3 months Secondary Outcome, Psychological well-being, measured using the WHO-5 Well-Being Index. , Outcomes will be measured at baseline, at 2 weeks post-implementation and at 3 months post-implementation.
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 19/06/2026 To improve clarity as per reviewer comment. Secondary Outcome, Life satisfaction, measured using the Cantril Self-Anchoring Ladder. , 2 week and 3 months Secondary Outcome, Life satisfaction, measured using the Cantril Self-Anchoring Ladder. , Outcomes will be measured at baseline, at 2 weeks post-implementation and at 3 months post-implementation.
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 19/06/2026 To improve clarity, as per reviewer comment. Secondary Outcome, Perceived control over life circumstances, measured using a single-item autonomy scale. , 2 week and 3 months Secondary Outcome, Perceived control over life circumstances, measured using a single-item autonomy scale. , Outcomes will be measured at baseline, at 2 weeks post-implementation and at 3 months post-implementation.
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 19/06/2026 To improve clarity as per reviewer comment. Secondary Outcome, Functional impairment/disability, measured using WHODAS 2.0. , 2 week and 3 months Secondary Outcome, Functional impairment/disability, measured using WHODAS 2.0. , Outcomes will be measured at baseline, at 2 weeks post-implementation and at 3 months post-implementation.
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 19/06/2026 To improve clarity, as per reviewer comment. Secondary Outcome, Perceived social support, measured using the Multidimensional Scale of Perceived Social Support ., 2 weeks and 3 months Secondary Outcome, Perceived social support, measured using the Multidimensional Scale of Perceived Social Support ., Outcomes will be measured at baseline, at 2 weeks post-implementation and at 3 months post-implementation.
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 29/06/2026 Correct email address added. TRUE, Mildmay Uganda Research and Ethics Committee, Entebbe Rd, Lweeza, Entebbe, 24985, Uganda, , 08 Apr 2026, +256312210200, eve.namitala@mildmay.or.ug, 41229_38460_4737.pdf TRUE, Mildmay Uganda Research and Ethics Committee, Entebbe Rd, Lweeza, Entebbe, 24985, Uganda, , 08 Apr 2026, +256312210200, mailbox@mildmay.or.ug, 41229_38460_4737.pdf