An interventional study of Structured Culturally Adapted Home-Based Exercise Program and Routine Exercise Advice in Depression Disorder, sponsored by Ariana Medical Complex. Not yet recruiting. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Ariana Medical Complex · Not applicable, Interventional, and Supportive care
The goal of this clinical trial is to learn whether a structured, culturally adapted home-based exercise program helps Afghan women with depression stay more active than routine exercise advice. The study will also examine whether taking part in the exercise program improves depression symptoms, daily functioning, and participant satisfaction, and whether the program is safe.
The main questions the study aims to answer are:
Researchers will compare a structured home-based exercise program with routine exercise advice to see which approach leads to better exercise adherence.
About 60 women aged 18 to 50 years with mild to moderate depression will take part. Participants will be randomly assigned (by chance) to one of two groups.
Participants in the structured exercise group will:
Participants in the routine exercise advice group will:
All participants will take part in the study for 8 weeks. At the beginning and end of the study, they will complete questionnaires about their depression symptoms and their ability to carry out everyday activities. At the end of the study, participants will also complete a questionnaire about their satisfaction with the program, and researchers will ask about any medical problems or injuries that occurred during the study.
The information from this study may help researchers understand whether a culturally adapted home-based structured exercise program is a practical and effective way to support Afghan women with depression and encourage regular physical activity.
Depression is one of the most common mental health disorders worldwide and is a leading cause of disability. Women are affected more frequently than men and often experience substantial impairment in emotional well-being, family life, social participation, and daily functioning. In Afghanistan, women may face additional challenges that increase their risk of depression, including prolonged exposure to conflict, financial hardship, caregiving responsibilities, social restrictions, current political restrictions, and limited access to mental health services. In addition, current restrictions imposed by the de facto authorities prohibit women from accessing public parks and gyms, substantially limiting opportunities for outdoor and facility-based physical activity. As a result, many women have few opportunities to engage in regular exercise despite its recognised benefits for both physical and mental health.
Regular physical activity has been shown to improve depressive symptoms and overall well-being. Proposed mechanisms include improvements in neurotransmitter function, reduction of stress-related physiological responses, enhancement of neuroplasticity, and positive psychological effects such as improved self-efficacy, mood, and quality of life. Exercise is therefore widely recommended as an adjunct to standard treatment for mild and moderate depression.
Although the benefits of exercise are well established, maintaining regular participation remains a major challenge. Many people begin exercising but discontinue after a short period because of motivational, environmental, cultural, or practical barriers. For Afghan women, these barriers may be particularly important. Opportunities to participate in organised exercise programmes are limited, and access to women-only fitness facilities is restricted. Cultural expectations, household responsibilities, concerns about privacy and modesty, transportation difficulties, and limited safe outdoor environments may further reduce participation in physical activity.
Home-based exercise programmes may provide a practical alternative by allowing women to exercise in a familiar and culturally acceptable environment without requiring specialised facilities or equipment. However, simply advising people to exercise may not be sufficient to encourage sustained participation. Programmes that provide clear instructions, culturally appropriate educational materials, and structured support may help improve adherence by increasing confidence, reducing uncertainty, and making exercise easier to incorporate into everyday life.
Despite growing international evidence supporting exercise as part of depression management, little research has examined culturally adapted home-based exercise interventions among Afghan women. Furthermore, limited evidence exists regarding exercise adherence in this population. Understanding whether a culturally appropriate programme improves adherence is important because the effectiveness of exercise depends largely on participants' ability and willingness to continue exercising over time.
This pilot randomised controlled trial has been designed to evaluate the feasibility and preliminary effectiveness of a structured culturally adapted home-based exercise programme for Afghan women with mild to moderate depression receiving outpatient psychiatric care. The study will compare this structured approach with routine exercise advice delivered as part of usual clinical care. The primary focus is to determine whether providing a culturally tailored exercise programme improves adherence to physical activity over an eight-week period.
In addition to evaluating exercise adherence, the study will explore whether greater participation in physical activity is associated with improvements in depressive symptoms, functional status, participant satisfaction, and the overall acceptability of the intervention. Information regarding adverse events occurring during participation will also be collected to better understand the safety of implementing a home-based exercise programme in this population.
The intervention has been developed to reflect the cultural and practical circumstances of Afghan women. The programme consists of illustrated guidance for home-based exercises that can be performed without specialised equipment and can be adapted to individual physical ability and available time. This flexible approach is intended to improve long-term engagement while respecting individual differences in daily responsibilities, physical fitness, and health status.
The study also seeks to generate preliminary data that may support the planning of future larger-scale clinical trials. As no previous randomised studies have specifically investigated culturally adapted home-based exercise adherence among Afghan women with depression, information from this pilot study will help estimate adherence rates, assess study feasibility, identify implementation challenges, and inform sample size calculations for future definitive research.
If the structured home-based exercise programme demonstrates improved adherence and favourable clinical outcomes, it could provide a practical, low-cost, and culturally appropriate strategy for integrating physical activity into routine mental health care for women with depression in Afghanistan. Because the intervention requires minimal resources and can be delivered without specialised exercise facilities, it may also be suitable for implementation in other low-resource or culturally similar settings where access to supervised exercise programmes is limited.
The findings of this study are expected to contribute to the limited evidence on behavioural interventions for depression in Afghanistan and may support the development of culturally appropriate, non-pharmacological approaches that complement existing psychiatric care. The results may also help healthcare providers and policymakers better understand how structured home-based physical activity programmes can be incorporated into comprehensive depression management within resource-constrained healthcare systems.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 60 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →This is the only study on the registry with Ariana Medical Complex as lead sponsor.
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Exclusion Criteria:
Participants assigned to this arm will receive usual psychiatric care plus a structured, culturally adapted home-based exercise program. The intervention includes an illustrated exercise booklet containing breathing, stretching, walking, and light-to-moderate aerobic exercises that can be performed safely at home without specialised equipment. Participants will receive initial visual instruction on performing the exercises and will be encouraged to choose exercises according to their preferences, physical abilities, and available time during the 8-week study period. Participants will record each exercise session in a logbook to monitor exercise adherence.
Behavioral: Structured Culturally Adapted Home-Based Exercise Program
Participants assigned to this arm will receive usual psychiatric care and routine advice on the benefits of physical activity, including general recommendations such as walking and household physical activities. They will not receive the structured home-based exercise program, illustrated exercise booklet, or exercise instruction provided to the experimental group. Participants will receive an exercise logbook to record any physical activity or exercise performed during the 8-week study period, allowing comparison of exercise adherence between the study groups.
Behavioral: Routine Exercise Advice
Participants will receive a structured, culturally adapted home-based exercise program in addition to usual psychiatric care. The intervention includes an illustrated exercise booklet containing breathing, stretching, indoor walking, brisk walking (where feasible), and light-to-moderate aerobic exercises that can be performed at home without specialised equipment. Participants will receive an initial face-to-face training session on how to perform the exercises safely and correctly. They will be encouraged to select exercises according to their preferences, physical abilities, and available time over the 8-week study period. An exercise logbook will be provided to record the date, type, and duration of each exercise session for adherence monitoring.
Participants will receive usual psychiatric care and routine verbal advice on the benefits of physical activity, including general recommendations such as walking and household physical activities. No structured exercise program, illustrated exercise booklet, supervised exercise instruction, or scheduled exercise follow-up will be provided. Participants will receive an exercise logbook to record any physical activity or exercise performed during the 8-week study period to allow assessment of exercise adherence.
Exercise adherence
Primary Outcome Measure 1: Exercise adherence - Total exercise sessions completed. Exercise adherence will be measured as the total number of exercise sessions of at least 30 minutes' duration completed during the 8-week intervention, as recorded in participant-completed exercise logbooks.
Time frame: Baseline to Week 8 (8 weeks)
Total Exercise Duration
Total exercise duration will be measured as the cumulative number of minutes of exercise completed during the 8-week intervention, as recorded in participant-completed exercise logbooks. The primary comparison will evaluate whether participants receiving the structured culturally adapted home-based exercise program demonstrate greater exercise adherence than participants receiving routine exercise advice.
Time frame: 8 weeks
Depression Severity
Depression severity will be measured using the Hamilton Depression Rating Scale (HDRS). HDRS assessments will be conducted at: * Baseline (Week 0) * End of intervention (Week 8) The change in HDRS score will be calculated as the difference between baseline and Week 8 scores. The study will compare: * Within-group changes from baseline to Week 8. * Differences in improvement between intervention groups. Change in HDRS score = Baseline HDRS score - Week 8 HDRS score Higher positive values indicate greater improvement in depressive symptoms.
Time frame: 8 weeks
Functional Status
Functional status will be assessed using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), 12-item version. WHODAS 2.0 assessments will be completed at: * Baseline (Week 0) * End of intervention (Week 8) Changes in functional status will be evaluated by comparing WHODAS 2.0 scores before and after the intervention. Change in WHODAS 2.0 score = Baseline Score - Week 8 score Higher positive values indicate greater improvement in functioning and reduction in disability. Mean changes in WHODAS 2.0 scores will be compared: * Within each group (baseline versus Week 8) * Between the intervention and control groups after 8 weeks
Time frame: 8 weeks
Participant Satisfaction
Participant satisfaction with the assigned intervention will be assessed using a structured satisfaction questionnaire developed for the study. The questionnaire will assess participants' perceptions regarding: * Ease of participation * Acceptability of the intervention * Perceived usefulness of the intervention * Willingness to continue exercising after study completion * Overall satisfaction with the intervention Responses will be collected using a Likert-scale format, and overall satisfaction scores will be summarized and compared between study groups. Mean satisfaction scores and the distribution of responses will be summarized using descriptive statistics and compared between groups where appropriate.
Time frame: 8 weeks
No study locations are listed for this record.
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Plan to share: No — Individual participant data (IPD) will not be shared with other researchers. Study data will be maintained securely by the research team, and access will be limited to authorized study personnel to protect participant confidentiality. De-identified aggregate results may be reported in scientific publications and presentations.
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