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Depression DisorderNCT07745777

Exercise Adherence in Afghan Women With Depression

A study testing Structured Culturally Adapted Home-Based Exercise Program and Routine Exercise Advice in people with Depression Disorder, run by Ariana Medical Complex.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Depression Disorder
What is being tested?
Structured Culturally Adapted Home-Based Exercise Program and Routine Exercise Advice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Sep 2026to 30 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Female participants who self-identify as women.
  • Age 18 to 50 years.
  • Able to read and understand the study information (at least school graduate).
  • Diagnosis of mild to moderate depression according to DSM-5 criteria.
  • Medically able to participate in moderate physical activity.
  • Willing to participate in the study and provide written informed consent.

Who cannot join

  • Severe depression requiring hospitalization.
  • Psychotic disorders.
  • Bipolar disorder.
  • Severe cardiovascular disease or respiratory disease limiting exercise participation.
  • Musculoskeletal conditions preventing participation in exercise.
  • Pregnancy-related conditions restricting physical activity.
  • Cognitive impairment affecting the ability to provide informed consent.
  • Regular exercise habits before enrolment.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Nommanudien Naibkhil, Pharm. D. contact

+93786785956

n.naibkhil@gmail.com

About this study

Official title: A Randomized Controlled Trial Comparing Exercise Adherence Between a Structured Culturally Adapted Home-Based Exercise Program and Routine Exercise Advice Among Afghan Women With Depression

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:

Read more
  • Does a structured home-based exercise program help participants exercise more regularly over 8 weeks?
  • Does the program improve depression symptoms and daily functioning?
  • Is the program acceptable to participants, and are there any safety concerns?

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:

  • Receive an illustrated exercise booklet with simple home-based exercises, such as breathing, stretching, walking, and light aerobic activities.
  • Choose exercises that suit their preferences, abilities, and daily schedules.
  • Record each exercise session in a logbook, including the date, type of exercise, and how long they exercised.

Participants in the routine exercise advice group will:

  • Receive their usual psychiatric care and general advice about the benefits of physical activity.
  • Receive a logbook to record any physical activity or exercise they complete during the study.

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.

Read the detailed description

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.

Being tested
Structured Culturally Adapted Home-Based Exercise Program, Routine Exercise Advice
Keywords
depression, Exercise adherence, Physical activity, Home-based exercise, Culturally adapted exercise, Behavioral intervention, Afghan women, Women's mental health, Exercise therapy, Mental health, Randomized controlled trial, Outpatient psychiatry
Medical subject headings
Depression, Motor Activity, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Structured Culturally Adapted Home-Based Exercise ProgramBehavioural

    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.

  • Routine Exercise AdviceBehavioural

    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.

Study groups in NCT07745777
Study groupRoleWhat they receive
Structured Culturally Adapted Home-Based Exercise ProgramExperimentalParticipants 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.
Receives: Behavioral: Structured Culturally Adapted Home-Based Exercise Program
Routine Exercise AdviceActive comparatorParticipants 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.
Receives: Behavioral: Routine Exercise Advice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to Week 8 (8 weeks)

Secondary outcomes (4)
  1. 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.

    Measured: 8 weeks

  2. 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.

    Measured: 8 weeks

  3. 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

    Measured: 8 weeks

  4. 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.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. One group will receive a structured, culturally adapted home-based exercise program in addition to usual psychiatric care, while the other group will receive routine exercise advice as part of usual psychiatric care. Participants in both groups will be followed for 8 weeks, and outcomes will be assessed at baseline and at the end of the study. The primary comparison will evaluate exercise adherence between the two groups, with secondary analyses assessing changes in depression severity, functional status, participant satisfaction, and safety.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07745777
Sponsor's protocol ID
AMCIRB14050501-32-03
Status last verified
Aug 2026
First submitted
27 Jul 2026
Last updated
4 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing Structured Culturally Adapted Home-Based Exercise Program and Routine Exercise Advice in people with Depression Disorder, run by Ariana Medical Complex.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nommanudien Naibkhil, Pharm. D. (+93786785956, n.naibkhil@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exercise adherence (time frame: Baseline to Week 8 (8 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.

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