NCT07745777

Brief 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. 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:

  • 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
28 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

August 4, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

July 27, 2026

Last Update Submit

August 3, 2026

Conditions

Keywords

depressionExercise adherencePhysical activityHome-based exerciseCulturally adapted exerciseBehavioral interventionAfghan womenWomen's mental healthExercise therapyMental healthRandomized controlled trialOutpatient psychiatry

Outcome Measures

Primary Outcomes (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.

    Baseline to Week 8 (8 weeks)

Secondary Outcomes (4)

  • Total Exercise Duration

    8 weeks

  • Depression Severity

    8 weeks

  • Functional Status

    8 weeks

  • Participant Satisfaction

    8 weeks

Study Arms (2)

Structured Culturally Adapted Home-Based Exercise Program

EXPERIMENTAL

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

Routine Exercise Advice

ACTIVE COMPARATOR

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

Interventions

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.

Structured Culturally Adapted Home-Based Exercise Program

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.

Routine Exercise Advice

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study is limited to individuals who self-identify as female because it is designed to evaluate a culturally adapted home-based exercise program specifically for Afghan women with depression. The intervention was developed to address gender-specific cultural, social, and environmental barriers to physical activity experienced by women in Afghanistan.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionMotor ActivityPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Pazhman Sediqi, Neurologist

    Ariana Medical Complex

    STUDY DIRECTOR
  • Sodaba Rahraw, MD

    Ariana Medical Complex

    PRINCIPAL INVESTIGATOR
  • Nommanudien Naibkhil, Pharm. D.

    Ariana Medical Complex

    STUDY CHAIR

Central Study Contacts

Nommanudien Naibkhil, Pharm. D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research Department

Study Record Dates

First Submitted

July 27, 2026

First Posted

August 4, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

August 4, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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.