Health TrialsbyHealthPanel

Exercise Adherence in Afghan Women With Depression

ConditionDepression Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorAriana Medical Complex

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Severe depression requiring hospitalization.

Psychotic disorders.

Bipolar disorder.

Severe cardiovascular disease or respiratory disease limiting exercise participation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Structured Culturally Adapted Home-Based Exercise Program

    Behavioral

    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 Advice

    Behavioral

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Structured Culturally Adapted Home-Based Exercise ProgramExperimental treatment 1 intervention
Group B: Routine Exercise AdviceActive comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline to Week 8 (8 weeks)

Secondary outcomes

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.

Time frame
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.

Time frame
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

Time frame
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.

Time frame
8 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ariana Medical Complex

Lead sponsor

Source ClinicalTrials.gov

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