Comparison of the effect of 8 weeks of physical activity and mindfulness-based stress reduction program on psychological factors, sleep quality and pattern in patients with major depression (clinical trial study with a control group)

Comparison of the effect of 8 weeks of physical activity and mindfulness-based stress reduction program on psychological factors, sleep quality and pattern in patients with major depression (clinical trial study with control group)

Clinical trials with control group, parallel groups, single-blind, randomized, phase 3, 60 patients

This study is a single-blind trial. The study sample population is consists of all Patients with Methamphetamine-Induced Mood Disorder referring to Farabi Hospital in Kermanshah, that 60 persons will be selected in the available method and randomly will be divided into two groups. The first group will receive a physical activity program, the second group will receive a mindfulness-based stress reduction treatment program (MBSR), the third group will receive a combination of physical activity. All subjects in all four groups will assess by completing a questionnaire at the baseline, 8 weeks later and four weeks after the end of the study in the follow-up test.

Both genders; Major Depression Disorder diagnosed by a psychiatrist, Major Depression Disorder diagnosed according to Diagnostic and Statistical Manual of Mental Disorders fifth edition and Beck questionnaire; having major depressive symptoms for at least 2 weeks, not having chronic physical illnesses. Patients who are not agree to participate in the study will be excluded.

The physical activity will include aerobic exercise for 8 weeks and 2 sessions. The MBSR group includes breathing exercises, mindfulness, and commitment and acceptance. The combination group includes MBSR and aerobic exercise. Sertraline 50 to 200 mg daily for the control group.

Depression symptoms, anxiety, stress, emotion regulation, insomnia severity, sleep quality,

Patients are divided into four equal groups (1. physical activity, 2. mindfulness, 3. combination of physical activity and mindfulness and 4. control) based on a randomized ten-block design using random allocation software. To randomly assign 60 patients to the four groups, six different blocks of 10 different letters A and B and C and D, which indicate physical activity, mindfulness, combination of physical activity and mindfulness and control groups respectively, will be initially created. These blocks then will be numbered from one to ten. In the next step, each of these blocks will be randomly selected by performing lottery using 10 card with letters from 1 to 10 on them. Thus, in each lottery, by selecting a block, a combination of 6 letters of the letters A and B and C and D will be obtained. At the end of the 10 drawings, after selecting 10 blocks, a total of 60 letters A and B and C and D will be obtained. The resulting combination of letters A and B and C and D is single, and will be placed in 60 separate and sealed envelopes, respectively. following each patient recourse, an envelope will be opened to determine the group of that patient.

Outcome examiners (people who distribute questionnaires among patients) are blind to the type of groups.