<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT201102275923N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-03-16</date_registration>
      <primary_sponsor>Institutes of Research Management and Monitoring, University of Malaya</primary_sponsor>
      <public_title>Employee Assistance Programme (EAP) for Stress: An Intervention study of psychological symptoms and sickness absence in public university</public_title>
      <acronym>Employee assistance programme, Wellness Programme, Stress, Job Stress, Sickness absence</acronym>
      <scientific_title>Employee Assistance Programme for Stress: An Intervention study of psychological symptoms and sickness absence in public university</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-04-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6403</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Self Perceived depression. Condition 2: Self-perceived anxiety. Condition 3: Self-perceived stress. Condition 4: Blood pressure. Condition 5: Fasting serum lipid. Condition 6: Fasting Blood Sugar.</hc_freetext>
      <i_freetext>Intervention 1: InterventionEmployee Assistance Program will include:•Three days of training program for participants. •EAP Individual counseling •Stress Relaxation Therapy6.6.1Three days of training program for participants. This workshop will be done by EAP specialist from Turning Point Integrated Wellness Sdn Bhd and investigator himself. The objectives of this 3 days workshop are to ensure participants will be able to: •Understand what EAP is •Understand what stress is •Recognize symptoms of stress •Identify sources of stress •Acquire some skills on how to cope with stress Workshop Methodology The workshop will start with the theoretical discussions on “What is Stress? (Definition)”; “How does Stress happen and how to make it work for you”; “Various elements and sources of Stress” “Job Burnout” and coupled with a simple stress evaluation test that measure stress levels and symptoms of stress for all participants, to help identify and focus on areas that cause stress to that person. Three major stress coping techniques will be taught and experienced during the session itself with Role Play/exercises. In this workshop, we will do one coping skill as in relation with oneself, another coping skill on interpersonal relationship (others) and third skills is coping with change and transition (environment). First coping skill, a creative-based method in managing stress will be applied here combining with Relaxation Techniques using specific breathing, imagery and visualizing methods. The exercise will be further enhanced with cognitive restructuring method in order to complete the full set coping skill. For second coping skill, we will be working with stress by enhancing our communication skills for interpersonal relationship. There are two important components in effective communication - listening and conveying the messages. Participants will practice communication skills through a series of exercises during the session itself. For third coping skills, we will be focusing on how to handle change and transition. Every person goes through an internal transition process when external situations or events change. Going through transitions, takes energy and causes both physical and emotional stresses. We will be focusing on understanding “How to recognize the different stages of transition?” and “how to identify problems occurring from incomplete transitions at the different stages of transition and the various strategies in managing transition?” through lectures and exercises during the session itself.The final session will be discuss about healthy lifestyle which consist of healthy eating, physical activity and stop smoking.6.6.2	EAP Individual counseling EAP individual counseling will be given three monthly and as needed by referral from supervisor for the whole one year program. In every session, participants will be allocated 30 minutes to one hour for them to discuss problems especially the psychological aspects. EAP counselor will listen and give the proper advice to participants. Compliance to stress relaxation therapy will also be emphasized here. Participants also can discuss about their medical condition and blood pressure will be measured in each session. This counseling session will be done by investigator; who is the Occupational Health Doctor with training in EAP counseling. Investigator had undergone 3 phase EAP counseling training which consist of:Phase 1: Counseling Skills for In-house Counselors – 3 daysPhase 2: Understanding Clients – 3 daysPhase 3: Simulation Exercises – 3 days6.6.3Stress Relaxation TherapyStress Relaxation Therapy will be taught to the participants by theory and practical session for one day period. The therapy includes deep breathing therapy, progressive muscular relaxation, imagery, musical and. To ensure compliance to the therapy, self-help material, phone follow-up and 3 monthly one-to-one counseling will be emphasized on this therapy. The best relaxation is achieved by using physical and mental techniques together. These useful physical relaxation techniques can help them to reduce muscle tension and manage the effects of the fight-or-flight response on your body. This is particularly important if they need to think clearly and perform precisely when they are under pressure. There are four types of Stress Relaxation Therapy:i)Deep Breathing TherapyDeep breathing is a simple, but very effective, method of relaxation. It is a core component of everything from the. Intervention 2: Control Group Participants in control group will be given self-help pamphlet on stress management.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Marzuki Bin Isahak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Social and Prevetive Medicine, Faculty of Medicine, University of Malaya</address>
        <city>Kuala Lumpur</city>
        <country1>Malaysia</country1>
        <zip>50603</zip>
        <telephone>+60332901293</telephone>
        <email>drmarzuki79@yahoo.com</email>
        <affiliation>University of Malaya</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Azlan Darus</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Social and Prevetive Medicine, Faculty of Medicine, University of Malaya</address>
        <city>Kuala Lumpur</city>
        <country1>Malaysia</country1>
        <zip>50603</zip>
        <telephone>+60379674756</telephone>
        <email>azdarus@um.edu.my</email>
        <affiliation>University of Malaya</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Malaysia</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria:&#13;
1. Staff aged between 35 to 65 years old.&#13;
2. Working in University of Malaya and has join University of Malaya Wellness Programme.&#13;
&#13;
Exclusion criteria:&#13;
1. Staff with underlying psychological illnesses.</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.9</hc_code>
      <hc_code>F43.0</hc_code>
      <hc_code>F31.3</hc_code>
      <hc_code>I10</hc_code>
      <hc_code>E78.0</hc_code>
      <hc_code>E10, E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>The patient is currently depressed, as in a depressive episode of either mild or moderate severity</hc_keyword>
      <hc_keyword>Anxiety NOS</hc_keyword>
      <hc_keyword>A transient disorder that develops in an individual without any other apparent mental disorder in response to exceptional physical and mental stress and that usually subsides within hours or days. Individual vulnerability and coping capacity play a role i</hc_keyword>
      <hc_keyword>High blood pressure</hc_keyword>
      <hc_keyword>Familial hypercholesterolaemia</hc_keyword>
      <hc_keyword>Insulin-dependent diabetes mellitus, Non-insulin-dependent diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>InterventionEmployee Assistance Program will include:•Three days of training program for participants. •EAP Individual counseling •Stress Relaxation Therapy6.6.1Three days of training program for participants. This workshop will be done by EAP specialist from Turning Point Integrated Wellness Sdn Bhd and investigator himself. The objectives of this 3 days workshop are to ensure participants will be able to: •Understand what EAP is •Understand what stress is •Recognize symptoms of stress •Identify sources of stress •Acquire some skills on how to cope with stress Workshop Methodology The workshop will start with the theoretical discussions on “What is Stress? (Definition)”; “How does Stress happen and how to make it work for you”; “Various elements and sources of Stress” “Job Burnout” and coupled with a simple stress evaluation test that measure stress levels and symptoms of stress for all participants, to help identify and focus on areas that cause stress to that person. Three major stress coping techniques will be taught and experienced during the session itself with Role Play/exercises. In this workshop, we will do one coping skill as in relation with oneself, another coping skill on interpersonal relationship (others) and third skills is coping with change and transition (environment). First coping skill, a creative-based method in managing stress will be applied here combining with Relaxation Techniques using specific breathing, imagery and visualizing methods. The exercise will be further enhanced with cognitive restructuring method in order to complete the full set coping skill. For second coping skill, we will be working with stress by enhancing our communication skills for interpersonal relationship. There are two important components in effective communication - listening and conveying the messages. Participants will practice communication skills through a series of exercises during the session itself. For third coping skills, we will be focusing on how to handle change and transition. Every person goes through an internal transition process when external situations or events change. Going through transitions, takes energy and causes both physical and emotional stresses. We will be focusing on understanding “How to recognize the different stages of transition?” and “how to identify problems occurring from incomplete transitions at the different stages of transition and the various strategies in managing transition?” through lectures and exercises during the session itself.The final session will be discuss about healthy lifestyle which consist of healthy eating, physical activity and stop smoking.6.6.2	EAP Individual counseling EAP individual counseling will be given three monthly and as needed by referral from supervisor for the whole one year program. In every session, participants will be allocated 30 minutes to one hour for them to discuss problems especially the psychological aspects. EAP counselor will listen and give the proper advice to participants. Compliance to stress relaxation therapy will also be emphasized here. Participants also can discuss about their medical condition and blood pressure will be measured in each session. This counseling session will be done by investigator; who is the Occupational Health Doctor with training in EAP counseling. Investigator had undergone 3 phase EAP counseling training which consist of:Phase 1: Counseling Skills for In-house Counselors – 3 daysPhase 2: Understanding Clients – 3 daysPhase 3: Simulation Exercises – 3 days6.6.3Stress Relaxation TherapyStress Relaxation Therapy will be taught to the participants by theory and practical session for one day period. The therapy includes deep breathing therapy, progressive muscular relaxation, imagery, musical and. To ensure compliance to the therapy, self-help material, phone follow-up and 3 monthly one-to-one counseling will be emphasized on this therapy. The best relaxation is achieved by using physical and mental techniques together. These useful physical relaxation techniques can help them to reduce muscle tension and manage the effects of the fight-or-flight response on your body. This is particularly important if they need to think clearly and perform precisely when they are under pressure. There are four types of Stress Relaxation Therapy:i)Deep Breathing TherapyDeep breathing is a simple, but very effective, method of relaxation. It is a core component of everything from the</i_keyword>
      <i_keyword>Control Group Participants in control group will be given self-help pamphlet on stress management</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-perceived depression, anxiety and stress. Timepoint: After 6 months. Method of measurement: DASS questionnaire.</prim_outcome>
      <prim_outcome>Work psychological risk factors. Timepoint: 6 months. Method of measurement: JCQ questionnaire.</prim_outcome>
      <prim_outcome>Sickness absence. Timepoint: 6 months. Method of measurement: Secondary data of sickness leaves from human resource department.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fasting blood sugar. Timepoint: After 6 months. Method of measurement: Blood biochemical measurement.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: After 6 months. Method of measurement: Clinical measurement with manual sphigmanometer.</sec_outcome>
      <sec_outcome>Fasting serum lipid. Timepoint: After 6 months. Method of measurement: Blood biochemical measurement.</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: After 6 months. Method of measurement: Clinical measurement of height and weight.</sec_outcome>
      <sec_outcome>Waist-hip ratio. Timepoint: After 6 months. Method of measurement: Clinical measurement of waist and hip circumference.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Institutes of Research Management and Monitoring, University of Malaya</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2009-08-20</approval_date>
        <contact_name>University Malaya Medical Centre Medical Ethics Committee</contact_name>
        <contact_address>University Malaya Medical Centre, Lembah Pantai, Kuala Lumpur Federal Territory Malaysia</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
