<?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>IRCT20141012019511N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-08</date_registration>
      <primary_sponsor>Islamic Azad University of Alborz, Iran</primary_sponsor>
      <public_title>Efficacy of Cognitive-Behavioral Therapy Approach for Adherence and  Depression (CBT-AD) on Depression and Non-Adherence to treatment</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of Cognitive-Behavioral Therapy Approach for Adherence and  Depression (CBT-AD) on improving Illness Representations, Non-Adherence and Depression in women with Rheumatoid Arthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17457</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method of randomization was the Simple randomization assignment. The Unit of randomization was individual. Random sequence was created through random allocation rule. Hiding the random allocation using sequentially opaque envelopes (SNOSE method), and the individual involved in the implementation of the randomization process was separated from other researchers in order to reduce the probable bias.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Rheumatoid Arthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The main modules for CBT-AD are (1) psychoeducation and motivational interviewing regarding treating depression and being adherent to one's medical regimen; (2) adherence training; (3) activity scheduling;(4) cognitive restructuring; (5) problem solving; (6) relaxation training/diaphragmatic breathing; and (7) review, maintenance, and relapse prevention.The treatment follows a modular approach so that core CBT skills can be learned, followed by focused work on problems specific to the individual. To maximize the balance between providing support to clients and also teaching new skills, we recommend that the format of every session begins with a mood check (we provide the Center for epidemiologic studies Depression Scale; CES-D), a review of adherence and of homework and ongoing progress from previous modules, and setting an agenda for the session. This should be done at the start of every session, regardless of whether it is a new module or a continuation of a module. We also recommend that therapists be flexible with clients in terms of the order of the modules, the amount of time spent on any one module, and the application of emergent client problems to the specific modules of treatment. This modular approach helps to make the treatment more relevant for each client and allows a more flexible sequence in the delivery of interventions based on the client’s presenting issues.Each module builds on previous modules, and each session begins with an assessment and discussion of depression and adherence for the previous week. The course of treatment is designed to be similar to a standardized cognitive-behavioral therapy, but though clients learn core CBT skills (cognitive restructuring and activity scheduling), active training in problem-solving and relaxation are also implemented. The problem-solving techniques complement the skills training for adherence. Because problem-solving skills can be impaired as a result of depression and because effective problem-solving skills are important for the management of medical illness, it is essential to directly teach these skills.Finally, we teach applied relaxation and slow breathing to help patients cope with side effects of medications, illness-related symptoms, or pain.These relaxation exercises can also improve sleep hygiene and stress management. Intervention 2: Control group: talk therapy or treatment as usual in psychological interventions, Includes 4 common 30-minute sessions.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Only part of the data, such as information on the main outcome, that in the present study, is the severity of depression and the secondary outcome (Medical Adherence) variable is shared.

When:
Starting the access period from 1397

To whom:
Data will only be available to researchers in academia and universities.

Conditions:
The application of the present study documents is permitted in the development of clinical research and referral in the compilations.

Where to obtain:
Dr Mohammad Reza Seirafy, No 12, Moazzen Blvd, Rajaee Shahr, Karaj, Alborz. Postal code: msf_3@yahoo.com

How to obtain:
The applicant for research information can receive a documentation of study at the end of 2018-2019 by email to Dr Mohammad Reza Sairafi.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Namjoo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University of Alborz, Moazen Boulevared, Rajai Street, Karaj, Alborz</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713135</zip>
        <telephone>+98 26 3418 2580</telephone>
        <email>namjoopsy@gmail.com</email>
        <affiliation>Islamic Azad University of Alborz, Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammadreza Seirafy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University of Alborz, Moazen Boulevared, Rajai Street, Karaj, Alborz</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713135</zip>
        <telephone>+98 26 3418 2560</telephone>
        <email>msf_3@yahoo.com</email>
        <affiliation>Islamic Azad University of Alborz</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Aged 18 to 65 years old
Disease Activity based on DAS score &lt;2.4; a score of disease activity in 28 joints, using the website www.das-score.nl
Body Mass Index (BMI) &lt;35
At least 12 class education (diploma certificate)
Participants haven't use any other psychotherapy during six months before entering the study
Mild to Moderate Depression without Suicidal Thoughts (diagnosis by clinical psychologist and severity determination by Beck Depression Inventory)
Poor follow-up from medical recommendations (based on GAS scale scores)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Severe Psychological Damage in the Axis I and the diagnosis of Personality Disorder in the Psychiatric Axis II .
Significant Cognitive Impairment
Finding social support problems (such as family and nurse)
Medication or Current Substance Abuse.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M05.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Seropositive Rheumatoid Arthritis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The main modules for CBT-AD are (1) psychoeducation and motivational interviewing regarding treating depression and being adherent to one's medical regimen; (2) adherence training; (3) activity scheduling;(4) cognitive restructuring; (5) problem solving; (6) relaxation training/diaphragmatic breathing; and (7) review, maintenance, and relapse prevention.The treatment follows a modular approach so that core CBT skills can be learned, followed by focused work on problems specific to the individual. To maximize the balance between providing support to clients and also teaching new skills, we recommend that the format of every session begins with a mood check (we provide the Center for epidemiologic studies Depression Scale; CES-D), a review of adherence and of homework and ongoing progress from previous modules, and setting an agenda for the session. This should be done at the start of every session, regardless of whether it is a new module or a continuation of a module. We also recommend that therapists be flexible with clients in terms of the order of the modules, the amount of time spent on any one module, and the application of emergent client problems to the specific modules of treatment. This modular approach helps to make the treatment more relevant for each client and allows a more flexible sequence in the delivery of interventions based on the client’s presenting issues.Each module builds on previous modules, and each session begins with an assessment and discussion of depression and adherence for the previous week. The course of treatment is designed to be similar to a standardized cognitive-behavioral therapy, but though clients learn core CBT skills (cognitive restructuring and activity scheduling), active training in problem-solving and relaxation are also implemented. The problem-solving techniques complement the skills training for adherence. Because problem-solving skills can be impaired as a result of depression and because effective problem-solving skills are important for the management of medical illness, it is essential to directly teach these skills.Finally, we teach applied relaxation and slow breathing to help patients cope with side effects of medications, illness-related symptoms, or pain.These relaxation exercises can also improve sleep hygiene and stress management.</i_keyword>
      <i_keyword>Control group: talk therapy or treatment as usual in psychological interventions, Includes 4 common 30-minute sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: Before and after the intervention. Method of measurement: Beck Depression Inventory (BDI).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Medical Adherence. Timepoint: Before and after the intervention. Method of measurement: General Adherence Scale (GAS).</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>Islamic Azad University of Alborz, Iran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-18</approval_date>
        <contact_name>Ethics committee of Alborz Islamic Azad University of Medical Sciences, Iran</contact_name>
        <contact_address>No 12, Moazzen Blvd, Rajaee Shahr, Karaj, Alborz Province karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
