xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06006936</url>
    </required_header>
    <id_info>
      <org_study_id>REB #2023-210</org_study_id>
      <secondary_id>DCO150GP</secondary_id>
      <secondary_id>6447</secondary_id>
      <nct_id>NCT06006936</nct_id>
    </id_info>
    <brief_title>Testing an Evidence-Based Self-Help Program for Infertility-Related Distress in Women</brief_title>
    <official_title>Testing the Efficacy of the 'Coping With Infertility' Self-Help Program: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Regina</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Canadian Institutes of Health Research (CIHR)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Saskatchewan Health Research Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Calgary</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Regina</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Now affecting one in six couples in Canada, infertility is defined as a lack of conception&#xD;
        after 12 or more months of regular, unprotected sexual intercourse. Infertility can result&#xD;
        from a number of causes; however, women are responsible for accommodating rigid treatment&#xD;
        regimens and carry a disproportionate share of the psychological burden associated with&#xD;
        infertility. Thirty to forty percent of women presenting for the evaluation of infertility&#xD;
        experiencing clinically significant depression or anxiety. Yet access to infertility-specific&#xD;
        mental health resources is extremely limited in Canada; current psychological interventions&#xD;
        are not specialized to this population and are largely ineffective at reducing distress.&#xD;
        Therefore, there is an enormous need to increase the efficacy and accessibility of mental&#xD;
        health resources for this population.&#xD;
  &#xD;
        To address this need, the 7-week Coping with Infertility (CWI) program was developed in&#xD;
        collaboration with women with lived experience with infertility. The CWI program aims to&#xD;
        reduce distress related to infertility and was recently tested in a small pilot study, where&#xD;
        it was found to be very effective in reducing depression and anxiety and improving quality of&#xD;
        life among individuals struggling to get pregnant. The goal of this clinical study is to test&#xD;
        the CWI program in adult women experiencing infertility. The main questions it aims to answer&#xD;
        are if the CWI program is effective at improving mental health and well-being in women&#xD;
        experiencing infertility, and if demographic or lifestyle factors moderate the effect of the&#xD;
        treatment. For seven weeks, participants will receive the CWI program and complete online&#xD;
        questionnaires and interviews to assess the program's effects on infertility-related&#xD;
        distress, quality of life, depressive symptoms, anxiety, and relationship quality. They will&#xD;
        then complete these questionnaires biweekly for 16 weeks following the program. Researchers&#xD;
        will compare the CWI program to a waitlist/treatment as usual control condition to see if the&#xD;
        program reduces psychological distress above and beyond women's ordinary coping strategies.&#xD;
        If the program is effective in improving psychological well-being in this clinical study, the&#xD;
        researchers will make the program widely and freely available to women throughout Canada and&#xD;
        the world.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Infertility is associated with severe psychological consequences; psychiatric disorders are&#xD;
        common, particularly in women, yet current psychological interventions are not specialized to&#xD;
        this population and are largely ineffective. The 7-week Coping with Infertility (CWI) program&#xD;
        is a self-help program based on cognitive behaviour therapy that aims to improve mental&#xD;
        health in women and individuals assigned female at birth who are experiencing infertility.&#xD;
        This study aims to test the efficacy of the CWI program.&#xD;
  &#xD;
        In the proposed study, a single-blind randomized controlled trial, participants will be&#xD;
        randomly assigned to either the specialized CWI program or a waitlist/treatment as usual&#xD;
        control condition using stratified block randomization. Infertility-related distress, quality&#xD;
        of life, depression, anxiety, and relationship quality will be assessed at baseline, midway&#xD;
        through the program, post-treatment, and biweekly for 16 weeks after treatment. It is&#xD;
        expected that participants assigned to the CWI program will show significantly reduced&#xD;
        infertility-related distress, depression, and anxiety, and improved quality of life and&#xD;
        relationship quality relative to baseline and the waitlist control condition. Moderation&#xD;
        analyses will examine potential treatment moderators including sexual orientation and gender&#xD;
        identity, as well as cultural background, disability status, and whether participants are&#xD;
        pursuing fertility treatments. Participants who complete the CWI program will also provide&#xD;
        qualitative feedback on how the program can be improved. The results of this trial could&#xD;
        establish the CWI program as an effective short-term therapy option for women experiencing&#xD;
        infertility, addressing a significant gap in infertility treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Participants will be randomly assigned to either receive the CWI program or to remain in a treatment-as-usual (TAU) control condition using stratified block randomization. The two arms will be stratified based on whether participants are attempting to conceive naturally or undergoing fertility treatments.&#xD;
  Participants in the intervention condition will receive one 10-minute video module from the CWI program every week for seven weeks. Each video module will include a homework assignment encouraging participants to integrate the module content into everyday life.&#xD;
  Participants in the TAU control condition will not receive video modules or homework; instead, they will continue with everyday life-including their attempts to conceive-until the conclusion of the study. TAU participants will be offered the intervention following the conclusion of the study.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>A research assistant (RA) who is not involved with this study will use the randomization scheme to prepare opaque envelopes with each participant's treatment assignment, to be opened at the end of each enrolment session. While it is not possible to maintain full blinding of either the participant or the researchers given the nature of the intervention, all outcomes will be collected by an RA who is blind to participants' treatment allocation.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Fertility Quality of Life (FertiQoL) Score, at Mid-Treatment, Post-Treatment and Biweekly for 16 Weeks Post-Treatment</measure>
      <time_frame>6 months (FertiQoL completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment)</time_frame>
      <description>Fertility-related quality of life will be measured via the 24 items contained within the core FertiQoL scale. Scores range from 0 to 100; participants will be considered to exhibit significantly poorer quality of life if their FertiQoL score is less than or equal to 71.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mean Infertility-Related Distress Scores on the Copenhagen Multi-Centre Psychosocial Infertility - Fertility Problem Stress Scales (COMPI-FPSS), at Post-Treatment and Biweekly for 16 Weeks Post-Treatment</measure>
      <time_frame>6 months (COMPI-FPSS completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment)</time_frame>
      <description>Infertility-related distress will be measured via the nine items contained within the COMPI-FPSS. Scores range from 9 to 38; higher scores indicate greater distress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Depression Scores on the Patient Health Questionnaire-9 (PHQ-9), at Post-Treatment and Biweekly for 16 Weeks Post-Treatment</measure>
      <time_frame>6 months (PHQ-9 completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment)</time_frame>
      <description>Depressive symptoms will be measured via the nine items contained within the PHQ-9. Scores range from 0 to 27; participants will be considered to exhibit major depressive disorder if their PHQ-9 score is greater than or equal to 10.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Anxiety Scores on the Generalized Anxiety Disorder-7 (GAD-7), at Post-Treatment and Biweekly for 16 Weeks Post-Treatment</measure>
      <time_frame>6 months (GAD-7 completed completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment)</time_frame>
      <description>Anxious symptoms will be measured via the seven items contained within the GAD-7. Scores range from 0 to 21; participants will be considered to exhibit generalized anxiety disorder if their GAD-7 score is greater than or equal to 10.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Relationship Quality on the Relationship Assessment Scale (RAS), at Post-Treatment and Biweekly for 16 Weeks Post-Treatment</measure>
      <time_frame>6 months (RAS completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment)</time_frame>
      <description>Relationship quality will be measured via the seven items contained within the RAS. Scores range from 7 to 35; higher scores indicate greater relationship stability, satisfaction, and quality while lower scores indicate greater relationship dissatisfaction and distress. Participants will be considered to exhibit relationship dissatisfaction and distress if their average RAS score is less than four.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of Mood and Anxiety Disorders at Baseline, Post-Treatment, and 16 Weeks After Treatment</measure>
      <time_frame>6 months (NetSCID completed at enrollment (week 0), post-program (week 8), and 16 weeks after the end of treatment)</time_frame>
      <description>The presence or absence of major depressive disorder, persistent depressive disorder, generalized anxiety disorder, and panic disorder will be determined using the Computerized Version of the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (NetSCID). Presence of any mood and anxiety disorders will be simultaneously and automatically calculated by the NetSCID system based on the relevant criteria results.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Mean Intervention Credibility and Participant Expectancy at Baseline, Using the Credibility and Expectancy Questionnaire (CEQ)</measure>
      <time_frame>CEQ completed at enrollment (week 0)</time_frame>
      <description>Intervention credibility and participant expectancy will be measured via the six items contained within the CEQ. Scores range from 3 to 27 for each of the two subscales; higher scores indicate greater program credibility and participant expectancy.</description>
    </other_outcome>
    <other_outcome>
      <measure>Mean Quality of Homework Completion on the Homework Rating Scale (HRS)</measure>
      <time_frame>7 weeks (HRS completed weekly throughout the program)</time_frame>
      <description>Homework compliance will be measured via the 12 items contained within the HRS. Scores range from 0 to 36; higher scores indicate better quality and quantity of completion.</description>
    </other_outcome>
    <other_outcome>
      <measure>Mean Treatment Acceptability Post-Treatment, Using the Treatment Acceptability/Adherence Scale (TAAS)</measure>
      <time_frame>TAAS completed one week after the end of treatment (week 8)</time_frame>
      <description>Intervention acceptability will be measured via the 10 items contained within the TAAS. Scores range from 10 to 70; higher scores indicate greater program acceptability and adherence.</description>
    </other_outcome>
    <other_outcome>
      <measure>Mean Adverse Events Perceived to be Related to the Intervention Post-Treatment, Using the Negative Effects Questionnaire (NEQ)</measure>
      <time_frame>NEQ completed one week after the end of treatment (week 8)</time_frame>
      <description>Potential adverse events perceived to be related to the intervention will be measured via the 20 items contained within the NEQ. Items will be summed to determine the number of negative effects participants have experienced, divided by whether they believe the experience was caused by the treatment or other circumstances; higher scores indicate more negative effects attributed to the intervention.</description>
    </other_outcome>
    <other_outcome>
      <measure>Mean Healthcare Utilization, Medical and Productivity Costs in the 16 Weeks After Treatment, Using the Treatment Inventory of Costs in Patients with Psychiatric Disorders (TiC-P)</measure>
      <time_frame>TiC-P completed 16 weeks after the end of treatment (week 24)</time_frame>
      <description>Participants' healthcare utilization will be measured via the 33 items contained within the TiC-P. An additional section has been added to specifically ask about receipt of fertility treatments. Direct medical costs incurred by participants during the 16 weeks post-treatment will be calculated by multiplying the number of appointments participants have had with different general healthcare and mental healthcare professionals by the unit cost of these services in Canada. Similarly, productivity costs incurred during the 16 weeks post-treatment will be calculated by multiplying the number of hours of productivity lost to absenteeism or reduced efficiency by a standard cost price of productivity (e.g., $30 CAD per hour).</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">170</enrollment>
    <condition>Infertility</condition>
    <condition>Distress, Emotional</condition>
    <condition>Mental Health Issue</condition>
    <arm_group>
      <arm_group_label>Intervention Condition</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This arm will receive the Coping with Infertility intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist/Treatment as Usual Control Condition</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This arm will continue with everyday life-including their attempts to conceive.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Coping with Infertility Self-Help Program</intervention_name>
      <description>The CWI program consists of seven 10-minute videos, each with accompanying homework assignments.&#xD;
  The first module, cognitive restructuring, includes instructions on challenging extreme or unhelpful automatic thoughts. The second module, challenging negative core beliefs, includes looking for patterns in thinking that illustrate core beliefs. The third module features behavioural activation techniques and emphasizes the importance of regular pleasure and skill-based activities. The fourth module highlights coping with grief and factors that contribute to grief, such as individual differences in grieving style. The fifth module supports strengthening relationships through responding to requests for affection and outlines several common relationship mistakes. The sixth module demonstrates how to identify and use values to make decisions and guide behaviour. The seventh module summarizes how thoughts, actions, and interactions can contribute to well-being when experiencing infertility.</description>
      <arm_group_label>Intervention Condition</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Assigned female at birth&#xD;
  &#xD;
            -  Experiencing infertility (defined as [a] lack of conception after 12 or more months of&#xD;
               regular, unprotected, heterosexual intercourse, or [b] currently undergoing fertility&#xD;
               treatments)&#xD;
  &#xD;
            -  Fluent in English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Under the age of 18&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jennifer L. Gordon, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Unviersity of Regina</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jennifer L. Gordon, Ph.D.</last_name>
      <phone>306-585-4389</phone>
      <email>Jennifer.Gordon@uregina.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Megan Poulter, B.A. (Hons.)</last_name>
      <phone>204-391-9440</phone>
      <email>MeganPoulter@uregina.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Regina</name>
        <address>
          <city>Regina</city>
          <state>Saskatchewan</state>
          <zip>S4S 0A2</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Jennifer L. Gordon, Ph.D.</last_name>
        <phone>306-585-4389</phone>
        <email>Jennifer.Gordon@uregina.ca</email>
      </contact>
      <contact_backup>
        <last_name>Megan Poulter, B.A. (Hons.)</last_name>
        <phone>204-391-9440</phone>
        <email>MeganPoulter@uregina.ca</email>
      </contact_backup>
      <investigator>
        <last_name>Jennifer L. Gordon, Ph.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Regina</investigator_affiliation>
      <investigator_full_name>Jennifer Gordon</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>infertility</keyword>
    <keyword>women</keyword>
    <keyword>mental health</keyword>
    <keyword>distress</keyword>
    <keyword>quality of life</keyword>
    <keyword>depression</keyword>
    <keyword>anxiety</keyword>
    <keyword>relationship quality</keyword>
    <keyword>randomized controlled trial</keyword>
    <keyword>intervention</keyword>
    <keyword>treatment</keyword>
    <keyword>self-help</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infertility</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06006936
  org study id: REB #2023-210
  secondary id: DCO150GP
  secondary id: 6447
  nct id: NCT06006936
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Now affecting one in six couples in Canada, infertility is defined as a lack of conception
        after 12 or more months of regular, unprotected sexual intercourse. Infertility can result
        from a number of causes; however, women are responsible for accommodating rigid treatment
        regimens and carry a disproportionate share of the psychological burden associated with
        infertility. Thirty to forty percent of women presenting for the evaluation of infertility
        experiencing clinically significant depression or anxiety. Yet access to infertility-specific
        mental health resources is extremely limited in Canada; current psychological interventions
        are not specialized to this population and are largely ineffective at reducing distress.
        Therefore, there is an enormous need to increase the efficacy and accessibility of mental
        health resources for this population.
  
        To address this need, the 7-week Coping with Infertility (CWI) program was developed in
        collaboration with women with lived experience with infertility. The CWI program aims to
        reduce distress related to infertility and was recently tested in a small pilot study, where
        it was found to be very effective in reducing depression and anxiety and improving quality of
        life among individuals struggling to get pregnant. The goal of this clinical study is to test
        the CWI program in adult women experiencing infertility. The main questions it aims to answer
        are if the CWI program is effective at improving mental health and well-being in women
        experiencing infertility, and if demographic or lifestyle factors moderate the effect of the
        treatment. For seven weeks, participants will receive the CWI program and complete online
        questionnaires and interviews to assess the program's effects on infertility-related
        distress, quality of life, depressive symptoms, anxiety, and relationship quality. They will
        then complete these questionnaires biweekly for 16 weeks following the program. Researchers
        will compare the CWI program to a waitlist/treatment as usual control condition to see if the
        program reduces psychological distress above and beyond women's ordinary coping strategies.
        If the program is effective in improving psychological well-being in this clinical study, the
        researchers will make the program widely and freely available to women throughout Canada and
        the world.
  Infertility is associated with severe psychological consequences; psychiatric disorders are
        common, particularly in women, yet current psychological interventions are not specialized to
        this population and are largely ineffective. The 7-week Coping with Infertility (CWI) program
        is a self-help program based on cognitive behaviour therapy that aims to improve mental
        health in women and individuals assigned female at birth who are experiencing infertility.
        This study aims to test the efficacy of the CWI program.
  
        In the proposed study, a single-blind randomized controlled trial, participants will be
        randomly assigned to either the specialized CWI program or a waitlist/treatment as usual
        control condition using stratified block randomization. Infertility-related distress, quality
        of life, depression, anxiety, and relationship quality will be assessed at baseline, midway
        through the program, post-treatment, and biweekly for 16 weeks after treatment. It is
        expected that participants assigned to the CWI program will show significantly reduced
        infertility-related distress, depression, and anxiety, and improved quality of life and
        relationship quality relative to baseline and the waitlist control condition. Moderation
        analyses will examine potential treatment moderators including sexual orientation and gender
        identity, as well as cultural background, disability status, and whether participants are
        pursuing fertility treatments. Participants who complete the CWI program will also provide
        qualitative feedback on how the program can be improved. The results of this trial could
        establish the CWI program as an effective short-term therapy option for women experiencing
        infertility, addressing a significant gap in infertility treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants will be randomly assigned to either receive the CWI program or to remain in a treatment-as-usual (TAU) control condition using stratified block randomization. The two arms will be stratified based on whether participants are attempting to conceive naturally or undergoing fertility treatments.
  Participants in the intervention condition will receive one 10-minute video module from the CWI program every week for seven weeks. Each video module will include a homework assignment encouraging participants to integrate the module content into everyday life.
  Participants in the TAU control condition will not receive video modules or homework; instead, they will continue with everyday life-including their attempts to conceive-until the conclusion of the study. TAU participants will be offered the intervention following the conclusion of the study.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: A research assistant (RA) who is not involved with this study will use the randomization scheme to prepare opaque envelopes with each participant's treatment assignment, to be opened at the end of each enrolment session. While it is not possible to maintain full blinding of either the participant or the researchers given the nature of the intervention, all outcomes will be collected by an RA who is blind to participants' treatment allocation.
  measure: Fertility Quality of Life (FertiQoL) Score, at Mid-Treatment, Post-Treatment and Biweekly for 16 Weeks Post-Treatment
  time frame: 6 months (FertiQoL completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment)
  description: Fertility-related quality of life will be measured via the 24 items contained within the core FertiQoL scale. Scores range from 0 to 100; participants will be considered to exhibit significantly poorer quality of life if their FertiQoL score is less than or equal to 71.
  measure: Mean Infertility-Related Distress Scores on the Copenhagen Multi-Centre Psychosocial Infertility - Fertility Problem Stress Scales (COMPI-FPSS), at Post-Treatment and Biweekly for 16 Weeks Post-Treatment
  time frame: 6 months (COMPI-FPSS completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment)
  description: Infertility-related distress will be measured via the nine items contained within the COMPI-FPSS. Scores range from 9 to 38; higher scores indicate greater distress.
  measure: Mean Depression Scores on the Patient Health Questionnaire-9 (PHQ-9), at Post-Treatment and Biweekly for 16 Weeks Post-Treatment
  time frame: 6 months (PHQ-9 completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment)
  description: Depressive symptoms will be measured via the nine items contained within the PHQ-9. Scores range from 0 to 27; participants will be considered to exhibit major depressive disorder if their PHQ-9 score is greater than or equal to 10.
  measure: Mean Anxiety Scores on the Generalized Anxiety Disorder-7 (GAD-7), at Post-Treatment and Biweekly for 16 Weeks Post-Treatment
  time frame: 6 months (GAD-7 completed completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment)
  description: Anxious symptoms will be measured via the seven items contained within the GAD-7. Scores range from 0 to 21; participants will be considered to exhibit generalized anxiety disorder if their GAD-7 score is greater than or equal to 10.
  measure: Mean Relationship Quality on the Relationship Assessment Scale (RAS), at Post-Treatment and Biweekly for 16 Weeks Post-Treatment
  time frame: 6 months (RAS completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment)
  description: Relationship quality will be measured via the seven items contained within the RAS. Scores range from 7 to 35; higher scores indicate greater relationship stability, satisfaction, and quality while lower scores indicate greater relationship dissatisfaction and distress. Participants will be considered to exhibit relationship dissatisfaction and distress if their average RAS score is less than four.
  measure: Occurrence of Mood and Anxiety Disorders at Baseline, Post-Treatment, and 16 Weeks After Treatment
  time frame: 6 months (NetSCID completed at enrollment (week 0), post-program (week 8), and 16 weeks after the end of treatment)
  description: The presence or absence of major depressive disorder, persistent depressive disorder, generalized anxiety disorder, and panic disorder will be determined using the Computerized Version of the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (NetSCID). Presence of any mood and anxiety disorders will be simultaneously and automatically calculated by the NetSCID system based on the relevant criteria results.
  measure: Mean Intervention Credibility and Participant Expectancy at Baseline, Using the Credibility and Expectancy Questionnaire (CEQ)
  time frame: CEQ completed at enrollment (week 0)
  description: Intervention credibility and participant expectancy will be measured via the six items contained within the CEQ. Scores range from 3 to 27 for each of the two subscales; higher scores indicate greater program credibility and participant expectancy.
  measure: Mean Quality of Homework Completion on the Homework Rating Scale (HRS)
  time frame: 7 weeks (HRS completed weekly throughout the program)
  description: Homework compliance will be measured via the 12 items contained within the HRS. Scores range from 0 to 36; higher scores indicate better quality and quantity of completion.
  measure: Mean Treatment Acceptability Post-Treatment, Using the Treatment Acceptability/Adherence Scale (TAAS)
  time frame: TAAS completed one week after the end of treatment (week 8)
  description: Intervention acceptability will be measured via the 10 items contained within the TAAS. Scores range from 10 to 70; higher scores indicate greater program acceptability and adherence.
  measure: Mean Adverse Events Perceived to be Related to the Intervention Post-Treatment, Using the Negative Effects Questionnaire (NEQ)
  time frame: NEQ completed one week after the end of treatment (week 8)
  description: Potential adverse events perceived to be related to the intervention will be measured via the 20 items contained within the NEQ. Items will be summed to determine the number of negative effects participants have experienced, divided by whether they believe the experience was caused by the treatment or other circumstances; higher scores indicate more negative effects attributed to the intervention.
  measure: Mean Healthcare Utilization, Medical and Productivity Costs in the 16 Weeks After Treatment, Using the Treatment Inventory of Costs in Patients with Psychiatric Disorders (TiC-P)
  time frame: TiC-P completed 16 weeks after the end of treatment (week 24)
  description: Participants' healthcare utilization will be measured via the 33 items contained within the TiC-P. An additional section has been added to specifically ask about receipt of fertility treatments. Direct medical costs incurred by participants during the 16 weeks post-treatment will be calculated by multiplying the number of appointments participants have had with different general healthcare and mental healthcare professionals by the unit cost of these services in Canada. Similarly, productivity costs incurred during the 16 weeks post-treatment will be calculated by multiplying the number of hours of productivity lost to absenteeism or reduced efficiency by a standard cost price of productivity (e.g., $30 CAD per hour).
  arm group label: Intervention Condition
  arm group type: Experimental
  description: This arm will receive the Coping with Infertility intervention.
  arm group label: Waitlist/Treatment as Usual Control Condition
  arm group type: No Intervention
  description: This arm will continue with everyday life-including their attempts to conceive.
  intervention type: Behavioral
  intervention name: Coping with Infertility Self-Help Program
  description: The CWI program consists of seven 10-minute videos, each with accompanying homework assignments.
  The first module, cognitive restructuring, includes instructions on challenging extreme or unhelpful automatic thoughts. The second module, challenging negative core beliefs, includes looking for patterns in thinking that illustrate core beliefs. The third module features behavioural activation techniques and emphasizes the importance of regular pleasure and skill-based activities. The fourth module highlights coping with grief and factors that contribute to grief, such as individual differences in grieving style. The fifth module supports strengthening relationships through responding to requests for affection and outlines several common relationship mistakes. The sixth module demonstrates how to identify and use values to make decisions and guide behaviour. The seventh module summarizes how thoughts, actions, and interactions can contribute to well-being when experiencing infertility.
  arm group label: Intervention Condition
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jennifer L. Gordon, Ph.D.
  role: Principal Investigator
  affiliation: Unviersity of Regina
  last name: Jennifer L. Gordon, Ph.D.
  phone: 306-585-4389
  email: Jennifer.Gordon@uregina.ca
  last name: Megan Poulter, B.A. (Hons.)
  phone: 204-391-9440
  email: MeganPoulter@uregina.ca
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: University of Regina
  investigator full name: Jennifer Gordon
  investigator title: Associate Professor
  mesh term: Infertility
  sharing ipd: No