<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/NCT03012412</url>
  </required_header>
  <id_info>
    <org_study_id>SFRH/BD/68392/2010-04</org_study_id>
    <nct_id>NCT03012412</nct_id>
  </id_info>
  <brief_title>Mindfulness Based Program for Infertility</brief_title>
  <acronym>MBPI</acronym>
  <official_title>Mindfulness Based Program for Infertility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Coimbra</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Portuguese Fertility Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Coimbra</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current study aims to test the efficacy a mindfulness based intervention for women facing&#xD;
      fertility problems - the Mindfulness Based Program for Infertility (MBPI). MBPI comprises 10&#xD;
      weekly group sessions of approximately 2 hours each, run in small groups of 10-15 women. The&#xD;
      main goal of MBPI intervention is to reduce depressive and anxiety symptoms and promote&#xD;
      infertility self-efficacy and acceptance and mindfulness skills. The MBPI is intended to&#xD;
      develop willingness/acceptance through a process of contacting the present moment and be in&#xD;
      touch with the unfolding experience in an open and non-judgmental way, particularly&#xD;
      infertility-related experiences.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Mindfulness Based Program for Infertility (MBPI) was developed based on the Mindfulness&#xD;
      Based Program for Stress Reduction, the Mind/Body Program for Infertility and basic&#xD;
      principles of Acceptance and Commitment Therapy. This program aims, fundamentally, learning&#xD;
      and practicing emotion regulation skills, particularly mindfulness and acceptance. It&#xD;
      addresses values (chosen life directions) clarification, interpersonal communication, healthy&#xD;
      lifestyles, and emotional self-care. The training of these skills occurs at all sessions and&#xD;
      is also encouraged between sessions. Support materials are provided for this, including a&#xD;
      Participant's Manual and an audio CD with several mindfulness meditation instructions. The&#xD;
      MBPI encloses 10 weekly sessions of 2 hours each, except for one of the sessions that lasts&#xD;
      for one day. It is a structured psychosocial intervention program, with a group format (max.&#xD;
      15 women). Male partners are invited to participate in 3 sessions.&#xD;
&#xD;
      MBPI sessions were carried out by a clinical psychologist with previous training in&#xD;
      contextual-behavioral therapies. A Therapist Manual was structured, describing the details&#xD;
      for conducting each session.&#xD;
&#xD;
      Most of the MBPI sessions follow a similar structure. They begin with a first half-hour of&#xD;
      sharing (optional). After the first half hour a formal mindfulness practice is held, followed&#xD;
      by sharing how participants felt, what they have noticed, how was the experience for them.&#xD;
      The set of formal practices selected for the MBPI is commonly used in mindfulness programs.&#xD;
      Informal mindfulness practice is also presented as early as the second session through&#xD;
      mindful eating. The three minutes breathing space exercise ends each session. Metaphors and&#xD;
      experiential exercises are included in most of the sessions. These comprise an experiential&#xD;
      exercise of listening to others, the introduction of values clarification (valued life&#xD;
      directions) through the imagery exercise &quot;10 years of marriage&quot;, the integration of a greater&#xD;
      number of positive aspects in day-to-day experience, a psychoeducational component regarding&#xD;
      healthy lifestyle (exercise, nutrition, caffeine, alcohol, nicotine, etc.). Moreover, the&#xD;
      promotion of psychological flexibility/acceptance is intended to be achieved through&#xD;
      mindfulness practice, but also through the use of metaphors such as &quot;the mind as a radio&#xD;
      always on&quot;, &quot;the coach and passengers&quot; and through emphasizing the importance of values&#xD;
      clarification and committed action.&#xD;
&#xD;
      Previously to data collection, ethical approval was obtained from the Scientific Council of&#xD;
      the Faculty of Psychology and Educational Sciences of the University of Coimbra. Participants&#xD;
      were women aged 18 years old or older, presenting a medically established infertility&#xD;
      diagnosis. Participants answered a recruitment announcement posted at the Portuguese&#xD;
      Fertility Association (patients association) website after getting the approval of this&#xD;
      association board. Participants were informed about the voluntary and confidential nature of&#xD;
      the data. A semi-structured clinical interview was used for MBPI admission. This interview&#xD;
      allows the gathering of demographic and clinical data and the screening for severe&#xD;
      psychopathology. Women who answered the recruitment announcement but lived in places where&#xD;
      the MBPI sessions were not scheduled were invited to participate in the study as members of&#xD;
      the control group and were given the opportunity to participate in future editions.&#xD;
&#xD;
      All participants were required to sign the informed consent and a numerical unique code was&#xD;
      assigned to each participant.&#xD;
&#xD;
      The study encompassed three different assessment moments (T0, T1, T2) namely before&#xD;
      intervention (T0), at the end of the intervention (T1) and at six months (T2). Another&#xD;
      follow-up study conducted seven years (T3) after the intervention was also designed for the&#xD;
      participants who completed the MBPI (not the control group).&#xD;
&#xD;
      The assessment protocol was completed at home. It was delivered to the participants in the&#xD;
      MBPI group during the admission interview and at the end of the last MBPI session. It was&#xD;
      then returned to the research team by mail. The assessment protocol was sent and returned by&#xD;
      mail to participants in the control group (stationary post envelopes were provided).&#xD;
      Concerning the seven years follow-up study data collection was carried out online.&#xD;
&#xD;
      All quantitative data were analyzed using SPSS (version 20). Independent samples t tests were&#xD;
      conducted to explore whether there were differences between the groups regarding demographic&#xD;
      variables. Depending on the nature of clinical variables, the groups were compared through&#xD;
      independent samples t tests, qui-squared tests and Fisher tests. When significant differences&#xD;
      were found Pearson and point-biserial correlation coefficients were used. Independent samples&#xD;
      t tests were also performed to explore the equivalence between the groups regarding the study&#xD;
      variables. The effect size considered for these analyses was the Eta square (ƞ2).&#xD;
&#xD;
      To explore mean differences between pre-treatment (T0) and post-treatment (T1) (main time&#xD;
      effect), between groups (main group effect) and time X group interaction effect repeated&#xD;
      measures ANOVAs were conducted, considering the MBPI and the control group as the&#xD;
      between-subjects factor. Mean differences of the study variables were also studied in each&#xD;
      group through paired samples t tests. In order to explore mean differences between&#xD;
      post-treatment (T1), six-months follow-up (T2) and 7 years follow-up (T3) in MBPI&#xD;
      participants repeated measures ANOVAs were conducted. Effect sizes were assessed through&#xD;
      partial Eta2 (ƞ2p). Independent samples t tests and repeated measures ANOVAs assumptions were&#xD;
      verified through Skweness and Kurtosis measures. Sphericity assumption for the repeated&#xD;
      measures ANOVAs were analyzed through Mauchly's W. Whenever this assumption was not verified&#xD;
      we used the Huynh-Feldt Epsilon (ɛ &gt; .75) or the Greenhouse-Geisser Epsilon (ɛ &lt; .75), that&#xD;
      correspond to probability correction factors of the F statistics significance.&#xD;
&#xD;
      Lastly, to understand mechanisms underlying the effect of the MBPI on the reduction of&#xD;
      depressive symptoms scores, a mediation analysis based upon regression analysis was&#xD;
      conducted. In this model, the intervention was the predictor (coded as 0 = control; 1 =&#xD;
      MBPI), self-efficacy at T1 was the mediator variable and depressive symptoms at T1 was the&#xD;
      outcome variable. Self-efficacy and depressive symptoms at T0 were included as covariates in&#xD;
      the model, to allow for a better prediction model, rather than using computed variables based&#xD;
      on the changes in these scores. Significance of indirect effects was calculated using PROCESS&#xD;
      macro in SPSS (Model 4) with bootstrap procedures (5000 samples) for determining statistical&#xD;
      significance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2009</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in depressive symptoms assessed by the Beck Depressive Inventory (BDI)</measure>
    <time_frame>7 years and 8 months (from Baseline to 7-years follow-up)</time_frame>
    <description>Assessed by the Beck Depressive Inventory (BDI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Mindfulness skills assessed by the Five Facet Mindfulness Questionnaire (FFMQ)</measure>
    <time_frame>7 years and 8 months (from Baseline to 7-years follow-up)</time_frame>
    <description>Assessed by the Five Facet Mindfulness Questionnaire (FFMQ)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in perceptions of infertility self-efficacy assessed by the Infertility Self-efficacy Scale (ISE)</measure>
    <time_frame>7 years and 8 months (from Baseline to 7-years follow-up)</time_frame>
    <description>Assessed by the Infertility Self-efficacy Scale (ISE)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in anxiety symptoms assessed by the Spielberger State Anxiety Inventory (STAI-Y1)</measure>
    <time_frame>7 years and 8 months (from Baseline to 7-years follow-up)</time_frame>
    <description>Assessed by the Spielberger State Anxiety Inventory (STAI-Y1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in acceptance skills assessed by the Acceptance and Action Questionnaire (AAQ-II)</measure>
    <time_frame>7 years and 8 months (from Baseline to 7-years follow-up)</time_frame>
    <description>Assessed by the Acceptance and Action Questionnaire (AAQ-II)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in self-compassion assessed by the Self-compassion Scale (SCS)</measure>
    <time_frame>7 years and 8 months (from Baseline to 7-years follow-up)</time_frame>
    <description>Assessed by the Self-compassion Scale (SCS)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in external shame assessed by the Others As Shamer (OAS)</measure>
    <time_frame>7 years and 8 months (from Baseline to 7-years follow-up)</time_frame>
    <description>Assessed by the Others As Shamer (OAS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in entrapment assessed by the Entrapment Scale (ES)</measure>
    <time_frame>8 months (from Baseline to 6-months follow-up)</time_frame>
    <description>Assessed by the Entrapment Scale (ES)</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in defeat assessed by the Defeat Scale (DS)</measure>
    <time_frame>8 months (from Baseline to 6-months follow-up)</time_frame>
    <description>Assessed by the Defeat Scale (DS)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Mindfulness Based Program for Infertility</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Behavioral: MBPI&#xD;
The Mindfulness Based Program for Infertility is a manualized group psychological intervention derived from contextual or 3rd wave cognitive-behavioral therapies intended to develop mindfulness and acceptance skills, as well as to promote perceptions of self-efficacy to deal with the demands of an infertility diagnosis and medical treatment. It comprises 10 weekly sessions of approximately 2hr each, run in small groups (ranging from 10 to 15 participants).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment As Usual (TAU)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard infertility medical treatment provided by IVF clinics (public and private) - no psychological intervention being pursued.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness Based Program for Infertility</intervention_name>
    <description>The Mindfulness Based Program for Infertility is a manualized group psychological intervention derived from contextual or 3rd wave cognitive-behavioral therapies intended to develop mindfulness and acceptance skills, as well as to promote perceptions of self-efficacy to deal with the demands of an infertility diagnosis and medical treatment. It comprises 10 weekly sessions of approximately 2hr each, run in small groups (ranging from 10 to 13 participants).</description>
    <arm_group_label>Mindfulness Based Program for Infertility</arm_group_label>
    <other_name>MBPI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women dealing with an infertility diagnosis (independently of female, male, both&#xD;
             female and male or unknown factor), pursuing infertility medical treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe psychiatric problems assessed through a semi-structured clinical interview used&#xD;
             for MBPI admission&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>48 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>José A Pinto-Gouveia, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>CINEICC - Faculty of Psychology and Educational Sciences of the University of Coimbra</affiliation>
  </overall_official>
  <reference>
    <citation>Galhardo A, Cunha M, Pinto-Gouveia J. Measuring self-efficacy to deal with infertility: Psychometric properties and confirmatory factor analysis of the Portuguese version of the infertility self-efficacy scale. Res Nurs Health. 2013 Feb;36(1):65-74. doi: 10.1002/nur.21516. Epub 2012 Oct 18.</citation>
    <PMID>23081663</PMID>
  </reference>
  <reference>
    <citation>Galhardo A, Moura-Ramos M, Cunha M, Pinto-Gouveia J. The infertility trap: how defeat and entrapment affect depressive symptoms. Hum Reprod. 2016 Feb;31(2):419-26. doi: 10.1093/humrep/dev311. Epub 2015 Dec 17.</citation>
    <PMID>26677954</PMID>
  </reference>
  <reference>
    <citation>Galhardo A, Pinto-Gouveia J, Cunha M, Matos M. The impact of shame and self-judgment on psychopathology in infertile patients. Hum Reprod. 2011 Sep;26(9):2408-14. doi: 10.1093/humrep/der209. Epub 2011 Jul 4.</citation>
    <PMID>21727160</PMID>
  </reference>
  <results_reference>
    <citation>Galhardo A, Cunha M, Pinto-Gouveia J. Mindfulness-Based Program for Infertility: efficacy study. Fertil Steril. 2013 Oct;100(4):1059-67. doi: 10.1016/j.fertnstert.2013.05.036. Epub 2013 Jun 27.</citation>
    <PMID>23809500</PMID>
  </results_reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>May 2, 2018</last_update_submitted>
  <last_update_submitted_qc>May 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Coimbra</investigator_affiliation>
    <investigator_full_name>Ana Galhardo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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>


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/NCT03012412
org study id: SFRH/BD/68392/2010-04
nct id: NCT03012412
lead sponsor: 
collaborator: 
has dmc: No
The current study aims to test the efficacy a mindfulness based intervention for women facing
      fertility problems - the Mindfulness Based Program for Infertility (MBPI). MBPI comprises 10
      weekly group sessions of approximately 2 hours each, run in small groups of 10-15 women. The
      main goal of MBPI intervention is to reduce depressive and anxiety symptoms and promote
      infertility self-efficacy and acceptance and mindfulness skills. The MBPI is intended to
      develop willingness/acceptance through a process of contacting the present moment and be in
      touch with the unfolding experience in an open and non-judgmental way, particularly
      infertility-related experiences.
The Mindfulness Based Program for Infertility (MBPI) was developed based on the Mindfulness
      Based Program for Stress Reduction, the Mind/Body Program for Infertility and basic
      principles of Acceptance and Commitment Therapy. This program aims, fundamentally, learning
      and practicing emotion regulation skills, particularly mindfulness and acceptance. It
      addresses values (chosen life directions) clarification, interpersonal communication, healthy
      lifestyles, and emotional self-care. The training of these skills occurs at all sessions and
      is also encouraged between sessions. Support materials are provided for this, including a
      Participant's Manual and an audio CD with several mindfulness meditation instructions. The
      MBPI encloses 10 weekly sessions of 2 hours each, except for one of the sessions that lasts
      for one day. It is a structured psychosocial intervention program, with a group format (max.
      15 women). Male partners are invited to participate in 3 sessions.

      MBPI sessions were carried out by a clinical psychologist with previous training in
      contextual-behavioral therapies. A Therapist Manual was structured, describing the details
      for conducting each session.

      Most of the MBPI sessions follow a similar structure. They begin with a first half-hour of
      sharing (optional). After the first half hour a formal mindfulness practice is held, followed
      by sharing how participants felt, what they have noticed, how was the experience for them.
      The set of formal practices selected for the MBPI is commonly used in mindfulness programs.
      Informal mindfulness practice is also presented as early as the second session through
      mindful eating. The three minutes breathing space exercise ends each session. Metaphors and
      experiential exercises are included in most of the sessions. These comprise an experiential
      exercise of listening to others, the introduction of values clarification (valued life
      directions) through the imagery exercise "10 years of marriage", the integration of a greater
      number of positive aspects in day-to-day experience, a psychoeducational component regarding
      healthy lifestyle (exercise, nutrition, caffeine, alcohol, nicotine, etc.). Moreover, the
      promotion of psychological flexibility/acceptance is intended to be achieved through
      mindfulness practice, but also through the use of metaphors such as "the mind as a radio
      always on", "the coach and passengers" and through emphasizing the importance of values
      clarification and committed action.

      Previously to data collection, ethical approval was obtained from the Scientific Council of
      the Faculty of Psychology and Educational Sciences of the University of Coimbra. Participants
      were women aged 18 years old or older, presenting a medically established infertility
      diagnosis. Participants answered a recruitment announcement posted at the Portuguese
      Fertility Association (patients association) website after getting the approval of this
      association board. Participants were informed about the voluntary and confidential nature of
      the data. A semi-structured clinical interview was used for MBPI admission. This interview
      allows the gathering of demographic and clinical data and the screening for severe
      psychopathology. Women who answered the recruitment announcement but lived in places where
      the MBPI sessions were not scheduled were invited to participate in the study as members of
      the control group and were given the opportunity to participate in future editions.

      All participants were required to sign the informed consent and a numerical unique code was
      assigned to each participant.

      The study encompassed three different assessment moments (T0, T1, T2) namely before
      intervention (T0), at the end of the intervention (T1) and at six months (T2). Another
      follow-up study conducted seven years (T3) after the intervention was also designed for the
      participants who completed the MBPI (not the control group).

      The assessment protocol was completed at home. It was delivered to the participants in the
      MBPI group during the admission interview and at the end of the last MBPI session. It was
      then returned to the research team by mail. The assessment protocol was sent and returned by
      mail to participants in the control group (stationary post envelopes were provided).
      Concerning the seven years follow-up study data collection was carried out online.

      All quantitative data were analyzed using SPSS (version 20). Independent samples t tests were
      conducted to explore whether there were differences between the groups regarding demographic
      variables. Depending on the nature of clinical variables, the groups were compared through
      independent samples t tests, qui-squared tests and Fisher tests. When significant differences
      were found Pearson and point-biserial correlation coefficients were used. Independent samples
      t tests were also performed to explore the equivalence between the groups regarding the study
      variables. The effect size considered for these analyses was the Eta square (ƞ2).

      To explore mean differences between pre-treatment (T0) and post-treatment (T1) (main time
      effect), between groups (main group effect) and time X group interaction effect repeated
      measures ANOVAs were conducted, considering the MBPI and the control group as the
      between-subjects factor. Mean differences of the study variables were also studied in each
      group through paired samples t tests. In order to explore mean differences between
      post-treatment (T1), six-months follow-up (T2) and 7 years follow-up (T3) in MBPI
      participants repeated measures ANOVAs were conducted. Effect sizes were assessed through
      partial Eta2 (ƞ2p). Independent samples t tests and repeated measures ANOVAs assumptions were
      verified through Skweness and Kurtosis measures. Sphericity assumption for the repeated
      measures ANOVAs were analyzed through Mauchly's W. Whenever this assumption was not verified
      we used the Huynh-Feldt Epsilon (ɛ > .75) or the Greenhouse-Geisser Epsilon (ɛ < .75), that
      correspond to probability correction factors of the F statistics significance.

      Lastly, to understand mechanisms underlying the effect of the MBPI on the reduction of
      depressive symptoms scores, a mediation analysis based upon regression analysis was
      conducted. In this model, the intervention was the predictor (coded as 0 = control; 1 =
      MBPI), self-efficacy at T1 was the mediator variable and depressive symptoms at T1 was the
      outcome variable. Self-efficacy and depressive symptoms at T0 were included as covariates in
      the model, to allow for a better prediction model, rather than using computed variables based
      on the changes in these scores. Significance of indirect effects was calculated using PROCESS
      macro in SPSS (Model 4) with bootstrap procedures (5000 samples) for determining statistical
      significance.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Changes in depressive symptoms assessed by the Beck Depressive Inventory (BDI)
time frame: 7 years and 8 months (from Baseline to 7-years follow-up)
description: Assessed by the Beck Depressive Inventory (BDI)
measure: Changes in Mindfulness skills assessed by the Five Facet Mindfulness Questionnaire (FFMQ)
time frame: 7 years and 8 months (from Baseline to 7-years follow-up)
description: Assessed by the Five Facet Mindfulness Questionnaire (FFMQ)
measure: Changes in perceptions of infertility self-efficacy assessed by the Infertility Self-efficacy Scale (ISE)
time frame: 7 years and 8 months (from Baseline to 7-years follow-up)
description: Assessed by the Infertility Self-efficacy Scale (ISE)
measure: Changes in anxiety symptoms assessed by the Spielberger State Anxiety Inventory (STAI-Y1)
time frame: 7 years and 8 months (from Baseline to 7-years follow-up)
description: Assessed by the Spielberger State Anxiety Inventory (STAI-Y1)
measure: Changes in acceptance skills assessed by the Acceptance and Action Questionnaire (AAQ-II)
time frame: 7 years and 8 months (from Baseline to 7-years follow-up)
description: Assessed by the Acceptance and Action Questionnaire (AAQ-II)
measure: Changes in self-compassion assessed by the Self-compassion Scale (SCS)
time frame: 7 years and 8 months (from Baseline to 7-years follow-up)
description: Assessed by the Self-compassion Scale (SCS)
measure: Changes in external shame assessed by the Others As Shamer (OAS)
time frame: 7 years and 8 months (from Baseline to 7-years follow-up)
description: Assessed by the Others As Shamer (OAS)
measure: Changes in entrapment assessed by the Entrapment Scale (ES)
time frame: 8 months (from Baseline to 6-months follow-up)
description: Assessed by the Entrapment Scale (ES)
measure: Changes in defeat assessed by the Defeat Scale (DS)
time frame: 8 months (from Baseline to 6-months follow-up)
description: Assessed by the Defeat Scale (DS)
arm group label: Mindfulness Based Program for Infertility
arm group type: Experimental
description: Behavioral: MBPI
The Mindfulness Based Program for Infertility is a manualized group psychological intervention derived from contextual or 3rd wave cognitive-behavioral therapies intended to develop mindfulness and acceptance skills, as well as to promote perceptions of self-efficacy to deal with the demands of an infertility diagnosis and medical treatment. It comprises 10 weekly sessions of approximately 2hr each, run in small groups (ranging from 10 to 15 participants).
arm group label: Treatment As Usual (TAU)
arm group type: No Intervention
description: Standard infertility medical treatment provided by IVF clinics (public and private) - no psychological intervention being pursued.
intervention type: Behavioral
intervention name: Mindfulness Based Program for Infertility
description: The Mindfulness Based Program for Infertility is a manualized group psychological intervention derived from contextual or 3rd wave cognitive-behavioral therapies intended to develop mindfulness and acceptance skills, as well as to promote perceptions of self-efficacy to deal with the demands of an infertility diagnosis and medical treatment. It comprises 10 weekly sessions of approximately 2hr each, run in small groups (ranging from 10 to 13 participants).
arm group label: Mindfulness Based Program for Infertility
other name: MBPI
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 48 Years
healthy volunteers: No
last name: José A Pinto-Gouveia, MD, PhD
role: Study Chair
affiliation: CINEICC - Faculty of Psychology and Educational Sciences of the University of Coimbra
citation: Galhardo A, Cunha M, Pinto-Gouveia J. Measuring self-efficacy to deal with infertility: Psychometric properties and confirmatory factor analysis of the Portuguese version of the infertility self-efficacy scale. Res Nurs Health. 2013 Feb;36(1):65-74. doi: 10.1002/nur.21516. Epub 2012 Oct 18.
PMID: 23081663
citation: Galhardo A, Moura-Ramos M, Cunha M, Pinto-Gouveia J. The infertility trap: how defeat and entrapment affect depressive symptoms. Hum Reprod. 2016 Feb;31(2):419-26. doi: 10.1093/humrep/dev311. Epub 2015 Dec 17.
PMID: 26677954
citation: Galhardo A, Pinto-Gouveia J, Cunha M, Matos M. The impact of shame and self-judgment on psychopathology in infertile patients. Hum Reprod. 2011 Sep;26(9):2408-14. doi: 10.1093/humrep/der209. Epub 2011 Jul 4.
PMID: 21727160
citation: Galhardo A, Cunha M, Pinto-Gouveia J. Mindfulness-Based Program for Infertility: efficacy study. Fertil Steril. 2013 Oct;100(4):1059-67. doi: 10.1016/j.fertnstert.2013.05.036. Epub 2013 Jun 27.
PMID: 23809500
responsible party type: Principal Investigator
investigator affiliation: University of Coimbra
investigator full name: Ana Galhardo
investigator title: Principal Investigator
mesh term: Infertility
sharing ipd: No