Mindfulness Based Program for Infertility
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Mindfulness Based Program for Infertility
Intervention type(s): Behavioral
Intervention description(s): 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).
Other intervention name(s): MBPI
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment