Contexto institucional y político de la agricultura en Morata de Tajuña

The primary aim of this study was to assess the feasibility of a partner-focused, single- session intervention on a perinatal psychiatry inpatient unit. As noted earlier, a feasibility study is designed to clarify whether a study can be conducted. As such, Orsmond and Cohn’s (2015) guidelines for feasibility study objectives shape the ways in which the results are presented. The main objectives are described below.

Evaluate Sample Characteristics and Recruitment Capability

In total, 20 male partners of women admitted to the PPIU between May 8th, 2017 and November 15th, 2017 participated in the study. The majority of the women in the sample were in the postpartum period (n =15); the other five participating patients were pregnant. At the time of data collection, 10% of patients had no children; 40% had one child; 40% had two children, and 10% had three children. Patient ages ranged from 19 to 40 years old (M = 28.55, SD = 4.67); they were hospitalized for an average of approximately 12 days (M = 12.05, SD = 5.41). Eighty percent of the women in the study were White. The sample’s modal household income ranged from 50,000 - $74,999. See Table 3 for a list of patient characteristics.

Diagnostically, 75% of the patients in the sample endorsed depressive symptoms that were in the clinical range based on their EPDS scores (M = 18.60, SD = 6.38). Similarly, 80% of the patients scored in the clinical range on the anxiety measure, the GAD-7 (M = 14.0, SD = 6.03). Relationship satisfaction scores, measured by the CSI-16, ranged from 6 – 81 (M = 59.25,

SD = 22.71). Four patients (20% of the sample) endorsed CSI-16 scores below 51.5, thereby demonstrating significant relationship dissatisfaction.

Partners’ ages ranged from 20 to 40 years old (M = 31.35, SD = 5.21). They were also majority White (90%). Diagnostically, 15% of partners in the sample endorsed depression scores in the clinical range (M = 6.70, SD = 4.01) on the pre-intervention questionnaire. Regarding anxiety symptoms, six partners (30% of the sample) exceeded the GAD-7 clinical cut-off score (M = 5.70, SD = 4.91). As for the other key study variables, relationship satisfaction scores ranged from 17 – 79 (M = 56.50, SD = 17.11). Seven partners (35% of the sample) scored below 51.5 on the CSI-16, scores that demonstrate significant relationship dissatisfaction. With regard to EE, partner scores on the PRS were in the lower range on average (M = 16, SD = 2.99) with scores that ranged from 11 (the minimum score) to 22 (the medium range). As for partner support self-efficacy, scores ranged from 6.25 to 96.43 (M = 48.94, SD = 25.88); of note, the sample’s large range and standard deviation demonstrates the wide range of self-efficacy that partners experienced in the context of offering support to patients. Finally, male alexithymia scores ranged from 1.74 to 5.70 (M = 3.98, SD = 1.18), which is in the normative range for this measure.

From a recruitment capability perspective, 20 out of 21 eligible partners (95%) opted to participate in the study. The one couple who declined to participate in the study mutually stated that they preferred to have a couple therapy session during the patient’s hospitalization in lieu of a partner-only meeting. The couple was experiencing acute relationship distress that was

contributing to the patient’s psychological symptoms and subsequent hospitalization, and they believed that it would be more beneficial to meet as a couple. This recruitment rate compares

favorably with the benchmark rates noted earlier for interventions targeting perinatal distress (67%) and single-session interventions (86%).

During the six-month recruitment window, 47 other women were admitted to the unit who did not participate in the study, none of whom met the eligibility criteria. Common reasons for ineligibility included the following: the patient did not have a partner (n = 23); the patient was not in the perinatal period (i.e., when there is an open bed on the PPIU, overflow patients from other units are transferred to the PPIU; n = 13), or the partner was unable to visit during the patient’s hospitalization (n = 8). See Table 4 for demographic information of patients who were not eligible to participate. The study clinician offered to speak on the phone with partners who were not able to visit during the patient’s hospitalization. Four out of the eight partners expressed interest in a Skype session and while these sessions were not part of the research study, the content of the sessions was not qualitatively different from in-person meetings with partners. Clarifying Data Collection Procedures and Outcome Measures

Both patients and partners appeared to demonstrate understanding of the questionnaires’ content based on their ability to complete the pre-intervention and follow-up measures. Patients took approximately 10 minutes to complete their pre-intervention measures, as well as the measures that they completed four weeks after discharge. Partner pre-intervention measures took approximately 20 minutes to complete, and the measures that they completed immediately after the intervention required approximately 10 minutes. At the four-week follow-up, partners took approximately 10 minutes to complete the follow-up questionnaire.

For most partners, the data collection procedures did not appear to represent a burden, especially among partners who attended the partner session on the PPIU during non-visiting hours between 8:00am-12:00pm and 1:00pm-4:30pm when patients are scheduled for groups and

individual meetings. Patients are unavailable to see visitors during these times, and it was therefore uncomplicated for partners to meet individually with the study clinician and take the time to complete the study questionnaires before and after the meeting. However, some partners’ work and home schedules only allowed them to be present during visiting hours in the evenings for a shorter duration of time, and these partners occasionally expressed hesitation about meeting (as well as completing the measures), given the limited time that they had available to visit with the patient. In these cases, partners were encouraged to complete the pre-intervention

questionnaires in advance of the meeting to maximize their time on the unit. Examining Acceptability of the Intervention

Partners completed both quantitative and qualitative measures to assess for acceptability of the intervention. As noted earlier, the CSQ-8 was the primary measure of acceptability (M = 31.25, SD =.97; see full CSQ-8 in Table 2); in this study, the mean score across partners exceeded the norms of the measure (M = 27.09, SD = 4.01), indicating high reported levels of satisfaction with the intervention itself. Specifically, all 20 partners reported that they were very satisfied with the care that they received. When asked to rate the extent to which the program had met each individual partner’s needs, 15 endorsed the item ‘Almost All’ and five partners

endorsed the item ‘Most.’ That all partners’ needs were not fully met lends cause to explore the qualitative feedback that partners offered in the post-intervention follow-up survey, as well as the four-week follow-up survey.

The qualitative feedback that partners offered immediately after the intervention and at the four-week follow-up mark highlights more specific aspects of the intervention that partners benefited from and areas that they identified for change within the intervention. Qualitative

feedback from partners was informally analyzed to explore themes that would further shape the intervention for continued use. These different themes are listed below:

Psychoeducation. Several partners described benefiting from learning the cognitive- behavioral framework (i.e., noting that the “the thoughts-feelings-behaviors triangle visual” was helpful) and how this interaction contributes to the development and maintenance of patients’ symptoms. Other partners reported benefiting from learning more about the patient's disorder. Some extolled the benefits of learning about specific aspects of the disorder (e.g., intrusive thoughts in the postpartum period), while others noted the importance of better understanding their partner’s overall experience.

Participant #10: “I had no idea what my partner was going through or how to help - learning more about anxiety and how it effects people made a big difference for me.” Participant #16: “It was incredibly helpful to have support and increased understanding for what my wife has been experiencing. I didn't know what to do to support her before and I feel like I have a much better sense now.”

Participant #24: “It helped me to learn more about what my wife has been going

through. I never really understand why things were so hard for her. It was also helpful to learn about how to be there for her more. I’ve never really known how to help her over these last months.”

Communication skills. Several partners noted that they benefited from "learning new strategies" for offering support as they examined their current communication patterns and clarified skills for helping patients to feel heard and understood. Specifically, a number of partners were enthusiastic about learning active listening skills and using them within their relationship. Several partners specifically noted increased feelings of self-efficacy in regard to their capacity to offer support.

Participant #22: “I really enjoyed and responded to the active listening portion, I feel like that will be effective with my wife and I.”

Participant #26: “This helped me a lot to know how to really listen to my wife and help her to feel understood. It also helped me to think more about her perspective and ways that I can support her.”

As they discussed their experience in learning communication skills, several partners commented that these skills were “concrete,” “practical and easy,” and that they benefited from clear directives of “how to put them into practice.”

Self-care and general support. Partners also described the many benefits they derived from receiving attention and support themselves. Although the intervention was framed as an opportunity to help partners gain information and skills for offering support, rather than a therapy session, partners reported benefiting from having “a space to work through [their] experience.” They also endorsed the importance of feeling integrated into the patient’s care.

Participant #22: “I love the fact that there is some therapy for the partners of the women staying here. I believe that me getting help as well is crucial for my wife's improvement because it will equip me with the things I need to help her through this.”

Participant #24: “No one had ever asked how I’ve been doing with everything going on and I appreciated the support.”

Participant #28: “It was just really helpful to get support and to have a space to work through my experience. It has been a difficult stretch of time and this was certainly needed.”

Participant #30: “This meeting was very helpful. It was very helpful to think about what had been going on at home before my wife came to UNC so that I can be more helpful when she comes home. I also really appreciated being able to talk to someone about my experience.”

Participant #32: “I felt like my opinion was really valued. All the other treaters who we have seen haven't really asked for my perspective much. It was nice to feel like someone was invested in how I'm doing, in addition to my wife.”

Participant #36: “I really appreciated getting support. This has been an ordeal for our whole family and it was a relief to have someone to talk to.”

several partners described family members who did not understand or “believe in mental illness,” a perspective that often coincided with behavioral reactions (e.g., criticism, hostility) that can serve to worsen patient symptoms. In these cases, partners sought skills for intervening on and improving these family dynamics. Specifically, they expressed a desire for skills that would help them feel equipped to talk to other family members and help them understand how they can best offer support.

A number of partners also were eager to receive more information, specifically as it pertained to different forms of treatment. Several partners expressed an interest in learning more about psychotropic medication for their partners. In addition to questions about the safety and efficacy of medication during the perinatal period, partners were interested in learning more about the course of medications (e.g., “Will she need to be on medication forever?”). They also expressed interest in learning more about individual and dyadic psychosocial interventions for reducing symptoms of perinatal distress. After being introduced to certain core clinical tenets (e.g., the thoughts-feelings-behaviors CBT triangle, the ACT bus metaphor), several partners expressed a desire to gain more exposure to these psychological frameworks. Partners also wanted to learn more about effectively implementing communication skills: “I would love to have sessions on how to work on active listening, and materials I could read about it so I can be better equipped.” Broadly, this feedback suggests that partners want to know more about the treatments that the patients are receiving to ensure that they are consistently acting in ways that promote the patient’s emotional well-being.

Evaluating the Context for Implementing the Intervention

The inpatient treatment setting where the study occurred had sufficient resources to manage the study and the intervention. Each partner meeting occurred in a consultation room on

the unit and was conducted by the same therapist, a white, male Ph.D. student in clinical psychology with training in couple therapy and perinatal mental health. The sessions were guided by the manual that was written for this intervention. To confirm adequate treatment adherence, two trained undergraduate coders independently listened to audiotapes of the same 10 randomly selected sessions. Both coders followed a manual created specifically for this study that was written to assess the extent to which the therapist delivered the intervention as it was designed. Primarily, the coders rated the therapist’s adherence to the treatment delivery. In addition, the coders rated each session based on any additional content that was presented and if that content seemed appropriate given what was occurring in the session. Treatment adherence and deviation from content were both rated on a Likert-type scale from 1-7. For the rating of overall adherence to the treatment manual, the two coders rated each of the 10 sessions with a maximum score of 7. This indicated that the study clinician engaged in the various behaviors outlined in the protocol (e.g., presenting psychoeducation material, introducing communication skills) without including extraneous material. The scores for presenting additional information in the session were low (M = 1.4, SD = .82) and indicate that within each session where deviations occurred, the coders deemed them to be appropriate given what was occurring in the session. The high adherence scores and low deviation scores from both coders suggest that the

intervention was delivered in a manner that was consistent with the manual across partner sessions.

In terms of obstacles to treatment on the PPIU, one central issue that arose during the intervention pertained to childcare. As noted earlier, 15 of the participating couples were in the postpartum period and when partners visited the unit, most brought their child or children to the hospital for them to visit with the mother. Yet, the rules on the unit dictate that mothers cannot

be left alone with their children while on the unit. Given that, infants occasionally joined the partners for the intervention session. In other cases, friends and family visited the unit along with the partner, and this allowed the partner to engage individually in the intervention session. Preliminary Evaluation of Potential Intervention Effects

The following section details preliminary analyses of patient and partner responses to the intervention. Although the absence of a control group precludes us from drawing any definitive conclusions about the data, we examined trends and patterns of change from pre-intervention to the four-week follow-up. Of note, each of the 20 patients completed the four-week follow-up measures; 16 partners completed the measures at follow-up.

Data analysis entailed several steps. In addition to calculating means and standard deviations, (see Table 5 and Table 6 for a full list of pre-intervention and four-week follow-up scores for patients and partners), correlation matrices were obtained for patient and partner main study variables, as well as for cross-partner correlations. Change over time was then measured for each patient and partner-specific variable using three distinct approaches: (a) inferential analyses (i.e., hierarchical linear modeling, t-tests, ANOVA), (b) within-group effect sizes, and (c) clinically significant and reliable change.

Hierarchical linear modeling (HLM) was used to assess response to treatment by examining change across time for measures that were completed by both partners (i.e., EPDS, GAD-7, CSI-16). This technique has been used extensively within dyadic analysis due to its capacity to assess for change in each partner’s pre-intervention to four-week follow-up change scores simultaneously, thereby accounting for the natural dependencies of the data (Atkins, Eldridge, Baucom, & Christensen, 2005). In that way, the use of HLM can clarify change across

multiple levels of grouping, facilitating analyses of each individual partners’ data while nested within their relationship.

Among study variables for measures that only one member of the dyad completed (i.e., patients completed the SIRRS-R, and partners completed the PRS), within-group t-tests were conducted to measure treatment effects by comparing pre-intervention and four-week follow-up scores. In addition, a repeated measures ANOVA was conducted to assess the partner support self-efficacy measure, completed only by partners. This was the only measure that either partner completed at more than two time points because we hypothesized that the intervention may produce different scores on this specific measure from pre-intervention to immediately after the intervention. As such, the measure was collected three times: before the intervention,

immediately after, and at the four-week follow-up.

The second approach to examining change, within-group effect sizes, was used to gain a more nuanced understanding of the effects of the intervention. While HLM, t-tests, and

ANOVAs assess for the presence of statistical significance from pre-intervention to four-week follow-up, calculating effect sizes takes into account the magnitude of change. In order to calculate within-group effect size, the differences between pre-intervention and four-week follow-up means for each study variable were obtained and divided by their pooled standard deviation.

Finally, real-world applicability was examined by calculating clinically significant and reliable change, an approach informed by methods described in Jacobson and Truax’s (1990) foundational paper. Including these measures of change helps clarify whether shifts observed before and after the intervention are clinically meaningful. Each of the three outcome variables completed by patients and partners before the intervention and at the four-week follow-up have

empirically validated cut-off scores that were used within the analyses (Delgadillo, 2012; Funk & Rogge, 2007; Matthey, 2004). The other measures that were collected before the intervention and at the four-week follow-up (i.e., partner support self-efficacy measure, PRS, SIRRS-R) all lack reliability coefficients, which precluded us from calculating clinically significant or reliable change.

Within this sample, change was considered to be clinically significant if a pre-

intervention score fell below the measure’s cut-off score and the four-week follow-up score was greater than the measure’s cut-off score (supposing that greater scores on this measure