Clinical trial NCT02469324: A Comparative RCT of Brief Internet-based Compassionate Mind Training and Cognitive-behavioral Therapy for Mothers and Their Babies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Comparison of Internet-based CBT and CMT
Lead sponsor: i4Health
Sponsor class: OTHER
Collaborators: name: Compassionate Mind Foundation
First posted: 2015-06-11
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The current study is a two condition randomized controlled trial for women who are pregnant, interested in becoming pregnant, or pregnant within the last year. The conditions include a brief Cognitive Behavioral Therapy and a brief Compassionate Mind Training intervention. Participants in each condition will complete a 45 minute didactic exercises and readings followed by an email with exercises to continue practicing for a total of 2 weeks. After 2 weeks, participants will receive post-baseline assessment measures (e.g., depression, anxiety, affect, self-reassurance, self-attacking, self-criticizing, self-compassion). Participants will be recruited through a women's clinic in the United Kingdom by Michelle Cree, M.S. and through listservs by Yotam Heineberg, Psy.D. The researchers will also invite individuals in their social networks through email and through the Amazon Mechanical Turk System.

Detailed description: The primary aim of this study is to provide support for the clinical utility of Internet-based Compassionate-Mind Training (CMT) with pregnant women, women who were recently pregnant, or women who are interested in becoming pregnant. Specifically, the investigators will compare an existing treatment, Internet-based Cognitive-Behavioral Therapy (CBT) psychoeducational resources to Internet-based CMT psychoeducational resources. The researchers hypothesize Internet-based CMT is more effective than Internet-based CBT in enhancing self-compassion and self-reassuring and decreasing self-criticizing and self-attacking. Additionally, the researchers hypothesize the CBT and CMT conditions will have near equivalence for improving participant affect as well as depression and anxiety.

An additional aim of the study is to assess the feasibility and acceptability of the course. As such, participants in each condition will be invited to complete the feedback questions for the course. The feedback questions will then be used in the hopes of adapting and improving the course based on participant feedback.

Up to 7.1% of new mothers in the United States may experience depression within the first three months of giving birth (Gavin et al., 2005). If minor depressive episodes are included, then the prevalence rate becomes as high as 19.2% (Gavin et al., 2005). The global incidence of postnatal depression is likely even higher (Almond, 2009). This course will target women who are interested in becoming pregnant, currently pregnant, or pregnant in the last year who seek to improve well-being during the perinatal period.

There is a strong base of research to suggest that maternal depression has significant impacts on offspring (Forman et al., 2007; Goodman, 2007). These effects tend to develop while the child is still in-utero (Forman et al., 2007; Goodman, 2007) and continue until the offspring reaches adulthood (Goodman \& Brand, 2008). Research by Martins and Gaffan (2000) suggests that insecure attachment patterns are more common in children of depressed mothers than children of non-depressed mothers. Furthermore, insecure attachment style has substantial implications for persistent issues in functioning not only during childhood but throughout the entire lifespan (Martins \& Gaffan, 2000). Since attachment is perhaps the most vital relationship during a human life, it is crucial to help make this relationship a positive one.

Of the PPD interventions analyzed in a meta-analysis by Clatworthy (2012), the briefest intervention was shown to positively impact PPD (Matthey, Kavanagh, Howie, Barnett, \& Charles, 2004), whereas the longest intervention analyzed did not show an effect (Buist, Westley, \& Hill, 1999). There is evidence to suggest that interventions based on psychological models are more effective than purely educational material (Clatworthy, 2012). Internet interventions, including the present course, have the advantages of being low cost while reaching large audiences around the world.

Nonconsumable interventions, or reusable interventions, are predominately automated and can be reused with minimal cost for each additional individual participant (Muñoz, 2010). Nonconsumable interventions are important for reducing health disparities worldwide, as they can be reused at low cost. The current Internet Intervention, which will aim to increase compassion, is both non-consumable and firmly grounded in the principles of Dr. Paul Gilbert's CFT. Additionally, the CFT condition will be compared to a CBT Internet intervention to assess relative efficacy. The researchers will focus specifically on the constructs of self-compassion, self-reassurance, self-attacking, depression, anxiety, and mood.

Self-compassion involves an individual being both aware and open to the internal suffering that one experiences (Neff, Hsieh, \& Dejitterat, 2005), while keeping in mind that being imperfect is a trait shared across all humans (Neff \& Vonk, 2009; Neff, 2009). Samaie and Farahani (2011) found that self-compassion served as a significant moderator between rumination and stress, suggesting that higher levels of self-compassion can decrease the relationship between rumination and stress (Samaie \& Farahani, 2011). Also, self-compassion has also been linked to one's ability to balance one's own needs and the needs of another in a conflict situation (Yarnell \& Neff, 2013). The cultivation of self-compassion has been shown to improve quality of shared decision making in interpersonal relationships as well as improve an individual's ability to balance her needs in a relationship with the needs of her partner (Yarnell \& Neff, 2013).

CFT, which has an aim to increase compassion, is a movement towards a more biopsychosocial science of psychotherapy (Gilbert, 2010; Lawrence \& Lee, 2013). It seeks to increase systemic harmony and ability to cultivate compassion for others, receive compassion from others, and direct compassion towards the self. This approach draws from social, developmental, evolutionary and Buddhist psychology (Gilbert, 2009). CFT holds that psychopathology manifests from unbalanced systems of affect regulation, such that the threat-based system is activated disproportionately to the contentment, safety, and soothing system. As such, this approach seeks to educate the participant about these systems and to increase the contentment, safety, and soothing system activity in order to augment compassion and well-being (Lawrence \& Lee, 2013). Compassionate Mind Training (CMT) is the intervention component from the principles of CFT (Gilbert \& Procter, 2006).

A lack of stimulation in the contentment, soothing, and safety system may also have physiological effects, particularly by inhibiting the production of oxytocin (Cree, 2010). When maternal oxytocin is disregulated, the parent-child bonding process can be adversely affected (Carter, 1998). Furthermore, irregularities in neuroendocrine activity related to attachment, history of the parent, and social atmosphere can make the bonding process more difficult (Carter, 2003). The use of CFT with a perinatal population has the ability to stimulate the aforementioned systems, improve the mother's compassion, and positively impact the attachment with her baby.

In a preliminary study, the researchers contacted participants from the UCSF Mothers and Babies Internet Project (Barrera, Kelman, \& Muñoz, 2014). The majority of respondents stated they would be interested in learning how to be more compassionate (83% of English participants; 94% of Spanish participants). Also, these women asserted that Internet-based CMT would be useful to them (mean rating=7.41 out of 10).

The hypotheses of the current study are:

1. Following completion of the didactic portion of the course, participants will see greater increases in self-reassurance and decreases in self-attacking and self-criticizing in the CMT condition relative to the CBT condition.
2. Following completion of the didactic portion of the course, participants will see near equivalent affect improvements in the CMT and CBT conditions.
3. Following completion of the entire course, participants will see greater increases in self-compassion in the CMT condition relative to the CBT condition.
4. Following completion of the entire course, participants will see near equivalent reductions in depression and anxiety in the CMT and CBT conditions.

Eligibility criteria: Inclusion Criteria:

* Participants in the present study will include women over the age of 18 who are currently pregnant, pregnant within the last year, or endorse interest in becoming pregnant in the future. Additional inclusion criteria include proficiency in English and access to the Internet.

Exclusion Criteria:

* Exclusion criteria consist of not having interest in becoming pregnant, being male, or being under the age of 18.

Primary outcomes:
measure: The Forms of Self-Criticizing/Attacking and Self-Reassurance Scale (FSCRS)
timeFrame: at baseline and following 45 minute didactic
measure: Patient Health Questionnaire-4 (PHQ-4)
timeFrame: at baseline and following 2 week follow up
measure: Self-Compassion Scale - Short Form (SCS-SF)
timeFrame: at baseline and following 2 week follow up
measure: Participant Feedback Questionnaire (PFQ)
timeFrame: at 2 week follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto University
state: California
Study officials:
affiliation: Palo Alto University
name: Alex R Kelman, MS
role: PRINCIPAL_INVESTIGATOR
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