A Comparative RCT of Brief Internet-based Compassionate Mind Training and Cognitive-behavioral Therapy for Mothers and Their Babies

February 22, 2016 updated by: Alex Kelman, i4Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Palo Alto University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cognitive-Behavioral Therapy
see intervention explanation
Behavioral: Cognitive Behavioral Therapy
The course will be two weeks long, including the didactic portion of each course and the follow-up exercises (meditations for the CMT condition and exercises for the CBT condition) practiced daily for a total of two weeks. The course will contain two distinct parts. Part (a) will consist of a 45-minute didactic lesson that covers the basics of each approach. The course will provide a narrative rationale and the motivation for participants to complete the exercise portion of the course. Part (b) will be presented following completion of the didactic portion of the course. Participants will receive an automatically generated email following completion of the didactic that will include information on the follow-up exercises, suggestions for how to continue practicing, and a link to the the didactic portion of the course in case they want to review it again. Two weeks after enrollment and the completion of Part (b), participants will be invited to complete the post baseline measures.
Experimental: Compassionate Mind Training
Behavioral: Compassionate Mind Training
see above

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Forms of Self-Criticizing/Attacking and Self-Reassurance Scale (FSCRS)
Time Frame: at baseline and following 45 minute didactic
The Forms of Self-Criticizing/Attacking and Self-Reassurance Scale (FSCRS) will be administered to participants before and after the didactic portion of the course to assess change. This measure assesses levels of self-criticizing and attacking and capacity for self-reassurance (Gilbert, Clarke, Hempel, Miles, & Irons, 2004). The FSCRS is divided into three subscales: inadequate self, hated self, and reassured self. The items are on a Likert-Scale and there are five possible answers: "Not at all like me" (0 points); "A little bit like me" (1); "Moderately like me" (2); "Quite a bit like me" (3); and '"Extremely like me" (4). In a sample of female college students, Cronbach's alpha for inadequate self was at 0.90 and 0.86 for hated self and reassured self subscales (Gilbert et al., 2004).
at baseline and following 45 minute didactic
Patient Health Questionnaire-4 (PHQ-4)
Time Frame: at baseline and following 2 week follow up
The Patient Health Questionnaire-4 (PHQ-4) will be given to participants before the didactic portion of the course and following completion of the entire course to assess change. The PHQ-4 inventory consists of two self-report questions that measure depression through the PHQ-2 and two self-report questions that measure anxiety symptom severity through the GAD-2 (Kroenke, Spitzer, Williams, & Löwe, 2009). The items are on a Likert-Scale and there are four possible answers: "Not at all" (0 points); "Several days" (1); "More than half the days" (2); and "Nearly every day" (3). In the general population, Cronbach's alpha was .78 for PHQ-2 and .75 for GAD-2 (Löwe et al., 2010). When compared to SCID for DSM-IV diagnoses, a scaled score of 3 on the PHQ-2 scale demonstrated sensitivity of 87% and specificity of 78% for MDD, and it demonstrated comparable diagnostic performance relative to longer measures (Löwe, Kroenke, & Gräfe, 2005).
at baseline and following 2 week follow up
Self-Compassion Scale - Short Form (SCS-SF)
Time Frame: at baseline and following 2 week follow up
The Self-Compassion Scale - Short Form (SCS-SF) will be given to participants before the didactic portion of the course and after completion of the entire course to assess change. Women who endorsed being "currently pregnant" at baseline will receive the SCS-SF again at 4-weeks postpartum to assess for any changes in self-compassion at this time. The SCS-SF measures how individuals respond to themselves during times of stress in order to assess level of self-compassion (Raes, Pommier, Neff, & Van Gucht, 2010). The items are on a Likert-Scale, and there are five possible answers that range from "Almost Never" (1 point) to "Almost Always (5)." The SCS-SF has a near perfect correlation with the longer version of the measure at .97. It has a Cronbach's alpha of .86 in the general population in the United States (Raes et al., 2010).
at baseline and following 2 week follow up
Participant Feedback Questionnaire (PFQ)
Time Frame: at 2 week follow up
Participants from each condition will be invited to complete additional questionnaires regarding utilization of the course materials and the overall acceptability of the course to assess change. The Participant Feedback Questionnaires (PFQs) will include feedback on the number of times participants used the exercises and their overall impressions of the course materials.
at 2 week follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

i4Health

Collaborators

Compassionate Mind Foundation

Investigators

  • Principal Investigator: Alex R Kelman, MS, Palo Alto University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

June 5, 2015

First Submitted That Met QC Criteria

June 8, 2015

First Posted (Estimate)

June 11, 2015

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 15-018-H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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