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

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ClinicalTrials.gov Identifier: NCT02469324
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : February 23, 2016
Sponsor:
Collaborator:
Compassionate Mind Foundation
Information provided by (Responsible Party):
Alex Kelman, i4Health

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.

Condition or disease Intervention/treatment Phase
Comparison of Internet-based CBT and CMT Behavioral: Cognitive Behavioral Therapy Behavioral: Compassionate Mind Training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : April 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

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




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469324


Locations
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United States, California
Palo Alto University
Palo Alto, California, United States, 94304
Sponsors and Collaborators
i4Health
Compassionate Mind Foundation
Investigators
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Principal Investigator: Alex R Kelman, MS Palo Alto University

Publications:
Goodman, S. H., & Brand, S. R. (2008). Parental psychopathology and its relation to child psychopathology. In Handbook of clinical psychology (pp. 937-965).
Buist, A., Westley, D., & Hill, C. (1999). Antenatal prevention of postnatal depression. Archives of Women's Mental Health, 1(4), 167-173. doi:10.1007/s007370050024
Neff, K. D., Hsieh, Y.-P., & Dejitterat, K. (2005). Self-compassion, achievement goals, and coping with academic failure. Self and Identity, 4(3), 263-287. doi:10.1080/13576500444000317
Yarnell, L. M., & Neff, K. D. (2013). Self-compassion, interpersonal conflict resolutions, and well-being. Self and Identity, 12(2), 146-159. doi:10.1080/15298868.2011.649545
Samaie, G., & Farahani, H. a. (2011). Self-compassion as a moderator of the relationship between rumination, self-reflection and stress. Procedia - Social and Behavioral Sciences, 30, 978-982. doi:10.1016/j.sbspro.2011.10.190
Gilbert, P. (2009). Introducing compassion-focused therapy. Advances in Psychiatric Treatment, 15(3), 199-208. doi:10.1192/apt.bp.107.005264
Gilbert, P. (2010). The Compassionate Mind: A New Approach to Life's Challenges (p. 544). New Harbinger Publications.
Gilbert, P., & Procter, S. (2006). Compassionate mind training for people with high shame and self-criticism: Overview and pilot study of a group therapy approach. Clinical Psychology and Psychotherapy, 13, 353-379. doi:10.1002/cpp
Cree, M. (2010). Compassion focused therapy with perinatal and mother-infant distress. International Journal of Cognitive Therapy, 3(2), 159-171.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alex Kelman, PhD Candidate in Clinical Psychology - under the supervision of Alinne Barrera, PhD, Palo Alto University and i4Health, i4Health
ClinicalTrials.gov Identifier: NCT02469324     History of Changes
Other Study ID Numbers: 15-018-H
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016