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
|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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
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
- 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).
- 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).
- 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).
- 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.
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
|United States, California|
|Palo Alto University|
|Palo Alto, California, United States, 94304|
|Principal Investigator:||Alex R Kelman, MS||Palo Alto University|