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The prevalence of CFT at the counseling center and university made it difficult during recruitment of subjects to find participants without exposure to CFT to be used as a treatment-as-usual control.
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The proposed study is a randomized controlled trial (RCT) that takes place at Brigham Young University's (BYU) Counseling and Psychological Services (CAPS). The proposed study follows from the CAPS open trial which led to revisions of the compassion-focused therapy (CFT) protocol authored by Paul Gilbert. In essence, the study is taking existing evidence-based group treatments offered at CAPS, and comparing patient outcomes in a systematic manner. The investigators intend to replicate the improvement rates observed in the open trial with the revised CFT protocol and ascertain if outcomes are comparable to members who receive treatment-as-usual-TAU CAPS groups and those receiving CFT.
Hypotheses:
Compassion-based interventions (CBIs) have become popular in the last ~30 years, either as standalone interventions or adjuncts to other treatments. Compassion focused therapy (CFT) is a CBI that was originally designed to be an adjunct to other interventions (e.g., individual psychotherapy). The focus on increasing compassion (especially self-compassion) grew out of the recognition that self-compassion has a strong positive relationship with well-being and a mirroring negative relationship with psychopathology (i.e., depression and anxiety). Indeed, six identified CBIs have been subjected to rigorous testing in RCTs, finding a medium effect on average (d = 0.55) across outcomes (e.g., depression, distress, well-being). CFT is "the most evaluated, and is the most appropriate for use in clinical populations" of all CBIs. CFT's evidence basis is expansive, prompting researchers to compose a review of its benefits for different populations and presenting problems (e.g., psychotic-spectrum disorders, people wanting to quit smoking). Researchers called for large-scale and high-quality trials having larger samples to further evaluate CFT. In particular, they call for this research to clarify equivocal results on important outcomes (i.e., some nonsignificant reductions of self-criticism). They also called for the inclusion of comparison groups stating that the next step was demonstrate that it produces comparable effects to other evidence-based interventions. A limitation noted by researchers was the existing CFT research includes a range of session length (i.e., as low as one and up to 16 weeks) and strategies (e.g., using cognitive restructuring, letter-writing, client-chosen practice with audio recordings) which varied widely between research groups. Furthermore, a portion of the evidence basis for CFT involves its combination with other third-wave psychotherapeutic interventions (i.e., acceptance and commitment therapy). Taken together, CFT has been adapted in multiple ways and its quality of evidence needs to be expanded, strengthening measurement and research designs as well as employing a standardized protocol that can be replicated with fidelity at multiple settings. The above limitations in existing CFT research prompted an open trial testing the effectiveness and feasibility of a standardized CFT protocol created by Paul Gilbert for group therapy at BYU's CAPS. The intent was to refine the CFT protocol so that it could be used in randomized trials, such as the one proposed in the present study. The production and empirical refinement of the CFT protocol by the BYU CAPS open trial directly addresses a serious problem in existing CFT trials that use incomparable treatment protocols. The investigators' CFT protocol was designed to be delivered in a group format. The investigators' BYU lab (http://cgrp.byu.edu) has a long tradition of making an empirical case for equivalence of group and individual treatments when delivered with fidelity. Indeed, three recent papers by the investigators provide compelling evidence for format equivalence using findings from both highly controlled randomized clinical trials and daily practice. Prior to the open trial, CFT had been delivered using a group treatment format, but its use with clinical populations is embryonic. Thus, the investigators' goal is to integrate CFT treatment as a group intervention targeting college counseling center clients to provide a rigorous empirical test of CFT theory. The investigators intend to do this by comparing CFT to treatment-as-usual groups for various presenting problems (e.g., depression and anxiety, eating disorders and sexual concerns) over the course of group treatment. Doing so will answer the call for higher-quality evidence and evaluate if (a) the theory-specified path of self-criticism to shame is present in treatment groups, and (b) this path can be mediated by CFT using the model.
Aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as Usual | Experimental | Participants in this arm will receive treatment as usual (TAU) as an intervention. |
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| Compassion-Focused Therapy | Experimental | Participants in this arm will be enrolled in a CFT group intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment as Usual | Behavioral | Treatment as usual-TAU groups include:
|
| Measure | Description | Time Frame |
|---|---|---|
| Fears of Compassion Scale (FCS) | The FCS is a 38-item scale measuring fears of compassion on a five-point scale (0 = don't agree at all to 4 = completely agree). The FCS includes three scales, with higher scores indicating greater fears of compassion. Scales include: (1) expressing compassion for others (minimum score: 0; maximum score: 40), (2) responding to the expression of compassion from others (minimum score: 0; maximum score: 52), and (3) expressing kindness and compassion toward the self (minimum score: 0; maximum score: 60). | Pre-treatment (prior to first session, with measures cut off at session two) |
| Fears of Compassion Scale (FCS) | The FCS is a 38-item scale measuring fears of compassion on a five-point scale (0 = don't agree at all to 4 = completely agree). The FCS includes three scales, with higher scores indicating greater fears of compassion. Scales include: (1) expressing compassion for others (minimum score: 0; maximum score: 40), (2) responding to the expression of compassion from others (minimum score: 0; maximum score: 52), and (3) expressing kindness and compassion toward the self (minimum score: 0; maximum score: 60). | Mid-treatment (between week six and week seven of intervention) |
| Fears of Compassion Scale (FCS) | The FCS is a 38-item scale measuring fears of compassion on a five-point scale (0 = don't agree at all to 4 = completely agree). The FCS includes three scales, with higher scores indicating greater fears of compassion. Scales include: (1) expressing compassion for others (minimum score: 0; maximum score: 40), (2) responding to the expression of compassion from others (minimum score: 0; maximum score: 52), and (3) expressing kindness and compassion toward the self (minimum score: 0; maximum score: 60). | Post-treatment (within two weeks of the conclusion of the twelfth group session) |
| Fears of Compassion Scale (FCS) | The FCS is a 38-item scale measuring fears of compassion on a five-point scale (0 = don't agree at all to 4 = completely agree). The FCS includes three scales, with higher scores indicating greater fears of compassion. Scales include: (1) expressing compassion for others (minimum score: 0; maximum score: 40), (2) responding to the expression of compassion from others (minimum score: 0; maximum score: 52), and (3) expressing kindness and compassion toward the self (minimum score: 0; maximum score: 60). |
| Measure | Description | Time Frame |
|---|---|---|
| Outcome Questionnaire-45 (OQ-45) | The OQ-45 is a 45-item scale that measures client psychiatric distress on interpersonal relations, symptom distress, and social role performance on a five-point scale (ranging from 0 = never to 4 = almost always) (minimum score: 0; maximum score: 180). Higher scores indicate greater distress. | Weekly (12 weeks) |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Gary M Burlingame, PhD | Brigham Young University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham Young University | Provo | Utah | 84602 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27866082 | Background | Baumeister D, Sedgwick O, Howes O, Peters E. Auditory verbal hallucinations and continuum models of psychosis: A systematic review of the healthy voice-hearer literature. Clin Psychol Rev. 2017 Feb;51:125-141. doi: 10.1016/j.cpr.2016.10.010. Epub 2016 Nov 1. | |
| Background | Beavan V. Towards a definition of "hearing voices": A phenomenological approach. Psychosis. 2011; 3(1): 63-73. doi:10.1080/17522431003615622 | ||
| 24215148 |
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It is likely that all collected IPD data will be used in future studies that support programmatic research in BYU CAPS and the investigators' continuing research on compassion therapy. Confidentiality will be maintained by using an assigned ID number.
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Members will be randomized to treatment-as-usual (TAU) CAPS groups or CFT groups.
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| Compassion-Focused Therapy (CFT) | Behavioral | The CFT protocol assumes that participants have no prior experience with meditation, mindfulness, and self-compassion and teaches principles of each as well as skills such as guided meditations. |
|
| 90-day assessment (90 days after completion of intervention) |
| Compassionate Engagement and Action Scales (CEAS) | The CEAS is a 39-item scale. The CEAS includes three scales, including compassion for self, compassion for others, and compassion from others. A total score can be calculated for each subscale (minimum score: 10; maximum score: 100), with higher scores indicating greater compassionate engagement and action. Furthermore, each scale is divided into two subscales: engagement and action. For each scale, subscale scores can be calculated for engagement (minimum score: 6; maximum score: 60) and action (minimum score: 4; maximum score: 40). | Pre-treatment (prior to first session, with measures cut off at session two) |
| Compassionate Engagement and Action Scales (CEAS) | The CEAS is a 39-item scale. The CEAS includes three scales, including compassion for self, compassion for others, and compassion from others. A total score can be calculated for each subscale (minimum score: 10; maximum score: 100), with higher scores indicating greater compassionate engagement and action. Furthermore, each scale is divided into two subscales: engagement and action. For each scale, subscale scores can be calculated for engagement (minimum score: 6; maximum score: 60) and action (minimum score: 4; maximum score: 40). | Mid-treatment (between week six and week seven of intervention) |
| Compassionate Engagement and Action Scales (CEAS) | The CEAS is a 39-item scale. The CEAS includes three scales, including compassion for self, compassion for others, and compassion from others. A total score can be calculated for each subscale (minimum score: 10; maximum score: 100), with higher scores indicating greater compassionate engagement and action. Furthermore, each scale is divided into two subscales: engagement and action. For each scale, subscale scores can be calculated for engagement (minimum score: 6; maximum score: 60) and action (minimum score: 4; maximum score: 40). | Post-treatment (within two weeks of the conclusion of the twelfth group session) |
| Compassionate Engagement and Action Scales (CEAS) | The CEAS is a 39-item scale. The CEAS includes three scales, including compassion for self, compassion for others, and compassion from others. A total score can be calculated for each subscale (minimum score: 10; maximum score: 100), with higher scores indicating greater compassionate engagement and action. Furthermore, each scale is divided into two subscales: engagement and action. For each scale, subscale scores can be calculated for engagement (minimum score: 6; maximum score: 60) and action (minimum score: 4; maximum score: 40). | 90-day assessment (90 days after completion of intervention) |
| Forms of Self Criticism and Self Reassuring Scale (FSCRS) | The FSCRS is a 22-item scale developed to measure people's critical and self-reassuring responses to setbacks or disappointments on a five-point scale (ranging from 0 = not at all like me to 4 = extremely like me). The FSCRS measures two forms of self-criticalness (i.e., inadequate self and hated self) and one form to self-reassure (i.e., reassure self). A score can be calculated for the inadequate self (minimum score: 0; maximum score: 36), hated self (minimum score: 0; maximum score: 20), and reassure self (minimum score: 0; maximum score: 32), with higher scores indicating a stronger inadequate self, hated self, and reassure self, respectively. | Pre-treatment (prior to first session, with measures cut off at session two) |
| Forms of Self Criticism and Self Reassuring Scale (FSCRS) | The FSCRS is a 22-item scale developed to measure people's critical and self-reassuring responses to setbacks or disappointments on a five-point scale (ranging from 0 = not at all like me to 4 = extremely like me). The FSCRS measures two forms of self-criticalness (i.e., inadequate self and hated self) and one form to self-reassure (i.e., reassure self). A score can be calculated for the inadequate self (minimum score: 0; maximum score: 36), hated self (minimum score: 0; maximum score: 20), and reassure self (minimum score: 0; maximum score: 32), with higher scores indicating a stronger inadequate self, hated self, and reassure self, respectively. | Mid-treatment (between week six and week seven of intervention) |
| Forms of Self Criticism and Self Reassuring Scale (FSCRS) | The FSCRS is a 22-item scale developed to measure people's critical and self-reassuring responses to setbacks or disappointments on a five-point scale (ranging from 0 = not at all like me to 4 = extremely like me). The FSCRS measures two forms of self-criticalness (i.e., inadequate self and hated self) and one form to self-reassure (i.e., reassure self). A score can be calculated for the inadequate self (minimum score: 0; maximum score: 36), hated self (minimum score: 0; maximum score: 20), and reassure self (minimum score: 0; maximum score: 32), with higher scores indicating a stronger inadequate self, hated self, and reassure self, respectively. | Post-treatment (within two weeks of the conclusion of the twelfth group session) |
| Forms of Self Criticism and Self Reassuring Scale (FSCRS) | The FSCRS is a 22-item scale developed to measure people's critical and self-reassuring responses to setbacks or disappointments on a five-point scale (ranging from 0 = not at all like me to 4 = extremely like me). The FSCRS measures two forms of self-criticalness (i.e., inadequate self and hated self) and one form to self-reassure (i.e., reassure self). A score can be calculated for the inadequate self (minimum score: 0; maximum score: 36), hated self (minimum score: 0; maximum score: 20), and reassure self (minimum score: 0; maximum score: 32), with higher scores indicating a stronger inadequate self, hated self, and reassure self, respectively. | 90-day assessment (90 days after completion of intervention) |
| Self-criticism and Rumination Scale (SCRS) | The SCRS is a 10-item scale developed to measure trait self-critical rumination on a four-point scale (ranging from 1 = not at all to 4 = very well). The SCRS utilizes a mean score (minimum score: 0; maximum score: 4). Higher scores indicate more self-critical rumination. | Pre-treatment (prior to first session, with measures cut off at session two) |
| Self-criticism and Rumination Scale (SCRS) | The SCRS is a 10-item scale developed to measure trait self-critical rumination on a four-point scale (ranging from 1 = not at all to 4 = very well). The SCRS utilizes a mean score (minimum score: 0; maximum score: 4). Higher scores indicate more self-critical rumination. | Mid-treatment (between week six and week seven of intervention) |
| Self-criticism and Rumination Scale (SCRS) | The SCRS is a 10-item scale developed to measure trait self-critical rumination on a four-point scale (ranging from 1 = not at all to 4 = very well). The SCRS utilizes a mean score (minimum score: 0; maximum score: 4). Higher scores indicate more self-critical rumination. | Post-treatment (within two weeks of the conclusion of the twelfth group session) |
| Self-criticism and Rumination Scale (SCRS) | The SCRS is a 10-item scale developed to measure trait self-critical rumination on a four-point scale (ranging from 1 = not at all to 4 = very well). The SCRS utilizes a mean score (minimum score: 0; maximum score: 4). Higher scores indicate more self-critical rumination. | 90-day assessment (90 days after completion of intervention) |
| External and Internal Shame Scale (EISS) | The EISS is an 8-item scale developed to assess shame that is directed at the individual from external ("People around me see me as not being up to their standards") and internal ("I am an unworthy person") sources on a five-point scale (0 = never to 4 = always). The EISS has an external shame subscale (minimum score: 0; maximum score: 16) and an internal shame subscale (minimum score: 0; maximum score: 16), with 4 items for each, and also has a total scale score (minimum score: 0; maximum score: 32). Higher scores indicate more shame. | Pre-treatment (prior to first session, with measures cut off at session two) |
| External and Internal Shame Scale (EISS) | The EISS is an 8-item scale developed to assess shame that is directed at the individual from external ("People around me see me as not being up to their standards") and internal ("I am an unworthy person") sources on a five-point scale (0 = never to 4 = always). The EISS has an external shame subscale (minimum score: 0; maximum score: 16) and an internal shame subscale (minimum score: 0; maximum score: 16), with 4 items for each, and also has a total scale score (minimum score: 0; maximum score: 32). Higher scores indicate more shame. | Mid-treatment (between week six and week seven of intervention) |
| External and Internal Shame Scale (EISS) | The EISS is an 8-item scale developed to assess shame that is directed at the individual from external ("People around me see me as not being up to their standards") and internal ("I am an unworthy person") sources on a five-point scale (0 = never to 4 = always). The EISS has an external shame subscale (minimum score: 0; maximum score: 16) and an internal shame subscale (minimum score: 0; maximum score: 16), with 4 items for each, and also has a total scale score (minimum score: 0; maximum score: 32). Higher scores indicate more shame. | Post-treatment (within two weeks of the conclusion of the twelfth group session) |
| External and Internal Shame Scale (EISS) | The EISS is an 8-item scale developed to assess shame that is directed at the individual from external ("People around me see me as not being up to their standards") and internal ("I am an unworthy person") sources on a five-point scale (0 = never to 4 = always). The EISS has an external shame subscale (minimum score: 0; maximum score: 16) and an internal shame subscale (minimum score: 0; maximum score: 16), with 4 items for each, and also has a total scale score (minimum score: 0; maximum score: 32). Higher scores indicate more shame. | 90-day assessment (90 days after completion of intervention) |
| Group Questionnaire (GQ) | The GQ is a 30 item measure of the quality of therapeutic relationship in groups. It is measured on a 7-point Likert scale from 1 (not true at all) to 7 (very true). There are three subscales, each scored individually: positive bonding relationship (minimum score: 13; maximum score: 91), positive working relationship (minimum score: 8; maximum score: 56), and negative relationship (minimum score: 9; maximum score: 63). There is no total score. Higher scores on positive bonding indicate a strong alliance. Higher scores on positive work indicate that the member is experiencing the group as meeting their expectations for the changes they seek in group and that the group is working together to achieve mutually agreed upon goals. Higher scores on negative relationship could indicate alliance rupture with the leader, empathic failure with other members, or conflict in the group. | Weekly (12 weeks) |
| CFT knowledge and skill assessment (KSA) | The KSA was developed by the investigators. It assesses CFT knowledge and CFT skills, and asks member to identify which CFT practices they are using and the frequency of use. The goal of this tool is to assess the degree to which the member remembers key information and is using CFT behavioral practices, which is assessed for each module except for module 12. The number of questions varies per week from 2 to 5 questions. The KSA is scored according to the percentage of questions that the participant got right (minimum score: 0; maximum score: 1). | Weekly (11 weeks) |
| Background |
| Braehler C, Gumley A, Harper J, Wallace S, Norrie J, Gilbert P. Exploring change processes in compassion focused therapy in psychosis: results of a feasibility randomized controlled trial. Br J Clin Psychol. 2013 Jun;52(2):199-214. doi: 10.1111/bjc.12009. Epub 2012 Oct 24. |
| 26170048 | Background | Burlingame GM, Gleave R, Erekson D, Nelson PL, Olsen J, Thayer S, Beecher M. Differential effectiveness of group, individual, and conjoint treatments: An archival analysis of OQ-45 change trajectories. Psychother Res. 2016 Sep;26(5):556-72. doi: 10.1080/10503307.2015.1044583. Epub 2015 Jul 14. |
| 27918191 | Background | Burlingame GM, Seebeck JD, Janis RA, Whitcomb KE, Barkowski S, Rosendahl J, Strauss B. Outcome differences between individual and group formats when identical and nonidentical treatments, patients, and doses are compared: A 25-year meta-analytic perspective. Psychotherapy (Chic). 2016 Dec;53(4):446-461. doi: 10.1037/pst0000090. |
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