Effectiveness of Compassion Focused Therapy (CFT)

Compassion Clinical Trial

Official title:

Effectiveness of Compassion Focused Therapy (CFT) Adapted to a Group Format: Outcomes and Mechanisms of Change

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05044715
• Other study ID #: IRB2020-220
• Status: Terminated
• Phase: N/A
• Start date: August 29, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2023
• Source: Brigham Young University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

1. Group members attending a 12-session CFT group will have higher levels of compassion and self-reassurance as well as lower levels of self-criticism (and self-hate), fears of compassion, shame, and psychiatric distress when compared to members attending the parallel TAU groups.

2. Amount of change in compassion, self-reassurance, self-criticism (and self-hate), fears of compassion, and shame will be comparable for CFT measures authored by Dr. Gilbert as measures developed by independent compassion researchers.

3. There will be comparable levels of change in general psychiatric distress, as measured by the Outcome Questionnaire -45 (OQ-45), in members attending CFT and TAU groups. However, there will be greater change in members attending CFT groups on measures of compassion.

4. CFT will lead to lower levels of internalized shame through the mechanisms of fear reduction and increases in the 3 flows of compassion.

Description:

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:

1. To assess the effects of CFT with a college counseling center population by measuring self-criticism (including self-reassurance and self-hate), compassion (i.e., for self, others, and from others), fears of compassion, shame, guilt and psychiatric distress to replicate the open trial outcomes.

2. To assess differences in effectiveness due to measurement source. In the open trial, investigators used measures created by Paul Gilbert (a founder of CFT) and those developed by independent researchers. This study replicates the process used in the open trial and the investigators do so again to ascertain if there is a measurement bias.

3. To assess the differential effectiveness of CFT groups compared to treatment-as-usual (TAU) groups run in Brigham Young University's (BYU) Counseling and Psychological Services (CAPS). CFT group protocols have been developed for clients presenting with: (a) general distress-mood disorders, (2) anxiety disorders, (3) eating disorders, and (4) challenges reconciling intersecting identities of faith and/or sexuality. CAPS currently offers evidence-based groups for each of these populations (e.g., general process, anxiety, eating, and intersecting identities, respectively). The investigators will compare members in groups that are randomly assigned to parallel CFT or TAU groups on compassion and general distress measures.

4. To assess the effect of mediation between reducing the fears of compassion, increases in compassion and the final outcome of reducing self-criticism and shame. This effect has been reported in the CFT literature; however, the previous analyses did not adequately report parameters (e.g., the unmediated effect) making interpretation incomplete.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: May 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Struggles with issues of shame or self-criticism

• Have an Outcome Questionnaire (OQ-45) total score at or above 64 (i.e., denoting psychiatric distress in the clinical range)

• Are willing to commit to at least 4 sessions of group treatment

• Are willing to complete the OQ-45 and GQ (standardized CAPS measures) on a weekly basis

• Are willing to have group be their primary mode of treatment to ensure group will be the primary vehicle for change

• Are willing to complete the study measures

Exclusion Criteria

• Clients who do not meet criteria or decline to participate

Related Conditions & MeSH terms

• Compassion
• Guilt
• Self-Criticism
• Shame

Intervention

Behavioral:
• Treatment as Usual
Treatment as usual-TAU groups include: Mood Groups - General Process Groups Anxiety Groups - Cognitive Behavioral Therapy Body Image and Eating Concerns Groups Reconciling Faith and Sexuality Groups
• Compassion-Focused Therapy (CFT)
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.

Locations

Country	Name	City	State
United States	Brigham Young University	Provo	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Brigham Young University

Country where clinical trial is conducted

United States, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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).	90-day assessment (90 days after completion of intervention)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Secondary	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)
Secondary	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)
Secondary	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)