Clinical trial NCT05044715: Effectiveness of Compassion Focused Therapy (CFT)
Official title: Effectiveness of Compassion Focused Therapy (CFT) Adapted to a Group Format: Outcomes and Mechanisms of Change
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Compassion
Self-Criticism
Shame
Guilt
Lead sponsor: Brigham Young University
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Members will be randomized to treatment-as-usual (TAU) CAPS groups or CFT groups.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fears of Compassion Scale (FCS)
timeFrame: Pre-treatment (prior to first session, with measures cut off at session two)
measure: Fears of Compassion Scale (FCS)
timeFrame: Mid-treatment (between week six and week seven of intervention)
measure: Fears of Compassion Scale (FCS)
timeFrame: Post-treatment (within two weeks of the conclusion of the twelfth group session)
measure: Fears of Compassion Scale (FCS)
timeFrame: 90-day assessment (90 days after completion of intervention)
measure: Compassionate Engagement and Action Scales (CEAS)
timeFrame: Pre-treatment (prior to first session, with measures cut off at session two)
measure: Compassionate Engagement and Action Scales (CEAS)
timeFrame: Mid-treatment (between week six and week seven of intervention)
measure: Compassionate Engagement and Action Scales (CEAS)
timeFrame: Post-treatment (within two weeks of the conclusion of the twelfth group session)
measure: Compassionate Engagement and Action Scales (CEAS)
timeFrame: 90-day assessment (90 days after completion of intervention)
measure: Forms of Self Criticism and Self Reassuring Scale (FSCRS)
timeFrame: Pre-treatment (prior to first session, with measures cut off at session two)
measure: Forms of Self Criticism and Self Reassuring Scale (FSCRS)
timeFrame: Mid-treatment (between week six and week seven of intervention)
measure: Forms of Self Criticism and Self Reassuring Scale (FSCRS)
timeFrame: Post-treatment (within two weeks of the conclusion of the twelfth group session)
measure: Forms of Self Criticism and Self Reassuring Scale (FSCRS)
timeFrame: 90-day assessment (90 days after completion of intervention)
measure: Self-criticism and Rumination Scale (SCRS)
timeFrame: Pre-treatment (prior to first session, with measures cut off at session two)
measure: Self-criticism and Rumination Scale (SCRS)
timeFrame: Mid-treatment (between week six and week seven of intervention)
measure: Self-criticism and Rumination Scale (SCRS)
timeFrame: Post-treatment (within two weeks of the conclusion of the twelfth group session)
measure: Self-criticism and Rumination Scale (SCRS)
timeFrame: 90-day assessment (90 days after completion of intervention)
measure: External and Internal Shame Scale (EISS)
timeFrame: Pre-treatment (prior to first session, with measures cut off at session two)
measure: External and Internal Shame Scale (EISS)
timeFrame: Mid-treatment (between week six and week seven of intervention)
measure: External and Internal Shame Scale (EISS)
timeFrame: Post-treatment (within two weeks of the conclusion of the twelfth group session)
measure: External and Internal Shame Scale (EISS)
timeFrame: 90-day assessment (90 days after completion of intervention)
Secondary outcomes:
measure: Outcome Questionnaire-45 (OQ-45)
timeFrame: Weekly (12 weeks)
measure: Group Questionnaire (GQ)
timeFrame: Weekly (12 weeks)
measure: CFT knowledge and skill assessment (KSA)
timeFrame: Weekly (11 weeks)
Other outcomes:
Locations:
city: Provo
country: United States
facility: Brigham Young University
state: Utah
Study officials:
affiliation: Brigham Young University
name: Gary M Burlingame, PhD
role: PRINCIPAL_INVESTIGATOR
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