Ignite Creation Date:
2024-05-06 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05044715
Status:
TERMINATED
Last Update Posted:
2023-06-09
First Post:
2021-08-06
Brief Title:
Effectiveness of Compassion Focused Therapy CFT
Sponsor:
Brigham Young University
Organization:
Brigham Young University
Study Overview
Official Title:
Effectiveness of Compassion Focused Therapy CFT Adapted to a Group Format Outcomes and Mechanisms of Change
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed study is a randomized controlled trial RCT that takes place at Brigham Young Universitys 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
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 eg 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 ie depression and anxiety Indeed six identified CBIs have been subjected to rigorous testing in RCTs finding a medium effect on average d 055 across outcomes eg depression distress well-being CFT is the most evaluated and is the most appropriate for use in clinical populations of all CBIs CFTs evidence basis is expansive prompting researchers to compose a review of its benefits for different populations and presenting problems eg 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 ie 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 ie as low as one and up to 16 weeks and strategies eg 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 ie 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 BYUs 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 httpcgrpbyuedu 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 eg 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 ie 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 Universitys 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 andor sexuality CAPS currently offers evidence-based groups for each of these populations eg 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 eg the unmediated effect making interpretation incomplete
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 ie 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 Universitys 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 andor sexuality CAPS currently offers evidence-based groups for each of these populations eg 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 eg the unmediated effect making interpretation incomplete
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None