CompassionNCT05044715

Effectiveness of Compassion Focused Therapy (CFT)

A study testing Treatment as Usual and Compassion-Focused Therapy (CFT) in people with Compassion and Self-Criticism, run by Brigham Young University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Compassion, Self-Criticism, Shame
What is being tested?: Treatment as Usual and Compassion-Focused Therapy (CFT)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 29 Aug 2022to 31 May 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Clients who do not meet criteria or decline to participate

Trial locations and contacts

1 site in 1 country.

United States1 site

Brigham Young University
Provo, Utah, 84602

Other trials in United States

About this study

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

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:

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

Read the 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:

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.
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.
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.
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.

Conditions: Compassion, Self-Criticism, Shame, Guilt
Being tested: Treatment as Usual, Compassion-Focused Therapy (CFT)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treatment as UsualBehavioural
Treatment as usual-TAU groups include:
1. Mood Groups - General Process Groups
2. Anxiety Groups - Cognitive Behavioral Therapy
3. Body Image and Eating Concerns Groups
4. Reconciling Faith and Sexuality Groups
Compassion-Focused Therapy (CFT)Behavioural
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.

Study groups in NCT05044715
Study group	Role	What they receive
Treatment as Usual	Experimental	Participants in this arm will receive treatment as usual (TAU) as an intervention. Receives: Behavioral: Treatment as Usual
Compassion-Focused Therapy	Experimental	Participants in this arm will be enrolled in a CFT group intervention. Receives: Behavioral: Compassion-Focused Therapy (CFT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 90-day assessment (90 days after completion of intervention)

Secondary outcomes (3)

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.
Measured: Weekly (12 weeks)
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.
Measured: 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).
Measured: Weekly (11 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Aug 202231 May 2023

First posted16 Sep 2021
Study start29 Aug 2022
Primary completion31 Mar 2023
Study completion31 May 2023

Why it stopped: 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (32)Papers the sponsor has linked to this study.
Other trials for CompassionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Members will be randomized to treatment-as-usual (TAU) CAPS groups or CFT groups.
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05044715
Sponsor's protocol ID: IRB2020-220
Status last verified: Jun 2023
First submitted: 6 Aug 2021
Last updated: 9 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: 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.

Publications

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.
PubMed 27866082
Beavan V. Towards a definition of "hearing voices": A phenomenological approach. Psychosis. 2011; 3(1): 63-73. doi:10.1080/17522431003615622
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.
PubMed 24215148
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.
PubMed 26170048
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.
PubMed 27918191
Chandwick P, Lees S, Birchwood M. The revised Beliefs About Voices Questionnaire (BAVQ-R). Br J Psychiatry. 2000 Sep;177:229-32. doi: 10.1192/bjp.177.3.229.
PubMed 11040883
Chapman CL, Burlingame GM, Gleave R, Rees F, Beecher M, Porter GS. Clinical prediction in group psychotherapy. Psychother Res. 2012;22(6):673-81. doi: 10.1080/10503307.2012.702512. Epub 2012 Jul 10.
PubMed 22775060
Corstens D, Longden E, McCarthy-Jones S, Waddingham R, Thomas N. Emerging perspectives from the hearing voices movement: implications for research and practice. Schizophr Bull. 2014 Jul;40 Suppl 4(Suppl 4):S285-94. doi: 10.1093/schbul/sbu007.
PubMed 24936088
Weng HY, Fox AS, Shackman AJ, Stodola DE, Caldwell JZ, Olson MC, Rogers GM, Davidson RJ. Compassion training alters altruism and neural responses to suffering. Psychol Sci. 2013 Jul 1;24(7):1171-80. doi: 10.1177/0956797612469537. Epub 2013 May 21.
PubMed 23696200
Dillon J. The tale of an ordinary little girl. Psychosis. 2010; 2(1): 79-83. doi:10.1080/17522430903384305
Hammersley P, Read J, Woodall S, Dillon J. Childhood Trauma and Psychosis: The Genie Is Out of the Bottle. Journal of Psychological Trauma. 2008; 6(2-3): 7-20. doi:10.1300/j513v06n02_02
Gilbert P, Procter S. Compassionate mind training for people with high shame and self-criticism: Overview and pilot study of a group therapy approach. Clinical Psychology and Psychotherapy. 2006; 13(6): 353.
Gilbert P, Clarke M, Hempel S, Miles JN, Irons C. Criticizing and reassuring oneself: An exploration of forms, styles and reasons in female students. Br J Clin Psychol. 2004 Mar;43(Pt 1):31-50. doi: 10.1348/014466504772812959.
PubMed 15005905
Goss K, Allan S. The development and application of compassion-focused therapy for eating disorders (CFT-E). Br J Clin Psychol. 2014 Mar;53(1):62-77. doi: 10.1111/bjc.12039.
PubMed 24588762
Hofmann SG, Grossman P, Hinton DE. Loving-kindness and compassion meditation: potential for psychological interventions. Clin Psychol Rev. 2011 Nov;31(7):1126-32. doi: 10.1016/j.cpr.2011.07.003. Epub 2011 Jul 26.
PubMed 21840289

Want to know more?

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Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Compassion Focused Therapy (CFT) Adapted to a Group Format: Outcomes and Mechanisms of Change
ClinicalTrials.gov ID: NCT05044715
Acronym / sponsor ID: IRB2020-220
Conditions: Compassion, Self-Criticism, Shame, Guilt
Study type: Interventional
Recruitment status: TerminatedReason stopped: 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.
Enrolment: 14 participants (actual)
Lead sponsor: Brigham Young UniversityUniversity, hospital or other
Study start: 29 Aug 2022 (actual)
Primary completion: 31 Mar 2023 (actual)
Study completion: 31 May 2023 (actual)
First posted: 16 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Hypotheses:

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.
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.
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.
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

Aims:

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.
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.
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.
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Members will be randomized to treatment-as-usual (TAU) CAPS groups or CFT groups.

Arm	Type	Receives
Treatment as Usual	Experimental	Behavioral: Treatment as UsualParticipants in this arm will receive treatment as usual (TAU) as an intervention.
Compassion-Focused Therapy	Experimental	Behavioral: Compassion-Focused Therapy (CFT)Participants in this arm will be enrolled in a CFT group intervention.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (1 listed)

Clients who do not meet criteria or decline to participate

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Treatment as UsualTreatment as usual-TAU groups include: 1. Mood Groups - General Process Groups 2. Anxiety Groups - Cognitive Behavioral Therapy 3. Body Image and Eating Concerns Groups 4. Reconciling Faith and Sexuality Groups	Behavioural	Treatment as Usual
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.	Behavioural	Compassion-Focused Therapy

Primary outcome

Fears of Compassion Scale (FCS)
Time frame: Pre-treatment (prior to first session, with measures cut off at session two)
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).
Fears of Compassion Scale (FCS)
Time frame: Mid-treatment (between week six and week seven of intervention)
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).
Fears of Compassion Scale (FCS)
Time frame: Post-treatment (within two weeks of the conclusion of the twelfth group session)
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).
Fears of Compassion Scale (FCS)
Time frame: 90-day assessment (90 days after completion of intervention)
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).
Compassionate Engagement and Action Scales (CEAS)
Time frame: Pre-treatment (prior to first session, with measures cut off at session two)
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).
Compassionate Engagement and Action Scales (CEAS)
Time frame: Mid-treatment (between week six and week seven of intervention)
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).
Compassionate Engagement and Action Scales (CEAS)
Time frame: Post-treatment (within two weeks of the conclusion of the twelfth group session)
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).
Compassionate Engagement and Action Scales (CEAS)
Time frame: 90-day assessment (90 days after completion of intervention)
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).
Forms of Self Criticism and Self Reassuring Scale (FSCRS)
Time frame: Pre-treatment (prior to first session, with measures cut off at session two)
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.
Forms of Self Criticism and Self Reassuring Scale (FSCRS)
Time frame: Mid-treatment (between week six and week seven of intervention)
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.
Forms of Self Criticism and Self Reassuring Scale (FSCRS)
Time frame: Post-treatment (within two weeks of the conclusion of the twelfth group session)
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.
Forms of Self Criticism and Self Reassuring Scale (FSCRS)
Time frame: 90-day assessment (90 days after completion of intervention)
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.
Self-criticism and Rumination Scale (SCRS)
Time frame: Pre-treatment (prior to first session, with measures cut off at session two)
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.
Self-criticism and Rumination Scale (SCRS)
Time frame: Mid-treatment (between week six and week seven of intervention)
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.
Self-criticism and Rumination Scale (SCRS)
Time frame: Post-treatment (within two weeks of the conclusion of the twelfth group session)
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.
Self-criticism and Rumination Scale (SCRS)
Time frame: 90-day assessment (90 days after completion of intervention)
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.
External and Internal Shame Scale (EISS)
Time frame: Pre-treatment (prior to first session, with measures cut off at session two)
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.
External and Internal Shame Scale (EISS)
Time frame: Mid-treatment (between week six and week seven of intervention)
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.
External and Internal Shame Scale (EISS)
Time frame: Post-treatment (within two weeks of the conclusion of the twelfth group session)
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.
External and Internal Shame Scale (EISS)
Time frame: 90-day assessment (90 days after completion of intervention)
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.

3 secondary outcomes

Outcome Questionnaire-45 (OQ-45)
Time frame: Weekly (12 weeks)
Group Questionnaire (GQ)
Time frame: Weekly (12 weeks)
CFT knowledge and skill assessment (KSA)
Time frame: Weekly (11 weeks)

Results and safety

The study was stopped early (reason given: 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.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
Background: PubMed 27866082Baumeister 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.
BackgroundBeavan V. Towards a definition of "hearing voices": A phenomenological approach. Psychosis. 2011; 3(1): 63-73. doi:10.1080/17522431003615622
Background: PubMed 24215148Braehler 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.
Background: PubMed 26170048Burlingame 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.
Background: PubMed 27918191Burlingame 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.
Background: PubMed 11040883Chandwick P, Lees S, Birchwood M. The revised Beliefs About Voices Questionnaire (BAVQ-R). Br J Psychiatry. 2000 Sep;177:229-32. doi: 10.1192/bjp.177.3.229.
Background: PubMed 22775060Chapman CL, Burlingame GM, Gleave R, Rees F, Beecher M, Porter GS. Clinical prediction in group psychotherapy. Psychother Res. 2012;22(6):673-81. doi: 10.1080/10503307.2012.702512. Epub 2012 Jul 10.
Background: PubMed 24936088Corstens D, Longden E, McCarthy-Jones S, Waddingham R, Thomas N. Emerging perspectives from the hearing voices movement: implications for research and practice. Schizophr Bull. 2014 Jul;40 Suppl 4(Suppl 4):S285-94. doi: 10.1093/schbul/sbu007.
Background: PubMed 23696200Weng HY, Fox AS, Shackman AJ, Stodola DE, Caldwell JZ, Olson MC, Rogers GM, Davidson RJ. Compassion training alters altruism and neural responses to suffering. Psychol Sci. 2013 Jul 1;24(7):1171-80. doi: 10.1177/0956797612469537. Epub 2013 May 21.
BackgroundDillon J. The tale of an ordinary little girl. Psychosis. 2010; 2(1): 79-83. doi:10.1080/17522430903384305
BackgroundHammersley P, Read J, Woodall S, Dillon J. Childhood Trauma and Psychosis: The Genie Is Out of the Bottle. Journal of Psychological Trauma. 2008; 6(2-3): 7-20. doi:10.1300/j513v06n02_02
BackgroundGilbert P, Procter S. Compassionate mind training for people with high shame and self-criticism: Overview and pilot study of a group therapy approach. Clinical Psychology and Psychotherapy. 2006; 13(6): 353.
Individual participant dataSharing planned: Undecided. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gary M Burlingame, PhD principal investigator

Brigham Young University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Treatment as Usual and Compassion-Focused Therapy (CFT) in people with Compassion and Self-Criticism, run by Brigham Young University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fears of Compassion Scale (FCS) (time frame: Pre-treatment (prior to first session, with measures cut off at session two)). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05044715, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.