Effectiveness of Compassion Focused Therapy (CFT)

NCT05044715 | Terminated

• 1 other identifier: IRB2020-220
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

Compassion; Self-Criticism; Shame; Guilt

Outcome Measures

Primary Outcomes (20)

• Fears of Compassion Scale (FCS)

  The FCS is a 38-item scale measuring fears of compassion on a five-point scale (0 = don't agree at all to 4 = completely agree). The FCS includes three scales, with higher scores indicating greater fears of compassion. Scales include: (1) expressing compassion for others (minimum score: 0; maximum score: 40), (2) responding to the expression of compassion from others (minimum score: 0; maximum score: 52), and (3) expressing kindness and compassion toward the self (minimum score: 0; maximum score: 60).

  Pre-treatment (prior to first session, with measures cut off at session two)

• Fears of Compassion Scale (FCS)

  The FCS is a 38-item scale measuring fears of compassion on a five-point scale (0 = don't agree at all to 4 = completely agree). The FCS includes three scales, with higher scores indicating greater fears of compassion. Scales include: (1) expressing compassion for others (minimum score: 0; maximum score: 40), (2) responding to the expression of compassion from others (minimum score: 0; maximum score: 52), and (3) expressing kindness and compassion toward the self (minimum score: 0; maximum score: 60).

  Mid-treatment (between week six and week seven of intervention)

• Fears of Compassion Scale (FCS)

  The FCS is a 38-item scale measuring fears of compassion on a five-point scale (0 = don't agree at all to 4 = completely agree). The FCS includes three scales, with higher scores indicating greater fears of compassion. Scales include: (1) expressing compassion for others (minimum score: 0; maximum score: 40), (2) responding to the expression of compassion from others (minimum score: 0; maximum score: 52), and (3) expressing kindness and compassion toward the self (minimum score: 0; maximum score: 60).

  Post-treatment (within two weeks of the conclusion of the twelfth group session)

• Fears of Compassion Scale (FCS)

  The FCS is a 38-item scale measuring fears of compassion on a five-point scale (0 = don't agree at all to 4 = completely agree). The FCS includes three scales, with higher scores indicating greater fears of compassion. Scales include: (1) expressing compassion for others (minimum score: 0; maximum score: 40), (2) responding to the expression of compassion from others (minimum score: 0; maximum score: 52), and (3) expressing kindness and compassion toward the self (minimum score: 0; maximum score: 60).

  90-day assessment (90 days after completion of intervention)

• Compassionate Engagement and Action Scales (CEAS)

  The CEAS is a 39-item scale. The CEAS includes three scales, including compassion for self, compassion for others, and compassion from others. A total score can be calculated for each subscale (minimum score: 10; maximum score: 100), with higher scores indicating greater compassionate engagement and action. Furthermore, each scale is divided into two subscales: engagement and action. For each scale, subscale scores can be calculated for engagement (minimum score: 6; maximum score: 60) and action (minimum score: 4; maximum score: 40).

  Pre-treatment (prior to first session, with measures cut off at session two)

• Compassionate Engagement and Action Scales (CEAS)

  The CEAS is a 39-item scale. The CEAS includes three scales, including compassion for self, compassion for others, and compassion from others. A total score can be calculated for each subscale (minimum score: 10; maximum score: 100), with higher scores indicating greater compassionate engagement and action. Furthermore, each scale is divided into two subscales: engagement and action. For each scale, subscale scores can be calculated for engagement (minimum score: 6; maximum score: 60) and action (minimum score: 4; maximum score: 40).

  Mid-treatment (between week six and week seven of intervention)

• Compassionate Engagement and Action Scales (CEAS)

  The CEAS is a 39-item scale. The CEAS includes three scales, including compassion for self, compassion for others, and compassion from others. A total score can be calculated for each subscale (minimum score: 10; maximum score: 100), with higher scores indicating greater compassionate engagement and action. Furthermore, each scale is divided into two subscales: engagement and action. For each scale, subscale scores can be calculated for engagement (minimum score: 6; maximum score: 60) and action (minimum score: 4; maximum score: 40).

  Post-treatment (within two weeks of the conclusion of the twelfth group session)

• Compassionate Engagement and Action Scales (CEAS)

  The CEAS is a 39-item scale. The CEAS includes three scales, including compassion for self, compassion for others, and compassion from others. A total score can be calculated for each subscale (minimum score: 10; maximum score: 100), with higher scores indicating greater compassionate engagement and action. Furthermore, each scale is divided into two subscales: engagement and action. For each scale, subscale scores can be calculated for engagement (minimum score: 6; maximum score: 60) and action (minimum score: 4; maximum score: 40).

  90-day assessment (90 days after completion of intervention)

• Forms of Self Criticism and Self Reassuring Scale (FSCRS)

  The FSCRS is a 22-item scale developed to measure people's critical and self-reassuring responses to setbacks or disappointments on a five-point scale (ranging from 0 = not at all like me to 4 = extremely like me). The FSCRS measures two forms of self-criticalness (i.e., inadequate self and hated self) and one form to self-reassure (i.e., reassure self). A score can be calculated for the inadequate self (minimum score: 0; maximum score: 36), hated self (minimum score: 0; maximum score: 20), and reassure self (minimum score: 0; maximum score: 32), with higher scores indicating a stronger inadequate self, hated self, and reassure self, respectively.

  Pre-treatment (prior to first session, with measures cut off at session two)

• Forms of Self Criticism and Self Reassuring Scale (FSCRS)

  The FSCRS is a 22-item scale developed to measure people's critical and self-reassuring responses to setbacks or disappointments on a five-point scale (ranging from 0 = not at all like me to 4 = extremely like me). The FSCRS measures two forms of self-criticalness (i.e., inadequate self and hated self) and one form to self-reassure (i.e., reassure self). A score can be calculated for the inadequate self (minimum score: 0; maximum score: 36), hated self (minimum score: 0; maximum score: 20), and reassure self (minimum score: 0; maximum score: 32), with higher scores indicating a stronger inadequate self, hated self, and reassure self, respectively.

  Mid-treatment (between week six and week seven of intervention)

• Forms of Self Criticism and Self Reassuring Scale (FSCRS)

  The FSCRS is a 22-item scale developed to measure people's critical and self-reassuring responses to setbacks or disappointments on a five-point scale (ranging from 0 = not at all like me to 4 = extremely like me). The FSCRS measures two forms of self-criticalness (i.e., inadequate self and hated self) and one form to self-reassure (i.e., reassure self). A score can be calculated for the inadequate self (minimum score: 0; maximum score: 36), hated self (minimum score: 0; maximum score: 20), and reassure self (minimum score: 0; maximum score: 32), with higher scores indicating a stronger inadequate self, hated self, and reassure self, respectively.

  Post-treatment (within two weeks of the conclusion of the twelfth group session)

• Forms of Self Criticism and Self Reassuring Scale (FSCRS)

  The FSCRS is a 22-item scale developed to measure people's critical and self-reassuring responses to setbacks or disappointments on a five-point scale (ranging from 0 = not at all like me to 4 = extremely like me). The FSCRS measures two forms of self-criticalness (i.e., inadequate self and hated self) and one form to self-reassure (i.e., reassure self). A score can be calculated for the inadequate self (minimum score: 0; maximum score: 36), hated self (minimum score: 0; maximum score: 20), and reassure self (minimum score: 0; maximum score: 32), with higher scores indicating a stronger inadequate self, hated self, and reassure self, respectively.

  90-day assessment (90 days after completion of intervention)

• Self-criticism and Rumination Scale (SCRS)

  The SCRS is a 10-item scale developed to measure trait self-critical rumination on a four-point scale (ranging from 1 = not at all to 4 = very well). The SCRS utilizes a mean score (minimum score: 0; maximum score: 4). Higher scores indicate more self-critical rumination.

  Pre-treatment (prior to first session, with measures cut off at session two)

• Self-criticism and Rumination Scale (SCRS)

  The SCRS is a 10-item scale developed to measure trait self-critical rumination on a four-point scale (ranging from 1 = not at all to 4 = very well). The SCRS utilizes a mean score (minimum score: 0; maximum score: 4). Higher scores indicate more self-critical rumination.

  Mid-treatment (between week six and week seven of intervention)

• Self-criticism and Rumination Scale (SCRS)

  The SCRS is a 10-item scale developed to measure trait self-critical rumination on a four-point scale (ranging from 1 = not at all to 4 = very well). The SCRS utilizes a mean score (minimum score: 0; maximum score: 4). Higher scores indicate more self-critical rumination.

  Post-treatment (within two weeks of the conclusion of the twelfth group session)

• Self-criticism and Rumination Scale (SCRS)

  The SCRS is a 10-item scale developed to measure trait self-critical rumination on a four-point scale (ranging from 1 = not at all to 4 = very well). The SCRS utilizes a mean score (minimum score: 0; maximum score: 4). Higher scores indicate more self-critical rumination.

  90-day assessment (90 days after completion of intervention)

• External and Internal Shame Scale (EISS)

  The EISS is an 8-item scale developed to assess shame that is directed at the individual from external ("People around me see me as not being up to their standards") and internal ("I am an unworthy person") sources on a five-point scale (0 = never to 4 = always). The EISS has an external shame subscale (minimum score: 0; maximum score: 16) and an internal shame subscale (minimum score: 0; maximum score: 16), with 4 items for each, and also has a total scale score (minimum score: 0; maximum score: 32). Higher scores indicate more shame.

  Pre-treatment (prior to first session, with measures cut off at session two)

• External and Internal Shame Scale (EISS)

  The EISS is an 8-item scale developed to assess shame that is directed at the individual from external ("People around me see me as not being up to their standards") and internal ("I am an unworthy person") sources on a five-point scale (0 = never to 4 = always). The EISS has an external shame subscale (minimum score: 0; maximum score: 16) and an internal shame subscale (minimum score: 0; maximum score: 16), with 4 items for each, and also has a total scale score (minimum score: 0; maximum score: 32). Higher scores indicate more shame.

  Mid-treatment (between week six and week seven of intervention)

• External and Internal Shame Scale (EISS)

  The EISS is an 8-item scale developed to assess shame that is directed at the individual from external ("People around me see me as not being up to their standards") and internal ("I am an unworthy person") sources on a five-point scale (0 = never to 4 = always). The EISS has an external shame subscale (minimum score: 0; maximum score: 16) and an internal shame subscale (minimum score: 0; maximum score: 16), with 4 items for each, and also has a total scale score (minimum score: 0; maximum score: 32). Higher scores indicate more shame.

  Post-treatment (within two weeks of the conclusion of the twelfth group session)

• External and Internal Shame Scale (EISS)

  The EISS is an 8-item scale developed to assess shame that is directed at the individual from external ("People around me see me as not being up to their standards") and internal ("I am an unworthy person") sources on a five-point scale (0 = never to 4 = always). The EISS has an external shame subscale (minimum score: 0; maximum score: 16) and an internal shame subscale (minimum score: 0; maximum score: 16), with 4 items for each, and also has a total scale score (minimum score: 0; maximum score: 32). Higher scores indicate more shame.

  90-day assessment (90 days after completion of intervention)

Secondary Outcomes (3)

• Outcome Questionnaire-45 (OQ-45)

  Weekly (12 weeks)

• Group Questionnaire (GQ)

  Weekly (12 weeks)

• CFT knowledge and skill assessment (KSA)

  Weekly (11 weeks)

Study Arms (2)

Treatment as Usual

EXPERIMENTAL

Participants in this arm will receive treatment as usual (TAU) as an intervention.

Behavioral: Treatment as Usual

Compassion-Focused Therapy

EXPERIMENTAL

Participants in this arm will be enrolled in a CFT group intervention.

Behavioral: Compassion-Focused Therapy (CFT)

Interventions

Treatment as Usual BEHAVIORAL

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

Treatment as Usual

Compassion-Focused Therapy (CFT) BEHAVIORAL

The CFT protocol assumes that participants have no prior experience with meditation, mindfulness, and self-compassion and teaches principles of each as well as skills such as guided meditations.

Compassion-Focused Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Clients who do not meet criteria or decline to participate

Sponsors & Collaborators

• Brigham Young University: lead

Study Sites (1)

Brigham Young University

Provo, Utah, 84602, United States

Location

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MeSH Terms

Interventions

Therapeutics

Study Officials

• Gary M Burlingame, PhD

  Brigham Young University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/Department Chair, Clinical Psychology

Model Details: Members will be randomized to treatment-as-usual (TAU) CAPS groups or CFT groups.

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: September 16, 2021
• Study Start: August 29, 2022
• Primary Completion: March 31, 2023
• Study Completion: May 31, 2023
• Last Updated: June 9, 2023

Record last verified: 2023-06

Locations

US (1)