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ShameNCT02121561

Examining the Effectiveness of Self-Acceptance Group Therapy

A study testing Self-Acceptance Group Therapy in people with Shame, run by University of Mississippi Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

When people feel shame, they experience negative thoughts about themselves ("I'm a bad person") and urges to avoid others. Shame is related to many psychological problems, such as depression, social anxiety, and borderline personality disorder (BPD). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Shame
What is being tested?
Self-Acceptance Group Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
Apr 2014to Jun 2015
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Eligible participants will be adults (age 18 or older) who are fluent in English (as all materials will be presented in English) and report elevated levels of trait shame on the Experience of Shame Scale (ESS) at screening. Specifically, based on past research, individuals must score at least 55 on the ESS screening items, which is consistent with levels of shame often reported by clinical samples. In addition, all interested individuals must have a therapist/case manager/psychiatrist who provides them with individual psychotherapy on a regular basis and for whom the participant is willing to sign an Authorization for Release of Health Information.

Who cannot join

  • Individuals will be excluded from the present study if they do not report significant difficulties with shame (i.e. ESS screening item scores less than 55), do not have an individual therapist/case manager/psychiatrist who monitors and addresses their broader mental health concerns, are experiencing active psychosis (i.e. delusions and/or hallucinations), or are experiencing an episode of mania.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

Other trials in United States

About this study

When people feel shame, they experience negative thoughts about themselves ("I'm a bad person") and urges to avoid others. Shame is related to many psychological problems, such as depression, social anxiety, and borderline personality disorder (BPD). Because there are currently no well-tested treatments for shame, this study will examine the utility of Self-Acceptance Group Therapy (SAGT). SAGT is short-term group therapy that addresses shame specifically. Changes in shame, mood, and behavior will be examined over the course of treatment and a one-month follow-up.

Based on theory and existing evidence, Hypothesis 1a is that individuals with elevated initial levels of shame will report improvements on all outcome measures (e.g., reductions in trait shame, increases in self-acceptance) from pre-treatment to post-treatment, and Hypothesis 1b is that these gains will be maintained at follow-up one month after treatment completion.

Read the detailed description

Shame is an unpleasant self-conscious emotion that can be experienced following unwanted outcomes and events (Lewis, 1971). Cognitively, shame involves the attribution of negative outcomes to global, stable characterological flaws (e.g., thinking "That happened because I am a bad person;" Tracy \& Robins, 2006). Behaviorally, shame involves urges to avoid or withdraw from other people in order to hide perceived flaws (e.g., Lindsay-Hartz et al., 1995). Shame has been theoretically implicated in the development and maintenance of many forms of psychopathology and problematic behaviors, including depression, social anxiety, and borderline personality pathology (e.g., Beck \& Alford, 2009; Clark \& Wells, 1995; Rizvi et al., 2011; Schoenleber \& Berenbaum, 2012). Indeed, research indicates that shame is ubiquitous in psychopathology (see Tangney \& Dearing, 2002), resulting in increasing recognition that treatments specifically addressing shame are needed (see Dearing \& Tangney, 2011). Although a few promising and potentially shame-relevant treatments have recently been described (Brown et al., 2011; Germer \& Neff, 2013; Gilbert, 2011), no well-validated treatments currently exist and these novel treatments generally do not address both the cognitive and the behavioral components of shame.

Evidence that shame involves both problematic thinking patterns and maladaptive actions suggests that effective interventions for shame need to address each of these components. Indeed, there is some initial evidence that cognitive and behavioral therapy techniques can reduce shame, at least in response to specific triggers. For example, cognitive restructuring in the context of cognitive processing therapy has been found to reduce trauma-related self-blaming thoughts (Resick et al., 2002), and women instructed in how to use the dialectical behavior therapy opposite-action skill to address a specified shame trigger reported reductions in shame about the given trigger (Rizvi \& Linehan, 2005).

Drawing from this literature, a shame-focused intervention, Self-Acceptance Group Therapy (SAGT), was developed to target both the cognitive and behavioral components of shame from a cognitive-behavior therapy framework. SAGT is an 8-week group treatment that involves psychoeducation and training in cognitive and behavioral shame-coping skills in order to promote improvements in self-acceptance, which is the conceptual opposite of shame. For example, group members are taught how to recognize and challenge shame-eliciting thoughts, as well as how to effectively discuss shame-eliciting topics with others in order to alleviate shame, foster adaptive social support, and enhance their ability to demonstrate self-kindness/compassion. As in other cognitive-behavior therapies, group members complete weekly homework assignments that allow them to practice their new skills. In addition, in-session activities are used to promote further skills practice and target the social disconnection created by shame. An initial version of SAGT was provided to 8 women Veterans at the G.V. (Sonny) Montgomery VA Medical Center by one of the researchers (Dr. Schoenleber). Preliminary data indicate that group members reported large reductions in trait shame (d = 1.55) and improvements in self-acceptance (d = 2.15). Based on feedback provided by these group members, an updated version of the SAGT protocol has been prepared. The primary aim of the present study is to examine whether the current version of Self-Acceptance Group Therapy is effective in improving shame, as well as emotional and interpersonal functioning among individuals with elevated shame.

Based on theory and existing evidence, Hypothesis 1a is that individuals with elevated initial levels of shame will report improvements on all outcome measures (e.g., trait shame, self-acceptance, psychiatric symptoms) from pre-treatment to post-treatment, and Hypothesis 1b is that these gains will be maintained at follow-up one month after treatment completion.

Conditions
Shame
Being tested
Self-Acceptance Group Therapy
Keywords
Shame

What participants receive

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

  • Self-Acceptance Group TherapyBehavioural

    SAGT is an 8-week group therapy for persons with high levels of shame focused on providing psychoeducation regarding shame and self-acceptance and teaching skills for effectively responding to shame. SAGT is based on a cognitive-behavioral framework. Group members are taught how to recognize and challenge shame-eliciting thoughts, effectively discuss shame-eliciting topics with others, and build self-acceptance. Group members also complete weekly homework assignments that allow them to practice their new skills. All sessions include a review of homework and previously discussed concepts, introduction of new material, and in-session discussions/activities. The content of SAGT includes: defining self-acceptance and recognizing shame; increasing balanced thinking about oneself; improving social connections; increasing skillful interpersonal disclosure; challenging unhelpful expectations; handling setbacks; review and commitment to future practice.

Study groups in NCT02121561
Study groupRoleWhat they receive
Self-Acceptance Group TherapyExperimentalParticipants receive Self-Acceptance Group Therapy
Receives: Behavioral: Self-Acceptance Group Therapy

What is being measured

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

  1. Changes in shame on the Experience of Shame Scale

    Measured: Baseline, Week 8, Week 12

Secondary outcomes (9)
  1. Changes in shame intolerance on the Shame-Aversive Reactions Questionnaire

    Measured: Baseline, Week 8, Week 12

  2. Change in mood on the Positive and Negative Affect Schedule-Revised

    Measured: Baseline, Week 8, Week 12

  3. Change in interpersonal functioning on the Loneliness Scale

    Measured: Baseline, Week 8, Week 12

  4. Change in self-compassion on the Self-Compassion Scale

    Measured: Baseline, Week 8, Week 12

  5. Change in psychiatric symptoms on the Depression Anxiety Stress Scale

    Measured: Baseline, Week 8, Week 12

  6. Change in social anxiety on the Social Interaction Anxiety Scale

    Measured: Baseline, Week 8, Week 12

  7. Change in quality of life on the World Health Organization Quality of Life scale

    Measured: Baseline, Week 8, Week 12

  8. Changes in severity of borderline personality symptoms on the Borderline Evaluation of Severity over Time

    Measured: Baseline, Week 8, Week 12

  9. Change in emotion regulation difficulties on the Difficulties in Emotion Regulation Scale

    Measured: Baseline, Week 8, Week 12

Timeline

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

  1. First posted23 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02121561
Sponsor's protocol ID
UMississippi2014-0010
Status last verified
Jun 2015
First submitted
21 Apr 2014
Last updated
2 Jul 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Self-Acceptance Group Therapy in people with Shame, run by University of Mississippi Medical Center 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 1 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: finished, as of the sponsor's last update on 2 Jul 2015. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Changes in shame on the Experience of Shame Scale (time frame: Baseline, Week 8, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 2 Jul 2015.

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