Coping Skills Training for Self-Harm

(RESCUE Trial)

Overseen By Erin Kaufman, Ph.D.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must not be taking: Psychophysiological medications

Disqualifiers: Developmental disability, Psychosis, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how teaching two coping skills can help adolescents who have harmed themselves at least three times and attempted suicide at least once. Researchers seek to understand how often and effectively these skills are used in daily life and whether life stress or family dynamics influence this. Participants will practice these skills with a parent, and some will undergo brain scans to detect changes in brain activity related to skill use. Adolescents who have self-harmed multiple times and have access to a smartphone are suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding and improving mental health support for adolescents.

Will I have to stop taking my current medications?

The trial excludes participants who are taking medications that affect psychophysiological responses, so you may need to stop certain medications. However, the protocol does not specify which medications these are, so it's best to discuss your current medications with the trial team.

What prior data suggests that these coping skills are safe for adolescents with self-harm history?

Research has shown that the GIVE and Opposite to Emotion Action skills, part of Dialectical Behavior Therapy (DBT), are promising for safety and effectiveness. GIVE helps reduce self-harm and suicidal behaviors. Studies have found that people using DBT often experience fewer suicide attempts and less self-harming behavior.

Opposite to Emotion Action is another DBT skill that helps manage strong emotions by encouraging individuals to act contrary to their emotional urges. For instance, facing a feared object or situation can help reduce fear over time. Reports suggest this approach can help break negative behavior patterns and improve emotional management.

Overall, DBT skills like GIVE and Opposite to Emotion Action are well-tolerated and have been used safely in various settings, showing positive effects for those dealing with self-harm and intense emotions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the coping skills training methods, GIVE and Opposite to Emotion Action, because they offer new approaches to managing self-harm, which is often addressed with therapies like cognitive-behavioral therapy (CBT) or medication. Unlike traditional treatments that might focus on altering thoughts or using medication, GIVE emphasizes enhancing interpersonal effectiveness and relationship skills, which can foster emotional resilience. Opposite to Emotion Action, on the other hand, encourages individuals to act contrary to their harmful urges, providing a practical strategy to counteract negative emotions. These innovative techniques could empower individuals with self-directed tools for immediate emotional regulation, potentially reducing the risk of self-harm with a more hands-on, experiential approach.

What evidence suggests that this trial's treatments could be effective for self-harm?

Studies have shown that Dialectical Behavior Therapy (DBT) helps reduce self-harm and suicidal behaviors in teenagers. One important skill in DBT, "Opposite to Emotion Action," teaches individuals to manage strong emotions by acting contrary to their immediate feelings. This skill has proven effective in helping people better control their emotions and reduce self-harm. Additionally, DBT overall has been linked to significant improvements in lowering self-harm and suicidal thoughts. In this trial, participants will experience both the GIVE and Opposite to Emotion Action skills, which are being tested for their effectiveness in helping teenagers manage self-harm behaviors. ^{2 3 4 6 7}

Who Is on the Research Team?

Erin Kaufman, Ph.D.

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for teens who have self-harmed at least three times, including one suicide attempt with serious intent. They must be willing to use a phone app for surveys, practice skills with a parent during arguments, and possibly undergo brain scans.

Inclusion Criteria

3+ incidents of self-inflicted injury (SII) with at least one episode scoring a minimum of '3' on lethality and '4' on intent

English language proficiency

Access to a smart phone

Exclusion Criteria

I am taking medications known to affect my mood or thinking.

Moderate to severe developmental or intellectual disability, psychosis, or a schizophrenia spectrum diagnosis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete interviews and questionnaires assessing psychiatric diagnoses, SII, and life stress, and 50 participants complete fMRI paradigms.

1 week

1 visit (in-person)

Pre-Intervention EMA

Participants complete a 2-week EMA protocol to measure daily affect, perceived stressors, SII, and suicidal thoughts.

2 weeks

Skills Training and Assessment

Participants learn and practice either GIVE or opposite-to-emotion action skills, with assessments of behavioral, affective, and physiological regulatory processes.

4-5 weeks

3 visits (in-person)

Post-Intervention EMA

Participants complete two 10-day EMA periods to assess skill use and related variables.

4 weeks

Follow-up

Participants complete a remote follow-up visit 6 months post-EMA3 to reassess SII, symptom severity, and life stressors.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• GIVE
• Opposite to emotion action

Trial Overview

The study compares two coping strategies: 'Opposite to emotion action' and 'GIVE'. It checks how often and when these skills are used after teaching, their retention over time, and the impact of stress on learning them.

How Is the Trial Designed?

Group I: Opposite action Experimental Treatment 1 Intervention

Participants will be randomly assigned to this arm either first or second. All participants complete both arms.

Group II: GIVE Experimental Treatment 1 Intervention

Participants will be randomly assigned to this arm either first or second. All participants complete both arms.

GIVE is already approved in United States, European Union for the following indications:

Approved in United States as Dialectical Behavior Therapy for:

• Borderline Personality Disorder
• Suicidal Ideation
• Self-Harm Behaviors

Approved in European Union as Dialectical Behavior Therapy for:

• Borderline Personality Disorder
• Suicidal Ideation
• Self-Harm Behaviors

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The Living Through Distress (LTD) program, a DBT-informed skills group, significantly reduced the frequency of deliberate self-harm (DSH) among 82 adults with DSH or Borderline Personality Disorder compared to a treatment-as-usual group.

Improvements in emotion regulation were also noted, and the benefits in reducing DSH were maintained at a 3-month follow-up, indicating that DBT skills training can be an effective intervention for managing emotional distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical behaviour therapy-informed skills training for deliberate self-harm: a controlled trial with 3-month follow-up data. Gibson, J., Booth, R., Davenport, J., et al.[2014]

The 'Living Through Distress' (LTD) Group, a modified version of Dialectical Behaviour Therapy (DBT), showed significant reductions in deliberate self-harm incidents and increased distress tolerance among 114 psychiatric patients, with these improvements maintained at a 3-month follow-up.

Participants also experienced a decrease in their average number of inpatient days, with over 50% having no hospital admissions in the year following the group, suggesting that this adapted DBT approach may effectively reduce self-harm behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Living through distress: a skills training group for reducing deliberate self-harm. Booth, R., Keogh, K., Doyle, J., et al.[2022]

Dialectical behaviour therapy for adolescents (DBT-A) was found to be a highly cost-effective treatment for reducing self-harm compared to enhanced usual care, based on a study of 77 adolescents over 19 weeks.

The probability of DBT-A being cost-effective increased significantly with higher willingness to pay thresholds, reaching up to 99.5% for self-harm outcomes, indicating strong support for its economic viability in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of dialectical behaviour therapy vs. enhanced usual care in the treatment of adolescents with self-harm. Haga, E., Aas, E., Grøholt, B., et al.[2022]

In a 1-year follow-up study of 75 adolescents who received either dialectical behavior therapy adapted for adolescents (DBT-A) or enhanced usual care (EUC), DBT-A was found to be more effective in reducing the frequency of self-harm compared to EUC.

While DBT-A showed sustained benefits in reducing self-harm, improvements in suicidal ideation, depression, and borderline symptoms were observed in the EUC group over the follow-up year, indicating that both treatments can lead to positive outcomes, but DBT-A may be particularly beneficial for long-term self-harm reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical Behavior Therapy Compared With Enhanced Usual Care for Adolescents With Repeated Suicidal and Self-Harming Behavior: Outcomes Over a One-Year Follow-Up. Mehlum, L., Ramberg, M., Tørmoen, AJ., et al.[2022]

Dialectical behavior therapy (DBT) significantly reduces various aspects of suicidal ideation (SI) in individuals with borderline personality disorder (BPD) over a six-month treatment period, but it only decreases the intensity of non-suicidal self-injury (NSSI) ideation.

Emotions such as shame and guilt play a crucial role in moderating the effectiveness of DBT, with higher levels of shame/guilt leading to greater reductions in SI and NSSI ideation, indicating that addressing these emotions may enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in suicide and non-suicidal self-injury ideation and the moderating role of specific emotions over the course of dialectical behavior therapy. Rizvi, SL., Fitzpatrick, S.[2021]

Dialectical behaviour therapy (DBT) significantly reduces self-harm in patients with personality disorders, with a 9% decrease in risk for every 2 months of treatment compared to standard care.

While DBT may incur higher treatment costs (average of 5,685 GBP) compared to usual treatment (3,754 GBP), the benefits in reducing self-harm are notable, especially for those who complete the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and cost-effectiveness of dialectical behaviour therapy for self-harming patients with personality disorder: a pragmatic randomised controlled trial. Priebe, S., Bhatti, N., Barnicot, K., et al.[2022]

A 24-week Dialectical Behavior Therapy Skills Training (DBT-ST) program significantly reduced emotion dysregulation and dysfunctional coping in 100 adults with borderline personality disorder (BPD) traits who were not actively self-harming.

Participants also showed increased mindfulness and DBT skills use, although the study faced a high dropout rate of 49%, indicating a need for further research to confirm these findings in larger, controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical behaviour therapy skills reconsidered: applying skills training to emotionally dysregulated individuals who do not engage in suicidal and self-harming behaviours. Kells, M., Joyce, M., Flynn, D., et al.[2022]

Citations

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DBT has been shown to reduce suicide-related outcomes in published studies. ... This meta-analysis found that DBT was effective for reducing suicidal behavior.

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Core Evidence & Research

Marsha Linehan and her colleagues found that DBT resulted in significant improvements for chronically suicidal and self-injuring women with borderline ...

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