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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to compare two core intervention skills among adolescents with a history of engaging in at least 3 lifetime incidents of self-inflicted injury (SII), at least one of which was a suicide attempt of at least moderate lethality and moderate intent to die. The main questions it aims to answer are: Whether and when youth use skills in daily life, how quickly skill use declines after teaching, and whether exposure to life stress influences skill learning and retention. The Investigators also want to know whether brain-related, family-related, and physiology-related factors influence skills practice and any associated changes in self-harm/suicide risk and emotion dysregulation. Participants will complete surveys 5 times a day on their phones at baseline, and following each skill learning session. All participants will learn and practice the two skills with a parent while discussing topics they often argue about. During these discussions, participants will be hooked up to psychophysiological equipment to measure their cardiovascular functioning and their palm sweat. Participants' discussions will be coded for skill use and also for indices of family functioning. Approximately half of the participants will undergo two sets of fMRI scans to assess potential neural underpinnings of skill use.

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 data supports the effectiveness of the treatment GIVE, Dialectical Behavior Therapy, DBT, Opposite to emotion action, Opposite Action, DBT Skill for self-harm?

Research shows that Dialectical Behavior Therapy (DBT) and its skills training can effectively reduce self-harm behaviors. Studies indicate that even modified versions of DBT, like skills training alone, can help improve emotion regulation and decrease self-harm incidents. ^{1 2 3 4 5}

Is Dialectical Behavior Therapy (DBT) safe for humans?

Research on Dialectical Behavior Therapy (DBT) and its skills training shows it is generally safe for humans, as it has been used effectively to reduce self-harm and improve emotional regulation in various groups, including those with borderline personality disorder and adolescents. ^{2 3 4 5 6}

How is the treatment GIVE, Opposite to emotion action (DBT Skill) different from other treatments for self-harm?

This treatment is unique because it focuses on teaching coping skills to manage emotional distress, which can reduce self-harm behaviors. Unlike traditional therapies, it is a modified version of Dialectical Behavior Therapy (DBT) that is less resource-intensive and can be delivered in a group setting, making it more accessible. ^{1 2 3 4 7}

Research Team

Erin Kaufman, Ph.D.

Principal Investigator

University of Utah

Eligibility Criteria

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

English language proficiency

Access to a smart phone

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

Exclusion Criteria

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Living through distress: a skills training group for reducing deliberate self-harm. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of dialectical behaviour therapy vs. enhanced usual care in the treatment of adolescents with self-harm. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Dialectical behaviour therapy-informed skills training for deliberate self-harm: a controlled trial with 3-month follow-up data. [2014]

4. England 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. [2022]

5. United States 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. [2022]

6. Switzerland 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. [2022]

7. England 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. [2021]