Guanfacine Extended Release and Mindfulness Skills Therapy

Browse trials for

• Stress Disorders, Traumatic 1,149

Study arms

• Experimental
  GXR and Mindfulness Skills

  Guanfacine Extended Release (GXR) will be started at 1 mg/day at Week 1 and tapered up by 1 mg per week to a maximum dose of 7 mg/day by week 7 (maximum of 6 weeks on drug). GXR dosing will be flexible for the first 5 weeks of the study based upon patient response and tolerability to drug. Optimal dose will be defined as that necessary to achieve ≥ 30% reduction in symptoms and a CGI-Improvement Score ≤ 2. Upon re-evaluation at (T1) and entry into the psychotherapy protocol dosing will become fixed for the remainder of the study. Mindfulness Skills Therapy will occur for the next 10 weeks.

  Drug: Guanfacine Extended Release · Behavioral: Mindfulness Skills Therapy

• Active comparator
  Placebo and Mindfulness Skills

  Placebo will be started at "1 mg/day" at Week 1 and tapered up by "1 mg" per week to a maximum dose of "7 mg/day" by week 7 (maximum of 6 weeks on drug). Placebo dosing will be flexible for the first 5 weeks of the study based upon patient response. Optimal dose will be defined as that necessary to achieve ≥ 30% reduction in symptoms and a CGI-Improvement Score ≤ 2. Upon re-evaluation at (T1) and entry into the psychotherapy protocol dosing will become fixed for the remainder of the study. Mindfulness Skills Therapy will occur for the next 10 weeks.

  Behavioral: Mindfulness Skills Therapy · Drug: Placebo

Interventions

• DrugGuanfacine Extended Release

  Intuniv (guanfacine) is a prescription medicine used to treat attention deficit hyperactivity disorder (ADHD) in children who are at least 6 years old. An open-label trail of guanfacine extended release (GXR 1-4 mg/daily; Intuniv™) suggested benefits in improving behavioral and emotional regulation in children and adolescents with symptoms of traumatic stress. However, to date no controlled clinical trial has been completed assessing the effects of GXR on traumatic stress symptoms in youths

  Also known as: Intuniv

• BehavioralMindfulness Skills Therapy

  Mindfulness is a therapy for anxiety and stress. Mindfulness forms of therapy involve regulation of attention, maintaining it in immediate experience, regardless of the valence and desirability of the experience. To reduce anxiety, Mindfulness encourages observing and accepting anxiety-related thoughts

• DrugPlacebo

  Placebo oral capsule

Primary outcomes

1. Changes in the Structured Trauma-Related Experiences and Symptoms Screener (STRESS)

   a self-report and observer-report instrument for youths 7-18 years that inventories 25 adverse childhood experiences and potentially traumatic events and assesses symptoms of post-traumatic stress disorder using the revised criteria published in DSM 5. Total score and DSM 5 domains B-E are included (intrusive symptoms, avoidance, cognitive-mood symptoms, arousal-reactivity symptoms and symptoms of dissociation).

   Time frame: Completed as part of the initial evaluation (T0), after drug dose has been determined to be stable and fixed (T1), and after completing the Mindfulness Therapy. (T2) (approximately 20 weeks in total)

2. Changes in theRetrospective-Modified Overt Aggression Scale (R-MOAS)

   (R-MOAS) assesses the frequency and severity of 16 aggressive behaviors over the past week in four areas: verbal aggression, physical aggression towards others, aggression toward oneself, and destruction or hostile misuse of property. Numeric weighting amplifies the seriousness of more harmful behaviors in the total score. Reliability and validity data on the instrument are published. A total score ≥ 24 is required to identify clinically significant aggression.

   Time frame: Completed as part of the initial evaluation (T0), after drug dose has been determined to be stable and fixed (T1), and after completing the Mindfulness Therapy. (T2)(approximately 20 weeks in total)

3. Changes in ADHD RS-IV

   An 18-item caregiver-completed rating scale developed to measure the behaviors of youths with ADHD

   Time frame: Completed as part of the initial evaluation (T0), after drug dose has been determined to be stable and fixed (T1), and after completing the Mindfulness Therapy. (T2)(approximately 20 weeks in total)

4. Changes in the Emotion Reactivity Scale (ERS)

   A 21-item self-report measure of emotion sensitivity, intensity, and persistence. The scale assesses emotional reactivity.

   Time frame: Completed as part of the initial evaluation (T0), after drug dose has been determined to be stable and fixed (T1), and after completing the Mindfulness Therapy. (T2). Also at each medication management appointment(approximately 20 weeks in total)

5. Youth Self Report (CBCL)

   Assesses self-report functioning and internalizing and externalizing symptoms. The YSR contains social competence items and 112 items assessing self-reported symptoms.

   Time frame: Completed at initial visit only (week 1)

6. Kaufman Brief Intelligence Test-2

   The KBIT is normed for ages 4-90 years and yields a verbal IQ, non-verbal IQ, and full-scale IQ.

   Time frame: Completed by the adolescent at the initial visit only (week 1)

Secondary outcomes

1. Guanfacine Extended Release and Mindfulness Skills Therapy reducing traumatic stress

   1. To measure whether Guanfacine Extended Release (GXR) 1-7 mg/daily compared to placebo will help diminish traumatic stress-related symptoms of concentration difficulties, aggression and anger, irritability, anxiety, fear, and depression in 12-17 year old youths who have experienced lifetime traumatic stress as assessed by clinician-reports, and observer- and self-reports on psychometrically validated rating scales.

   Time frame: 20 weeks

2. Tolerance of Guanfacine Extended Release in subjects between the ages of 12-17 years old.

   2. To measure how well 12-17 year-old children tolerate Guanfacine Extended Release (GXR) 1-7 mg/daily compared to placebo. Tolerance assessed by review of adverse events.

   Time frame: 20 weeks

3. Clinical Global Impressions Improvement Scale

   The CGI-Improvement scale assesses patient overall improvement of symptoms compared with symptoms at study baseline. It is rated on a 7-point scale with scores ranging between 1 ("very much improved), 2 ("improved"), 3 ("minimally improved"), 4 ("no change from baseline") to 7 ("very much worse").

   Time frame: Completed ater drug dose has been determined to be stable and fixed (T1) and after completing the Mindfulness Therapy (T2) and each medication management visit.(approximately 20 weeks in total)

4. Clinical Global Impressions Severity Scale

   The CGI-Severity scale assesses the overall severity of a patient's psychiatric condition on a 7-point scale with scores ranging from 1 ("not ill") to 7 ("extremely severe").

   Time frame: Completed as part of the initial evaluation (T0), after drug dose has been determined to be stable and fixed (T1), and after completing the Mindfulness Therapy. (T2). Also at each medication management appointment(approximately 20 weeks in total)

5. Client Credibility Questionnaire (CCQ)

   measures youth and parent expectancies of treatment

   Time frame: the CCQ will be administered to all youth and parents at the end of session one following presentation of the treatment rationale(approximately 20 weeks in total)

6. Group Engagement Scale (GES)

   20-item scale, that assesses youth attitude/satisfaction toward their specific group. Each item is rated on a 9-point scale. Groups can prompt different attitudes among group members which can affect the effectiveness of the intervention. The GES yields high alphas (\>0.9). (Those receiving individual Mindfulness will not receive this scale)

   Time frame: At each of the Mindfulness Skills Therapy sessions if the subject is in group therapy.(approximately 10 weeks)

7. The Screen for Child Anxiety Related Emotional Disorders (SCARED)

   a 41-item self or observer-completed screen for child and adolescent anxiety disorders. Sub-scores assess for the presence of panic disorder, generalized anxiety disorder, separation anxiety disorder, social anxiety disorder, and significant school avoidance. Total scores ≥ 25 may indicate the presence of an anxiety disorder.

   Time frame: Completed as part of the initial evaluation (T0), after drug dose has been determined to be stable and fixed (T1), and after completing the Mindfulness Therapy. (T2). Also at each medication management visit(approximately 20 weeks in total)

8. Patient Health Questionnaire (PHQ-9)

   a 9-item self-report instrument assessing symptoms of depression. In clinically referred populations a total score ≥ 10 may identify clinically significant depression given the higher base-rate of depression in clinical populations than in epidemiological samples.

   Time frame: Completed as part of the initial evaluation (T0), after drug dose has been determined to be stable and fixed (T1), and after completing the Mindfulness Therapy. (T2) Also at each medication management visit(approximately 20 weeks in total)

Individual participant data

Plan to share: Yes — This is a multi center study being conducted in collaboration with Yale University. All shared data will be coded, with the code being held exclusively by the original contributing institute.