The first purpose is to evaluate the efficacy of d-cycloserine (DCS) in augmenting treatment for social anxiety disorder. Individuals will receive 5 weeks of cognitive-behavioral therapy (CBT), randomized into one of four treatment groups. Participants will receive either one pill of DSC or one placebo pill, both one hour prior to sessions 2, 3, 4, and 5 and immediately afterward. The investigators hypothesize that individuals receiving post-session DCS will show a greater decrease in social anxiety symptoms after receiving CBT.

Secondly, this study aims to determine whether DCS can enhance fear extinction retention. We will test fear extinction retention in eligible participants and randomly assign them to either precede this procedure with the administration of DCS or a placebo.

A third aim of the study is to examine the impact of sleep quality on in-session extinction and treatment outcome of CBT for social anxiety disorder. We will have subjects in the study complete a baseline sleep assessment and a sleep diary for the night before and after each treatment session. We expect that poor sleep quality the night before a session will reduce in-session learning, and that poor sleep quality the night after the session will moderate the relationship between in-session learning and treatment outcome.

Organization
The University of Texas at Austin
Principal Investigator
Jasper Smits, PhD
Eligibility Criteria
  • Male or female outpatients 18 or older with a primary psychiatric diagnosis (designated by the patient as the most important source of current distress) of social anxiety disorder as defined by DSM-5 criteria 
  • A total score ? 60 on the LSAS 
  • Physical examination and laboratory findings without clinically significant abnormalities 
  • Willingness and ability to participate in the informed consent process and comply with the requirements of the study protocol
Exclusion Criteria
  • A lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders, or obsessive-compulsive disorder; an eating disorder in the past 6 months; organic brain syndrome, mental retardation or other cognitive dysfunction that could interfere with capacity to engage in therapy; a history of substance or alcohol abuse or dependence (other than nicotine) in the last 6 months or otherwise unable to commit to refraining from alcohol use during the acute period of study participation
  • PTSD within the past 6 months. Entry of patients with other mood or anxiety disorders will be permitted if the social anxiety disorder is judged to be the predominant disorder, in order to increase accrual of a clinically relevant sample. Patients with significant suicidal ideation (MADRS item 10 score > 3) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
  • Patients must be off concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers) for at least 2 weeks prior to initiation of randomized treatment.
  • Significant personality dysfunction likely to interfere with study participation
  • Serious medical illness or instability for which hospitalization may be likely within the next year
  • Patients with a current or past history of seizures
  • Pregnant and lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months)
  • Any concurrent psychotherapy initiated within 3 months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of the SAD is excluded. Prohibited psychotherapy includes CBT or psychodynamic therapy focusing on exploring specific, dynamic causes of the phobic symptomatology and providing management skills. General supportive therapy initiated more than 3 months prior is acceptable.
  • Prior non-response to adequately-delivered exposure (as defined by the patient?s report of receiving specific and regular exposure assignments as part of a previous treatment).
  • Patients with a history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment. Current use of isoniazid or ethionamide compounds
  • Insufficient command of the English language

 

Contact
Sara Witcraft, sadtreatment@gmail.com, 512-471?7694
Location
Anxiety & Health Behaviors Lab, The University of Texas at Austin
State
TX