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Completed

NCT Number: NCT01102803

D-Cycloserine to Enhance Cognitive Behavioral Therapy (CBT) for Acrophobia

The purpose of this study is to investigate the utility of post-session administration of D-cycloserine to enhance fear extinction in a sample of people with acrophobia who will be treated with CBT.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Southern Methodist University

Dallas, Texas, 75206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females 18-65 years of age with a psychiatric diagnosis of acrophobia defined by DSM-IV criteria.
  • Willingness and ability to 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 (amphetamines, benzodiazepines, barbiturates, cocaine metabolites, marijuana, narcotics, and sedative hypnotics) abuse or dependence 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.
  • Patients with posttraumatic stress disorder and panic disorder within the past 6 months are excluded. Entry of patients with other mood or anxiety disorders will be permitted 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 women, 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 acrophobia is excluded. Prohibited psychotherapy includes CBT therapy focusing on exploring specific, dynamic causes of the phobic symptomatology and provides management skills. General supportive therapy initiated > 3 months prior is acceptable.
  • Prior non-response to adequately delivered exposure (i.e., as defined by the patient's report of receiving specific and regular exposure assignments as part of a previous treatment) will exclude participants from the study.
  • Patients with a history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment.
  • Patients receiving isoniazid.
  • Patients unable to understand study procedures and participate in the informed consent process.

Treatment and study plan

Individual Cognitive Behavioral Therapy (CBT)

Behavioral

The aim of CBT is to help participants become more comfortable with heights situations. Participants will receive 2 sessions over two weeks of individual CBT.

Other names: CBT, DCS

D-cycloserine

Drug

D-Cycloserine

Placebo

Drug

Sugar Pill

Primary outcomes

  1. Acrophobia Questionnaire With Avoidance (AAVQ)

    Time frame: 2 months

    Self-report measure that assesses fear and avoidance of a variety of heights situations. This questionnaire (Cohen, 1977) describes 20 situations and assesses levels of avoidance (0-3) and anxiety (0-6). These scales widely used measure of acrophobia with adequate retest reliability (r = .82-.86) and validity (Baker et al., 1973). Higher scores indicate higher levels of avoidance/anxiety (i.e., worse outcome). All subscales are summed for a total score. AAVQ will be assessed at each visit throughout the 2 month protocol. The minimum score is 0, the maximum is 90.

Secondary outcomes

  1. Attitudes Towards Heights Questionnaire (ATHQ)

    Time frame: 2 months

    Self-report measures that assesses thoughts and feelings towards heights situations. This questionnaire (Abelson and Curtis, 1989) includes six heights situations and assesses attitudes toward these situations using a 0-10 scale. Higher scores indicate a worse outcome and total scores are summed over subscales. Will be assessed at each visit throughout the 2 month protocol. The minimum score is a 0; the maximum is a 60.

  2. Clinical Global Improvement Scale (CGI)

    Time frame: 2 months

    Clinician-rated measure of improvement in acrophobia symptoms and severity. Will be assessed at each visit throughout the 2 month protocol. The CGI-S and CGI-I are widely used measures of global psychopathology severity and improvement initially developed for the study of psychotropic drugs (Guy, 1970). In order to obtain CGI ratings, the therapists (blind to study condition) interviewed the participant and used the SCID (including the specific phobia module) as well as the additional measures of acrophobia symptoms (BAT, AAQ, AAVQ, and ATHQ). In the current study, response was defined as either "very much improved" or "much improved" on CGI-I (score ≤ 2). Remission was defined as either "normal" or "minimally ill" on CGI-S (score ≤ 2). The minimum rating is a 1 and the highest is a 7. Lower scores indicate a better outcome.

  3. Behavioral Avoidance Test (BAT)

    Time frame: 2 months

    During the initial screen, at post-treatment, and at follow-up, participants underwent a behavioral avoidance test in the virtual reality height environment. Participants reported on a 0-100 scale (100 being the most intense fear) their SUDS for floors 1, 2, 3, 4, 9, 19 of the virtual glass elevator and balconies. This test has been used successfully as a measure of treatment gains in previous studies of acrophobia research (Ressler et al., 2004). For the outcome analyses, we included the level of fear reported at the highest floor of the virtual elevator environment (19th floor). Higher scores indicate a worse outcome.

Sponsors and collaborators

Lead sponsor

Southern Methodist University

Other

Registry information

Official study title

Evaluation of the Effects of Post-Session Administration of D-cycloserine On Exposure Therapy Outcomes

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 13, 2010
Registry last updated
Feb 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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