search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Testosterone enhancement of exposure therapy in social anxiety disorder


- candidate number27158
- NTR NumberNTR6418
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-mei-2017
- Secondary IDsNL47410.091.14 2014-004475-23
- Public TitleTestosterone enhancement of exposure therapy in social anxiety disorder
- Scientific TitleEnhancement of exposure therapy for social anxiety disorder with testosterone: A proof-of-concept randomized placebo-controlled trial
- ACRONYMTestosterone enhancement of exposure therapy in SAD
- hypothesisWe expect to detect testosterone effects on response to exposure in terms of subjective anxiety and self reported social anxiety symptoms. Additionally we expect testosterone effects on implicit avoidance tendencies. Lastly, Personality traits, feelings of submissiveness/dominance, avoidance behavior on fear learning task, extinction capacity and a proxy of fetal testosterone will be examined exploratory. As such, no hypotheses were formed regarding these possible predictors.
- Healt Condition(s) or Problem(s) studiedExposure therapy, Social Anxiety Disorder
- Inclusion criteria- Woman, 18-45 years old
- Social Anxiety Disorder (SAD) as established with a structured interview (MINI), and with speech anxiety as primary fear
- Self reported SAD symptoms above clinical cut-off (score > 30 on the Liebowitz Social Anxiety Scale)
- Exclusion criteria- Prior non response to exposure therapy (i.c. speech exposure) for SAD symptoms, as defined by the patientís report of receiving specific and regular exposure assignments as part of previous therapy.
- Entry of patients with other mood or anxiety disorders will be permitted in order to increase accrual of a clinically relevant sample; however in cases where SAD is not judged to be the predominant disorder, participants will not be eligible.
- Psychosis or delusion disorders (current or in the past)
- Patients with significant suicidal ideations or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from participation and referred for appropriate clinical intervention.
- Mental retardation
- Substance or alcohol dependence
- Somatic illness
- Women of childbearing potential that are not willing to use an active form of birth-control during the trial
- Pregnancy or lactation
- Infertility
- Antipsychotic medication
- Participants that use antidepressants or benzodiazepines will not be excluded, but have to be on a stable dose for at least 6 weeks prior to enrollment.
- Insufficient ability to speak and write Dutch
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2017
- planned closingdate1-dec-2018
- Target number of participants52
- InterventionsParticipants will be randomly allocated to receive exposure therapy plus testosterone (sublingual, 0.50 mg) or exposure therapy plus identical looking placebo. Participants will receive two 60 minutes exposure sessions, targeting speech anxiety.
During the first exposure session participants will receive testosterone/Placebo. Testosterone/Placebo will be administered four hours prior to the first exposure session. During the second session participants will receive exposure therapy without testosterone/placebo.
- Primary outcomeOur main outcome is subjective anxiety, as assessed by Subjective Units of Distress (SUDs). participants will provide fear ratings (ranging from 0; no fear to 100 most anxiety imaginable) prior and during both exposure sessions.
- Secondary outcome- Fear of scrutiny at post-treatment (assessed by the Social Phobia Scale (SPS). (Time points: baseline, post-assessment and follow-up)
- Implicit avoidance of angry/happy/neutral faces will be assessed with an Approach Avoidance Task. (Time points: Baseline and post-assessment)
- Feelings of submissiveness and dominance will be assessed exploratory via the Social Comparison scale (SCS). (Time points: baseline, prior and after exposure sessions, post-assessment, follow-up)
- Harm Expectancy (HE) ratings will be assessed exploratory (Time points: prior and after both exposure sessions)
- Video-tapes of participantsí performance during each exposure session will be rated with the Social Performance Rating Scale (SPRS), which is an evaluation of behavioral indicators of anxiety.
- In addition some predictor variables will be assessed exploratory: fear learning and low cost avoidance (via two brief computer tasks; time points: baseline). Personality traits (assessed via a short version of the NEO-FFI, time point: baseline), salivary testosterone and cortisol levels (time points: baseline, prior to testosterone intake, prior and after both exposure sessions), and a proxy of fetal testosterone assessed via a 2D:4D digit ratio (Time point: baseline)
- Timepoints- Baseline assessment
- Exposure session 1 (one week after baseline assessment)
- Exposure session 2 + post exposure assessment (one week after exposure 1)
- Follow-up assessment (four weeks after exposure session 2, online assessment)
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMsc. Moniek Hutschemaekers
- CONTACT for SCIENTIFIC QUERIESMsc. Moniek Hutschemaekers
- Sponsor/Initiator Prof. dr. Karin Roelofs
- Funding
(Source(s) of Monetary or Material Support)
Prof. dr. Karin Roelofs
- Publications
- Brief summaryIn this randomized placebo controlled trial we will investigate the effects of testosterone on exposure for social anxiety disorder in women. Fifty-two women (age 18-45 years) will be recruited. Eligible participants will i) have a social anxiety disorder as established by a structured interview; ii) have SAD symptoms of at least moderate severity (LSAS >30); iii) be naive to exposure therapy. Participants will be randomly allocated to receive brief standardized exposure plus testosterone (sublingual, 0.50 mg) or exposure plus identical looking placebo. Testosterone/Placebo will be administered 4 hours prior to the first exposure session. Our main outcome is subjective anxiety as assessed with subjective units of distress (SUDs) ratings. In addition, we will assess self-reported social anxiety symptoms (SPS), automatic socio-anxiolytic behavior tendencies by means of implicit measures, fear learning and avoidance behavior by brief computer tasks.
- Main changes (audit trail)16-nov-2017 -IK:

Secondary outcome:
- Fear of scrutiny at post-treatment (assessed by the Social Phobia Scale (SPS). (Time points: baseline, post-assessment and follow-up)
- Implicit avoidance of angry/happy/neutral faces will be assessed with an Approach Avoidance Task. (Time points: Baseline and post-assessment)
- Feelings of submissiveness and dominance will be assessed exploratory via the Social Comparison scale (SCS). (Time points: baseline, prior and after exposure sessions, post-assessment, follow-up)
- Harm Expectancy (HE) ratings will be assessed exploratory (Time points: prior and after both exposure sessions)
- Video-tapes of participantsí performance during each exposure session will be rated with the Social Performance Rating Scale (SPRS), which is an evaluation of behavioral indicators of anxiety.
- In addition some predictor variables will be assessed exploratory: fear learning and low cost avoidance (via two brief computer tasks; time points: baseline). Personality traits (assessed via a short version of the NEO-FFI, time point: baseline), salivary testosterone and cortisol levels (time points: baseline, prior to testosterone intake, prior and after both exposure sessions), and a proxy of fetal testosterone assessed via a 2D:4D digit ratio (Time point: baseline)

replaced by

- Fear of scrutiny at post-treatment (assessed by the Social Phobia Scale (SPS). (Time points: baseline, post-assessment and follow-up)
- Implicit avoidance of angry/happy/neutral faces will be assessed with an Approach Avoidance Task. (Time points: Baseline and post-assessment)
- Feelings of submissiveness and dominance will be assessed exploratory via the Social Comparison scale (SCS). (Time points: baseline, prior and after exposure sessions, post-assessment, follow-up)
- Harm Expectancy (HE) ratings will be assessed exploratory (Time points: prior and after both exposure sessions)
- Video-tapes of participantsí performance during each exposure session will be rated with the Social Performance Rating Scale (SPRS), which is an evaluation of behavioral indicators of anxiety.
- In addition some predictor variables will be assessed exploratory: fear learning and low cost avoidance (via two brief computer tasks; time points: baseline). Personality traits (assessed via a short version of the NEO-FFI, time point: baseline), Salivary testosterone and cortisol levels (time points: baseline, prior to testosterone intake, prior and directly after both speech exposures and 30 minutes after speech exposure) , and a proxy of fetal testosterone assessed via a 2D:4D digit ratio (Time point: baseline)
- RECORD1-mei-2017 - 16-nov-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl