|- candidate number||26903|
|- NTR Number||NTR6496|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-mrt-2017|
|- Secondary IDs||NL47573.099.14 RTPO (Regionale Toetstingscommissie Patientgebonden Onderzoek te Leeuwarden)|
|- Public Title||Interpretive bias modification in the treatment of dental phobia|
|- Scientific Title||The effect of cognitive bias modification of interpretive bias
in the treatment of dental phobia
|- hypothesis||Patients who received CBM-I training will start their exposure therapy with lower anxiety levels, and their anxiety levels will reduce faster compared to patients that receive a placebo training.|
|- Healt Condition(s) or Problem(s) studied||Dental phobia|
|- Inclusion criteria||- Age ¡Ý18 yrs |
- No mental disabilities
- Main diagnosis is dental phobia, if other diagnoses are also applicable, they may not
interfere with the treatment
- Availability of a computer (PC, laptop, tablet or Smartphone) and access to the internet
- Basic internet skills
- Dutch reading abilities
|- Exclusion criteria||- Age < 18 yrs|
- Mental disabilities
- Other diagnoses than dental phobia for which the patients is treated by the special care
dentist (for example extreme gagging reflex)
- Treatment under general anaesthesia instead of exposure therapy
- No availability of a computer and internet
- Lack of basic internet skills
- Lack of Dutch reading abilities or illiteracy
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||21-okt-2014|
|- planned closingdate||31-dec-2019|
|- Target number of participants||48|
|- Interventions||The CBM-I computerized training (also known as ¡®recognition task¡¯) consists of short scenarios of initially ambiguous dental situations. A word is left out of the final sentence of the scenario. In the positive CBM-I group the missing word will give a positive meaning to the ambiguous situation, and participants are trained to make positive emotional interpretations. |
|- Primary outcome||- DAS score (trait anxiety of dental treatment: Dental Anxiety Scale)|
- Interpretive bias score (measured by the recognition task, see also: study procedures).
|- Secondary outcome|| - DPFR score (anticipation anxiety of dental treatment: the duration of
- K-ATB score (trait anxiety of dental treatment: the short version of the Dental
- AS-score (Visual analogue scale that indicates the overall anxiety level of dental
- The number of drop-out during the research (specifically: after which time during a
CBM-I session and at which CBM-I session).
- Reason for drop-out.
|- Timepoints||t0 before training|
t1 after training but before treatment
t2 after4th treatment session
|- Trial web site||/|
|- status||recruitement status not public|
|- CONTACT FOR PUBLIC QUERIES|| M.M. Bildt |
|- CONTACT for SCIENTIFIC QUERIES|| M.M. Bildt |
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Martini Hospital Groningen|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: Cognitive biases play an important role in the etiology and continuation of anxiety disorders. These biases can be altered by ¡®cognitive bias modification¡¯ (CBM) and thereby . reduce psychological complaints. |
Moreover, the method is not strainful to the patients. Interpretive bias is one of the major cognitive biases, especially in anxiety disorders. Anxiety symptoms can be reduced by CBM training of interpretive bias (CBM-I). For instance, this effect has been shown in generalized anxiety disorder, anxiety sensitivity, and social anxiety. However, no studies are known that investigate the effect of CBM-I on dental phobia. In the present study, the effect of CBM-I on specific anxiety complaints will be investigated in patients with dental phobia.
These patients will receive the CBM-I training prior to the treatment-as-usual (exposure therapy). We hypothesize that patients who received CBM-I training will start their exposure therapy with lower anxiety levels, and that their anxiety levels will reduce faster compared to patients who receive a placebo training.
Objective: The main objective in this study is to investigate the effect of interpretive bias modification on anxiety levels and interpretive bias in dental phobia.
Study design: Double-blind randomized controlled trial.
Study population: 48 Adult patients (¡Ý18 yrs), who have applied to the Centre for Special Dental Care (Martini Ziekenhuis), in order to treat their dental phobia. These patients have no mental disabilities and participate in the research fully voluntarily, with no material or financial compensation.
Intervention: The CBM-I training consists of short scenarios of initially ambiguous dental situations. A word is left out of the final sentence of the scenario. In the positive CBM-I group the missing word will give a positive meaning to the ambiguous situation, and participants are trained to make positive emotional interpretations. For the placebo group, only neutral meanings are given to the scenarios that are similar to those in the experimental group. All participants receive the training four times: two times per week, 20 minutes per session, 20 trials (scenarios) per session, during two weeks prior to the exposure therapy (the treatment-as-usual).
Main study parameters/endpoints: The main study parameters are the change in interpretive bias score and four anxiety scores (DPFR score: anticipation anxiety of dental treatment, the DAS and K-ATB score: both trait anxiety of dental treatment, and the AS-score Visual analogue scale that indicates the overall anxiety level of dental treatment).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants receive four training sessions (20 minutes each, two sessions per week) during the two weeks prior to the exposure therapy. This is an online training which the participant can perform at home.
There will be no treatment delay; instead, the waiting weeks between the intake session and the first exposure therapy session will be usefully filled in. The training modifies the interpretive bias in a positive direction. This is considered a positive effect (a negative interpretive bias is associated with anxiety symptoms, whereas healthy, non-anxious individuals interpret ambiguous information in a positive direction.
The CBM-I training corrects the negative interpretive bias towards a positive outcome or stimulates a positive bias).
The placebo group receives a neutral computer task, similar to the CBM-I training (without stimulation towards a positive or negative direction). Both tasks are not psychological or physical strainful. There are no risks for the patients. Patients participate in the research fully voluntarily, they may withdraw from the research at any moment and without any consequences, data will be handled anonymously.
|- Main changes (audit trail)|
|- RECORD||15-mrt-2017 - 10-jul-2017|