ClaustrophobiaNCT04663672
Efficacy of Targeted Memory Reactivation for Enhancing Exposure Therapy
A study testing Experimental Scent and In-Vivo Exposure in people with Claustrophobia and Obsessive-Compulsive Disorder, run by University of Texas at Austin at 1 site in United States.
Trial summary
This study evaluates whether a scent applied during exposure therapy and during subsequent sleep will increase the durability of treatment effects for individuals with fear of spiders, contamination, and enclosed spaces. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Claustrophobia, Obsessive-Compulsive Disorder, Arachnophobia
- What is being tested?
- Experimental Scent and In-Vivo Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2019to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Marked anxiety in at least one fear domain (spiders, contamination, or enclosed spaces), as determined by the presence of both:
- self-reported peak anxiety of at least 50 on a 100 point scale in response to two behavioral approach tasks
- self-report measures meeting the following cutoffs for the target fear:
- Fear of Spiders Questionnaire ≥ 50
- Obsessive-Compulsive Inventory-Revised (Washing Subscale) ≥ 4
- Claustrophobia Screener ≥ 2
Who cannot join
- Diagnosed sleep disorder
- Current sleep medication usage
- Inability to differentiate two different odors from an indoor scent diffuser
- Current psychotherapy for fear of spiders, snakes, enclosed spaces, or contamination
- Current use of air fresheners, scented candles, or other items with odors related to those used in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Laboratory for the Study of Anxiety Disorders, University of Texas at Austin
Austin, Texas, 78712
About this study
Official title: Placebo-Controlled, Randomized, Double-Blind Study of the Efficacy of Targeted Memory Reactivation for Enhancing Exposure Therapy
This study evaluates whether a scent applied during exposure therapy and during subsequent sleep will increase the durability of treatment effects for individuals with fear of spiders, contamination, and enclosed spaces.
Read the detailed description
Newly acquired memories encoded during wakefulness are spontaneously re-activated during sleep, resulting in synaptic potentiation and strengthening of the re-activated traces. Targeted memory reactivation (TMR) typically involves a period of initial learning in the presence of an olfactory or auditory contextual cue, coupled with later presentation of the cue during sleep to ostensibly facilitate memory reactivation and consolidation. Numerous studies have found evidence of improved task performance subsequent to cue-induced neuronal replay, however application of TMR to treatment of naturally acquired, clinically significant fear has been limited.
The present study will will provide a rigorous test of TMR's efficacy as an augmentative strategy for exposure therapy. It is hypothesized that participants who sleep in the presence of the same odor that they are exposed to during exposure therapy will exhibit reduced fear at follow up, relative to participants who sleep in the presence of a different odor, or a non-odorous control.
- Conditions
- Claustrophobia, Obsessive-Compulsive Disorder, Arachnophobia
- Being tested
- Experimental Scent, Control Scent, No-Scent Control, In-Vivo Exposure
- Keywords
- Targeted Memory Reactivation, Memory Consolidation, Exposure Therapy, Sleep
- Medical subject headings
- Claustrophobia, Obsessive-Compulsive Disorder, Arachnophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental ScentOther
Participants will sleep in the presence of the exposure scent, delivered by an Airwick Essential Oils diffuser
Control ScentOther
Participants will sleep in the presence of a novel scent, delivered by an Airwick Essential Oils diffuser
No-Scent ControlOther
Participants will sleep in the presence of an odorless control vehicle, delivered by an Airwick Essential Oils diffuser
In-Vivo ExposureBehavioural
Participants will receive 40 minutes of in-vivo exposure therapy to feared targets in the presence of a distinctive exposure scent.
| Study group | Role | What they receive |
|---|---|---|
| Exposure Therapy + Exposure Scent Cue During Sleep | Experimental | Participants will undergo exposure treatment for their target fear while in the presence of a distinctive odor. Exposure will occur in repeated 4-minute trials. Exposure will continue for 40 minutes or until peak fear decreases by at least 35 points on a 100 point scale, compared to peak fear during the initial trial. Participants will subsequently sleep in the presence of the exposure scent. Receives: Other: Experimental Scent; Behavioral: In-Vivo Exposure |
| Exposure Therapy + Novel Scent During Sleep | Placebo comparator | Participants will undergo exposure treatment for their target fear while in the presence of a distinctive odor. Exposure will occur in repeated 4-minute trials. Exposure will continue for 40 minutes or until peak fear decreases by at least 35 points on a 100 point scale, compared to peak fear during the initial trial. Participants will subsequently sleep in the presence of a novel scent. Receives: Other: Control Scent; Behavioral: In-Vivo Exposure |
| Exposure Therapy + No-Scent Control During Sleep | Sham comparator | Participants will undergo exposure treatment for their target fear while in the presence of a distinctive odor. Exposure will occur in repeated 4-minute trials. Exposure will continue for 40 minutes or until peak fear decreases by at least 35 points on a 100 point scale, compared to peak fear during the initial trial. Participants will subsequently sleep in the presence of an odorless control vehicle. Receives: Other: No-Scent Control; Behavioral: In-Vivo Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fear response during two behavioral approach tasks across time points
Change in subjective units of distress (0 = no fear, to 100 = extreme fear) and skin conductance in response to approaching a feared stimulus, from baseline to one month follow-up
Measured: Baseline (Day 1); Post-treatment (Day 1; immediately after treatment); One Week Follow-Up (Day 8; one week after treatment); One Month Follow-Up (Day 31; one month after treatment)
Secondary outcomes (3)
Change in arachnophobia symptom severity across time-points
Change in total score on the Fear of Spiders Questionnaire from baseline to one month follow-up
Measured: Baseline (Day 1); One Week Follow-Up (Day 8; one week after treatment); One Month Follow-Up (Day 31; one month after treatment)
Change in claustrophobia symptom severity across time points
Change in total score on the Claustrophobia Questionnaire from baseline to one month follow-up
Measured: Baseline (Day 1); One Week Follow-Up (Day 8; one week after treatment); One Month Follow-Up (Day 31; one month after treatment)
Change in contamination fear symptom severity across time points
Change in total score on the contamination subscale of the Padua Inventory- Washington State University Revision from baseline to one month follow-up
Measured: Baseline (Day 1); One Week Follow-Up (Day 8; one week after treatment); One Month Follow-Up (Day 31; one month after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start29 Jan 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClaustrophobiaStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Telch, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663672
- Sponsor's protocol ID
- 2018-09-0058
- Status last verified
- Dec 2020
- First submitted
- 4 Dec 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled, Randomized, Double-Blind Study of the Efficacy of Targeted Memory Reactivation for Enhancing Exposure Therapy
- ClinicalTrials.gov ID
- NCT04663672
- Acronym / sponsor ID
- 2018-09-0058
- Conditions
- Claustrophobia, Obsessive-Compulsive Disorder, Arachnophobia
- Keywords
- Targeted Memory Reactivation, Memory Consolidation, Exposure Therapy, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates whether a scent applied during exposure therapy and during subsequent sleep will increase the durability of treatment effects for individuals with fear of spiders, contamination, and enclosed spaces.
Detailed description
Newly acquired memories encoded during wakefulness are spontaneously re-activated during sleep, resulting in synaptic potentiation and strengthening of the re-activated traces. Targeted memory reactivation (TMR) typically involves a period of initial learning in the presence of an olfactory or auditory contextual cue, coupled with later presentation of the cue during sleep to ostensibly facilitate memory reactivation and consolidation. Numerous studies have found evidence of improved task performance subsequent to cue-induced neuronal replay, however application of TMR to treatment of naturally acquired, clinically significant fear has been limited.
The present study will will provide a rigorous test of TMR's efficacy as an augmentative strategy for exposure therapy. It is hypothesized that participants who sleep in the presence of the same odor that they are exposed to during exposure therapy will exhibit reduced fear at follow up, relative to participants who sleep in the presence of a different odor, or a non-odorous control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exposure Therapy + Exposure Scent Cue During Sleep | Experimental | Other: Experimental Scent, Behavioral: In-Vivo ExposureParticipants will undergo exposure treatment for their target fear while in the presence of a distinctive odor. Exposure will occur in repeated 4-minute trials. Exposure will continue for 40 minutes or until peak fear decreases by at least 35 points on a 100 point scale, compared to peak fear during the initial trial. Participants will subsequently sleep in the presence of the exposure scent. |
| Exposure Therapy + Novel Scent During Sleep | Placebo comparator | Other: Control Scent, Behavioral: In-Vivo ExposureParticipants will undergo exposure treatment for their target fear while in the presence of a distinctive odor. Exposure will occur in repeated 4-minute trials. Exposure will continue for 40 minutes or until peak fear decreases by at least 35 points on a 100 point scale, compared to peak fear during the initial trial. Participants will subsequently sleep in the presence of a novel scent. |
| Exposure Therapy + No-Scent Control During Sleep | Sham comparator | Other: No-Scent Control, Behavioral: In-Vivo ExposureParticipants will undergo exposure treatment for their target fear while in the presence of a distinctive odor. Exposure will occur in repeated 4-minute trials. Exposure will continue for 40 minutes or until peak fear decreases by at least 35 points on a 100 point scale, compared to peak fear during the initial trial. Participants will subsequently sleep in the presence of an odorless control vehicle. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Marked anxiety in at least one fear domain (spiders, contamination, or enclosed spaces), as determined by the presence of both:
- Fear of Spiders Questionnaire ≥ 50
- Obsessive-Compulsive Inventory-Revised (Washing Subscale) ≥ 4
- Claustrophobia Screener ≥ 2
Key exclusion criteria (5 listed)
- Diagnosed sleep disorder
- Current sleep medication usage
- Inability to differentiate two different odors from an indoor scent diffuser
- Current psychotherapy for fear of spiders, snakes, enclosed spaces, or contamination
- Current use of air fresheners, scented candles, or other items with odors related to those used in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental ScentParticipants will sleep in the presence of the exposure scent, delivered by an Airwick Essential Oils diffuser | Other | Exposure Therapy + Exposure Scent Cue During Sleep |
| Control ScentParticipants will sleep in the presence of a novel scent, delivered by an Airwick Essential Oils diffuser | Other | Exposure Therapy + Novel Scent During Sleep |
| No-Scent ControlParticipants will sleep in the presence of an odorless control vehicle, delivered by an Airwick Essential Oils diffuser | Other | Exposure Therapy + No-Scent Control During Sleep |
| In-Vivo ExposureParticipants will receive 40 minutes of in-vivo exposure therapy to feared targets in the presence of a distinctive exposure scent. | Behavioural | Exposure Therapy + Exposure Scent Cue During Sleep, Exposure Therapy + No-Scent Control During Sleep, Exposure Therapy + Novel Scent During Sleep |
Primary outcome
Change in fear response during two behavioral approach tasks across time points
Time frame: Baseline (Day 1); Post-treatment (Day 1; immediately after treatment); One Week Follow-Up (Day 8; one week after treatment); One Month Follow-Up (Day 31; one month after treatment)
Change in subjective units of distress (0 = no fear, to 100 = extreme fear) and skin conductance in response to approaching a feared stimulus, from baseline to one month follow-up
3 secondary outcomes
Change in arachnophobia symptom severity across time-points
Time frame: Baseline (Day 1); One Week Follow-Up (Day 8; one week after treatment); One Month Follow-Up (Day 31; one month after treatment)
Change in claustrophobia symptom severity across time points
Time frame: Baseline (Day 1); One Week Follow-Up (Day 8; one week after treatment); One Month Follow-Up (Day 31; one month after treatment)
Change in contamination fear symptom severity across time points
Time frame: Baseline (Day 1); One Week Follow-Up (Day 8; one week after treatment); One Month Follow-Up (Day 31; one month after treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Scent and In-Vivo Exposure in people with Claustrophobia and Obsessive-Compulsive Disorder, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fear response during two behavioral approach tasks across time points (time frame: Baseline (Day 1); Post-treatment (Day 1; immediately after treatment); One Week Follow-Up (Day 8; one week after treatment); One Month Follow-Up (Day 31; one month after treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.