Anxiety DisordersNCT04584879
Transdiagnostic Treatment Personalization
A study testing Standard UP Treatment, Capitalization UP Treatment and Compensation UP Treatment in people with Anxiety Disorders and Depressive Disorder, run by Shannon E. Sauer-Zavala at 1 site in United States.
Trial summary
The primary purpose of this study is to explore whether the efficiency of treatment for anxiety and depressive disorders can be increased using two discrete strategies: personalized skill ordering and 2) treatment discontinuation based on proximal indicators of improvements. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders, Depressive Disorder, Post Traumatic Stress Disorder
- What is being tested?
- Standard UP Treatment, Capitalization UP Treatment and Compensation UP Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2019to 15 Sep 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosis of at least one emotional disorder
- fluent in English
- medication stability
Who cannot join
- concurrent therapy
- psychological condition that would be better addressed by alternative treatments
- have received more than 5 sessions of cognitive behavioral therapy in the past 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transdiagnostic Treatment Personalization: Prioritizing Therapy Components to Capitalize on Strengths or Compensate for Weaknesses
The primary purpose of this study is to explore whether the efficiency of treatment for anxiety and depressive disorders can be increased using two discrete strategies: personalized skill ordering and 2) treatment discontinuation based on proximal indicators of improvements. The present study will specifically use treatment components drawn from an evidence-based psychological intervention, the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP). This intervention has strong empirical support for patients presenting with anxiety, depressive, and related disorders and contains therapeutic skills that are common in psychological interventions (e.g., psychoeducation, mindfulness training, cognitive restructuring, countering emotional avoidance, increasing interoceptive tolerance). This study will determine if prioritizing the order of treatment modules to capitalize on patient strengths or compensate for weakensses increases treatmen efficacy. Additionally, it will also identify under what conditions briefer treatment modules may be appropriate.
- Conditions
- Anxiety Disorders, Depressive Disorder, Post Traumatic Stress Disorder, Obsessive-Compulsive Disorder
- Being tested
- Standard UP Treatment, Capitalization UP Treatment, Compensation UP Treatment
- Keywords
- Unified Protocol, Cognitive Behavioral Therapy, Personalization
- Medical subject headings
- Anxiety Disorders, Depressive Disorder, Stress Disorders, Post-Traumatic, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard UP TreatmentBehavioural
Participants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018).
Capitalization UP TreatmentBehavioural
Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
Compensation UP TreatmentBehavioural
Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.
| Study group | Role | What they receive |
|---|---|---|
| Standard Group, Brief Intervention | Experimental | Participants in this group will receive 6 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual. Receives: Behavioral: Standard UP Treatment |
| Standard Group, Full Intervention | Experimental | Participants in this group will receive 12 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual. Receives: Behavioral: Standard UP Treatment |
| Capitalization Group, Brief Intervention | Experimental | Participants in this group will receive 6 sessions of treatment organized to prioritize skills that capitalize on patient strengths. Receives: Behavioral: Capitalization UP Treatment |
| Capitalization Group, Full Intervention | Experimental | Participants in this group will receive 12 sessions of treatment organized to prioritize skills that capitalize on patient strengths. Receives: Behavioral: Capitalization UP Treatment |
| Compensation Group, Brief Intervention | Experimental | Participants in this group will receive 6 sessions of treatment organized to prioritize skills that compensate for patient weaknesses. Receives: Behavioral: Compensation UP Treatment |
| Compensation Group, Full Intervention | Experimental | Participants in this group will receive 12 sessions of treatment organized to prioritize skills that compensate for patient weaknesses. Receives: Behavioral: Compensation UP Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Severity
Clinical severity will be measured using the Diagnostic Interview for Anxiety, Mood, and Obsessive Compulsive and Related Neuropsychiatric Disorders (DIAMOND) dimensional clinician ratings. Scores range from 1-7; higher scores indicate greater severity.
Measured: 12 weeks (baseline, week 6 and week 12)
Change in Anxiety Symptoms
Anxiety symptoms will be measured using the Overall Anxiety Severity and Interference Scale (OASIS). This is a self-report measure in which scores range from 0-20; higher scores indicate more severe anxiety symptoms.
Measured: 12 weeks (baseline, week 1, week, 2, week, 3.....week 12)
Change in Depressive Symptoms
Depressive symptoms will be measured using the Overall Depression Severity and Interference Scale (ODSIS). This is a self-report measure in which scores range from 0-20; higher scores indicate more severe anxiety symptoms.
Measured: 12 weeks (baseline, week 1, week, 2, week, 3.....week 12)
Change in Aversive Reactions to Emotions
Aversive reactions to emotions will be measured using the distress aversion subscale of the Multidimensional Experiential Avoidance Questionnaire (MEAQ). This is a self-report measure in which scores range from 13-78; higher scores indicate greater negative reactions to emotional experiences.
Measured: 12 weeks (baseline, week 1, week, 2, week, 3.....week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start28 Oct 2019
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shannon E. Sauer-Zavala
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shannon E. Sauer-Zavala, University of Kentucky
- Investigators
- Shannon Sauer-Zavala, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584879
- Sponsor's protocol ID
- 53545
- Status last verified
- Oct 2020
- First submitted
- 6 Oct 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Southward MW, Terrill DR, Sauer-Zavala S. The effects of the Unified Protocol and Unified Protocol skills on loneliness in the COVID-19 pandemic. Depress Anxiety. 2022 Dec;39(12):913-921. doi: 10.1002/da.23297. Epub 2022 Nov 13.
PubMed 36372958
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdiagnostic Treatment Personalization: Prioritizing Therapy Components to Capitalize on Strengths or Compensate for Weaknesses
- ClinicalTrials.gov ID
- NCT04584879
- Acronym / sponsor ID
- 53545
- Conditions
- Anxiety Disorders, Depressive Disorder, Post Traumatic Stress Disorder, Obsessive-Compulsive Disorder
- Keywords
- Unified Protocol, Cognitive Behavioral Therapy, Personalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Shannon E. Sauer-ZavalaUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 14 Oct 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.
The primary purpose of this study is to explore whether the efficiency of treatment for anxiety and depressive disorders can be increased using two discrete strategies: personalized skill ordering and 2) treatment discontinuation based on proximal indicators of improvements. The present study will specifically use treatment components drawn from an evidence-based psychological intervention, the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP). This intervention has strong empirical support for patients presenting with anxiety, depressive, and related disorders and contains therapeutic skills that are common in psychological interventions (e.g., psychoeducation, mindfulness training, cognitive restructuring, countering emotional avoidance, increasing interoceptive tolerance). This study will determine if prioritizing the order of treatment modules to capitalize on patient strengths or compensate for weakensses increases treatmen efficacy. Additionally, it will also identify under what conditions briefer treatment modules may be appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Standard Group, Brief Intervention | Experimental | Behavioral: Standard UP TreatmentParticipants in this group will receive 6 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual. |
| Standard Group, Full Intervention | Experimental | Behavioral: Standard UP TreatmentParticipants in this group will receive 12 sessions of treatment in accordance with the standard, published Unified Protocol (UP) manual. |
| Capitalization Group, Brief Intervention | Experimental | Behavioral: Capitalization UP TreatmentParticipants in this group will receive 6 sessions of treatment organized to prioritize skills that capitalize on patient strengths. |
| Capitalization Group, Full Intervention | Experimental | Behavioral: Capitalization UP TreatmentParticipants in this group will receive 12 sessions of treatment organized to prioritize skills that capitalize on patient strengths. |
| Compensation Group, Brief Intervention | Experimental | Behavioral: Compensation UP TreatmentParticipants in this group will receive 6 sessions of treatment organized to prioritize skills that compensate for patient weaknesses. |
| Compensation Group, Full Intervention | Experimental | Behavioral: Compensation UP TreatmentParticipants in this group will receive 12 sessions of treatment organized to prioritize skills that compensate for patient weaknesses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of at least one emotional disorder
- fluent in English
- medication stability
Key exclusion criteria (3 listed)
- concurrent therapy
- psychological condition that would be better addressed by alternative treatments
- have received more than 5 sessions of cognitive behavioral therapy in the past 5 years
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 |
|---|---|---|
| Standard UP TreatmentParticipants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018). | Behavioural | Standard Group, Brief Intervention, Standard Group, Full Intervention |
| Capitalization UP TreatmentParticipants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths. | Behavioural | Capitalization Group, Brief Intervention, Capitalization Group, Full Intervention |
| Compensation UP TreatmentParticipants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses. | Behavioural | Compensation Group, Brief Intervention, Compensation Group, Full Intervention |
Primary outcome
Change in Clinical Severity
Time frame: 12 weeks (baseline, week 6 and week 12)
Clinical severity will be measured using the Diagnostic Interview for Anxiety, Mood, and Obsessive Compulsive and Related Neuropsychiatric Disorders (DIAMOND) dimensional clinician ratings. Scores range from 1-7; higher scores indicate greater severity.
Change in Anxiety Symptoms
Time frame: 12 weeks (baseline, week 1, week, 2, week, 3.....week 12)
Anxiety symptoms will be measured using the Overall Anxiety Severity and Interference Scale (OASIS). This is a self-report measure in which scores range from 0-20; higher scores indicate more severe anxiety symptoms.
Change in Depressive Symptoms
Time frame: 12 weeks (baseline, week 1, week, 2, week, 3.....week 12)
Depressive symptoms will be measured using the Overall Depression Severity and Interference Scale (ODSIS). This is a self-report measure in which scores range from 0-20; higher scores indicate more severe anxiety symptoms.
Change in Aversive Reactions to Emotions
Time frame: 12 weeks (baseline, week 1, week, 2, week, 3.....week 12)
Aversive reactions to emotions will be measured using the distress aversion subscale of the Multidimensional Experiential Avoidance Questionnaire (MEAQ). This is a self-report measure in which scores range from 13-78; higher scores indicate greater negative reactions to emotional experiences.
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 14 Oct 2020.
- Derived from this study: PubMed 36372958Southward MW, Terrill DR, Sauer-Zavala S. The effects of the Unified Protocol and Unified Protocol skills on loneliness in the COVID-19 pandemic. Depress Anxiety. 2022 Dec;39(12):913-921. doi: 10.1002/da.23297. Epub 2022 Nov 13.
- Individual participant dataSharing planned: No
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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.
Shannon Sauer-Zavala principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard UP Treatment, Capitalization UP Treatment and Compensation UP Treatment in people with Anxiety Disorders and Depressive Disorder, run by Shannon E. Sauer-Zavala 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 3 inclusion and 3 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 14 Oct 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. 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 Clinical Severity (time frame: 12 weeks (baseline, week 6 and week 12)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04584879, which also lists 1 linked publication.
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 14 Oct 2020.