Anxiety DisordersOPTIMAXNCT03945617
Optimizing Psychotherapy for Anxiety Disorders
A study testing Unified Treatment Protocol in people with Anxiety Disorders, run by University of Zurich at 1 site in Switzerland.
Trial summary
Anxiety disorders are highly prevalent and are associated with a high burden of disease, costs and individual impairment worldwide. Psychotherapy, especially cognitive behavioral therapy (CBT), is the first line treatment for anxiety disorders. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Unified Treatment Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2018to 31 Dec 2023
- 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
- aged between 18-65 years
- one of the following primary axis I disorders according to the Diagnostic and Statistical Manual of Mental Disorders (DSM): Panic Disorder with or without Agoraphobia; Social Anxiety Disorder; Anxiety Disorder not otherwise specified, Adjustment Disorder with Anxiety, Adjustment Disorder with Mixed Anxiety and Depression; Specific Phobia; Generalized Anxiety Disorder
- if on medication If on medication or in other types of treatments, patients must be willing to remain stable on their treatment for the duration of the acute phase/therapy of the study
- not currently receiving other psychotherapeutic treatment for anxiety or another condition
- fluent German
- provision of written informed consent
Who cannot join
- concomitant psychotherapy
- medical relative contraindications involve conditions that impede thorough exposure, e.g. cardiovascular diseases, autoimmune diseases or pregnancy
- current or past schizophrenia, psychosis, or bipolar disorder
- current suicidal ideation.
- current substance/alcohol dependence or abuse
- cluster A or B personality disorder
- pregnancy (for women)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University of Zurich
Zurich, 8032
Ava Schulz, Dr., 044(0)3891582, ava.schulz@uzh.ch
Christina Paersch, Dipl.-Psych., +41443891582, christina.paersch@uzh.ch
About this study
Anxiety disorders are highly prevalent and are associated with a high burden of disease, costs and individual impairment worldwide. Psychotherapy, especially cognitive behavioral therapy (CBT), is the first line treatment for anxiety disorders. CBT is effective in modifying dysfunctional cognitions and reducing avoidance behavior, thus leading to a lasting reduction of symptoms.
Even though CBT is generally effective, around 50% of patients do not benefit sufficiently from this treatment. The current study aims at optimizing the treatment of anxiety disorders by identifying predictors of treatment response. Multiple (neuro-)psychological, biological, genetic and behavioral variables will be combined into a comprehensive prediction model of treatment outcome. Knowledge on predictors can then be used to improve therapy on an individual patient level.
- Conditions
- Anxiety Disorders
- Being tested
- Unified Treatment Protocol
- Keywords
- anxiety, cognitive behavior therapy, transdiagnostic treatment, prediction
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified Treatment ProtocolBehavioural
The Unified Treatment Protocol (UP) is a transdiagnostic psychotherapeutic treatment manual for emotional disorders, that is based on CBT principles and focuses on changing dysfunctional emotion regulation.
| Study group | Role | What they receive |
|---|---|---|
| Unified treatment protocol | Experimental | This intervention group receives 16 sessions of CBT-based, individual psychotherapy using to the Unified Treatment Protocol for the treatment of emotional disorders by Barlow et al. (2011). Receives: Behavioral: Unified Treatment Protocol |
| Waitlist Control Group | No intervention | Participants in the waitlist control group gain access to the Unified Treatment after a waiting period of 16 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Anxiety Rating Scale
clinician rating of anxiety symptoms, range: 0-56, with higher values representing a worse outcome
Measured: change from T0 (entry to study) at mid-treatment (8 weeks after T0), change from T0 at post-treatment (after 16 weeks from T0), change from T0 at 6 months follow-up and change from T0 at one year from post-treatment
Overall Anxiety Severity and Impairment Scale
self-report measure of anxiety symptom severity and impairment; range: 0-20, with higher values representing worse outcome
Measured: change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment
Secondary outcomes (5)
Hamilton Depression Scale
clinician rating of depressive symptoms; range: 0-66, with higher values representing worse outcome
Measured: change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment
Beck Depression Inventory
self report measure of depression; range: 0-63, with higher values indicating worse outcome
Measured: change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment
Social Functioning Index (SFI)
change in social functioning; Subscales: "work" (range: 1-15) and "leisure time" (range: 1-30), with higher numbers indicating worse outcome
Measured: change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment
World Health Organization-5 Wellbeing Index
change in well-being; range: 0-25, with higher values indicating a better outcome
Measured: change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment
Beck Anxiety Inventory
self-report in anxiety symptoms, range 0-63, with higher values representing worse outcome
Measured: change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start1 Jan 2018
- Primary completion1 May 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Model description
- This is randomized controlled trial involving a before-after design with an intervention group that receives immediate access to treatment and a waitlist-control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Psychiatric University Hospital, Zurich, Swiss National Science Foundation, University of St.Gallen
- Responsible party
- Sponsor
- Investigators
- Birgit Kleim, Prof. Dr., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945617
- Sponsor's protocol ID
- 10001C_169827
- Acronym
- OPTIMAX
- Status last verified
- May 2019
- First submitted
- 27 Jul 2018
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Meine LE, Schaeuffele C, Recher D, Muller-Bardorff M, Paersch C, Schulz A, Galatzer-Levy I, Kleim B. Symptom Trajectories in Patients With Anxiety Disorders During Transdiagnostic Cognitive Behavioral Therapy. Depress Anxiety. 2026 Jul 21;2026:2743962. doi: 10.1155/da/2743962. eCollection 2026.
PubMed 42483149Meine LE, Muller-Bardorff M, Recher D, Paersch C, Schulz A, Spiller T, Galatzer-Levy I, Kowatsch T, Fisher AJ, Kleim B. Network analyses of ecological momentary emotion and avoidance assessments before and after cognitive behavioral therapy for anxiety disorders. J Anxiety Disord. 2024 Aug;106:102914. doi: 10.1016/j.janxdis.2024.102914. Epub 2024 Aug 13.
PubMed 39153405Muller-Bardorff M, Schulz A, Paersch C, Recher D, Schlup B, Seifritz E, Kolassa IT, Kowatsch T, Fisher A, Galatzer-Levy I, Kleim B. Optimizing Outcomes in Psychotherapy for Anxiety Disorders Using Smartphone-Based and Passive Sensing Features: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 May 14;13:e42547. doi: 10.2196/42547.
PubMed 38743473
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Psychotherapy for Anxiety Disorders
- ClinicalTrials.gov ID
- NCT03945617
- Acronym / sponsor ID
- OPTIMAX / 10001C_169827
- Conditions
- Anxiety Disorders
- Keywords
- anxiety, cognitive behavior therapy, transdiagnostic treatment, prediction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Psychiatric University Hospital, Zurich, Swiss National Science Foundation, University of St.Gallen
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 May 2019 (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.
Anxiety disorders are highly prevalent and are associated with a high burden of disease, costs and individual impairment worldwide. Psychotherapy, especially cognitive behavioral therapy (CBT), is the first line treatment for anxiety disorders. CBT is effective in modifying dysfunctional cognitions and reducing avoidance behavior, thus leading to a lasting reduction of symptoms.
Even though CBT is generally effective, around 50% of patients do not benefit sufficiently from this treatment. The current study aims at optimizing the treatment of anxiety disorders by identifying predictors of treatment response. Multiple (neuro-)psychological, biological, genetic and behavioral variables will be combined into a comprehensive prediction model of treatment outcome. Knowledge on predictors can then be used to improve therapy on an individual patient level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is randomized controlled trial involving a before-after design with an intervention group that receives immediate access to treatment and a waitlist-control group.
| Arm | Type | Receives |
|---|---|---|
| Unified treatment protocol | Experimental | Behavioral: Unified Treatment ProtocolThis intervention group receives 16 sessions of CBT-based, individual psychotherapy using to the Unified Treatment Protocol for the treatment of emotional disorders by Barlow et al. (2011). |
| Waitlist Control Group | No intervention | –Participants in the waitlist control group gain access to the Unified Treatment after a waiting period of 16 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged between 18-65 years
- one of the following primary axis I disorders according to the Diagnostic and Statistical Manual of Mental Disorders (DSM): Panic Disorder with or without Agoraphobia; Social Anxiety Disorder; Anxiety Disorder not otherwise specified, Adjustment Disorder with Anxiety, Adjustment Disorder with Mixed Anxiety and Depression; Specific Phobia; Generalized Anxiety Disorder
- if on medication If on medication or in other types of treatments, patients must be willing to remain stable on their treatment for the duration of the acute phase/therapy of the study
- not currently receiving other psychotherapeutic treatment for anxiety or another condition
- fluent German
Key exclusion criteria (7 listed)
- concomitant psychotherapy
- medical relative contraindications involve conditions that impede thorough exposure, e.g. cardiovascular diseases, autoimmune diseases or pregnancy
- current or past schizophrenia, psychosis, or bipolar disorder
- current suicidal ideation.
- current substance/alcohol dependence or abuse
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 |
|---|---|---|
| Unified Treatment ProtocolThe Unified Treatment Protocol (UP) is a transdiagnostic psychotherapeutic treatment manual for emotional disorders, that is based on CBT principles and focuses on changing dysfunctional emotion regulation. | Behavioural | Unified treatment protocol |
Primary outcome
Hamilton Anxiety Rating Scale
Time frame: change from T0 (entry to study) at mid-treatment (8 weeks after T0), change from T0 at post-treatment (after 16 weeks from T0), change from T0 at 6 months follow-up and change from T0 at one year from post-treatment
clinician rating of anxiety symptoms, range: 0-56, with higher values representing a worse outcome
Overall Anxiety Severity and Impairment Scale
Time frame: change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment
self-report measure of anxiety symptom severity and impairment; range: 0-20, with higher values representing worse outcome
5 secondary outcomes
Hamilton Depression Scale
Time frame: change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment
Beck Depression Inventory
Time frame: change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment
Social Functioning Index (SFI)
Time frame: change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment
World Health Organization-5 Wellbeing Index
Time frame: change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment
Beck Anxiety Inventory
Time frame: change from T0 (entry to study), at mid-treatment (8 weeks after T0), change from T0 at post-treatment (16 weeks after T0), change from T0 at 6 months follow-up and change from T0 at one year post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Derived from this study: PubMed 42483149Meine LE, Schaeuffele C, Recher D, Muller-Bardorff M, Paersch C, Schulz A, Galatzer-Levy I, Kleim B. Symptom Trajectories in Patients With Anxiety Disorders During Transdiagnostic Cognitive Behavioral Therapy. Depress Anxiety. 2026 Jul 21;2026:2743962. doi: 10.1155/da/2743962. eCollection 2026.
- Derived from this study: PubMed 39153405Meine LE, Muller-Bardorff M, Recher D, Paersch C, Schulz A, Spiller T, Galatzer-Levy I, Kowatsch T, Fisher AJ, Kleim B. Network analyses of ecological momentary emotion and avoidance assessments before and after cognitive behavioral therapy for anxiety disorders. J Anxiety Disord. 2024 Aug;106:102914. doi: 10.1016/j.janxdis.2024.102914. Epub 2024 Aug 13.
- Derived from this study: PubMed 38743473Muller-Bardorff M, Schulz A, Paersch C, Recher D, Schlup B, Seifritz E, Kolassa IT, Kowatsch T, Fisher A, Galatzer-Levy I, Kleim B. Optimizing Outcomes in Psychotherapy for Anxiety Disorders Using Smartphone-Based and Passive Sensing Features: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 May 14;13:e42547. doi: 10.2196/42547.
- Individual participant dataSharing planned: Undecided
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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.
Birgit Kleim, Prof. Dr. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Treatment Protocol in people with Anxiety Disorders, run by University of Zurich at 1 site in Switzerland.
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 7 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: status not confirmed, as of the sponsor's last update on 10 May 2019. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Birgit Kleim, Prof. Dr. (+41 (0)44 384 23 51, b.kleim@psychologie.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Rating Scale (time frame: change from T0 (entry to study) at mid-treatment (8 weeks after T0), change from T0 at post-treatment (after 16 weeks from T0), change from T0 at 6 months follow-up and change from T0 at one year from post-treatment). The study lists 2 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 NCT03945617, which also lists 3 linked publications.
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 10 May 2019.