Panic DisorderPROTECT-ADNCT02605668
Providing Tools for Effective Care and Treatment of Anxiety Disorders
A study testing Intensified psychological intervention and Standard intervention in people with Panic Disorder and Agoraphobia, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
PROTECT-AD is a cognitive behavioral treatment study involving highly qualified psychotherapeutic centers at seven German universities. It is our goal to further investigate and optimize existing effective treatments of anxiety disorders. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Panic Disorder, Agoraphobia, Specific Phobias
- What is being tested?
- Intensified psychological intervention and Standard intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 726 participants
- Where
- 1 siteGermany
- Study dates
- 12 Dec 2015to 24 Jul 2019
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age 15 - 70 years
- one or more of the following DSM-IV/5 anxiety disorders: Panic Disorder, Agoraphobia, Social Anxiety Disorder, Specific Phobia
- HAMA - Score > 18
- CGI - Score > 3
- Can attend therapy regularly (with or without support)
- Informed Consent
Who cannot join
- Every reason the protocol may not be upheld (e.g. planned hospitalization within study time frame, planning to move away, etc.)
- Current suicidal tendency
- DSM-5 Bipolar Disorder
- DSM-5 Psychotic Disorder
- DSM-5 Borderline Personality Disorder
- Current treatment of other mental disorder (drugs, psychotherapy)
- Current Alcohol, Benzodiazepine or other Substance Use Disorders
- Severe medical illness/condition (every serious physical illness, including cardiovascular, kidney, endocrinological and neurological conditions, Hepatitis or other clinical findings that suggest a severe illness and may affect participation in the study)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Technische Universität Dresden, Institute of Clinical Psychology and Psychotherapy
Dresden, Saxony, 01187
About this study
Official title: Providing Tools for Effective Care and Treatment of Anxiety Disorders (AD): Outcomes, Mediators and Moderators of Enhanced Extinction
PROTECT-AD is a cognitive behavioral treatment study involving highly qualified psychotherapeutic centers at seven German universities.
It is our goal to further investigate and optimize existing effective treatments of anxiety disorders. In order to achieve this, the investigators want to investigate the effect of extinction learning in an "intensified" psychological intervention on treatment outcome in adults and children with anxiety disorders.
The intensified psychological intervention is characterized by a higher number of exposure trials over a short time period. In the control condition the exposure trials take place in a weekly interval, analog to standard care.
Read the detailed description
Novel preclinical research evidence suggests extinction learning as the core mechanism of action of exposure-based therapies and provides according strategies to improve the effectiveness of treatment by optimized extinction. A translational research agenda is suggested to examine whether enhanced extinction learning components derived from preclinical research, applied within an "intensified" exposure-based treatment, improves outcomes. In a multicenter randomized clinical trial, linked to mechanistic subprojects, the investigators test in n=620 patients with primary AD allowing for comorbidity whether intensified psychological interventions based on augmented extinction learning (IPI) result in faster, stronger and more persistent outcomes on subjective, clinical, behavioral, physiological and neural indices as compared to an, otherwise identical, standard research treatment without explicit enhanced extinction (TAU). The investigators hypothesize that (a) enhanced extinction elements (IPI) will result in higher effect sizes, faster recovery, (b) more pronounced changes in an array of systems, including elements of extinction learning and in objective behavioral measures assessed in intersession exposure trials. The investigators also examine moderators of outcome (i.e. type of diagnosis, comorbidity) and explore whether IPI is associated with lower health care costs.
- Conditions
- Panic Disorder, Agoraphobia, Specific Phobias, Social Anxiety Disorder
- Being tested
- Intensified psychological intervention, Standard intervention
- Keywords
- Anxiety Disorders, Extinction Learning, Optimized Extinction, Behavioral Therapy, Massed Confrontation, Social Anxiety Disorder, Specific Phobia, Panic Disorder, Agoraphobia
- Medical subject headings
- Panic Disorder, Agoraphobia, Phobia, Specific, Phobia, Social, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensified psychological interventionBehavioural
12 sessions of Cognitive Behavioral Therapy a 100 minutes, over the course of 6 weeks (2 sessions per week/week 1 and 2, 3 sessions per week/week 3 und 4, 1 session per week/week 5 and 6)
Standard interventionBehavioural
12 sessions of Cognitive Behavioral Therapy a 100 minutes, over the course of 10 weeks (2 sessions per week/week 1 and 2, 1 session per week/week 3 to 10)
| Study group | Role | What they receive |
|---|---|---|
| Intensified Psychological Intervention | Experimental | Intensified psychological intervention (Cognitive Behavioral Therapy), based on optimized extinction learning Receives: Behavioral: Intensified psychological intervention |
| Treatment As Usual | Active comparator | Standard intervention (Cognitive Behavioral Therapy) without optimized extinction learning Receives: Behavioral: Standard intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in somatic and psychic anxiety symptoms
Anxiety symptoms are assessed using the clinician-rated Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A for the HAMA). Stronger, faster and more persistent reduction of anxiety symptoms in the IPI group than in the TAU group is expected.
Measured: assessed three times: Baseline, Post (1 week after end of therapy) and Follow up (6 months after end of therapy)
Secondary outcomes (15)
change in severity of the anxiety disorder
Severity of the anxiety disorder is assessed by the clinician-rated Clinical Global Impression Scale (CGI). It is anchored for anxiety disorders.
Measured: assessed five times: Baseline, therapy session 4 (week 2 of therapy), therapy session 11 (week 5 to week 9 of therapy), Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in categorial diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV/5)
categorical diagnoses are assessed using a German version of the Composite International Diagnostic Interview (CIDI).
Measured: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in screened anxiety symptoms
The DSM-5 cross-cutting symptom measure for anxiety disorders ("Cross-D") is used as a brief screener for anxiety symptoms.
Measured: assessed fivetimes: Baseline, therapy session 4 (week 2 of therapy), therapy session 11 (week 5 to week 9 of therapy), Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in depressive symptoms
depressive symptoms are assessed using the Beck Depression Inventory (BDI-II)
Measured: assessed fivetimes: Baseline, therapy session 4 (week 2 of therapy), therapy session 11 (week 5 to week 9 of therapy), Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in anxiety sensitivity
anxiety sensitivity is assessed using the Anxiety sensitivity inventory (ASI)
Measured: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in panic and agoraphobic symptoms
panic and agoraphobic symptoms are assessed using the Panic and agoraphobia scale (PAS)
Measured: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in agoraphobic avoidance
agoraphobic avoidance is assessed using the Mobility Inventory (MI)
Measured: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in symptoms of Generalized Anxiety Disorder
symptoms of generalized anxiety disorder (GAD)are assessed using the GAD-7
Measured: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in social anxiety
social anxiety is assessed using the Liebowitz Social Anxiety Scale (LSAS)
Measured: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in Specific Phobia symptoms
symptoms of specific phobia are assessed using an adapted version of the DSM-5 dimensional scale for specific phobias
Measured: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in disability
Disability is assessed using the 12-item version of the World Health Organization Disability Schedule (WHODAS 2.0)
Measured: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in quality of life
Quality of life is assessed using the EuroQol five-dimensional measure for quality of life (EQ5D)
Measured: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in psychopathological symptoms
psychopathological symptoms are assessed using the Brief Symptom Inventory (BSI), a short form of the Symptom Checklist 90 (SCL-90). At Baseline, Post and Follow Up, the 53 item Version is used, during therapy the 18 item version is used
Measured: assessed seven times: Baseline, therapy sessions 2 (week 1 of therapy), 4 (week 2), 7 (week 3 to 5), 10 (week 4 to 8), 11 (week 5 to 9), 12 (week 6 to 10) Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in agoraphobic cognitions
agoraphobic cognitions are assessed using the Agoraphobic Cognitions Questionnaire (ACQ)
Measured: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
fear of body sensations
fear of body sensations is assessed using the Body Sensations Questionnaire (BSQ)
Measured: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study start12 Dec 2015
- Primary completion24 Jul 2019
- Study completion24 Jul 2019
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 Panic DisorderStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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
- None (open label)
- Enrolment
- 726 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Ruhr University of Bochum, University Medicine Greifswald, Charite University, Berlin, Germany, University of Wuerzburg, Philipps University Marburg, Wuerzburg University Hospital, Universität Münster
- Responsible party
- Sponsor
- Investigators
- Hans-Ulrich Wittchen, Ph.D., Principal investigator, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605668
- Sponsor's protocol ID
- 01EE1402A
- Other IDs
- DRKS00008743
- Acronym
- PROTECT-AD
- Status last verified
- Sep 2019
- First submitted
- 24 Aug 2015
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Heinig I, Pittig A, Richter J, Hummel K, Alt I, Dickhover K, Gamer J, Hollandt M, Koelkebeck K, Maenz A, Tennie S, Totzeck C, Yang Y, Arolt V, Deckert J, Domschke K, Fydrich T, Hamm A, Hoyer J, Kircher T, Lueken U, Margraf J, Neudeck P, Pauli P, Rief W, Schneider S, Straube B, Strohle A, Wittchen HU. Optimizing exposure-based CBT for anxiety disorders via enhanced extinction: Design and methods of a multicentre randomized clinical trial. Int J Methods Psychiatr Res. 2017 Jun;26(2):e1560. doi: 10.1002/mpr.1560. Epub 2017 Mar 21.
PubMed 28322476
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing Tools for Effective Care and Treatment of Anxiety Disorders (AD): Outcomes, Mediators and Moderators of Enhanced Extinction
- ClinicalTrials.gov ID
- NCT02605668
- Acronym / sponsor ID
- PROTECT-AD / 01EE1402A
- Conditions
- Panic Disorder, Agoraphobia, Specific Phobias, Social Anxiety Disorder
- Keywords
- Anxiety Disorders, Extinction Learning, Optimized Extinction, Behavioral Therapy, Massed Confrontation, Social Anxiety Disorder, Specific Phobia, Panic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 726 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Ruhr University of Bochum, University Medicine Greifswald, Charite University, Berlin, Germany, University of Wuerzburg, Philipps University Marburg, Wuerzburg University Hospital, Universität Münster
- Study start
- 12 Dec 2015 (actual)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- 24 Jul 2019 (actual)
- First posted
- 16 Nov 2015 (estimated)
- 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.
PROTECT-AD is a cognitive behavioral treatment study involving highly qualified psychotherapeutic centers at seven German universities.
It is our goal to further investigate and optimize existing effective treatments of anxiety disorders. In order to achieve this, the investigators want to investigate the effect of extinction learning in an "intensified" psychological intervention on treatment outcome in adults and children with anxiety disorders.
The intensified psychological intervention is characterized by a higher number of exposure trials over a short time period. In the control condition the exposure trials take place in a weekly interval, analog to standard care.
Detailed description
Novel preclinical research evidence suggests extinction learning as the core mechanism of action of exposure-based therapies and provides according strategies to improve the effectiveness of treatment by optimized extinction. A translational research agenda is suggested to examine whether enhanced extinction learning components derived from preclinical research, applied within an "intensified" exposure-based treatment, improves outcomes. In a multicenter randomized clinical trial, linked to mechanistic subprojects, the investigators test in n=620 patients with primary AD allowing for comorbidity whether intensified psychological interventions based on augmented extinction learning (IPI) result in faster, stronger and more persistent outcomes on subjective, clinical, behavioral, physiological and neural indices as compared to an, otherwise identical, standard research treatment without explicit enhanced extinction (TAU). The investigators hypothesize that (a) enhanced extinction elements (IPI) will result in higher effect sizes, faster recovery, (b) more pronounced changes in an array of systems, including elements of extinction learning and in objective behavioral measures assessed in intersession exposure trials. The investigators also examine moderators of outcome (i.e. type of diagnosis, comorbidity) and explore whether IPI is associated with lower health care costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensified Psychological Intervention | Experimental | Behavioral: Intensified psychological interventionIntensified psychological intervention (Cognitive Behavioral Therapy), based on optimized extinction learning |
| Treatment As Usual | Active comparator | Behavioral: Standard interventionStandard intervention (Cognitive Behavioral Therapy) without optimized extinction learning |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- age 15 - 70 years
- one or more of the following DSM-IV/5 anxiety disorders: Panic Disorder, Agoraphobia, Social Anxiety Disorder, Specific Phobia
- HAMA - Score > 18
- CGI - Score > 3
- Can attend therapy regularly (with or without support)
Key exclusion criteria (8 listed)
- Every reason the protocol may not be upheld (e.g. planned hospitalization within study time frame, planning to move away, etc.)
- Current suicidal tendency
- DSM-5 Bipolar Disorder
- DSM-5 Psychotic Disorder
- DSM-5 Borderline Personality Disorder
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 |
|---|---|---|
| Intensified psychological intervention12 sessions of Cognitive Behavioral Therapy a 100 minutes, over the course of 6 weeks (2 sessions per week/week 1 and 2, 3 sessions per week/week 3 und 4, 1 session per week/week 5 and 6) | Behavioural | Intensified Psychological Intervention |
| Standard intervention12 sessions of Cognitive Behavioral Therapy a 100 minutes, over the course of 10 weeks (2 sessions per week/week 1 and 2, 1 session per week/week 3 to 10) | Behavioural | Treatment As Usual |
Primary outcome
change in somatic and psychic anxiety symptoms
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow up (6 months after end of therapy)
Anxiety symptoms are assessed using the clinician-rated Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A for the HAMA). Stronger, faster and more persistent reduction of anxiety symptoms in the IPI group than in the TAU group is expected.
15 secondary outcomes
change in severity of the anxiety disorder
Time frame: assessed five times: Baseline, therapy session 4 (week 2 of therapy), therapy session 11 (week 5 to week 9 of therapy), Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in categorial diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV/5)
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in screened anxiety symptoms
Time frame: assessed fivetimes: Baseline, therapy session 4 (week 2 of therapy), therapy session 11 (week 5 to week 9 of therapy), Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in depressive symptoms
Time frame: assessed fivetimes: Baseline, therapy session 4 (week 2 of therapy), therapy session 11 (week 5 to week 9 of therapy), Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in anxiety sensitivity
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in panic and agoraphobic symptoms
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in agoraphobic avoidance
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in symptoms of Generalized Anxiety Disorder
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in social anxiety
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in Specific Phobia symptoms
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in disability
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in quality of life
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in psychopathological symptoms
Time frame: assessed seven times: Baseline, therapy sessions 2 (week 1 of therapy), 4 (week 2), 7 (week 3 to 5), 10 (week 4 to 8), 11 (week 5 to 9), 12 (week 6 to 10) Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
change in agoraphobic cognitions
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
fear of body sensations
Time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)
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 16 Sep 2019.
- Background: PubMed 28322476Heinig I, Pittig A, Richter J, Hummel K, Alt I, Dickhover K, Gamer J, Hollandt M, Koelkebeck K, Maenz A, Tennie S, Totzeck C, Yang Y, Arolt V, Deckert J, Domschke K, Fydrich T, Hamm A, Hoyer J, Kircher T, Lueken U, Margraf J, Neudeck P, Pauli P, Rief W, Schneider S, Straube B, Strohle A, Wittchen HU. Optimizing exposure-based CBT for anxiety disorders via enhanced extinction: Design and methods of a multicentre randomized clinical trial. Int J Methods Psychiatr Res. 2017 Jun;26(2):e1560. doi: 10.1002/mpr.1560. Epub 2017 Mar 21.
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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.
Hans-Ulrich Wittchen, Ph.D. principal investigator
Technische Universität Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensified psychological intervention and Standard intervention in people with Panic Disorder and Agoraphobia, run by Technische Universität Dresden at 1 site in Germany.
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 8 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 16 Sep 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 Germany. 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 somatic and psychic anxiety symptoms (time frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow up (6 months after end of therapy)). 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 NCT02605668, 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 16 Sep 2019.