Generalized Anxiety DisorderIMPLEMENT2_0NCT03079336
Implementation of Psychological Treatment in Generalized Anxiety
A study testing Implementation - SOTA, Implementation - Prolonged focus on changes and Mastery your Anxiety and Worry (MAW) in people with Generalized Anxiety Disorder, run by University of Zurich at 1 site in Switzerland.
Trial summary
Pragmatic randomized controlled trial (expected N = 80) of cognitive-behavioral therapy (CBT) to contrast two psychotherapeutic implementation strategies (State-of-the-Art welcome phase vs. prolonged focus on sudden changes). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Implementation - SOTA, Implementation - Prolonged focus on changes and Mastery your Anxiety and Worry (MAW)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2017to May 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fulfill the diagnostic criteria for GAD based on the structured interview for DSM,
- are 18 years of age or older,
- Mastery of German language
- are seeking out a cognitive-behavioral therapy (CBT) for GAD at the outpatient clinic (Attenhoferstrasse 9) of the Institute for Psychology of the University of Zürich
- Informed consent as documented by signature
Who cannot join
- Acute Suicidal Ideation (BDI Suicide item > 1 or suicidal ideation in the telephone interview)
- Currently taking a psychotic or bipolar disorder medication, or
- Currently receiving treatment from a professional psychotherapist/psychiatrist.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Psychology, University of Zürich
Zurich, 8050
About this study
Official title: Design Development in Randomized Clinical Trials - Psychological Treatment in Generalized Anxiety
Pragmatic randomized controlled trial (expected N = 80) of cognitive-behavioral therapy (CBT) to contrast two psychotherapeutic implementation strategies (State-of-the-Art welcome phase vs. prolonged focus on sudden changes). Blinded allocation of implementation strategy for patients; open label for therapists (no blinding possible), randomized allocation for patients, therapist allocation via ABAB-design (crossed-therapist design). Post treatment self-reported outcome will be measured based on a latent outcome factor (i. e. "outcome composite").
Read the detailed description
State of research. The proposed trial has a common theme, i.e., the understanding of the enduring efficacy of psychological treatments in individuals who suffer from general anxiety disorder (GAD). There is meta-analytic evidence that bona fide psychotherapy is an effective treatment for GAD, but also for individuals that suffers from anxiety and depression. Nonetheless, in spite of the empirical evidence of the overall efficacy, there is a lack of randomized controlled studies that systematically investigate the therapists' variability (i. e. therapist effects) within the very same treatment protocol. The development of study designs to investigate potential health professional effects along treatment effects is a general claim for human interventions. This protocol includes one of the very first process-outcome trials in GAD that systematically examine theory-based patients' and therapists' characteristics simultaneously using longitudinal multilevel methodology.
Along with investigating therapist and patient characteristics, two methods for timing the check-in phase at the beginning of each session will be compared by keeping constant the standardized treatment manual for patients with GAD: (a) prolonged focus on subtle changes check-in condition lasting from 7 to 20 minutes and (b) a state of the art (SOA) check-in phase lasting from 5 to 10 minutes. To address the nested data structure, therapists will be allocated by a single-subject ABAB-design. A total of 80 patients (40 participants in each of the two conditions) with a primary GAD diagnosis will be treated by 20 advanced cognitive-behavioral therapy trainees at the psychotherapy outpatient clinic in the department of psychology at the university of Zürich.
Relevance. (a) Study population. GAD is a neglected disorder in the Swiss mental health system. GAD is associated with personal suffering, a reduced quality of life, and high economic costs. (b) Design development. Systematic integration of potential therapist effects is a neglected aspect in many areas of evidence-based human interventions (inside but also outside of psychological interventions). (c) Treatment development. Evidence-based treatments are usually far from being fully efficacious. There is a debate about innovative research agendas and how to foster the efficacy of such treatments. (d) Experimental process-outcome research. There is a need for future research to investigate theory-based therapist effects and in-session timing within rigorous experimental process-outcome research designs to better understand the factors involved in therapeutic change (e.g. http://www.nature.com/news/therapy-deficit-1.11477).
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Implementation - SOTA, Implementation - Prolonged focus on changes, Mastery your Anxiety and Worry (MAW)
- Keywords
- Randomized controlled design development, Translational Research, Psychological Interventions, Contextual Model of Psychotherapy
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation - SOTABehavioural
The implementation of an evidence-based treatment is largely principle-based - allowing considerable therapeutic flexibility in determining and timing of different treatment aspects. In this condition progress, subtle changes and sudden gains may be an explicit topic and there is no restraint to avoid such topics. However, the therapists are not obligated to take a systematized focus on potential subtle changes and they may use the timing of the sessions to involve the patients into the other tasks of therapy.
Implementation - Prolonged focus on changesBehavioural
Systematized sequence of exploration of subtle changes at a prolonged check-in phase: (1) the precise change situation, (2) related emotional states, (3) related helpful thoughts and self-verbalizations, (4) reinforcement of generalized self-efficacy and treatment motivation, (5) benefit for the upcoming session goals (Flückiger, Grosse Holtforth, et al. 2013, 2014).
Mastery your Anxiety and Worry (MAW)Behavioural
Also called Cognitive Behavioral Therapy
In the present study, the MAW-packet will be applied within a usual 16-session individual therapy format and up to 3 further booster sessions.
The session format of 50-60 minute usually consists of (a) a check-in phase of 5 to 15 minutes that includes a patients welcoming, reviewing self-help and agenda setting, (b) a working phase around 35-45 minutes that focuses on the previously agreed session goals, (c) a feedback phase of 5 to 10 minutes that summarizes the session and previews the upcoming self-help assignment.
| Study group | Role | What they receive |
|---|---|---|
| State of the art (SOTA) check-in phase | Experimental | The therapists will apply the usual SOTA check-in phase lasting between 5 and 10 minutes, as recommended in the preexisting guideline including reviewing progress in self-help and agenda setting (Zinbarg et al., 2006). Receives: Behavioral: Implementation - SOTA; Behavioral: Mastery your Anxiety and Worry (MAW) |
| Prolonged focus on subtle changes | Experimental | Based on the robust findings that over 90% of the patients will experience subtle changes, the therapists will extend the above mentioned check-in phase by systematized focus for 7 to 20 minutes capitalizing on small and subtle changes and exceptions. Receives: Behavioral: Implementation - Prolonged focus on changes; Behavioral: Mastery your Anxiety and Worry (MAW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 6 months treatment completion of a latent 5-facet, self-report outcome-factor
Latent factor of the below-mentioned 5 self-report questionnaires (outcome composite)
Measured: Baseline, treatment completion after 6 months (16 sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study startJan 2017
- Primary completionMay 2022
- Study completionMay 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Flueckiger, Prof Dr., Principal investigator, Department of Psychology, University of Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079336
- Sponsor's protocol ID
- PP00P1_163702
- Acronym
- IMPLEMENT2_0
- Status last verified
- May 2022
- First submitted
- 12 Jan 2017
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Fluckiger C, Visla A, Wolfer C, Hilpert P, Zinbarg RE, Lutz W, Grosse Holtforth M, Allemand M. Exploring change in cognitive-behavioral therapy for generalized anxiety disorder-A two-arms ABAB crossed-therapist randomized clinical implementation trial. J Consult Clin Psychol. 2021 May;89(5):454-468. doi: 10.1037/ccp0000639. Epub 2021 Apr 8.
PubMed 33829819Faleh R, Morelli S, Andriamiarana V, Roman ZJ, Fluckiger C, Brandt H. Dynamic latent class structural equation modeling: A hands-on tutorial for modeling intensive longitudinal data. Psychol Methods. 2026 Aug 10. doi: 10.1037/met0000849. Online ahead of print.
PubMed 42574109Visla A, Allemand M, Fluckiger C. Within- and between-patients associations between self-efficacy, outcome expectation, and symptom change in cognitive behavioral therapy for generalized anxiety disorder. J Clin Psychol. 2023 Jan;79(1):86-104. doi: 10.1002/jclp.23407. Epub 2022 Jul 4.
PubMed 35781807Visla A, Constantino MJ, Fluckiger C. Predictors of change in patient treatment outcome expectation during cognitive-behavioral psychotherapy for generalized anxiety disorder. Psychotherapy (Chic). 2021 Jun;58(2):219-229. doi: 10.1037/pst0000371.
PubMed 34410791Fluckiger C, Horvath AO, Brandt H. The evolution of patients' concept of the alliance and its relation to outcome: A dynamic latent-class structural equation modeling approach. J Couns Psychol. 2022 Jan;69(1):51-62. doi: 10.1037/cou0000555. Epub 2021 Jul 1.
PubMed 34197151Fluckiger C, Wolfer C, Held J, Hilpert P, Rubel J, Allemand M, Zinbarg RE, Visla A. How to customize a bona fide psychotherapy for generalized anxiety disorder? A two-arms, patient blinded, ABAB crossed-therapist randomized clinical implementation trial design [IMPLEMENT 2.0]. BMC Psychiatry. 2018 Apr 3;18(1):86. doi: 10.1186/s12888-018-1666-2.
PubMed 29614982
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design Development in Randomized Clinical Trials - Psychological Treatment in Generalized Anxiety
- ClinicalTrials.gov ID
- NCT03079336
- Acronym / sponsor ID
- IMPLEMENT2_0 / PP00P1_163702
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Randomized controlled design development, Translational Research, Psychological Interventions, Contextual Model of Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- May 2022 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 14 Mar 2017 (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.
Pragmatic randomized controlled trial (expected N = 80) of cognitive-behavioral therapy (CBT) to contrast two psychotherapeutic implementation strategies (State-of-the-Art welcome phase vs. prolonged focus on sudden changes). Blinded allocation of implementation strategy for patients; open label for therapists (no blinding possible), randomized allocation for patients, therapist allocation via ABAB-design (crossed-therapist design). Post treatment self-reported outcome will be measured based on a latent outcome factor (i. e. "outcome composite").
Detailed description
State of research. The proposed trial has a common theme, i.e., the understanding of the enduring efficacy of psychological treatments in individuals who suffer from general anxiety disorder (GAD). There is meta-analytic evidence that bona fide psychotherapy is an effective treatment for GAD, but also for individuals that suffers from anxiety and depression. Nonetheless, in spite of the empirical evidence of the overall efficacy, there is a lack of randomized controlled studies that systematically investigate the therapists' variability (i. e. therapist effects) within the very same treatment protocol. The development of study designs to investigate potential health professional effects along treatment effects is a general claim for human interventions. This protocol includes one of the very first process-outcome trials in GAD that systematically examine theory-based patients' and therapists' characteristics simultaneously using longitudinal multilevel methodology.
Along with investigating therapist and patient characteristics, two methods for timing the check-in phase at the beginning of each session will be compared by keeping constant the standardized treatment manual for patients with GAD: (a) prolonged focus on subtle changes check-in condition lasting from 7 to 20 minutes and (b) a state of the art (SOA) check-in phase lasting from 5 to 10 minutes. To address the nested data structure, therapists will be allocated by a single-subject ABAB-design. A total of 80 patients (40 participants in each of the two conditions) with a primary GAD diagnosis will be treated by 20 advanced cognitive-behavioral therapy trainees at the psychotherapy outpatient clinic in the department of psychology at the university of Zürich.
Relevance. (a) Study population. GAD is a neglected disorder in the Swiss mental health system. GAD is associated with personal suffering, a reduced quality of life, and high economic costs. (b) Design development. Systematic integration of potential therapist effects is a neglected aspect in many areas of evidence-based human interventions (inside but also outside of psychological interventions). (c) Treatment development. Evidence-based treatments are usually far from being fully efficacious. There is a debate about innovative research agendas and how to foster the efficacy of such treatments. (d) Experimental process-outcome research. There is a need for future research to investigate theory-based therapist effects and in-session timing within rigorous experimental process-outcome research designs to better understand the factors involved in therapeutic change (e.g. http://www.nature.com/news/therapy-deficit-1.11477).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| State of the art (SOTA) check-in phase | Experimental | Behavioral: Implementation - SOTA, Behavioral: Mastery your Anxiety and Worry (MAW)The therapists will apply the usual SOTA check-in phase lasting between 5 and 10 minutes, as recommended in the preexisting guideline including reviewing progress in self-help and agenda setting (Zinbarg et al., 2006). |
| Prolonged focus on subtle changes | Experimental | Behavioral: Implementation - Prolonged focus on changes, Behavioral: Mastery your Anxiety and Worry (MAW)Based on the robust findings that over 90% of the patients will experience subtle changes, the therapists will extend the above mentioned check-in phase by systematized focus for 7 to 20 minutes capitalizing on small and subtle changes and exceptions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- fulfill the diagnostic criteria for GAD based on the structured interview for DSM,
- are 18 years of age or older,
- Mastery of German language
- are seeking out a cognitive-behavioral therapy (CBT) for GAD at the outpatient clinic (Attenhoferstrasse 9) of the Institute for Psychology of the University of Zürich
- Informed consent as documented by signature
Key exclusion criteria (3 listed)
- Acute Suicidal Ideation (BDI Suicide item > 1 or suicidal ideation in the telephone interview)
- Currently taking a psychotic or bipolar disorder medication, or
- Currently receiving treatment from a professional psychotherapist/psychiatrist.
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 |
|---|---|---|
| Implementation - SOTAThe implementation of an evidence-based treatment is largely principle-based - allowing considerable therapeutic flexibility in determining and timing of different treatment aspects. In this condition progress, subtle changes and sudden gains may be an explicit topic and there is no restraint to avoid such topics. However, the therapists are not obligated to take a systematized focus on potential subtle changes and they may use the timing of the sessions to involve the patients into the other tasks of therapy. | Behavioural | State of the art (SOTA) check-in phase |
| Implementation - Prolonged focus on changesSystematized sequence of exploration of subtle changes at a prolonged check-in phase: (1) the precise change situation, (2) related emotional states, (3) related helpful thoughts and self-verbalizations, (4) reinforcement of generalized self-efficacy and treatment motivation, (5) benefit for the upcoming session goals (Flückiger, Grosse Holtforth, et al. 2013, 2014). | Behavioural | Prolonged focus on subtle changes |
| Mastery your Anxiety and Worry (MAW)Also: Cognitive Behavioral TherapyIn the present study, the MAW-packet will be applied within a usual 16-session individual therapy format and up to 3 further booster sessions. The session format of 50-60 minute usually consists of (a) a check-in phase of 5 to 15 minutes that includes a patients welcoming, reviewing self-help and agenda setting, (b) a working phase around 35-45 minutes that focuses on the previously agreed session goals, (c) a feedback phase of 5 to 10 minutes that summarizes the session and previews the upcoming self-help assignment. | Behavioural | Prolonged focus on subtle changes, State of the art (SOTA) check-in phase |
Primary outcome
Change from baseline to 6 months treatment completion of a latent 5-facet, self-report outcome-factor
Time frame: Baseline, treatment completion after 6 months (16 sessions)
Latent factor of the below-mentioned 5 self-report questionnaires (outcome composite)
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 26 May 2022.
- Results publication: PubMed 33829819Fluckiger C, Visla A, Wolfer C, Hilpert P, Zinbarg RE, Lutz W, Grosse Holtforth M, Allemand M. Exploring change in cognitive-behavioral therapy for generalized anxiety disorder-A two-arms ABAB crossed-therapist randomized clinical implementation trial. J Consult Clin Psychol. 2021 May;89(5):454-468. doi: 10.1037/ccp0000639. Epub 2021 Apr 8.
- Derived from this study: PubMed 42574109Faleh R, Morelli S, Andriamiarana V, Roman ZJ, Fluckiger C, Brandt H. Dynamic latent class structural equation modeling: A hands-on tutorial for modeling intensive longitudinal data. Psychol Methods. 2026 Aug 10. doi: 10.1037/met0000849. Online ahead of print.
- Derived from this study: PubMed 35781807Visla A, Allemand M, Fluckiger C. Within- and between-patients associations between self-efficacy, outcome expectation, and symptom change in cognitive behavioral therapy for generalized anxiety disorder. J Clin Psychol. 2023 Jan;79(1):86-104. doi: 10.1002/jclp.23407. Epub 2022 Jul 4.
- Derived from this study: PubMed 34410791Visla A, Constantino MJ, Fluckiger C. Predictors of change in patient treatment outcome expectation during cognitive-behavioral psychotherapy for generalized anxiety disorder. Psychotherapy (Chic). 2021 Jun;58(2):219-229. doi: 10.1037/pst0000371.
- Derived from this study: PubMed 34197151Fluckiger C, Horvath AO, Brandt H. The evolution of patients' concept of the alliance and its relation to outcome: A dynamic latent-class structural equation modeling approach. J Couns Psychol. 2022 Jan;69(1):51-62. doi: 10.1037/cou0000555. Epub 2021 Jul 1.
- Derived from this study: PubMed 29614982Fluckiger C, Wolfer C, Held J, Hilpert P, Rubel J, Allemand M, Zinbarg RE, Visla A. How to customize a bona fide psychotherapy for generalized anxiety disorder? A two-arms, patient blinded, ABAB crossed-therapist randomized clinical implementation trial design [IMPLEMENT 2.0]. BMC Psychiatry. 2018 Apr 3;18(1):86. doi: 10.1186/s12888-018-1666-2.
- 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.
Christoph Flueckiger, Prof Dr. principal investigator
Department of Psychology, University of Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation - SOTA, Implementation - Prolonged focus on changes and Mastery your Anxiety and Worry (MAW) in people with Generalized Anxiety Disorder, 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 5 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 26 May 2022. 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?
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 from baseline to 6 months treatment completion of a latent 5-facet, self-report outcome-factor (time frame: Baseline, treatment completion after 6 months (16 sessions)). 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 NCT03079336, which also lists 6 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 26 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.