NCT02605668

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
726

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 16, 2015

Completed
26 days until next milestone

Study Start

First participant enrolled

December 12, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2019

Completed
Last Updated

September 16, 2019

Status Verified

September 1, 2019

Enrollment Period

3.6 years

First QC Date

August 24, 2015

Last Update Submit

September 12, 2019

Conditions

Panic DisorderAgoraphobiaSpecific PhobiasSocial Anxiety Disorder

Keywords

Anxiety DisordersExtinction LearningOptimized ExtinctionBehavioral TherapyMassed ConfrontationSocial Anxiety DisorderSpecific PhobiaPanic DisorderAgoraphobia

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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)

    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

    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

    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

    assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy)

  • +10 more secondary outcomes

Study Arms (2)

Intensified Psychological Intervention

EXPERIMENTAL

Intensified psychological intervention (Cognitive Behavioral Therapy), based on optimized extinction learning

Behavioral: Intensified psychological intervention

Treatment As Usual

ACTIVE COMPARATOR

Standard intervention (Cognitive Behavioral Therapy) without optimized extinction learning

Behavioral: Standard intervention

Interventions

Intensified psychological interventionBEHAVIORAL

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)

Intensified Psychological Intervention
Standard interventionBEHAVIORAL

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)

Treatment As Usual

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technische Universität Dresden, Institute of Clinical Psychology and Psychotherapy

Dresden, Saxony, 01187, Germany

Location

Related Publications (1)

  • 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.

    PMID: 28322476BACKGROUND

MeSH Terms

Conditions

Panic DisorderAgoraphobiaPhobia, SpecificPhobia, SocialAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental DisordersPhobic Disorders

Study Officials

  • Hans-Ulrich Wittchen, Ph.D.

    Technische Universität Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2015

First Posted

November 16, 2015

Study Start

December 12, 2015

Primary Completion

July 24, 2019

Study Completion

July 24, 2019

Last Updated

September 16, 2019

Record last verified: 2019-09

Locations

DE(1)