Anxiety DisordersPhase 4NCT00071630
Therapeutic Processes and Treatment Outcome in Adolescents With Anxiety Disorders
A Phase 4 study testing Cognitive Behavioral Therapy in people with Anxiety Disorders, run by Temple University at 2 sites in 2 countries.
Trial summary
The purpose of this study is to examine the relationship between different aspects of cognitive behavior therapy (CBT) and treatment outcome. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 130 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2002to Aug 2005
- Phase
- Phase 4
- 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 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of separation anxiety disorder, generalized anxiety disorder, or social phobia
- At least one English-speaking parent
Who cannot join
- IQ < 80
- Psychotic symptoms
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Process as a Predictor of Outcomes in CBT for Youth
The purpose of this study is to examine the relationship between different aspects of cognitive behavior therapy (CBT) and treatment outcome.
Read the detailed description
Anxiety disorders are common among children; if untreated, they can negatively affect children's lives. Evidence suggests that CBT can benefit children with anxiety disorders, but the causal mechanisms between therapy and beneficial outcomes have not been thoroughly investigated.
Audio and videotaped sessions of children currently receiving CBT and those who received CBT in previous trials will be examined. Various rating scales will be used to rate therapeutic alliance, child involvement, and therapist flexibility for each session of CBT. To evaluate potential process variables that contribute to participant drop-out, this study will compare the early process variables for children who complete treatment and for those who discontinue treatment.
- Conditions
- Anxiety Disorders
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- Adolescent
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2003 (estimated)
- Study startSep 2002
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071630
- Sponsor's protocol ID
- R01MH064484
- Other IDs
- R01MH064484, DSIR CT-S
- Status last verified
- Sep 2008
- First submitted
- 29 Oct 2003
- Last updated
- 7 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Process as a Predictor of Outcomes in CBT for Youth
- ClinicalTrials.gov ID
- NCT00071630
- Acronym / sponsor ID
- R01MH064484
- Conditions
- Anxiety Disorders
- Keywords
- Adolescent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2002
- Study completion
- Aug 2005
- First posted
- 30 Oct 2003 (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.
The purpose of this study is to examine the relationship between different aspects of cognitive behavior therapy (CBT) and treatment outcome.
Detailed description
Anxiety disorders are common among children; if untreated, they can negatively affect children's lives. Evidence suggests that CBT can benefit children with anxiety disorders, but the causal mechanisms between therapy and beneficial outcomes have not been thoroughly investigated.
Audio and videotaped sessions of children currently receiving CBT and those who received CBT in previous trials will be examined. Various rating scales will be used to rate therapeutic alliance, child involvement, and therapist flexibility for each session of CBT. To evaluate potential process variables that contribute to participant drop-out, this study will compare the early process variables for children who complete treatment and for those who discontinue treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosis of separation anxiety disorder, generalized anxiety disorder, or social phobia
- At least one English-speaking parent
Key exclusion criteria (2 listed)
- IQ < 80
- Psychotic symptoms
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 |
|---|---|---|
| Cognitive Behavioral Therapy | Behavioural | – |
Primary outcome
Not reported in the source record.
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 7 Nov 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cognitive Behavioral Therapy in people with Anxiety Disorders, run by Temple University at 2 sites in 2 countries.
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 2 inclusion and 2 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 7 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Australia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
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 7 Nov 2013; AzTrials last refreshed its copy on 8 Nov 2026.