Building an Outcomes Assessment Infrastructure to Assess Anxiety Treatment

NCT02305537 | Completed

• 1 other identifier: 2014P000353
• Study Type: interventional
• Target: 559
• Locations: 1 country
• Sites: 1

Brief Summary

The collection of patient self-report and diagnostic data will allow us to examine the efficacy of the treatment delivered in the McLean Anxiety Mastery Program. Using data gathered through routine clinical care, the investigators seek to explore whether patients in treatment show improvements from admission to discharge, compared to patients on the waitlist, and whether these gains are maintained three months post-discharge. The following are included as examples of some of the study's hypotheses.

Conditions

Social Anxiety Disorder; Specific Phobia; Separation Anxiety Disorder; Panic Disorder; Agoraphobia; Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Score in Spence Children's Anxiety Scale (SCAS; Spence 1997).

  The SCAS is a 44-item self-report inventory that measures anxiety severity.

  Change between 0 weeks of treatment and after weeks of treatment, change between 4 weeks of treatment and 16 weeks after treatment

Secondary Outcomes (1)

• Change in Score in Center for Epidemiolgic Studies Depression Scale (CES-D; Radloff 1977).

  Change between 0 weeks of treatment and after weeks of treatment, change between 4 weeks of treatment and 16 weeks after treatment

Other Outcomes (1)

• Change in Score in Spence Children's Anxiety Scale (SCAS - Parent Report; Spence 2000).

  Change between 0 weeks of treatment and after weeks of treatment, change between 4 weeks of treatment and 16 weeks after treatment

Study Arms (2)

Treatment (Cognitive-Behavioral Therapy)

EXPERIMENTAL

Participants in the McLean Anxiety Mastery Program

Behavioral: McLean Anxiety Mastery Program

Waitlist

NO INTERVENTION

Participants on the waitlist for the McLean Anxiety Mastery Program

Interventions

McLean Anxiety Mastery Program BEHAVIORAL

Cognitive-Behavioral Therapy with Exposure and Response Prevention

Treatment (Cognitive-Behavioral Therapy)

Eligibility Criteria

• Age: 6 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All youth who are eligible to participate in the McLean Anxiety Mastery Program will be invited to participate in the research study.
• Eligibility criteria for the McLean Anxiety Mastery Program include:
• children and adolescents who are between the ages of 6 and 19 and
• who present with at least one of the following disorders:
• Separation Anxiety Disorder,
• Social Anxiety Disorder,
• Panic Disorder,
• Agoraphobia,
• Specific Phobia(s), and
• OCD.
• Interested and eligible patients and their caregivers should complete and submit an application (https://www.mcleanhospital.org/sites/default/files/2021-07/MAMP-Application-07032021\_0.pdf) to begin the phone screen process.

You may not qualify if:

• Patients ineligible for the treatment program, and therefore the study, include those who have engaged in substance abuse during the six weeks prior to the first evaluation (i.e., waitlist or admission) the phone screening,
• those who report that they are unwilling to refrain from self-injurious behaviors during the waitlist and treatment periods,
• those who are experiencing active symptoms of psychosis,
• those who exhibit severe behavioral disinhibition or aggression, and
• those who express an intent and/or plan to commit suicide or homicide at the time of their first evaluation the initial phone screening.
• Patients must be fluent in English to participate in the program because all off-grounds exposure groups will be conducted in English (whenever possible, however, translation services will be provided for patients whose parents are not fluent in English).

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Phobia, Social; Phobia, Specific; Anxiety, Separation; Panic Disorder; Agoraphobia; Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders; Neurodevelopmental Disorders

Study Officials

• Jacqueline Sperling, Ph.D.

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Program Director of the McLean Anxiety Mastery Program

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: December 2, 2014
• Study Start: October 1, 2014
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 20, 2025

Record last verified: 2023-03

Locations

US (1)