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Stress, Anxiety, and Mood Group Therapy

Primary Purpose

Depressive Disorders, Anxiety Disorders

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unified Protocol for The Treatment of Emotional Disorders
Sponsored by
Palo Alto University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorders focused on measuring depression, anxiety

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Normal color vision
  • Ability to travel to Palo Alto University
  • Experiencing symptoms of stress, anxiety, and/or depression

Sites / Locations

  • Palo Alto University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group therapy (Unified Protocol)

Arm Description

Participants experiencing stress, anxious, and/or depressive symptoms will receive 8 sessions of Unified Protocol for Emotional Disorders lasting for 90 minutes each. Includes psycho-education about (mal)adaptive emotion regulation, cognitive and behavioral tools to reduce symptoms of stress, anxiety, and/or depression.

Outcomes

Primary Outcome Measures

Level of depression as measured by the following questionnaire:
Mood and Anxiety Symptom Questionnaire- Anhedonic Depression subscale
Level of intolerance of uncertainty as measured by the following questionnaire:
Intolerance of Uncertainty Questionnaire
Level of rumination and reflection as measured by the following questionnaire:
Rumination Reflection Questionnaire
Level of anxious arousal as measured by the following questionnaire:
Mood and Anxiety Symptom Questionnaire- Anxious Apprehension subscale
Level of anxious apprehension as measured by the following questionnaire:
Penn State Worry Questionnaire
Level of alcohol use as measured by the following questionnaire:
Alcohol Use Disorders Identification Test
Level of positive and negative emotions as measured by the following questionnaire:
The Positive and Negative Affect Schedule
Level of behavioral regulation and metacognition as measured by the following questionnaire:
Behavioral Regulation Index and Metacognition Index
Level of trait mood as measured by the following questionnaire:
Trait Meta-Mood Scale.
Level of emotion regulation as measured by the following questionnaire:
Emotion Regulation Questionnaire
Level of mental imagery as measured by the following questionnaire:
Questionnaire of Mental Imagery
Level of cognitive functioning via neuropsychological testing session
Objective assessment of cognitive strengths and weaknesses

Secondary Outcome Measures

Full Information

First Posted
February 10, 2019
Last Updated
September 16, 2020
Sponsor
Palo Alto University
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1. Study Identification

Unique Protocol Identification Number
NCT03855683
Brief Title
Stress, Anxiety, and Mood Group Therapy
Official Title
Transdiagnostic Interventions for Emotional Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Suspended
Why Stopped
Social distancing regulations related to COVID19.
Study Start Date
March 6, 2019 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Palo Alto University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to identify cognitive mechanisms that might facilitate treatment response for individuals experiencing depression and/or anxiety. The Stress, Anxiety, and Mood group helps individuals experiencing symptoms of stress, anxiety, and mood by providing concrete coping skills to regulate emotions, to let go of negative thoughts, and build courage to talk to others about tough topics. Groups meet for 8 weeks, with sessions lasting 90 minutes each. In addition to group therapy, you will be asked to complete some computerized and paper and pencil-based tasks. If you are interested in learning more, please contact us at 650-417-2000 ext. 3642 or paloalto.study@gmail.com. All inquiries will be kept strictly confidential.
Detailed Description
PRIMARY OBJECTIVES: I. Identify specific patterns of executive function impairment that distinguish affective and cognitive symptoms in anxious and/or depressed patients. II. Identify specific components of executive function that predict Unified Protocol treatment response. This will set up subsequent cognitive intervention studies targeting those components. The phone screen includes a confidentiality statement explaining how their information will be kept confidential, demographic questions, and questions regarding the participants' medical and psychiatric history, and current psychological state. Responses to these questions will be used to determine if the individual meets inclusion criteria to engage in the study. If the participant meets study eligibility criteria, he/she will be invited to an informational session not exceeding two and a half hours at Dr. Warren's lab, which involves an explanation the project, informed consent, some questionnaires, and a diagnostic clinical interview. Also during the first visit, participants will be informed of the upcoming visits and the types of activities they will be asked to engage in for the purposes of this study. During a second visit, subjects will undergo cognitive testing designed to measure set shifting, working memory updating, cognitive inhibition, processing speed, general intelligence, and attentional control. These tests will be administered at Dr. Warren's lab and will not exceed two and a half hours. The remainder of the study visits will involve an 8-week, cognitive-behavioral group therapy titled "Unified Protocol," to take place at the Gronowski Clinic. Treatment groups will be facilitated by Dr. Warren and co-facilitated by trained graduate students selected by Dr. Warren.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorders, Anxiety Disorders
Keywords
depression, anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group therapy (Unified Protocol)
Arm Type
Experimental
Arm Description
Participants experiencing stress, anxious, and/or depressive symptoms will receive 8 sessions of Unified Protocol for Emotional Disorders lasting for 90 minutes each. Includes psycho-education about (mal)adaptive emotion regulation, cognitive and behavioral tools to reduce symptoms of stress, anxiety, and/or depression.
Intervention Type
Behavioral
Intervention Name(s)
Unified Protocol for The Treatment of Emotional Disorders
Intervention Description
Unified Protocol (UP) is is an 8-week intervention designed to specifically benefit individuals who report co-occurring symptoms of anxiety, stress, and mood by providing them with psychoeducation regarding (mal)adaptive emotion regulation, as well as with skills for effectively responding to stress. UP is based on a cognitive-behavioral framework and uses cognitive and behavioral therapy techniques. Each session of UP group therapy is 90 minutes in duration. Sessions themselves generally include a review of homework and previously discussed concepts, introduction of new material, and in-session discussions/activities.
Primary Outcome Measure Information:
Title
Level of depression as measured by the following questionnaire:
Description
Mood and Anxiety Symptom Questionnaire- Anhedonic Depression subscale
Time Frame
The change from baseline and post-treatment, approximately 8 weeks after baseline
Title
Level of intolerance of uncertainty as measured by the following questionnaire:
Description
Intolerance of Uncertainty Questionnaire
Time Frame
The change from baseline and post-treatment, approximately 8 weeks after baseline
Title
Level of rumination and reflection as measured by the following questionnaire:
Description
Rumination Reflection Questionnaire
Time Frame
The change from baseline and post-treatment, approximately 8 weeks after baseline
Title
Level of anxious arousal as measured by the following questionnaire:
Description
Mood and Anxiety Symptom Questionnaire- Anxious Apprehension subscale
Time Frame
The change from baseline and post-treatment, approximately 8 weeks after baseline
Title
Level of anxious apprehension as measured by the following questionnaire:
Description
Penn State Worry Questionnaire
Time Frame
The change from baseline and post-treatment, approximately 8 weeks after baseline
Title
Level of alcohol use as measured by the following questionnaire:
Description
Alcohol Use Disorders Identification Test
Time Frame
The change from baseline and post-treatment, approximately 8 weeks after baseline
Title
Level of positive and negative emotions as measured by the following questionnaire:
Description
The Positive and Negative Affect Schedule
Time Frame
The change from baseline and post-treatment, approximately 8 weeks after baseline
Title
Level of behavioral regulation and metacognition as measured by the following questionnaire:
Description
Behavioral Regulation Index and Metacognition Index
Time Frame
The change from baseline and post-treatment, approximately 8 weeks after baseline
Title
Level of trait mood as measured by the following questionnaire:
Description
Trait Meta-Mood Scale.
Time Frame
The change from baseline and post-treatment, approximately 8 weeks after baseline
Title
Level of emotion regulation as measured by the following questionnaire:
Description
Emotion Regulation Questionnaire
Time Frame
The change from baseline and post-treatment, approximately 8 weeks after baseline
Title
Level of mental imagery as measured by the following questionnaire:
Description
Questionnaire of Mental Imagery
Time Frame
The change from baseline and post-treatment, approximately 8 weeks after baseline
Title
Level of cognitive functioning via neuropsychological testing session
Description
Objective assessment of cognitive strengths and weaknesses
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Normal color vision Ability to travel to Palo Alto University Experiencing symptoms of stress, anxiety, and/or depression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacie Warren, PhD
Organizational Affiliation
Palo Alto University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palo Alto University
City
Los Altos
State/Province
California
ZIP/Postal Code
94022
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Stress, Anxiety, and Mood Group Therapy

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