Stress, Anxiety, and Mood Group Therapy

Transdiagnostic Interventions for Emotional Disorders

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.

Study Overview

• Status: Suspended
• Conditions: Anxiety Disorders; Depressive Disorders
• Intervention / Treatment: Behavioral: Unified Protocol for The Treatment of Emotional Disorders

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Altos, California, United States, 94022
      • Palo Alto University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Group therapy (Unified Protocol); 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.

Behavioral: Unified Protocol for The Treatment of Emotional Disorders; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of depression as measured by the following questionnaire:	Mood and Anxiety Symptom Questionnaire- Anhedonic Depression subscale	The change from baseline and post-treatment, approximately 8 weeks after baseline
Level of intolerance of uncertainty as measured by the following questionnaire:	Intolerance of Uncertainty Questionnaire	The change from baseline and post-treatment, approximately 8 weeks after baseline
Level of rumination and reflection as measured by the following questionnaire:	Rumination Reflection Questionnaire	The change from baseline and post-treatment, approximately 8 weeks after baseline
Level of anxious arousal as measured by the following questionnaire:	Mood and Anxiety Symptom Questionnaire- Anxious Apprehension subscale	The change from baseline and post-treatment, approximately 8 weeks after baseline
Level of anxious apprehension as measured by the following questionnaire:	Penn State Worry Questionnaire	The change from baseline and post-treatment, approximately 8 weeks after baseline
Level of alcohol use as measured by the following questionnaire:	Alcohol Use Disorders Identification Test	The change from baseline and post-treatment, approximately 8 weeks after baseline
Level of positive and negative emotions as measured by the following questionnaire:	The Positive and Negative Affect Schedule	The change from baseline and post-treatment, approximately 8 weeks after baseline
Level of behavioral regulation and metacognition as measured by the following questionnaire:	Behavioral Regulation Index and Metacognition Index	The change from baseline and post-treatment, approximately 8 weeks after baseline
Level of trait mood as measured by the following questionnaire:	Trait Meta-Mood Scale.	The change from baseline and post-treatment, approximately 8 weeks after baseline
Level of emotion regulation as measured by the following questionnaire:	Emotion Regulation Questionnaire	The change from baseline and post-treatment, approximately 8 weeks after baseline
Level of mental imagery as measured by the following questionnaire:	Questionnaire of Mental Imagery	The change from baseline and post-treatment, approximately 8 weeks after baseline
Level of cognitive functioning via neuropsychological testing session	Objective assessment of cognitive strengths and weaknesses	Baseline

Collaborators and Investigators

• Sponsor: Palo Alto University
• Investigators: Principal Investigator: Stacie Warren, PhD, Palo Alto University

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2019
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: February 10, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: depression; anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Depressive Disorder; Disease; Anxiety Disorders
• Other Study ID Numbers: 15-061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No