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Stress, Anxiety, and Mood Group Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03855683
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Stacie Warren, Ph.D., Palo Alto University

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.


Condition or disease Intervention/treatment Phase
Depressive Disorders Anxiety Disorders Behavioral: Unified Protocol for The Treatment of Emotional Disorders Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transdiagnostic Interventions for Emotional Disorders
Actual Study Start Date : March 6, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.




Primary Outcome Measures :
  1. Level of depression as measured by the following questionnaire: [ Time Frame: The change from baseline and post-treatment, approximately 8 weeks after baseline ]
    Mood and Anxiety Symptom Questionnaire- Anhedonic Depression subscale

  2. Level of intolerance of uncertainty as measured by the following questionnaire: [ Time Frame: The change from baseline and post-treatment, approximately 8 weeks after baseline ]
    Intolerance of Uncertainty Questionnaire

  3. Level of rumination and reflection as measured by the following questionnaire: [ Time Frame: The change from baseline and post-treatment, approximately 8 weeks after baseline ]
    Rumination Reflection Questionnaire

  4. Level of anxious arousal as measured by the following questionnaire: [ Time Frame: The change from baseline and post-treatment, approximately 8 weeks after baseline ]
    Mood and Anxiety Symptom Questionnaire- Anxious Apprehension subscale

  5. Level of anxious apprehension as measured by the following questionnaire: [ Time Frame: The change from baseline and post-treatment, approximately 8 weeks after baseline ]
    Penn State Worry Questionnaire

  6. Level of alcohol use as measured by the following questionnaire: [ Time Frame: The change from baseline and post-treatment, approximately 8 weeks after baseline ]
    Alcohol Use Disorders Identification Test

  7. Level of positive and negative emotions as measured by the following questionnaire: [ Time Frame: The change from baseline and post-treatment, approximately 8 weeks after baseline ]
    The Positive and Negative Affect Schedule

  8. Level of behavioral regulation and metacognition as measured by the following questionnaire: [ Time Frame: The change from baseline and post-treatment, approximately 8 weeks after baseline ]
    Behavioral Regulation Index and Metacognition Index

  9. Level of trait mood as measured by the following questionnaire: [ Time Frame: The change from baseline and post-treatment, approximately 8 weeks after baseline ]
    Trait Meta-Mood Scale.

  10. Level of emotion regulation as measured by the following questionnaire: [ Time Frame: The change from baseline and post-treatment, approximately 8 weeks after baseline ]
    Emotion Regulation Questionnaire

  11. Level of mental imagery as measured by the following questionnaire: [ Time Frame: The change from baseline and post-treatment, approximately 8 weeks after baseline ]
    Questionnaire of Mental Imagery

  12. Level of cognitive functioning via neuropsychological testing session [ Time Frame: Baseline ]
    Objective assessment of cognitive strengths and weaknesses



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03855683


Contacts
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Contact: Stacie Warren, PhD 650-417-2038 swarren@paloaltou.edu

Locations
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United States, California
Palo Alto University Recruiting
Los Altos, California, United States, 94022
Contact: Stacie Warren, PhD    650-417-2038    swarren@paloaltou.edu   
Contact: Jacqueline Kantor, MS    650-417-2000 ext 3642    jkantor@paloaltou.edu   
Sponsors and Collaborators
Palo Alto University
Investigators
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Principal Investigator: Stacie Warren, PhD Palo Alto University
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Responsible Party: Stacie Warren, Ph.D., Principal Investigator, Palo Alto University
ClinicalTrials.gov Identifier: NCT03855683    
Other Study ID Numbers: 15-061
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stacie Warren, Ph.D., Palo Alto University:
depression
anxiety
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Depressive Disorder
Pathologic Processes
Mental Disorders
Mood Disorders