Stress, Anxiety, and Mood Group Therapy

Sponsor
Palo Alto University (Other)
Overall Status
Suspended
CT.gov ID
NCT03855683
Collaborator
(none)
50
1
1
34.9
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Unified Protocol for The Treatment of Emotional Disorders
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. Identify specific patterns of executive function impairment that distinguish affective and cognitive symptoms in anxious and/or depressed patients.

  2. 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 Design

Study Type:
Interventional
Anticipated 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 :
Mar 6, 2019
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Level of depression as measured by the following questionnaire: [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: [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: [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: [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: [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: [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: [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: [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: [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: [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: [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 [Baseline]

    Objective assessment of cognitive strengths and weaknesses

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Normal color vision

  • Ability to travel to Palo Alto University

  • Experiencing symptoms of stress, anxiety, and/or depression

Contacts and Locations

Locations

Site City State Country Postal Code
1 Palo Alto University Los Altos California United States 94022

Sponsors and Collaborators

  • Palo Alto University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stacie Warren, Ph.D., Principal Investigator, Palo Alto University
ClinicalTrials.gov Identifier:
NCT03855683
Other Study ID Numbers:
  • 15-061
First Posted:
Feb 27, 2019
Last Update Posted:
Sep 18, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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., Principal Investigator, Palo Alto University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 18, 2020