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Stress, Anxiety, and Mood Group Therapy

Not Applicable
Suspended
Conditions
Depressive Disorders
Anxiety Disorders
Interventions
Behavioral: Unified Protocol for The Treatment of Emotional Disorders
Registration Number
NCT03855683
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
SUSPENDED
Sex
All
Target Recruitment
50
Inclusion Criteria
  • Normal color vision
  • Ability to travel to Palo Alto University
  • Experiencing symptoms of stress, anxiety, and/or depression
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Group therapy (Unified Protocol)Unified Protocol for The Treatment of Emotional DisordersParticipants 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.
Primary Outcome Measures
NameTimeMethod
Level of cognitive functioning via neuropsychological testing sessionBaseline

Objective assessment of cognitive strengths and weaknesses

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.

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

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

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

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

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

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

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

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

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

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Palo Alto University

🇺🇸

Los Altos, California, United States

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