An interventional study of Unified Protocol for The Treatment of Emotional Disorders in Depressive Disorders and Anxiety Disorders, sponsored by Palo Alto University. Suspended at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-09-18.
Sponsored by Palo Alto University · Not applicable, Interventional, and Treatment
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.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Palo Alto University is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
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Inclusion Criteria:
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.
Level of depression as measured by the following questionnaire:
Mood and Anxiety Symptom Questionnaire- Anhedonic Depression subscale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline
Plan to share: No
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This study is suspended, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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