Clinical trial NCT03855683: Stress, Anxiety, and Mood Group Therapy
Official title: Transdiagnostic Interventions for Emotional Disorders
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Depressive Disorders
Anxiety Disorders
Keywords: depression
anxiety
Lead sponsor: Palo Alto University
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Level of depression as measured by the following questionnaire:
timeFrame: The change from baseline and post-treatment, approximately 8 weeks after baseline
measure: Level of intolerance of uncertainty as measured by the following questionnaire:
timeFrame: The change from baseline and post-treatment, approximately 8 weeks after baseline
measure: Level of rumination and reflection as measured by the following questionnaire:
timeFrame: The change from baseline and post-treatment, approximately 8 weeks after baseline
measure: Level of anxious arousal as measured by the following questionnaire:
timeFrame: The change from baseline and post-treatment, approximately 8 weeks after baseline
measure: Level of anxious apprehension as measured by the following questionnaire:
timeFrame: The change from baseline and post-treatment, approximately 8 weeks after baseline
measure: Level of alcohol use as measured by the following questionnaire:
timeFrame: The change from baseline and post-treatment, approximately 8 weeks after baseline
measure: Level of positive and negative emotions as measured by the following questionnaire:
timeFrame: The change from baseline and post-treatment, approximately 8 weeks after baseline
measure: Level of behavioral regulation and metacognition as measured by the following questionnaire:
timeFrame: The change from baseline and post-treatment, approximately 8 weeks after baseline
measure: Level of trait mood as measured by the following questionnaire:
timeFrame: The change from baseline and post-treatment, approximately 8 weeks after baseline
measure: Level of emotion regulation as measured by the following questionnaire:
timeFrame: The change from baseline and post-treatment, approximately 8 weeks after baseline
measure: Level of mental imagery as measured by the following questionnaire:
timeFrame: The change from baseline and post-treatment, approximately 8 weeks after baseline
measure: Level of cognitive functioning via neuropsychological testing session
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Los Altos
country: United States
facility: Palo Alto University
state: California
Study officials:
affiliation: Palo Alto University
name: Stacie Warren, PhD
role: PRINCIPAL_INVESTIGATOR
References: