Stress, Anxiety, and Mood Group Therapy

NCT03855683 | Suspended

• 1 other identifier: 15-061
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorders; Anxiety Disorders

Keywords

depression; anxiety

Outcome Measures

Primary Outcomes (12)

• Level of depression as measured by the following questionnaire:

  Mood and Anxiety Symptom Questionnaire- Anhedonic Depression subscale

  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

  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

  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

  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

  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

  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

  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

  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.

  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

  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

  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

  Baseline

Study Arms (1)

Group therapy (Unified Protocol)

EXPERIMENTAL

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

Interventions

Unified Protocol for The Treatment of Emotional Disorders BEHAVIORAL

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.

Group therapy (Unified Protocol)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Palo Alto University: lead

Study Sites (1)

Palo Alto University

Los Altos, California, 94022, United States

Location

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Stacie Warren, PhD

  Palo Alto University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2019
• First Posted: February 27, 2019
• Study Start: March 6, 2019
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: September 18, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)