Depressive DisordersNCT03855683
Stress, Anxiety, and Mood Group Therapy
A study testing Unified Protocol for The Treatment of Emotional Disorders in people with Depressive Disorders and Anxiety Disorders, run by Palo Alto University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Depressive Disorders, Anxiety Disorders
- What is being tested?
- Unified Protocol for The Treatment of Emotional Disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2019to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Normal color vision
- Ability to travel to Palo Alto University
- Experiencing symptoms of stress, anxiety, and/or depression
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transdiagnostic Interventions for Emotional Disorders
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Depressive Disorders, Anxiety Disorders
- Being tested
- Unified Protocol for The Treatment of Emotional Disorders
- Keywords
- depression, anxiety
- Medical subject headings
- Depressive Disorder, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified Protocol for The Treatment of Emotional DisordersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Unified Protocol for The Treatment of Emotional Disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of depression as measured by the following questionnaire:
Mood and Anxiety Symptom Questionnaire- Anhedonic Depression subscale
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start6 Mar 2019
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2022 (estimated)
Why it stopped: Social distancing regulations related to COVID19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palo Alto University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stacie Warren, Ph.D., Palo Alto University
- Investigators
- Stacie Warren, PhD, Principal investigator, Palo Alto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855683
- Sponsor's protocol ID
- 15-061
- Status last verified
- Sep 2020
- First submitted
- 10 Feb 2019
- Last updated
- 18 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdiagnostic Interventions for Emotional Disorders
- ClinicalTrials.gov ID
- NCT03855683
- Acronym / sponsor ID
- 15-061
- Conditions
- Depressive Disorders, Anxiety Disorders
- Keywords
- depression, anxiety
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Social distancing regulations related to COVID19.
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Palo Alto UniversityUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group therapy (Unified Protocol) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Normal color vision
- Ability to travel to Palo Alto University
- Experiencing symptoms of stress, anxiety, and/or depression
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unified Protocol for The Treatment of Emotional DisordersUnified 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. | Behavioural | Group therapy (Unified Protocol) |
Primary outcome
Level of depression as measured by the following questionnaire:
Time frame: 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:
Time frame: 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:
Time frame: The change from baseline and post-treatment, approximately 8 weeks after baseline
Rumination Reflection Questionnaire
Level of anxious arousal as measured by the following questionnaire:
Time frame: The change from baseline and post-treatment, approximately 8 weeks after baseline
Mood and Anxiety Symptom Questionnaire- Anxious Apprehension subscale
Level of anxious apprehension as measured by the following questionnaire:
Time frame: The change from baseline and post-treatment, approximately 8 weeks after baseline
Penn State Worry Questionnaire
Level of alcohol use as measured by the following questionnaire:
Time frame: 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:
Time frame: The change from baseline and post-treatment, approximately 8 weeks after baseline
The Positive and Negative Affect Schedule
Level of behavioral regulation and metacognition as measured by the following questionnaire:
Time frame: The change from baseline and post-treatment, approximately 8 weeks after baseline
Behavioral Regulation Index and Metacognition Index
Level of trait mood as measured by the following questionnaire:
Time frame: The change from baseline and post-treatment, approximately 8 weeks after baseline
Trait Meta-Mood Scale.
Level of emotion regulation as measured by the following questionnaire:
Time frame: The change from baseline and post-treatment, approximately 8 weeks after baseline
Emotion Regulation Questionnaire
Level of mental imagery as measured by the following questionnaire:
Time frame: The change from baseline and post-treatment, approximately 8 weeks after baseline
Questionnaire of Mental Imagery
Level of cognitive functioning via neuropsychological testing session
Time frame: Baseline
Objective assessment of cognitive strengths and weaknesses
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacie Warren, PhD principal investigator
Palo Alto University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol for The Treatment of Emotional Disorders in people with Depressive Disorders and Anxiety Disorders, run by Palo Alto University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of depression as measured by the following questionnaire: (time frame: The change from baseline and post-treatment, approximately 8 weeks after baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.