Anxiety DepressionNCT04582071
Assessing Efficacy of Psychotherapy Intervention With Inflammatory Bowel Disease Surgery Patients
A study testing Psychotherapy in people with Anxiety Depression, run by NYU Langone Health.
Trial summary
The purpose of this research study is to understand the effects of therapy in lowering anxiety and improving quality of life in patients with IBD who are undergoing surgery Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Anxiety Depression
- What is being tested?
- Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Aug 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age18 years or older.
- Patients with documented diagnosis of Inflammatory Bowel Disease.
- Patients with documented need for IBD surgery
Who cannot join
- Patients younger than 18 years of age.
- Patient who has any condition, including physical, psychological, or psychiatric condition, which in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data and renders the patient an unsuitable candidate for the study.
About this study
The purpose of this research study is to understand the effects of therapy in lowering anxiety and improving quality of life in patients with IBD who are undergoing surgery
Read the detailed description
Pre- and post- surgery scores on the State Trait Anxiety Inventory will be used to measure levels of state-based anxiety as the primary outcome. Our hypothesis is that patients in the experimental group, will show a decrease in anxiety levels over the course of the four sessions, while the same group in the control group will not change significantly in their anxiety levels. It is hypothesized that this would be due to the psychotherapeutic intervention mitigating the inherent emotional stress and negative behavioral changes associated with surgery. It will be important to differentiate between the inpatient and outpatient groups, as their anxiety levels may inherently be discrepant. For patients with a three-step ileal pouch-anal anastomosis (IPAA), the three sessions subsequent to surgery will be conducted only after the first surgery. This is an exploratory study in which we are investigating the possibility of a range of potential outcomes to the intervention, including overall reduction of anxiety, depression, body image and improvement in quality of life.
- Conditions
- Anxiety Depression
- Being tested
- Psychotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
Psychotherapy is a term that we use to describe the use of the psychological method to understand and improve an individual's well-being and mental health. The Principal Investigator of this study, a clinical psychologist will be leading each of the sessions.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Psychotherapy, Intervention arm) | Experimental | Subjects undergoing a 3 step IPAA will receive the four sessions of psychotherapy preceding and following their first surgery only, and receive an additional set of questionnaires again after their third surgery. Receives: Behavioral: Psychotherapy |
| Arm 2 (Non-Therapy, Control Arm) | No intervention | Subjects will receive questionnaires which will be administered remotely via telemedicine if patient and psychologist/ research team member are unable to meet in person. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State - based anxiety
State based anxiety will be measured by the State-Trait Anxiety Inventory. This measure has 40 items. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the S-Anxiety scale.
Measured: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Secondary outcomes (9)
Change in participant's level of depression
Measured by PHQ-9- Patient Health Questionnaire. Questionnaire has 9 items scores each of the nine DSM-IV criteria as "0" (not at all) to "3". Subjects will achieve one out of four levels of depression severity, depending upon their scores: 0-4=minimal or none, 5-9=mild, 10-14=moderate, and 15-19=moderately severe to severe.
Measured: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Change in Quality of life of participants
Measured by IBD QoL- Inflammatory Bowel Disease Quality of Life Questionnaire. Questionnaire has 32 items and the higher scores indicate better quality of life.
Measured: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Increase ability to function
Measured by Work Productivity and Activity Impairment (WPAI). There is 6 items which yeilds four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment/absenteeism plus presenteeism) and Activity Impairment The sum of specific health problem impairment and impairment due to other health reasons is equal to impairment due to all health reasons. WPAI outcomes are expressed as impairment percentages, multiply scores by 100 to express in percentages, with higher numbers indicating greater impairment and less productivity
Measured: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Improved self efficacy in participants
Measured by The Self-Efficacy Scale with 8 items with higher scores which will indicate greater self-efficacy.
Measured: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Change in social support of participants
This will be measured by Social Support Survey which has 19 items to obtain a score for each of four subscales, calculate the average of the scores for each item in the subscale. Higher scores for an individual scale or for the overall support index indicate more support.
Measured: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Improvement in coping strategies
Measured by The Brief Cope questionnaire with 28 items which are 14 subscales with 2 items each. Sum of each subscale indicates a preference for particular coping strategies, which can be characterized as either effective or less effective.
Measured: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Change in the participants perception of body image
Measured by The Body Image Scale which includes 9 items. Participants score from 0 ("not at all") to 3 ("very much") on each of the 9 questions so that the lowest possible total score is 0 and the highest 27, with higher scores indicating increasing body image dissatisfaction.
Measured: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Change in the participants' perception of illness
Measured by The Brief Illness Perception Questionnaire which 9 items. Five of the items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two of the items assess emotional representations: concern (Item 6) and emotions (Item 8). One item assesses illness comprehensibility (Item 7). Assessment of the causal representation is by an open-ended response item adapted from the IPQ-R, which asks patients to list the three most important usual factors in their illness (Item 9). Responses to the causal item can be grouped into categories such as stress, lifestyle, hereditary, etc., determined by the particular illness studied, and categorical analysis can then be performed.
The Brief IPQ allows very simple interpretation of scores: increases in item scores represent linear increases in the dimension measured.
Measured: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Change in pain perception
Measured by Pain anxiety symptom scale short form 20 with 20 items. The PASS assesses pain-specific anxiety symptoms and consists of four 10-item subscales measuring cognitive anxiety responses, escape and avoidance, fearful thinking and physiological anxiety responses. Higher scores indicate greater anxiety symptoms.
Measured: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study startJan 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2022 (estimated)
Why it stopped: After further review and discussion, the scope of the study is being changed to better suit the patient population. No subjects were enrolled in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DepressionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Gerson, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582071
- Sponsor's protocol ID
- 20-00275
- Status last verified
- Aug 2021
- First submitted
- 5 Oct 2020
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Efficacy of Psychotherapy Intervention With Inflammatory Bowel Disease Surgery Patients
- ClinicalTrials.gov ID
- NCT04582071
- Acronym / sponsor ID
- 20-00275
- Conditions
- Anxiety Depression
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: After further review and discussion, the scope of the study is being changed to better suit the patient population. No subjects were enrolled in the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 9 Oct 2020 (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 research study is to understand the effects of therapy in lowering anxiety and improving quality of life in patients with IBD who are undergoing surgery
Detailed description
Pre- and post- surgery scores on the State Trait Anxiety Inventory will be used to measure levels of state-based anxiety as the primary outcome. Our hypothesis is that patients in the experimental group, will show a decrease in anxiety levels over the course of the four sessions, while the same group in the control group will not change significantly in their anxiety levels. It is hypothesized that this would be due to the psychotherapeutic intervention mitigating the inherent emotional stress and negative behavioral changes associated with surgery. It will be important to differentiate between the inpatient and outpatient groups, as their anxiety levels may inherently be discrepant. For patients with a three-step ileal pouch-anal anastomosis (IPAA), the three sessions subsequent to surgery will be conducted only after the first surgery. This is an exploratory study in which we are investigating the possibility of a range of potential outcomes to the intervention, including overall reduction of anxiety, depression, body image and improvement in quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Psychotherapy, Intervention arm) | Experimental | Behavioral: PsychotherapySubjects undergoing a 3 step IPAA will receive the four sessions of psychotherapy preceding and following their first surgery only, and receive an additional set of questionnaires again after their third surgery. |
| Arm 2 (Non-Therapy, Control Arm) | No intervention | –Subjects will receive questionnaires which will be administered remotely via telemedicine if patient and psychologist/ research team member are unable to meet in person. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients age18 years or older.
- Patients with documented diagnosis of Inflammatory Bowel Disease.
- Patients with documented need for IBD surgery
Key exclusion criteria (2 listed)
- Patients younger than 18 years of age.
- Patient who has any condition, including physical, psychological, or psychiatric condition, which in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data and renders the patient an unsuitable candidate for the study.
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 |
|---|---|---|
| PsychotherapyPsychotherapy is a term that we use to describe the use of the psychological method to understand and improve an individual's well-being and mental health. The Principal Investigator of this study, a clinical psychologist will be leading each of the sessions. | Behavioural | Arm 1 (Psychotherapy, Intervention arm) |
Primary outcome
Change in State - based anxiety
Time frame: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
State based anxiety will be measured by the State-Trait Anxiety Inventory. This measure has 40 items. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the S-Anxiety scale.
9 secondary outcomes
Change in participant's level of depression
Time frame: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Change in Quality of life of participants
Time frame: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Increase ability to function
Time frame: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Improved self efficacy in participants
Time frame: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Change in social support of participants
Time frame: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Improvement in coping strategies
Time frame: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Change in the participants perception of body image
Time frame: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Change in the participants' perception of illness
Time frame: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Change in pain perception
Time frame: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Jessica Gerson, MD principal investigator
NYU Langone Health
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with Anxiety Depression, run by NYU Langone Health.
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 2 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: withdrawn, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in State - based anxiety (time frame: Visit 1 (2 Weeks Pre-Surgery Visit), Visit 4 (3 months after surgery) Visit 5 (Approximately 6 months post-administration of last session)). 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 1 Sep 2021.