Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Wait List Controlled Trial of Brief ACT and Brief MBSR-informed Group Interventions for Anxiety in a University Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04236505
Recruitment Status : Active, not recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
City, University of London

Brief Summary:
A randomised wait-list-controlled trial is being run in a psychology department research clinic at a London University providing two four-week group interventions (one Acceptance and Commitment Therapy (ACT) and one MBSR-informed) to students presenting with mild to moderate anxiety. Pre and post measures of anxiety, depression, psychological flexibility, mindfulness, self-compassion, letter-number sequencing and trail making will be collected. Groups will be audio recorded for qualitative analysis and long term follow up outcomes will be collected.

Condition or disease Intervention/treatment Phase
Anxiety Stress Behavioral: Acceptance and Commitment Therapy (ACT) group based intervention Behavioral: Mindfulness based stress reduction (MBSR) informed brief mindfulness skills group intervention Behavioral: Wait list Control group Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are randomised into two intervention groups and a waitlist controlled group
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Wait List Controlled Trial of Brief ACT and Brief MBSR-informed Group Interventions for Anxiety in a University Setting
Actual Study Start Date : May 8, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: ACT group intervention
4 weekly 2hour group therapy interventions drawing from an Acceptance and Commitment Therapy (ACT) based protocol.
Behavioral: Acceptance and Commitment Therapy (ACT) group based intervention
4 week ACT psychological intervention group based on Flaxman and McIntosh's ACT in the work place group format

Experimental: Mindfulness skills group intervention
4 weekly 2 hour group therapy interventions drawing from an Mindfulness based stress reduction (MBSR) based protocol
Behavioral: Mindfulness based stress reduction (MBSR) informed brief mindfulness skills group intervention
4 week Mindfulness based stress reduction (MBSR) informed brief mindfulness skills group intervention

Placebo Comparator: Wait list control group
Wait list control group who at the time of the experimental group interventions are not attending a group and receiving treatment as usual. This group are offered a Mindfulness skills group intervention after the follow up data has been collected.
Behavioral: Wait list Control group
this group are placed on a wait list for group treatment whilst the other experimental groups run. This group are offered the MBSR based mindfulness skills once the follow up data has been collected from the other two experimental groups




Primary Outcome Measures :
  1. Acceptance and Action Questionnaire [ Time Frame: Measure collected at Baseline (week 0), post treatment (week 6) and at follow up (week 11) in experimental groups and in waiting list control group. . ]
    The Acceptance and Action Questionnaire-II (AAQ-II; Bond et al., 2011) measures psychological inflexibility or experiential avoidance.This 7-item one-factor scale is scored by adding together the seven items.Higher scores equal greater levels of psychological inflexibility. Measuring change in Psychological Flexibility.

  2. Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT) [ Time Frame: Measure collected at baseline (week 0), post each intervention (week 1, 2, 3, 4) and post treatment (week 6) and at follow up (week 11) by experimental group and the waiting list group completed the measure at baseline, post intervention and f-up ]
    CompACT; Francis, Dawson & Golijani-Moghaddam, 2016) was developed as a general measure of psychological flexibility (and constituent sub-processes) as conceptualized within the ACT model.This 23-item measure has shown initial advantages to the AAQ-II and its inclusion is intended to further test its validity. Measuring change in psychological Psychological flexibility

  3. Five Facet of Mindfulness Questionnaire (FFMQ) - SHORT FORM [ Time Frame: Measure collected at baseline (week 0), post each intervention (week 1, 2, 3, 4) and post treatment (week 6) and at follow up (week 11) by experimental group and the waiting list group completed the measure at baseline, post intervention and f-up ]
    The Five Facet of Mindfulness Questionnaire (FFMQ; Bohlmeijer, Ten Klooster, Fledderus,Veehof,& Baer, 2011) is a 39-item measure consisting of five subscales (1. observing, 2. describing, 3. acting with awareness, 4. non-judging of inner experience, and 5. non-reactivity to inner experience). The FFMQ short-version (24 items) has been used.The FFMQ short-version (24 items) captures 4 of the psychological flexibility processes: contact with the present moment; cognitive defusion; self as context; acceptance.Items of the FFMQ were measured on a 5-point Likert-type scale ranging from 1 (never or very rarely true) to 5 (very often or always true). A global FFMQ score are calculated using the mean of all 24 items (considering reverse-scoring). Measuring changes in mindfulness

  4. Generalised Anxiety Disorder Assessment (GAD-7) [ Time Frame: Measure collected at baseline (week 0), post each intervention (week 1, 2, 3, 4) and post treatment (week 6) and at follow up (week 11) by experimental group and the waiting list group completed the measure at baseline, post intervention and f-up ]

    The Generalised Anxiety Disorder Assessment (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006) is used to measure or assess the severity of generalised anxiety disorder (GAD) This self-administered instrument has 7 items. Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Response options include "not at all", "several days", "more than half the days" and "nearly every day" respectively, and then adding together the scores for the seven questions.

    GAD-7 total score for the seven items ranges from 0 to 21. Scores represent: 0-5 = Mild anxiety, 6-10 = Moderate anxiety, 11-15 = Moderately severe anxiety, and 15-21 = Severe anxiety.

    When used as a screening tool, further evaluation is recommended when the score is 10 or greater. Measuring changes in anxiety scores.


  5. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Measure collected at baseline (week 0), post each intervention (week 1, 2, 3, 4) and post treatment (week 6) and at follow up (week 11) by experimental group and the waiting list group completed the measure at baseline, post intervention and f-up ]

    The Patient Health Questionnaire-9 (PHQ-9; Kroenke & Spitzer, 2002) is used to measure or assess the severity of depression.

    This self-administered scale has 9 items. Each item asks the individual to rate the severity of his or her symptoms over the past two weeks.

    Response options include "not at all", "several days", "more than half the days" and "nearly every day" respectively, and then adding together the scores for the seven questions. Scores represent: 5-9 = mild depression / low mood, 0-14 - moderate depression / low mood, 15-19 - moderately severe depression / low mood, and 20-27 - severe depression/low mood. Measuring change in scores of low mood.

    When used as a screening tool, further evaluation is recommended when the score is 10 or greater.



Secondary Outcome Measures :
  1. Ruminative Responses Scale [ Time Frame: This measure was collected at Baseline (week 0), post treatment (week 6) and at follow up (week 11) in experimental groups and in waiting list control group. ]

    The Ruminative Responses Scale (RRS) of the Response Styles Questionnaire (RSQ; Nolen-Hoeksema & Morrow, 1991) assesses the extent to which individuals repeatedly focus on the causes, meanings, and consequences of their negative mood.

    This measure has 22 items and a factor analysis of the RRS has identified two separate subscales that are differentially related to symptoms of depression. The first, reflection, consists of five questions that assess the degree to which individuals engage in cognitive problem-solving to improve their. The second, brooding, consists of five items that assess the degree to which individuals passively focus on the reasons for their distress (Treynor et al., 2003).

    Brooding and reflection scores are computed by taking the average of items on each respective scale. Measuring a change in Rumination.


  2. Self compassion scale [ Time Frame: Measure collected at Baseline (week 0), post treatment (week 6) and at follow up (week 11) in experimental groups and in waiting list control group. ]
    This is a measure of self-compassion. This 26-item measure is based on an aggregate of responses on three subscales: (1) self-kindness versus self-judgment, (2) common humanity versus isolation, and (3) mindfulness versus overidentification. Subscale scores are computed by calculating the mean of subscale item responses. To compute a total self-compassion score, reverse score the negative subscale items -self-judgment, isolation, and over-identification (i.e., 1 = 5, 2 = 4, 3 = 3. 4 = 2, 5 = 1) -then compute a total mean. This will measure a change in self compassion.

  3. student engagement scale [ Time Frame: Measure collected at Baseline (week 0), post treatment (week 6) and at follow up (week 11) in experimental groups and in waiting list control group. ]

    Student Engagement Scale (SES; Gunuc & Kuzu, 2015) is a measure of student engagement for higher education. This 41-item measure consists of six subscales: 1) valuing, 2) sense of belonging, 3) cognitive engagement, 4) peer relationships (emotional engagement-I), 5) relationships with faculty members (emotional engagement-II), and 6) behavioural engagement.

    Items of the SES are measured on a five-point Likert-type scale ranging from 1 (I totally disagree) to 5 (I totally agree).

    Higher student engagement scores indicate that the student has a high level of engagement with the university, campus and class.

    This will measure a change in student engagement.


  4. Trail making test [ Time Frame: Measure collected at Baseline (week 0), post treatment (week 6) and at follow up (week 11) in experimental groups and in waiting list control group. ]
    Trail Making Test (TMT; Arnett, Seth & Labovitz, 1995) is a neuropsychological test of visual attention and task switching.The standard TMT comes in two forms: Trails A, where subjects connect a series of 25 numbered circles in ascending order, and Trails B, where subjects connect 25 circles alternating between ascending numbers and letters (e.g., 1-A-2-B, etc.).Completion times (in seconds) on the TMT are used to assess visual attention, speed of processing, mental flexibility, and executive function in patients by comparisons with normative data from appropriate control populations (Tombaugh, 2004). Results for both TMT A and B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.

  5. WAIS-1V Letter-number sequencing [ Time Frame: Measure collected at Baseline (week 0), post treatment (week 6) and at follow up (week 11) in experimental groups and in waiting list control group. ]
    WAIS-IV subtest Letter-Number Sequencing (LNS) is a well-validated measure of manipulation WM (Snyder, Miyake, & Hankin, 2015). The participant is read a series of numbers and letters and asked to recall the numbers in ascending order, followed by the letters in alphabetical order.The number of items is 21. With each item being marked 0 if reported incorrectly or 1 if reported correctly, the maximum score is 21. This is to measure the change in letter-number sequencing.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild to moderate anxiety

Exclusion Criteria:

  • dissociation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236505


Locations
Layout table for location information
United Kingdom
Psychology Department, City, University of London
London, United Kingdom, EC1V 0HB
Sponsors and Collaborators
City, University of London

Layout table for additonal information
Responsible Party: City, University of London
ClinicalTrials.gov Identifier: NCT04236505    
Other Study ID Numbers: ETH1819-0489
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by City, University of London:
Mindfulness
Acceptance and Commitment Therapy (ACT)
Student mental health
Additional relevant MeSH terms:
Layout table for MeSH terms
Anxiety Disorders
Mental Disorders