AnxietyNCT04236505
Wait List Controlled Trial of Brief ACT and Brief MBSR-informed Group Interventions for Anxiety in a University Setting
A study testing Acceptance and Commitment Therapy (ACT) group based intervention and Mindfulness based stress reduction (MBSR) informed brief mindfulness skills group intervention in people with Anxiety and Stress, run by City, University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Acceptance and Commitment Therapy (ACT) group based intervention and Mindfulness based stress reduction (MBSR) informed brief mindfulness skills group intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 May 2019to 31 Oct 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate anxiety
Who cannot join
- dissociation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Psychology Department, City, University of London
London, EC1V 0HB
About this study
Official title: A Wait List Controlled Trial of Brief ACT and Brief MBSR-informed Group Interventions for Anxiety in a University Setting
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.
Read the detailed description
This pilot study is designed as a randomised controlled trial comparing the effectiveness of two group interventions to a waitlist control (WLC) group: The first group is informed by Acceptance and Commitment Therapy (ACT), and the second group is informed by Mindfulness-Based Stress Reduction (MBSR). Student participants in the intervention groups will take part in either four 2-hour group sessions of ACT or MBSR-informed group interventions. Participants who are placed on the waitlist will be offered either brief ACT or brief MBSR-informed groups after 4 weeks. Both intervention and WLC groups will be administered an assessment battery before the interventions start (baseline), and soon after the intervention (post-intervention). All participants will complete the assessment battery measures at 8 weeks after post-measurement (4-week follow-up). After the completion of the 4-week follow-up measures, participants in the WLC group will be randomly allocated to either intervention groups, followed up by a post-measurement 4 weeks later after the completion of each intervention.
METHODS Therapeutic interventions: Participants of the intervention groups will be randomly allocated into either a 4- week ACT or MBSR-informed group. Instructions will be offered by the group facilitators, including discussion, reading assignments, as well as training and practice in a variety of acceptance- and mindfulness-based techniques.
ACT GROUP The ACT protocol proposed in this study has been adapted from a manual developed by Flaxman, McIntosh and Oliver (2018) for ACT training in workplace settings. This protocol has been adapted further by the authors in collaboration with Dr Kornilia Givissi and Dr Hana Villar for use in clinical settings and specifically applied to participants struggling with anxiety. This intervention combines psychoeducational and experiential practices to introduce concepts and develop skills in the six core processes of ACT. Participants will attend 4 two-hour weekly sessions of this group. The first five and last five minutes of each session will be for process measure completion. The focus of each session is detailed in the ACT protocol MBSR-INFORMED GROUP The 4-week MBSR protocol proposed in this study has been adapted from the work of Kabat-Zinn (1990), Segal, Williams, and Teasdale (2002) and has been adapted by Dr Trudi Edginton, an experienced mindfulness teacher. It has synthesised the main elements, includes all of the traditional practices and is congruent with the philosophical underpinning of the original MBSR group. This group consists of 4 two-hour weekly sessions. The first five and last five minutes of each session will be for process measure completion. The focus of each session is detailed in the MBSR-informed protocol .
Waitlist Control (WLC) group: Those assigned to the WLC group will not engage in the group interventions during the course of the intervention period. At the start of the pilot trial, they will be informed of the 4-week waiting period after which they will be randomly allocated into either intervention groups. They will be asked to complete the assessment battery measures at baseline and all follow-up timepoints.
Researcher/Practitioners: The ACT or MBSR-informed protocols in this study will be delivered by qualified and HCPC registered counselling and/or clinical psychology practitioners and are either employed or visiting lecturers in the Department of Psychology. They will all have received training in ACT and/or MBSR, and will undertake weekly clinical peer supervision to ensure fidelity to the intervention models. The research will be evaluated by the named staff members on this application and will not provide interventions but supervision to those delivering the protocols to the study participants.
Evaluation: Evaluation of the study will be conducted by the research clinic team. The evaluation will comprise of the assessment battery measures that will be self- administered at the start of the project and collected by the researcher, and therapy process measures that will be completed at the end of each session. To ensure confidentiality, measures will be de-identified and assigned a code. The researcher will remind the participants that they can choose not to complete the measures or answer any of the questions. Any paper-based measures completed by participants will be stored in a locked filing cabinet in the research clinic office until the data have been entered into a computer, after which hard copies will be securely destroyed. Data collected via tablet or other electronic devices will be stored on a City-protected cloud.
- Being tested
- Acceptance and Commitment Therapy (ACT) group based intervention, Mindfulness based stress reduction (MBSR) informed brief mindfulness skills group intervention, Wait list Control group
- Keywords
- Mindfulness, Acceptance and Commitment Therapy (ACT), Student mental health
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT) group based interventionBehavioural
4 week ACT psychological intervention group based on Flaxman and McIntosh's ACT in the work place group format
Mindfulness based stress reduction (MBSR) informed brief mindfulness skills group interventionBehavioural
4 week Mindfulness based stress reduction (MBSR) informed brief mindfulness skills group intervention
Wait list Control groupBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| ACT group intervention | Experimental | 4 weekly 2hour group therapy interventions drawing from an Acceptance and Commitment Therapy (ACT) based protocol. Receives: Behavioral: Acceptance and Commitment Therapy (ACT) group based intervention |
| Mindfulness skills group intervention | Experimental | 4 weekly 2 hour group therapy interventions drawing from an Mindfulness based stress reduction (MBSR) based protocol Receives: Behavioral: Mindfulness based stress reduction (MBSR) informed brief mindfulness skills group intervention |
| Wait list control group | Placebo comparator | 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. Receives: Behavioral: Wait list Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance and Action Questionnaire
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.
Measured: 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. .
Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT)
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
Measured: 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
Five Facet of Mindfulness Questionnaire (FFMQ) - SHORT FORM
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
Measured: 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
Generalised Anxiety Disorder Assessment (GAD-7)
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.
Measured: 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
Patient Health Questionnaire-9 (PHQ-9)
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.
Measured: 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
Secondary outcomes (5)
Ruminative Responses Scale
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.
Measured: 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.
Self compassion scale
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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-1V Letter-number sequencing
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start8 May 2019
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomised into two intervention groups and a waitlist controlled group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- City, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236505
- Sponsor's protocol ID
- ETH1819-0489
- Status last verified
- Jul 2020
- First submitted
- 15 Apr 2019
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Wait List Controlled Trial of Brief ACT and Brief MBSR-informed Group Interventions for Anxiety in a University Setting
- ClinicalTrials.gov ID
- NCT04236505
- Acronym / sponsor ID
- ETH1819-0489
- Keywords
- Mindfulness, Acceptance and Commitment Therapy (ACT), Student mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- City, University of LondonUniversity, hospital or other
- Study start
- 8 May 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 22 Jan 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.
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.
Detailed description
This pilot study is designed as a randomised controlled trial comparing the effectiveness of two group interventions to a waitlist control (WLC) group: The first group is informed by Acceptance and Commitment Therapy (ACT), and the second group is informed by Mindfulness-Based Stress Reduction (MBSR). Student participants in the intervention groups will take part in either four 2-hour group sessions of ACT or MBSR-informed group interventions. Participants who are placed on the waitlist will be offered either brief ACT or brief MBSR-informed groups after 4 weeks. Both intervention and WLC groups will be administered an assessment battery before the interventions start (baseline), and soon after the intervention (post-intervention). All participants will complete the assessment battery measures at 8 weeks after post-measurement (4-week follow-up). After the completion of the 4-week follow-up measures, participants in the WLC group will be randomly allocated to either intervention groups, followed up by a post-measurement 4 weeks later after the completion of each intervention.
METHODS Therapeutic interventions: Participants of the intervention groups will be randomly allocated into either a 4- week ACT or MBSR-informed group. Instructions will be offered by the group facilitators, including discussion, reading assignments, as well as training and practice in a variety of acceptance- and mindfulness-based techniques.
ACT GROUP The ACT protocol proposed in this study has been adapted from a manual developed by Flaxman, McIntosh and Oliver (2018) for ACT training in workplace settings. This protocol has been adapted further by the authors in collaboration with Dr Kornilia Givissi and Dr Hana Villar for use in clinical settings and specifically applied to participants struggling with anxiety. This intervention combines psychoeducational and experiential practices to introduce concepts and develop skills in the six core processes of ACT. Participants will attend 4 two-hour weekly sessions of this group. The first five and last five minutes of each session will be for process measure completion. The focus of each session is detailed in the ACT protocol MBSR-INFORMED GROUP The 4-week MBSR protocol proposed in this study has been adapted from the work of Kabat-Zinn (1990), Segal, Williams, and Teasdale (2002) and has been adapted by Dr Trudi Edginton, an experienced mindfulness teacher. It has synthesised the main elements, includes all of the traditional practices and is congruent with the philosophical underpinning of the original MBSR group. This group consists of 4 two-hour weekly sessions. The first five and last five minutes of each session will be for process measure completion. The focus of each session is detailed in the MBSR-informed protocol .
Waitlist Control (WLC) group: Those assigned to the WLC group will not engage in the group interventions during the course of the intervention period. At the start of the pilot trial, they will be informed of the 4-week waiting period after which they will be randomly allocated into either intervention groups. They will be asked to complete the assessment battery measures at baseline and all follow-up timepoints.
Researcher/Practitioners: The ACT or MBSR-informed protocols in this study will be delivered by qualified and HCPC registered counselling and/or clinical psychology practitioners and are either employed or visiting lecturers in the Department of Psychology. They will all have received training in ACT and/or MBSR, and will undertake weekly clinical peer supervision to ensure fidelity to the intervention models. The research will be evaluated by the named staff members on this application and will not provide interventions but supervision to those delivering the protocols to the study participants.
Evaluation: Evaluation of the study will be conducted by the research clinic team. The evaluation will comprise of the assessment battery measures that will be self- administered at the start of the project and collected by the researcher, and therapy process measures that will be completed at the end of each session. To ensure confidentiality, measures will be de-identified and assigned a code. The researcher will remind the participants that they can choose not to complete the measures or answer any of the questions. Any paper-based measures completed by participants will be stored in a locked filing cabinet in the research clinic office until the data have been entered into a computer, after which hard copies will be securely destroyed. Data collected via tablet or other electronic devices will be stored on a City-protected cloud.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants are randomised into two intervention groups and a waitlist controlled group
| Arm | Type | Receives |
|---|---|---|
| ACT group intervention | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT) group based intervention4 weekly 2hour group therapy interventions drawing from an Acceptance and Commitment Therapy (ACT) based protocol. |
| Mindfulness skills group intervention | Experimental | Behavioral: Mindfulness based stress reduction (MBSR) informed brief mindfulness skills group intervention4 weekly 2 hour group therapy interventions drawing from an Mindfulness based stress reduction (MBSR) based protocol |
| Wait list control group | Placebo comparator | Behavioral: Wait list Control groupWait 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mild to moderate anxiety
Key exclusion criteria (1 listed)
- dissociation
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 |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) group based intervention4 week ACT psychological intervention group based on Flaxman and McIntosh's ACT in the work place group format | Behavioural | ACT group intervention |
| Mindfulness based stress reduction (MBSR) informed brief mindfulness skills group intervention4 week Mindfulness based stress reduction (MBSR) informed brief mindfulness skills group intervention | Behavioural | Mindfulness skills group intervention |
| Wait list Control groupthis 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 | Behavioural | Wait list control group |
Primary outcome
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.
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
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
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.
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy (ACT) group based intervention and Mindfulness based stress reduction (MBSR) informed brief mindfulness skills group intervention in people with Anxiety and Stress, run by City, University of London at 1 site in United Kingdom.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Jul 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 Kingdom. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 study lists 5 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 20 Jul 2020.