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

NCT04236505 | Completed

• 1 other identifier: ETH1819-0489
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Stress

Keywords

Mindfulness; Acceptance and Commitment Therapy (ACT); Student mental health

Outcome Measures

Primary Outcomes (5)

• 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.

  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

  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

  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.

  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.

  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

  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

  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

  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

  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

  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.

Study Arms (3)

ACT group intervention

EXPERIMENTAL

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

Mindfulness skills group intervention

EXPERIMENTAL

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

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.

Behavioral: Wait list Control group

Interventions

Acceptance and Commitment Therapy (ACT) group based intervention BEHAVIORAL

4 week ACT psychological intervention group based on Flaxman and McIntosh's ACT in the work place group format

ACT group intervention

Mindfulness based stress reduction (MBSR) informed brief mindfulness skills group intervention BEHAVIORAL

4 week Mindfulness based stress reduction (MBSR) informed brief mindfulness skills group intervention

Mindfulness skills group intervention

Wait list Control group BEHAVIORAL

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

Wait list control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to moderate anxiety

You may not qualify if:

• dissociation

Sponsors & Collaborators

• City, University of London: lead

Study Sites (1)

Psychology Department, City, University of London

London, EC1V 0HB, United Kingdom

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomised into two intervention groups and a waitlist controlled group

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: January 22, 2020
• Study Start: May 8, 2019
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: July 20, 2020

Record last verified: 2020-07

Locations

GB (1)