AnxietyACTNCT02449759
An ACT Manual-based, Guided Self-help Intervention Pilot
A study testing ACT Intervention Group in people with Anxiety and Depression, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
This study aims to evaluate the effectiveness of a guided self-help intervention using Acceptance and Commitment Therapy (ACT). Half of the participants will receive the self-help manual whilst on a waiting list for individual therapy, while the other half will remain on a waiting list and not receive the manual. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- ACT Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2015to May 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- On the primary care waiting list for individual therapy
- Anxiety or depression/low mood assessed using the Depression, Anxiety and Stress Scales (DASS21). Those with mild to moderate (≥ 4 and ≤ 7) mixed anxiety (including panic, agoraphobia, obsessive compulsive disorder, generalised anxiety disorder and phobias) or depressive/low mood (including dysthymia; ≥ 5 and ≤ 10) will be included.
- For those participants presenting with both anxiety and depression, at least one must reach the minimum cut off score and neither should exceed the maximum cut-off score.
- Adequate English ability
- Able to give informed consent
Who cannot join
- High suicide risk (as indicated with a risk score of >0.3 on the Clinical Outcomes in Routine Evaluation questionnaire; CORE-34
- Participants that have been flagged at the referral meeting to receive specialised individual therapy (e.g. schema-focussed therapy)
- Medication change within the last three months*
- Currently receiving or received psychological help within the last 6 months using a Cognitive Behavioural Therapy or ACT modality (e.g. Beating the Blues, Anxiety Management Groups, Mindfulness, Individual therapy)
- Currently taking part in another research study
- Intellectual impairment (e.g. a learning disability)
- Referral for a primary diagnosis, other than anxiety/depression, that would significantly over arch any work focusing on anxiety/depression even if the above criteria is met for anxiety/depression (e.g. an eating disorder whereby the stated symptoms: cognitions, physical sensations, emotions and behaviours, are orientated solely around food).
- Those individuals who have started or changed medication within the last 3 months will still be eligible to participate, but will be put on hold until this time period has elapsed. They will be informed of this and told that they may not be entered into the trial if recruitment targets are met or individual treatment becomes available (the waiting list will be reviewed at the time).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Adult Psychology Department
Falkirk, Stirlingshire, FK1 5QE
About this study
Official title: Evaluating Acceptance and Commitment Therapy as a Low-intensity, Manual-based, Guided Self-help Intervention for Anxiety and Depression: A Pilot Study
This study aims to evaluate the effectiveness of a guided self-help intervention using Acceptance and Commitment Therapy (ACT). Half of the participants will receive the self-help manual whilst on a waiting list for individual therapy, while the other half will remain on a waiting list and not receive the manual. This study is looking specifically at individuals with mild to moderate anxiety and/or depression.
Read the detailed description
Many patients are offered written self-help material as a stage 1 (low intensity) intervention for anxiety and/or depression, as recommended by the United Kingdom's National Institute for Clinical Excellence's pathways framework (http://pathways.nice.org.uk/).
Acceptance and Commitment Therapy (ACT) is an emerging therapy that has been shown to help patients with mild to moderate anxiety and/or depression in therapist-led individual and group treatments. However, few studies have shown how effective ACT is in the form of a low-intensity, guided self-help intervention.
This study seeks to find out whether an ACT-based manual, sent to patients with anxiety and/or depression, increases their ability to effectively manage their difficulties and improve their quality of life. Participants on a primary care mental health waiting list will be invited to take part in this study.
Eligible participants will be randomly allocated to one of two groups: the ACT intervention or waiting list as usual. Participants receiving the ACT intervention will be posted a manual and will be asked to read a chapter each week for six weeks. A member of the research team will also phone them on two occasions to support their use of the manual, trouble shoot any difficulties and provide encouragement. All participants will be asked to complete nine, short questionnaires sent through the post prior to and after six weeks of self-help.
By comparing the results the study will demonstrate whether the ACT intervention is effective compared to wait list as usual.
- Conditions
- Anxiety, Depression
- Being tested
- ACT Intervention Group
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT Intervention GroupBehavioural
A six chapter, 58 page self-help manual based on the principles of Acceptance and Commitment Therapy
| Study group | Role | What they receive |
|---|---|---|
| ACT Intervention Group | Experimental | This group will receive an ACT self-help manual to be completed over the course of 6 weeks. They will also receive two brief telephone calls during the reading of the manual by a member of the research team. Receives: Behavioral: ACT Intervention Group |
| Control Group | No intervention | This group will receive no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change is being assessed using the Quality of Life BREF (WHOQOLBREF; Skevington et al., 2004) questionnaire
26-item self-report questionnaire
Measured: Baseline and 6 weeks
Secondary outcomes (1)
Change is being assessed using the Acceptance and Action Questionnaire II (AAQII; Bond, Hayes & Baer et. al, 2011).
A 7-item, unidimensional, self-report questionnaire which measures the construct of experiential avoidance/psychological inflexibility
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shane A Ford, Principal investigator, National Health Service, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449759
- Sponsor's protocol ID
- 166325
- Acronym
- ACT
- Status last verified
- Nov 2017
- First submitted
- 29 Apr 2015
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
PubMed 15085902Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.
PubMed 22035996
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Acceptance and Commitment Therapy as a Low-intensity, Manual-based, Guided Self-help Intervention for Anxiety and Depression: A Pilot Study
- ClinicalTrials.gov ID
- NCT02449759
- Acronym / sponsor ID
- ACT / 166325
- Conditions
- Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 20 May 2015 (estimated)
- 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.
This study aims to evaluate the effectiveness of a guided self-help intervention using Acceptance and Commitment Therapy (ACT). Half of the participants will receive the self-help manual whilst on a waiting list for individual therapy, while the other half will remain on a waiting list and not receive the manual. This study is looking specifically at individuals with mild to moderate anxiety and/or depression.
Detailed description
Many patients are offered written self-help material as a stage 1 (low intensity) intervention for anxiety and/or depression, as recommended by the United Kingdom's National Institute for Clinical Excellence's pathways framework (http://pathways.nice.org.uk/).
Acceptance and Commitment Therapy (ACT) is an emerging therapy that has been shown to help patients with mild to moderate anxiety and/or depression in therapist-led individual and group treatments. However, few studies have shown how effective ACT is in the form of a low-intensity, guided self-help intervention.
This study seeks to find out whether an ACT-based manual, sent to patients with anxiety and/or depression, increases their ability to effectively manage their difficulties and improve their quality of life. Participants on a primary care mental health waiting list will be invited to take part in this study.
Eligible participants will be randomly allocated to one of two groups: the ACT intervention or waiting list as usual. Participants receiving the ACT intervention will be posted a manual and will be asked to read a chapter each week for six weeks. A member of the research team will also phone them on two occasions to support their use of the manual, trouble shoot any difficulties and provide encouragement. All participants will be asked to complete nine, short questionnaires sent through the post prior to and after six weeks of self-help.
By comparing the results the study will demonstrate whether the ACT intervention is effective compared to wait list as usual.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT Intervention Group | Experimental | Behavioral: ACT Intervention GroupThis group will receive an ACT self-help manual to be completed over the course of 6 weeks. They will also receive two brief telephone calls during the reading of the manual by a member of the research team. |
| Control Group | No intervention | –This group will receive no intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- On the primary care waiting list for individual therapy
- Anxiety or depression/low mood assessed using the Depression, Anxiety and Stress Scales (DASS21). Those with mild to moderate (≥ 4 and ≤ 7) mixed anxiety (including panic, agoraphobia, obsessive compulsive disorder, generalised anxiety disorder and phobias) or depressive/low mood (including dysthymia; ≥ 5 and ≤ 10) will be included.
- For those participants presenting with both anxiety and depression, at least one must reach the minimum cut off score and neither should exceed the maximum cut-off score.
- Adequate English ability
- Able to give informed consent
Key exclusion criteria (8 listed)
- High suicide risk (as indicated with a risk score of >0.3 on the Clinical Outcomes in Routine Evaluation questionnaire; CORE-34
- Participants that have been flagged at the referral meeting to receive specialised individual therapy (e.g. schema-focussed therapy)
- Medication change within the last three months*
- Currently receiving or received psychological help within the last 6 months using a Cognitive Behavioural Therapy or ACT modality (e.g. Beating the Blues, Anxiety Management Groups, Mindfulness, Individual therapy)
- Currently taking part in another research 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 |
|---|---|---|
| ACT Intervention GroupA six chapter, 58 page self-help manual based on the principles of Acceptance and Commitment Therapy | Behavioural | ACT Intervention Group |
Primary outcome
Change is being assessed using the Quality of Life BREF (WHOQOLBREF; Skevington et al., 2004) questionnaire
Time frame: Baseline and 6 weeks
26-item self-report questionnaire
1 secondary outcome
Change is being assessed using the Acceptance and Action Questionnaire II (AAQII; Bond, Hayes & Baer et. al, 2011).
Time frame: Baseline and 6 weeks
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 6 Nov 2017.
- Background: PubMed 15085902Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
- Background: PubMed 22035996Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.
- 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.
Shane A Ford principal investigator
National Health Service, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT Intervention Group in people with Anxiety and Depression, run by University of Edinburgh 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 5 inclusion and 8 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 6 Nov 2017. 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. 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?
Change is being assessed using the Quality of Life BREF (WHOQOLBREF; Skevington et al., 2004) questionnaire (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02449759, which also lists 2 linked publications.
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 6 Nov 2017.