DepressionNCT05071768
Virtual Focused ACT Groups in Primary Care
A study testing Focused ACT in people with Depression and Anxiety, run by University of Manitoba at 3 sites in Canada.
Trial summary
Acceptance and commitment therapy (ACT) is a transdiagnostic intervention whose aim is to reduce experiential avoidance and promote psychological flexibility, which involves engaging in values-based behaviour while accepting painful internal experiences with openness and awareness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Quality of Life
- What is being tested?
- Focused ACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 3 sitesCanada
- Study dates
- 14 Mar 2022to 16 Feb 2023
- 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
- self-reported symptoms of depression and/or anxiety
- fluent in English
- access to reliable internet and a device with a webcam as well as a private/quite space from which to attend sessions
- no change in psychotropic medication for at least 6 weeks prior to the intervention
- willingness to maintain a stable medication type and dose for psychotropic medications during the intervention phase and for one month post-intervention
Who cannot join
- engagement in another psychological treatment during the intervention phase or one month post-intervention
- current psychosis
- bipolar disorder
- current substance use disorder
- cognitive/intellectual impairment
- current active suicidal ideation
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
ACCESS Downtown
Winnipeg, Manitoba, R3B 1E2
ACCESS Winnipeg West
Winnipeg, Manitoba, R3J 3R5
ACCESS Fort Garry
Winnipeg, Manitoba, R3T 6E8
About this study
Official title: Focused ACT in Primary Care: A Pilot Study of a Virtual Group-based Intervention
Acceptance and commitment therapy (ACT) is a transdiagnostic intervention whose aim is to reduce experiential avoidance and promote psychological flexibility, which involves engaging in values-based behaviour while accepting painful internal experiences with openness and awareness. A growing body of research supports the efficacy of brief ACT for a variety of issues, including depression, anxiety, chronic pain, and stress. Given that ACT is a transdiagnostic intervention that targets the core processes related to human suffering, this treatment may be particularly useful for implementation in primary care with diverse groups of individuals and presentations. The objective of this study is to develop and pilot test a brief, virtual, group-based ACT intervention for depression and anxiety delivered in primary care settings to determine if a future randomized controlled trial of this group treatment is both warranted and feasible. The investigators will examine (1) the feasibility and acceptability of the study procedures, (2) clinician adherence to the treatment protocol, and (3) a preliminary analysis of the treatment effectiveness. A total of 3 groups (N = 30-45) will be conducted via three primary care clinics in Winnipeg, Manitoba, Canada. The group treatment will be delivered over four 90-minute sessions. Participants will complete assessment measures at pretreatment, post-treatment, and at two follow-up time points (1-month post-treatment and 3-6-months post-treatment). All assessments and treatment sessions will be conducted virtually via videoconferencing platform.
- Conditions
- Depression, Anxiety, Quality of Life, Acceptance Processes
- Being tested
- Focused ACT
- Medical subject headings
- Depression, Anxiety Disorders, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused ACTBehavioural
Brief acceptance and commitment therapy
| Study group | Role | What they receive |
|---|---|---|
| ACT | Experimental | Focused ACT Group Treatment Receives: Behavioral: Focused ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Anxiety and Stress Scale 21-Items
21 items measuring depression, anxiety, and stress in the past week. Scores range from 0-42 for each of 3 scales (Depression, Anxiety, and Stress). Higher scores indicate worse outcomes (greater severity of depression, anxiety, and stress symptoms).
Measured: Pretreatment
Depression Anxiety and Stress Scale 21-Items
21 items measuring depression, anxiety, and stress in the past week. Scores range from 0-42 for each of 3 scales (Depression, Anxiety, and Stress). Higher scores indicate worse outcomes (greater severity of depression, anxiety, and stress symptoms).
Measured: 1 week following last treatment session
Depression Anxiety and Stress Scale 21-Items
21 items measuring depression, anxiety, and stress in the past week. Scores range from 0-42 for each of 3 scales (Depression, Anxiety, and Stress). Higher scores indicate worse outcomes (greater severity of depression, anxiety, and stress symptoms).
Measured: 1-month follow-up
Depression Anxiety and Stress Scale 21-Items
21 items measuring depression, anxiety, and stress in the past week. Scores range from 0-42 for each of 3 scales (Depression, Anxiety, and Stress). Higher scores indicate worse outcomes (greater severity of depression, anxiety, and stress symptoms).
Measured: 3-6-month follow-up
Acceptance and Action Questionnaire-II
7 items measuring experiential avoidance. Scores range from 7-49. Higher scores indicate worse outcomes (less psychological flexibility).
Measured: Pretreament
Acceptance and Action Questionnaire-II
7 items measuring experiential avoidance. Scores range from 7-49. Higher scores indicate worse outcomes (less psychological flexibility).
Measured: 1 week following last treatment session
Acceptance and Action Questionnaire-II
7 items measuring experiential avoidance. Scores range from 7-49. Higher scores indicate worse outcomes (less psychological flexibility).
Measured: 1-month Follow-up
Acceptance and Action Questionnaire-II
7 items measuring experiential avoidance. Scores range from 7-49. Higher scores indicate worse outcomes (less psychological flexibility).
Measured: 3-6-month Follow-up
Comprehensive assessment of Acceptance and Commitment Therapy processes
23 items measuring psychological flexibility (openness to experience, behavioural awareness, and valued action).
Total score ranges from 0-138; higher scores indicate better outcomes (greater psychological flexibility).
Openness to Experience subscale ranges from 0-60; higher scores indicate better outcomes (greater openness).
Behavioural Awareness subscale ranges from 0-30; higher scores indicate better outcomes (greater behavioural awareness).
Valued Action subscale ranges from 0-48; higher scores indicate better outcomes (greater valued action).
Measured: Pretreatment
Comprehensive assessment of Acceptance and Commitment Therapy processes
23 items measuring psychological flexibility (openness to experience, behavioural awareness, and valued action).
Total score ranges from 0-138; higher scores indicate better outcomes (greater psychological flexibility).
Openness to Experience subscale ranges from 0-60; higher scores indicate better outcomes (greater openness).
Behavioural Awareness subscale ranges from 0-30; higher scores indicate better outcomes (greater behavioural awareness).
Valued Action subscale ranges from 0-48; higher scores indicate better outcomes (greater valued action).
Measured: 1 week following last treatment session
Comprehensive assessment of Acceptance and Commitment Therapy processes
23 items measuring psychological flexibility (openness to experience, behavioural awareness, and valued action).
Total score ranges from 0-138; higher scores indicate better outcomes (greater psychological flexibility).
Openness to Experience subscale ranges from 0-60; higher scores indicate better outcomes (greater openness).
Behavioural Awareness subscale ranges from 0-30; higher scores indicate better outcomes (greater behavioural awareness).
Valued Action subscale ranges from 0-48; higher scores indicate better outcomes (greater valued action).
Measured: 1-month Follow-up
Comprehensive assessment of Acceptance and Commitment Therapy processes
23 items measuring psychological flexibility (openness to experience, behavioural awareness, and valued action).
Total score ranges from 0-138; higher scores indicate better outcomes (greater psychological flexibility).
Openness to Experience subscale ranges from 0-60; higher scores indicate better outcomes (greater openness).
Behavioural Awareness subscale ranges from 0-30; higher scores indicate better outcomes (greater behavioural awareness).
Valued Action subscale ranges from 0-48; higher scores indicate better outcomes (greater valued action).
Measured: 3-6-month Follow-up
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
16 items measuring level of satisfaction in different life domains (e.g., work, leisure activities, relationships).
Scores range from 14-70. Higher scores indicate better outcomes (greater life satisfaction and enjoyment).
Measured: Pretreatment
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
16 items measuring level of satisfaction in different life domains (e.g., work, leisure activities, relationships).
Scores range from 14-70. Higher scores indicate better outcomes (greater life satisfaction and enjoyment).
Measured: 1 week following last treatment session
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
16 items measuring level of satisfaction in different life domains (e.g., work, leisure activities, relationships).
Scores range from 14-70. Higher scores indicate better outcomes (greater life satisfaction and enjoyment).
Measured: 1-month Follow-up
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
16 items measuring level of satisfaction in different life domains (e.g., work, leisure activities, relationships).
Scores range from 14-70. Higher scores indicate better outcomes (greater life satisfaction and enjoyment).
Measured: 3-6-month Follow-up
Secondary outcomes (2)
Treatment Acceptability/Adherence Scale
10 items measuring treatment acceptability, adherence to treatment, and completion of treatment.
Scores range from 10-70. Higher scores indicate better outcomes (greater treatment acceptability).
Measured: Session 2 (2 weeks after start of treatment)
Percentage of planned treatment components delivered during treatment
Participant rating of whether planned treatment components were covered in each session Scores will be calculated as a percentage of agreement that planned topics were covered.
Higher percentages indicate higher treatment integrity.
Measured: Through treatment - 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start14 Mar 2022
- Primary completion16 Feb 2023
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Johns, University of Manitoba
- Investigators
- Erin Johns, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071768
- Sponsor's protocol ID
- H2021:298
- Status last verified
- Jun 2024
- First submitted
- 15 Sep 2021
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bond 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 22035996Coto-Lesmes R, Fernandez-Rodriguez C, Gonzalez-Fernandez S. Acceptance and Commitment Therapy in group format for anxiety and depression. A systematic review. J Affect Disord. 2020 Feb 15;263:107-120. doi: 10.1016/j.jad.2019.11.154. Epub 2019 Dec 2.
PubMed 31818766Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
PubMed 7726811Milosevic I, Levy HC, Alcolado GM, Radomsky AS. The Treatment Acceptability/Adherence Scale: Moving Beyond the Assessment of Treatment Effectiveness. Cogn Behav Ther. 2015;44(6):456-69. doi: 10.1080/16506073.2015.1053407. Epub 2015 Jun 19.
PubMed 26091250Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Schechter D, Endicott J, Nee J. Quality of life of 'normal' controls: association with lifetime history of mental illness. Psychiatry Res. 2007 Jul 30;152(1):45-54. doi: 10.1016/j.psychres.2006.09.008. Epub 2007 Mar 23.
PubMed 17363070
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused ACT in Primary Care: A Pilot Study of a Virtual Group-based Intervention
- ClinicalTrials.gov ID
- NCT05071768
- Acronym / sponsor ID
- H2021:298
- Conditions
- Depression, Anxiety, Quality of Life, Acceptance Processes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 8 Oct 2021 (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.
Acceptance and commitment therapy (ACT) is a transdiagnostic intervention whose aim is to reduce experiential avoidance and promote psychological flexibility, which involves engaging in values-based behaviour while accepting painful internal experiences with openness and awareness. A growing body of research supports the efficacy of brief ACT for a variety of issues, including depression, anxiety, chronic pain, and stress. Given that ACT is a transdiagnostic intervention that targets the core processes related to human suffering, this treatment may be particularly useful for implementation in primary care with diverse groups of individuals and presentations. The objective of this study is to develop and pilot test a brief, virtual, group-based ACT intervention for depression and anxiety delivered in primary care settings to determine if a future randomized controlled trial of this group treatment is both warranted and feasible. The investigators will examine (1) the feasibility and acceptability of the study procedures, (2) clinician adherence to the treatment protocol, and (3) a preliminary analysis of the treatment effectiveness. A total of 3 groups (N = 30-45) will be conducted via three primary care clinics in Winnipeg, Manitoba, Canada. The group treatment will be delivered over four 90-minute sessions. Participants will complete assessment measures at pretreatment, post-treatment, and at two follow-up time points (1-month post-treatment and 3-6-months post-treatment). All assessments and treatment sessions will be conducted virtually via videoconferencing platform.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACT | Experimental | Behavioral: Focused ACTFocused ACT Group Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- self-reported symptoms of depression and/or anxiety
- fluent in English
- access to reliable internet and a device with a webcam as well as a private/quite space from which to attend sessions
- no change in psychotropic medication for at least 6 weeks prior to the intervention
- willingness to maintain a stable medication type and dose for psychotropic medications during the intervention phase and for one month post-intervention
Key exclusion criteria (6 listed)
- engagement in another psychological treatment during the intervention phase or one month post-intervention
- current psychosis
- bipolar disorder
- current substance use disorder
- cognitive/intellectual impairment
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 |
|---|---|---|
| Focused ACTBrief acceptance and commitment therapy | Behavioural | ACT |
Primary outcome
Depression Anxiety and Stress Scale 21-Items
Time frame: Pretreatment
21 items measuring depression, anxiety, and stress in the past week. Scores range from 0-42 for each of 3 scales (Depression, Anxiety, and Stress). Higher scores indicate worse outcomes (greater severity of depression, anxiety, and stress symptoms).
Depression Anxiety and Stress Scale 21-Items
Time frame: 1 week following last treatment session
21 items measuring depression, anxiety, and stress in the past week. Scores range from 0-42 for each of 3 scales (Depression, Anxiety, and Stress). Higher scores indicate worse outcomes (greater severity of depression, anxiety, and stress symptoms).
Depression Anxiety and Stress Scale 21-Items
Time frame: 1-month follow-up
21 items measuring depression, anxiety, and stress in the past week. Scores range from 0-42 for each of 3 scales (Depression, Anxiety, and Stress). Higher scores indicate worse outcomes (greater severity of depression, anxiety, and stress symptoms).
Depression Anxiety and Stress Scale 21-Items
Time frame: 3-6-month follow-up
21 items measuring depression, anxiety, and stress in the past week. Scores range from 0-42 for each of 3 scales (Depression, Anxiety, and Stress). Higher scores indicate worse outcomes (greater severity of depression, anxiety, and stress symptoms).
Acceptance and Action Questionnaire-II
Time frame: Pretreament
7 items measuring experiential avoidance. Scores range from 7-49. Higher scores indicate worse outcomes (less psychological flexibility).
Acceptance and Action Questionnaire-II
Time frame: 1 week following last treatment session
7 items measuring experiential avoidance. Scores range from 7-49. Higher scores indicate worse outcomes (less psychological flexibility).
Acceptance and Action Questionnaire-II
Time frame: 1-month Follow-up
7 items measuring experiential avoidance. Scores range from 7-49. Higher scores indicate worse outcomes (less psychological flexibility).
Acceptance and Action Questionnaire-II
Time frame: 3-6-month Follow-up
7 items measuring experiential avoidance. Scores range from 7-49. Higher scores indicate worse outcomes (less psychological flexibility).
Comprehensive assessment of Acceptance and Commitment Therapy processes
Time frame: Pretreatment
23 items measuring psychological flexibility (openness to experience, behavioural awareness, and valued action). Total score ranges from 0-138; higher scores indicate better outcomes (greater psychological flexibility). Openness to Experience subscale ranges from 0-60; higher scores indicate better outcomes (greater openness). Behavioural Awareness subscale ranges from 0-30; higher scores indicate better outcomes (greater behavioural awareness). Valued Action subscale ranges from 0-48; higher scores indicate better outcomes (greater valued action).
Comprehensive assessment of Acceptance and Commitment Therapy processes
Time frame: 1 week following last treatment session
23 items measuring psychological flexibility (openness to experience, behavioural awareness, and valued action). Total score ranges from 0-138; higher scores indicate better outcomes (greater psychological flexibility). Openness to Experience subscale ranges from 0-60; higher scores indicate better outcomes (greater openness). Behavioural Awareness subscale ranges from 0-30; higher scores indicate better outcomes (greater behavioural awareness). Valued Action subscale ranges from 0-48; higher scores indicate better outcomes (greater valued action).
Comprehensive assessment of Acceptance and Commitment Therapy processes
Time frame: 1-month Follow-up
23 items measuring psychological flexibility (openness to experience, behavioural awareness, and valued action). Total score ranges from 0-138; higher scores indicate better outcomes (greater psychological flexibility). Openness to Experience subscale ranges from 0-60; higher scores indicate better outcomes (greater openness). Behavioural Awareness subscale ranges from 0-30; higher scores indicate better outcomes (greater behavioural awareness). Valued Action subscale ranges from 0-48; higher scores indicate better outcomes (greater valued action).
Comprehensive assessment of Acceptance and Commitment Therapy processes
Time frame: 3-6-month Follow-up
23 items measuring psychological flexibility (openness to experience, behavioural awareness, and valued action). Total score ranges from 0-138; higher scores indicate better outcomes (greater psychological flexibility). Openness to Experience subscale ranges from 0-60; higher scores indicate better outcomes (greater openness). Behavioural Awareness subscale ranges from 0-30; higher scores indicate better outcomes (greater behavioural awareness). Valued Action subscale ranges from 0-48; higher scores indicate better outcomes (greater valued action).
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Time frame: Pretreatment
16 items measuring level of satisfaction in different life domains (e.g., work, leisure activities, relationships). Scores range from 14-70. Higher scores indicate better outcomes (greater life satisfaction and enjoyment).
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Time frame: 1 week following last treatment session
16 items measuring level of satisfaction in different life domains (e.g., work, leisure activities, relationships). Scores range from 14-70. Higher scores indicate better outcomes (greater life satisfaction and enjoyment).
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Time frame: 1-month Follow-up
16 items measuring level of satisfaction in different life domains (e.g., work, leisure activities, relationships). Scores range from 14-70. Higher scores indicate better outcomes (greater life satisfaction and enjoyment).
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Time frame: 3-6-month Follow-up
16 items measuring level of satisfaction in different life domains (e.g., work, leisure activities, relationships). Scores range from 14-70. Higher scores indicate better outcomes (greater life satisfaction and enjoyment).
2 secondary outcomes
Treatment Acceptability/Adherence Scale
Time frame: Session 2 (2 weeks after start of treatment)
Percentage of planned treatment components delivered during treatment
Time frame: Through treatment - 4 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 27 Jun 2024.
- 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.
- Background: PubMed 31818766Coto-Lesmes R, Fernandez-Rodriguez C, Gonzalez-Fernandez S. Acceptance and Commitment Therapy in group format for anxiety and depression. A systematic review. J Affect Disord. 2020 Feb 15;263:107-120. doi: 10.1016/j.jad.2019.11.154. Epub 2019 Dec 2.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 7726811Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
- Background: PubMed 26091250Milosevic I, Levy HC, Alcolado GM, Radomsky AS. The Treatment Acceptability/Adherence Scale: Moving Beyond the Assessment of Treatment Effectiveness. Cogn Behav Ther. 2015;44(6):456-69. doi: 10.1080/16506073.2015.1053407. Epub 2015 Jun 19.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 17363070Schechter D, Endicott J, Nee J. Quality of life of 'normal' controls: association with lifetime history of mental illness. Psychiatry Res. 2007 Jul 30;152(1):45-54. doi: 10.1016/j.psychres.2006.09.008. Epub 2007 Mar 23.
- Individual participant dataSharing planned: No
Related trials for Depression
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
RecruitingObservational study
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
Anxiety Disorders, Depressive Disorder
RecruitingPhase 3
A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
Major Depressive Disorder
Recruiting
Anticipated Patient and Caregiver Burden
Amyotrophic Lateral Sclerosis
Recruiting
A Study of Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors
Survivorship
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.
Erin Johns, PhD principal investigator
University of Manitoba
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused ACT in people with Depression and Anxiety, run by University of Manitoba at 3 sites in Canada.
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 6 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 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
Depression Anxiety and Stress Scale 21-Items (time frame: Pretreatment). The study lists 16 primary outcomes in all. 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 NCT05071768, which also lists 7 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 27 Jun 2024.