Virtual Focused ACT Groups in Primary Care

Depression Clinical Trial

Official title:

Focused ACT in Primary Care: A Pilot Study of a Virtual Group-based Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05071768
• Other study ID #: H2021:298
• Status: Completed
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: February 16, 2023

Study information

• Verified date: December 2023
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 16, 2023
• Est. primary completion date: February 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acceptance Processes
• Anxiety
• Depression
• Quality of Life

Intervention

Behavioral:
• Focused ACT
Brief acceptance and commitment therapy

Locations

Country	Name	City	State
Canada	ACCESS Downtown	Winnipeg	Manitoba
Canada	ACCESS Fort Garry	Winnipeg	Manitoba
Canada	ACCESS Winnipeg West	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

References & Publications (7)

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. — View Citation

Coto-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. — View Citation

Kroenke 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. — View Citation

Lovibond 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. — View Citation

Milosevic 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. — View Citation

Schechter 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. — View Citation

Spitzer 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Pretreatment
Primary	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).	1 week following last treatment session
Primary	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).	1-month follow-up
Primary	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).	3-6-month follow-up
Primary	Acceptance and Action Questionnaire-II	7 items measuring experiential avoidance. Scores range from 7-49. Higher scores indicate worse outcomes (less psychological flexibility).	Pretreament
Primary	Acceptance and Action Questionnaire-II	7 items measuring experiential avoidance. Scores range from 7-49. Higher scores indicate worse outcomes (less psychological flexibility).	1 week following last treatment session
Primary	Acceptance and Action Questionnaire-II	7 items measuring experiential avoidance. Scores range from 7-49. Higher scores indicate worse outcomes (less psychological flexibility).	1-month Follow-up
Primary	Acceptance and Action Questionnaire-II	7 items measuring experiential avoidance. Scores range from 7-49. Higher scores indicate worse outcomes (less psychological flexibility).	3-6-month Follow-up
Primary	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).	Pretreatment
Primary	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).	1 week following last treatment session
Primary	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).	1-month Follow-up
Primary	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).	3-6-month Follow-up
Primary	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).	Pretreatment
Primary	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).	1 week following last treatment session
Primary	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).	1-month Follow-up
Primary	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).	3-6-month Follow-up
Secondary	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).	Session 2 (2 weeks after start of treatment)
Secondary	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.	Through treatment - 4 weeks