Virtual Focused ACT Groups in Primary Care

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.

Study Overview

• Status: Completed
• Conditions: Depression; Quality of Life; Anxiety; Acceptance Processes
• Intervention / Treatment: Behavioral: Focused ACT

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3B 1E2
      • ACCESS Downtown
    • Winnipeg, Manitoba, Canada, R3J 3R5
      • ACCESS Winnipeg West
    • Winnipeg, Manitoba, Canada, R3T 6E8
      • ACCESS Fort Garry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACT; Focused ACT Group Treatment	Behavioral: Focused ACT; Brief acceptance and commitment therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Acceptance and Action Questionnaire-II	7 items measuring experiential avoidance. Scores range from 7-49. Higher scores indicate worse outcomes (less psychological flexibility).	Pretreament
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
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
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
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Erin Johns, PhD, University of Manitoba

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Actual): February 16, 2023
• Study Completion (Actual): February 16, 2023

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 8, 2021

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: H2021:298

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No