Focused ACT in Primary Care: A Pilot Study of a Virtual Group-based Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Manitoba
- Enrollment
- 31
- Locations
- 3
- Primary Endpoint
- Acceptance and Action Questionnaire-II
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ACT
Focused ACT Group Treatment
Intervention: Focused ACT (Behavioral)
Outcomes
Primary Outcomes
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).
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).
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: 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).
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).
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).
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).
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).
Secondary Outcomes
- Percentage of planned treatment components delivered during treatment(Through treatment - 4 weeks)
- Treatment Acceptability/Adherence Scale(Session 2 (2 weeks after start of treatment))
Investigators
Erin Johns
Assistant Professor
University of Manitoba