Virtual Focused ACT Groups in Primary Care

Study Overview
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Brief Summary
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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.

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

Conditions
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Depression, Anxiety, Quality of Life, Acceptance Processes

Intervention / Treatment
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* Behavioral: Focused ACT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACT<br>Focused ACT Group Treatment | Behavioral: Focused ACT<br>* Brief acceptance and commitment therapy<br>|

What is the study measuring?
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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 |