Virtual Focused ACT Groups in Primary Care

Not Applicable

Completed

• Conditions: Acceptance Processes; Quality of Life; Depression; Anxiety
• Interventions: Behavioral: Focused ACT

• Registration Number: NCT05071768
• Lead Sponsor: University of Manitoba

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-10-07
• Study First Posted: 2021-10-08
• Study Start: 2022-03-14
• Primary Completion: 2023-02-16
• Study Completion: 2023-02-16
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ACT	Focused ACT	Focused ACT Group Treatment

Primary Outcome Measures

Name	Time	Method
Acceptance and Action Questionnaire-II	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	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	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	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).

Secondary Outcome Measures

Name	Time	Method
Percentage of planned treatment components delivered during treatment	Through treatment - 4 weeks	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.
Treatment Acceptability/Adherence Scale	Session 2 (2 weeks after start of treatment)	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).

Trial Locations

Locations (3)

ACCESS Winnipeg West; 🇨🇦 Winnipeg, Manitoba, Canada

ACCESS Fort Garry; 🇨🇦 Winnipeg, Manitoba, Canada

ACCESS Downtown; 🇨🇦 Winnipeg, Manitoba, Canada