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Virtual Focused ACT Groups in Primary Care

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05071768
Enrollment
31
Registered
2021-10-08
Start date
2022-03-14
Completion date
2023-02-16
Last updated
2024-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acceptance Processes, Anxiety, Depression, Quality of Life

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.

Interventions

BEHAVIORALFocused ACT

Brief acceptance and commitment therapy

Sponsors

University of Manitoba
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Depression Anxiety and Stress Scale 21-ItemsPretreatment21 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-IIPretreament7 items measuring experiential avoidance. Scores range from 7-49. Higher scores indicate worse outcomes (less psychological flexibility).
Comprehensive assessment of Acceptance and Commitment Therapy processesPretreatment23 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 FormPretreatment16 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

MeasureTime frameDescription
Treatment Acceptability/Adherence ScaleSession 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).
Percentage of planned treatment components delivered during treatmentThrough treatment - 4 weeksParticipant 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026