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OpenTrials
Completed

NCT Number: NCT05071768

Virtual Focused ACT Groups in Primary Care

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.

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Key information

Conditions

Depression Acceptance Processes Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ACCESS Downtown, Winnipeg, Manitoba, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Focused ACT

Behavioral

Brief acceptance and commitment therapy

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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).

  12. 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).

  13. 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).

  14. 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).

  15. 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).

  16. 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).

Secondary outcomes

  1. Treatment Acceptability/Adherence Scale

    Time frame: 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).

  2. Percentage of planned treatment components delivered during treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 8, 2021
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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