Virtual Focused ACT Groups in Primary Care

Sponsor
University of Manitoba (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05071768
Collaborator
(none)
45
Enrollment
3
Locations
1
Arm
3.9
Anticipated Duration (Months)
15
Patients Per Site
3.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Focused ACT
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Focused ACT in Primary Care: A Pilot Study of a Virtual Group-based Intervention
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: ACT

Focused ACT Group Treatment

Behavioral: Focused ACT
Brief acceptance and commitment therapy

Outcome Measures

Primary Outcome Measures

  1. Depression Anxiety and Stress Scale 21-Items [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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

  1. 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).

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1ACCESS DowntownWinnipegManitobaCanadaR3B 1E2
2ACCESS Winnipeg WestWinnipegManitobaCanadaR3J 3R5
3ACCESS Fort GarryWinnipegManitobaCanadaR3T 6E8

Sponsors and Collaborators

  • University of Manitoba

Investigators

  • Principal Investigator: Erin Johns, PhD, University of Manitoba

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Erin Johns, Assistant Professor, University of Manitoba
ClinicalTrials.gov Identifier:
NCT05071768
Other Study ID Numbers:
  • H2021:298
First Posted:
Oct 8, 2021
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 8, 2021