NCT05071768

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 8, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

March 14, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2023

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

11 months

First QC Date

September 15, 2021

Last Update Submit

June 26, 2024

Conditions

DepressionAnxietyQuality of LifeAcceptance Processes

Outcome Measures

Primary Outcomes (16)

  • 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 Outcomes (2)

  • Treatment Acceptability/Adherence Scale

    Session 2 (2 weeks after start of treatment)

  • Percentage of planned treatment components delivered during treatment

    Through treatment - 4 weeks

Study Arms (1)

ACT

EXPERIMENTAL

Focused ACT Group Treatment

Behavioral: Focused ACT

Interventions

Focused ACTBEHAVIORAL

Brief acceptance and commitment therapy

ACT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

ACCESS Downtown

Winnipeg, Manitoba, R3B 1E2, Canada

Location

ACCESS Winnipeg West

Winnipeg, Manitoba, R3J 3R5, Canada

Location

ACCESS Fort Garry

Winnipeg, Manitoba, R3T 6E8, Canada

Location

Related Publications (7)

  • Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.

    PMID: 22035996BACKGROUND

  • Coto-Lesmes R, Fernandez-Rodriguez C, Gonzalez-Fernandez S. Acceptance and Commitment Therapy in group format for anxiety and depression. A systematic review. J Affect Disord. 2020 Feb 15;263:107-120. doi: 10.1016/j.jad.2019.11.154. Epub 2019 Dec 2.

    PMID: 31818766BACKGROUND

  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PMID: 11556941BACKGROUND

  • Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

    PMID: 7726811BACKGROUND

  • Milosevic I, Levy HC, Alcolado GM, Radomsky AS. The Treatment Acceptability/Adherence Scale: Moving Beyond the Assessment of Treatment Effectiveness. Cogn Behav Ther. 2015;44(6):456-69. doi: 10.1080/16506073.2015.1053407. Epub 2015 Jun 19.

    PMID: 26091250BACKGROUND

  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PMID: 16717171BACKGROUND

  • Schechter D, Endicott J, Nee J. Quality of life of 'normal' controls: association with lifetime history of mental illness. Psychiatry Res. 2007 Jul 30;152(1):45-54. doi: 10.1016/j.psychres.2006.09.008. Epub 2007 Mar 23.

    PMID: 17363070BACKGROUND

MeSH Terms

Conditions

DepressionAnxiety DisordersBehavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsMental Disorders

Study Officials

  • Erin Johns, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 15, 2021

First Posted

October 8, 2021

Study Start

March 14, 2022

Primary Completion

February 16, 2023

Study Completion

February 16, 2023

Last Updated

June 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)