NCT05528536

Brief Summary

The goal of this trial is to learn if combining Acceptance and Commitment Therapy (ACT) and exercise works to reduce pain intensity, pain interference, and depressive symptoms in older adults with chronic pain and depressive symptoms. Researchers will compare ACT + exercise intervention (ACEx) to ACT + art intervention (Art+Ex) and usual care to see if ACT + exercise intervention works to reduce pain intensity, pain interference, and depressive symptoms. Participants will receive ACEx program, Art+Ex program, or usual care for 8 weeks and complete tests before and after the programs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
163

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 15, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 6, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2024

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

1.6 years

First QC Date

February 11, 2022

Last Update Submit

July 10, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change from baseline pain intensity and interference at 8 weeks

    Brief pain inventory (BPI) is used to measure pain intensity and interference, it is a 11 items scale, using an 11-point rating, of which 0 indicates not interference and 10 as interferes completely. The higher the numbers, the greater the pain intensity and pain interference.

    Baseline(T0) and 8 weeks after baseline (T1)

  • Change from baseline depression at 8 weeks

    The Patient Health Questionnaire (PHQ-9) is used to measure depression, it is a 9-item instrument, PHQ-9 scores of 5-9, 10-14, 15-19, 20 and above represent mild, moderate, moderately severe, and severe depression. Scores range between 0 and 27.

    Baseline(T0) and 8 weeks after baseline (T1)

Secondary Outcomes (9)

  • Change from baseline anxiety at 8 weeks

    Baseline(T0) and 8 weeks after baseline (T1)

  • Change from baseline psychological flexibility at 8 weeks

    Baseline(T0) and 8 weeks after baseline (T1)

  • Change from baseline pain self-efficacy at 8 weeks

    Baseline(T0) and 8 weeks after baseline (T1)

  • Change from baseline health-related quality of life at 8 weeks

    Baseline(T0) and 8 weeks after baseline (T1)

  • Change from baseline gait speed at 8 weeks

    Baseline(T0) and 8 weeks after baseline (T1)

  • +4 more secondary outcomes

Other Outcomes (11)

  • Pain intensity and interference at 3-month follow up

    20 weeks after baseline (T2)

  • Depression at 3-month follow up

    20 weeks after baseline (T2)

  • Anxiety at 3-month follow up

    20 weeks after baseline (T2)

  • +8 more other outcomes

Study Arms (3)

Acceptance and Commitment Therapy (ACT) and Exercise

EXPERIMENTAL

This group receives eight weeks' Acceptance and Commitment Therapy (ACT) and exercise intervention.

Behavioral: Acceptance and Commitment Therapy (ACT)Other: Exercise

Art and Exercise

SHAM COMPARATOR

This group receives eight weeks' art workshops (skill-based) and exercise intervention.

Other: ArtOther: Exercise

Treatment as usual

ACTIVE COMPARATOR

This group receives treatment as usual in the local community setting.

Other: Treatment as usual

Interventions

A two-hour ACT will focus on enhancing participant's psychological flexibility towards pain. All sessions will be delivered face-to-face within their local community centre.

Acceptance and Commitment Therapy (ACT) and Exercise
ArtOTHER

To be comparable with the experimental group, the Art session will be a two-hour long session which aims to share different art techniques, without any active components. All sessions will be delivered face-to-face within their local community centre.

Art and Exercise

An hour of low-to-moderate resistance exercise aims to increase their strength and balance. All sessions will be delivered face-to-face within their local community centre.

Acceptance and Commitment Therapy (ACT) and ExerciseArt and Exercise

treatment as usual within their community centres

Treatment as usual

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 60 years or above; and
  • have depressive symptoms of mild level or above (PHQ \> 5)
  • have chronic pain (\>3 months)
  • able to give informed consent to participate

You may not qualify if:

  • known history of autism, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, Parkinson's disease, or dementia
  • have had stroke, fracture, cardiovascular disease, cardiovascular surgery, artery disease, surgery on vertebrae, and knee replacement in the past 6 months
  • physical activity prohibited by a medical professional

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Chronic PainMotor Activity

Interventions

Acceptance and Commitment TherapyReproductive Techniques, AssistedExerciseTherapeutics

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesReproductive TechniquesInvestigative TechniquesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Terry Y.S. Lum, PhD

    Department of Social Work and Social Administration, The University of Hong Kong

    PRINCIPAL INVESTIGATOR
  • Gloria Wong, PhD

    School of Psychology and Clinical Language Sciences, University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Henry G. Leong Professor in Social Work and Social Administration; Principal Investigator of the JC JoyAge project

Study Record Dates

First Submitted

February 11, 2022

First Posted

September 6, 2022

Study Start

May 15, 2022

Primary Completion

December 31, 2023

Study Completion

January 19, 2024

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations