Effectiveness of the Cognitive Orientation to Daily Occupational Performance (CO-OP)

June 26, 2026 updated by: Louise Møldrup Nielsen

Effectiveness of the Cognitive Orientation to Daily Occupational Performance (CO-OP) in a Danish Rehabilitation Context

The goal of this clinical study is to examine the effectiveness of the Cognitive Orientation to daily Occupational Performance (CO-OP) in adults (18+) with accuired brain injury when applied in Danish rehabilitation context. The primary research question is: What is the effectiveness of the CO-OP approach on improvement of performance of daily activities (ADL) and quality of life compared to usual rehabilitation practice.

Participants in the intervention group will recieve the CO-OP intervention as part of their rehabilitation in the following phases:

Initial phase: Goalsetting is mandatory and based on the participant's prioritized ADL performance issues identified in their baseline COPM. Education phase: Individual education in the metacognitive Goal-Plan-Do-Check strategy. Training phase: CO-OP training that involves repetitive use of the Goal-Plan-Do-Check for problem solving and skill acquisition. The therapist employs dynamic performance analysis and guided discovery to help participants understand performance issues and formulate plans for achieving their goals. Participants then execute and evaluate these plans, with a focus on developing domain-specific cognitive strategies. The therapist actively encourages generalization and transfer of skills. Homework is mandatory.

Participants in the control group will recieve usual rehabilitation practice in the following phases:

Initial phase: Goalsetting is optional and may be based on previous assessment or on a conversation with the participant. Training phase: Different approaches may be taken such as observation and practice of activities or consultation about performance issues and how participants may deal with them. The therapist may guide the participant's performance verbally, physically or trough picture materials. Homework may be included.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Louise M Nielsen
  • Phone Number: +4587552413
  • Email: lmn@via.dk

Study Locations

  • Denmark
      • Viborg, Denmark, 8800
        • Recruiting
        • Rehabilitation center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Stroke or traumatic brain injury
  • Reffered from acute hospital or specialized rehabilitation units to municipal rehabilitation
  • Having at least on ADL performance issue

Exclusion Criteria:

  • Dementia, Psychotic diagnoses, commotio, Brain tumor or degenerative neurological conditions.
  • Alkohol or drug abuse
  • Not speeking or understanding Danish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Behavioral: CO-OP intervention
CO-OP intervention: Initial phase: Goalsetting is mandatory and based on the participant's prioritized ADL performance issues identified in their baseline COPM. Education phase: Individual education in the metacognitive Goal-Plan-Do-Check strategy. Training phase: CO-OP training that involves repetitive use of the Goal-Plan-Do-Check for problem solving and skill acquisition. The therapist employs dynamic performance analysis and guided discovery to help participants understand performance issues and formulate plans for achieving their goals. Participants then execute and evaluate these plans, with a focus on developing domain-specific cognitive strategies. The therapist actively encourages generalization and transfer of skills. Homework is mandatory.
Active Comparator: Control
Behavioral: Usual practice
Usual practice: Initial phase: Goalsetting is optional and may be based on previous assessment or on a conversation with the participant. Training phase: Different approaches may be taken such as observation and practice of activities or consultation about performance issues and how participants may deal with them. The therapist may guide the participant's performance verbally, physically or trough picture materials. Homework may be included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Canadian Occupational Performance Measure (COPM)
Time Frame: Baseline, up to 14 weeks, 26 weeks follow-up
Baseline, up to 14 weeks, 26 weeks follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Motor and Process Skills (AMPS) - ADL performance quality
Time Frame: Baseline, up to 14 weeks, 26 weeks follow-up
Participants ADL performance quality will be measured with the Occupational Therapy assesment instrument, AMPS. Both process and motor skills in ADL performance will be measured and reported separately
Baseline, up to 14 weeks, 26 weeks follow-up
EuroQol-5 Domain (EQ-5D-5L)
Time Frame: Baseline, up to 14 weeks, 26 weeks follow-up
Baseline, up to 14 weeks, 26 weeks follow-up
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time Frame: Baseline, up to 14 weeks, 26 weeks follow-up
Baseline, up to 14 weeks, 26 weeks follow-up
World Health Organization Quality Of Life (WHOQOL-bref)
Time Frame: Baseline, up to 14 weeks, 26 weeks follow-up
Baseline, up to 14 weeks, 26 weeks follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louise Møldrup Nielsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 26, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CO-OP project

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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