NCT02819986

Brief Summary

The purpose of the present study is to determine the effectiveness and feasibility of the Progressive Goal Attainment Program (PGAP) with individuals with anxiety and mood disorders. PGAP has been suggested as an effective therapy to reduce psychosocial barriers and help individuals return to life roles including readiness to return to work. PGAP has been shown to be effective with some chronic health conditions however has not been specifically studied in mental health populations. The study consists of 10 one hour weekly therapy sessions that focus on reducing psychosocial risk factors that result in disability through the use of goal setting, activity planning and activation, monitoring and challenging thoughts about return to work, and problem solving. Participants will also be asked to complete short self-report questionnaires as well as a semi-structured interview about the participants anxiety, mood, impact of disability, and current functioning at the beginning of session one and within two weeks after session 10. Two short questionnaires will also be completed at each session measuring the degree to which the participants daily life impacts and is affected by anxiety or mood symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable anxiety

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

June 20, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

November 16, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

2.4 years

First QC Date

June 20, 2016

Last Update Submit

March 16, 2020

Conditions

AnxietyMood Disorder

Keywords

occupational functioningWorriesPainDisability

Outcome Measures

Primary Outcomes (1)

  • Impact of PGAP on disability (participant perception)

    Level of disability will be measured using a modified version of the Pain Disability Index ( a 7 item self-report measure).

    one year

Secondary Outcomes (7)

  • Impact of PGAP on symptom change

    one year

  • Impact of PGAP on level of interference from mood and anxiety symptoms

    one year

  • Impact of PGAP on fear avoidance beliefs

    one year

  • PGAP retention rates

    one year

  • Satisfaction with the PGAP

    one year

  • +2 more secondary outcomes

Study Arms (1)

Progressive Goal Attainment Program

EXPERIMENTAL

10 one hour weekly therapy sessions focused on behavioural interventions

Behavioral: Progressive Goal Attainment Program

Interventions

Progressive Goal Attainment ProgramBEHAVIORAL

Behavioural intervention that consists of 10 one hour weekly therapy sessions that focus on goal setting, challenging thoughts about return to work, problem solving, behavioural activation, and resuming occupational roles.

Also known as: PGAP
Progressive Goal Attainment Program

Eligibility Criteria

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

You may qualify if:

  • Participants will be
  • between the ages of 18 and 65 years
  • have a principle diagnosis of an anxiety or mood disorder
  • have had changes in their work functioning, either currently not working due to their disability or on modified/reduced work.
  • be registered outpatients of the Anxiety Treatment and Research Clinic or Outpatient Mood Disorders Program, St. Joseph's Healthcare Hamilton,
  • are interested in return to work or have work related goals.

You may not qualify if:

  • current significant substance use
  • acute mental health (e.g. suicidality, psychosis, mania) that would interfere with the program completion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 3K7, Canada

Location

MeSH Terms

Conditions

Anxiety DisordersMood DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tanja Colonerus, MADS

    St. Joseph's Healthcare Hamilton

    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
Priniciple Investigator

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 30, 2016

Study Start

November 16, 2016

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

March 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)