Effectiveness of Using the Progressive Goal Attainment Program in Anxiety and Mood Disorders (PGAP)
Primary Purpose
Anxiety, Mood Disorder
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Progressive Goal Attainment Program
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring occupational functioning, Worries, Pain, Disability
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- current significant substance use
- acute mental health (e.g. suicidality, psychosis, mania) that would interfere with the program completion
Sites / Locations
- St. Joseph's Healthcare Hamilton
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Progressive Goal Attainment Program
Arm Description
10 one hour weekly therapy sessions focused on behavioural interventions
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Impact of PGAP on symptom change
Mood and anxiety symptoms will be measured using the Depression and Anxiety Stress Scales (a 21 item self-report measure).
Impact of PGAP on level of interference from mood and anxiety symptoms
Level of interference from mood and anxiety symptoms will be measured using the Illness Intrusiveness Rating Scale (13 item self-report measure).
Impact of PGAP on fear avoidance beliefs
Fear avoidance beliefs will be measured using the Fear Avoidance Beliefs Questionnaire (11 item self-report measure).
PGAP retention rates
Retention rates will be measured by tracking drop out rates.
Satisfaction with the PGAP
Satisfaction with the therapy will be assessed by using The Satisfaction with Therapy and Therapist Scale-Revised (13 item self-report measure).
Impact of PGAP on disability (clinician report)
Level of disability will be measured using the Multidimensional Scale of Independent Functioning (semi-structured interview).
Impact of PGAP on role functioning
Role functioning will be measured using the Multidimensional Scale of Independent Functioning (semi-structured interview).
Full Information
NCT ID
NCT02819986
First Posted
June 20, 2016
Last Updated
March 16, 2020
Sponsor
St. Joseph's Healthcare Hamilton
1. Study Identification
Unique Protocol Identification Number
NCT02819986
Brief Title
Effectiveness of Using the Progressive Goal Attainment Program in Anxiety and Mood Disorders
Acronym
PGAP
Official Title
Effectiveness and Feasibility of Using the Progressive Goal Attainment Program in Anxiety and Mood Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 16, 2016 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
April 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The purpose of the present study is to determine the effectiveness 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 with a clinician and follow the PGAP manual. The therapy sessions focus on reducing psychosocial risk factors that result in disability through the use of goal setting, activity planning, activation and re-engagement in activities, monitoring and challenging thoughts about return to work, and problem solving. Participants are also encouraged to participate in homework which involves daily activity planning, participating in planned activities, and tracking the activities completed. 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.
Our first hypothesis is that participants who receive PGAP will report significant reductions in functional disability as measured by self-report as well as by interview, decreases in self-reported work avoidance, increases in work readiness, and decreases in self-reported symptoms of anxiety and depression. Our second hypothesis is that mean reductions in the above-noted outcome variables will be similar in magnitude to those reported in published studies that have examined PGAP in chronic medically ill populations. Retention rates and satisfaction of the therapy will also be assessed to determine feasibility of implementing the program on a larger scale.
To examine the effectiveness of PGAP with participants with an anxiety or a mood disorder, the investigators will conduct a series of dependent sample t-tests on the outcome variables pre and post intervention. The investigators will also compare mean changes on the outcome variables to those in the published literature. The investigators will calculate retention rates with the aim of retaining more than 75% of participants, which is comparable to retention and drop out rates for psychotherapy trials with participants completing at least 8 out of 10 sessions or having returned to employment. Feasibility will also be measured by looking at satisfaction ratings. A minimal standard will be an average satisfaction rating across participants of midpoint (neutral) or above in terms of the therapy received.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Mood Disorder
Keywords
occupational functioning, Worries, Pain, Disability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Progressive Goal Attainment Program
Arm Type
Experimental
Arm Description
10 one hour weekly therapy sessions focused on behavioural interventions
Intervention Type
Behavioral
Intervention Name(s)
Progressive Goal Attainment Program
Other Intervention Name(s)
PGAP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Impact of PGAP on disability (participant perception)
Description
Level of disability will be measured using a modified version of the Pain Disability Index ( a 7 item self-report measure).
Time Frame
one year
Secondary Outcome Measure Information:
Title
Impact of PGAP on symptom change
Description
Mood and anxiety symptoms will be measured using the Depression and Anxiety Stress Scales (a 21 item self-report measure).
Time Frame
one year
Title
Impact of PGAP on level of interference from mood and anxiety symptoms
Description
Level of interference from mood and anxiety symptoms will be measured using the Illness Intrusiveness Rating Scale (13 item self-report measure).
Time Frame
one year
Title
Impact of PGAP on fear avoidance beliefs
Description
Fear avoidance beliefs will be measured using the Fear Avoidance Beliefs Questionnaire (11 item self-report measure).
Time Frame
one year
Title
PGAP retention rates
Description
Retention rates will be measured by tracking drop out rates.
Time Frame
one year
Title
Satisfaction with the PGAP
Description
Satisfaction with the therapy will be assessed by using The Satisfaction with Therapy and Therapist Scale-Revised (13 item self-report measure).
Time Frame
one year
Title
Impact of PGAP on disability (clinician report)
Description
Level of disability will be measured using the Multidimensional Scale of Independent Functioning (semi-structured interview).
Time Frame
one year
Title
Impact of PGAP on role functioning
Description
Role functioning will be measured using the Multidimensional Scale of Independent Functioning (semi-structured interview).
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
current significant substance use
acute mental health (e.g. suicidality, psychosis, mania) that would interfere with the program completion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanja Colonerus, MADS
Organizational Affiliation
St. Joseph's Healthcare Hamilton
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3K7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Using the Progressive Goal Attainment Program in Anxiety and Mood Disorders
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