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Trial record 2 of 747 for:    Recruiting, Not yet recruiting, Available Studies | "Mood Disorders"

Effectiveness of Using the Progressive Goal Attainment Program in Anxiety and Mood Disorders (PGAP)

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ClinicalTrials.gov Identifier: NCT02819986
Recruitment Status : Not yet recruiting
First Posted : June 30, 2016
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
Tanja Colonerus, St. Joseph's Healthcare Hamilton

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.

Condition or disease Intervention/treatment
Anxiety Mood Disorder Behavioral: Progressive Goal Attainment Program

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness and Feasibility of Using the Progressive Goal Attainment Program in Anxiety and Mood Disorders
Study Start Date : July 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Progressive Goal Attainment Program
10 one hour weekly therapy sessions focused on behavioural interventions
Behavioral: Progressive Goal Attainment Program
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.
Other Name: PGAP



Primary Outcome Measures :
  1. Impact of PGAP on disability (participant perception) [ Time Frame: one year ]
    Level of disability will be measured using a modified version of the Pain Disability Index ( a 7 item self-report measure).


Secondary Outcome Measures :
  1. Impact of PGAP on symptom change [ Time Frame: one year ]
    Mood and anxiety symptoms will be measured using the Depression and Anxiety Stress Scales (a 21 item self-report measure).

  2. Impact of PGAP on level of interference from mood and anxiety symptoms [ Time Frame: one year ]
    Level of interference from mood and anxiety symptoms will be measured using the Illness Intrusiveness Rating Scale (13 item self-report measure).

  3. Impact of PGAP on fear avoidance beliefs [ Time Frame: one year ]
    Fear avoidance beliefs will be measured using the Fear Avoidance Beliefs Questionnaire (11 item self-report measure).

  4. PGAP retention rates [ Time Frame: one year ]
    Retention rates will be measured by tracking drop out rates.

  5. Satisfaction with the PGAP [ Time Frame: one year ]
    Satisfaction with the therapy will be assessed by using The Satisfaction with Therapy and Therapist Scale-Revised (13 item self-report measure).

  6. Impact of PGAP on disability (clinician report) [ Time Frame: one year ]
    Level of disability will be measured using the Multidimensional Scale of Independent Functioning (semi-structured interview).

  7. Impact of PGAP on role functioning [ Time Frame: one year ]
    Role functioning will be measured using the Multidimensional Scale of Independent Functioning (semi-structured interview).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Participants will be

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819986


Contacts
Contact: Tanja Colonerus, MADS 905 522-1155 ext 39867 tcoloner@stjoes.ca
Contact: Karen Rowa, PhD 905 522-1155 ext 33656 krowa@stjoes.ca

Locations
Canada, Ontario
St. Joseph's Healthcare Hamilton Not yet recruiting
Hamilton, Ontario, Canada, L8N 3K7
Contact: Tanja Colonerus, MADS    905 522-1155 ext 39867    tcoloner@stjoes.ca   
Contact: Karen Rowa, PhD    905 522-1155    krowa@stjoes.ca   
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Investigators
Principal Investigator: Tanja Colonerus, MADS St. Joseph's Healthcare Hamilton

Responsible Party: Tanja Colonerus, Priniciple Investigator, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT02819986     History of Changes
Other Study ID Numbers: 1784
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Tanja Colonerus, St. Joseph's Healthcare Hamilton:
occupational functioning
Worries
Pain
Disability

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Mood Disorders
Pathologic Processes
Mental Disorders