Effectiveness of Using the Progressive Goal Attainment Program in Anxiety and Mood Disorders (PGAP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02819986|
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : April 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Mood Disorder||Behavioral: Progressive Goal Attainment Program||Not Applicable|
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)|
|Official Title:||Effectiveness and Feasibility of Using the Progressive Goal Attainment Program in Anxiety and Mood Disorders|
|Actual Study Start Date :||November 16, 2016|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
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
- 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).
- 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).
- 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).
- 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).
- PGAP retention rates [ Time Frame: one year ]Retention rates will be measured by tracking drop out rates.
- 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).
- 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).
- 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).
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
|Contact: Tanja Colonerus, MADS||905 522-1155 ext email@example.com|
|Contact: Karen Rowa, PhD||905 522-1155 ext firstname.lastname@example.org|
|St. Joseph's Healthcare Hamilton||Recruiting|
|Hamilton, Ontario, Canada, L8N 3K7|
|Contact: Tanja Colonerus, MADS 905 522-1155 ext 39867 email@example.com|
|Contact: Karen Rowa, PhD 905 522-1155 firstname.lastname@example.org|
|Principal Investigator:||Tanja Colonerus, MADS||St. Joseph's Healthcare Hamilton|