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

Anxiety Clinical Trial

— PGAP  

Official title:

Effectiveness and Feasibility of Using the Progressive Goal Attainment Program in Anxiety and Mood Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819986
• Other study ID #: 1784
• Status: Completed
• Phase: N/A
• Start date: November 16, 2016
• Est. completion date: April 2019

Study information

• Verified date: March 2020
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Mood Disorder
• Mood Disorders

Intervention

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.

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	one year
Secondary	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).	one year
Secondary	Impact of PGAP on fear avoidance beliefs	Fear avoidance beliefs will be measured using the Fear Avoidance Beliefs Questionnaire (11 item self-report measure).	one year
Secondary	PGAP retention rates	Retention rates will be measured by tracking drop out rates.	one year
Secondary	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).	one year
Secondary	Impact of PGAP on disability (clinician report)	Level of disability will be measured using the Multidimensional Scale of Independent Functioning (semi-structured interview).	one year
Secondary	Impact of PGAP on role functioning	Role functioning will be measured using the Multidimensional Scale of Independent Functioning (semi-structured interview).	one year