Clinical trial NCT02819986: Effectiveness of Using the Progressive Goal Attainment Program in Anxiety and Mood Disorders
Official title: Effectiveness and Feasibility of Using the Progressive Goal Attainment Program in Anxiety and Mood Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Mood Disorder
Keywords: occupational functioning
Worries
Pain
Disability
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Impact of PGAP on disability (participant perception)
timeFrame: one year
Secondary outcomes:
measure: Impact of PGAP on symptom change
timeFrame: one year
measure: Impact of PGAP on level of interference from mood and anxiety symptoms
timeFrame: one year
measure: Impact of PGAP on fear avoidance beliefs
timeFrame: one year
measure: PGAP retention rates
timeFrame: one year
measure: Satisfaction with the PGAP
timeFrame: one year
measure: Impact of PGAP on disability (clinician report)
timeFrame: one year
measure: Impact of PGAP on role functioning
timeFrame: one year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare Hamilton
name: Tanja Colonerus, MADS
role: PRINCIPAL_INVESTIGATOR
References: