PracticeGround: Transforming Training and Delivery of Mental Health EBPs

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Depression, Insomnia, Suicide

Being tested

Behavioral Activation for Depression, Cognitive Behavior Therapy for Insomnia, Collaborative Assessment and Management of Suicidality, Care-as-Usual Psychotherapy

Medical subject headings

Depression, Sleep Initiation and Maintenance Disorders, Suicide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Behavioral Activation for Depression, Cognitive Behavior Therapy for Insomnia, Collaborative Assessment and Management of SuicidalityBehavioural

  Evidence-based interventions for treating depression and concurrent problems

• Care-as-Usual PsychotherapyBehavioural

  Usual care psychotherapy for depression and concurrent problems

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Depression, Anxiety, and Stress Scale (DASS)

   Higher scores on subscales from this 23-item measure reflected higher depression, anxiety, stress, and suicidality. Other researchers added two suicidality items to the original 21-item measure with permission from the original authors. Each subscale score is computed by summing the subscale items, then multiplying by 2. Total possible scores for the depression, anxiety, and stress subscales range from 0-42. We categorized DASS depression, anxiety, and stress scores into severity levels coded as 0, 1, and 2: Normal (0 through 9), Mild/moderate (10 through 20), and Severe/extremely severe (21 through 42) (Psychology Foundation of Australia, 2018). The DASS suicide subscale ranged from 0-12 and not recategorized.

   Measured: baseline, 4 weeks, 8 weeks, 12 weeks

2. Beck Depression Inventory (BDI-II)

   Higher scores on this 21-item reflect greater depressive symptoms in the past two weeks. All items are summed to a total score (possible range 0-63). We categorized BDI scores into severity levels coded as 0, 1, and 2: Minimal (raw scores 0 through 13), Mild/moderate (14 through 28), and Severe (29 through 63).

   Measured: baseline, 4 weeks, 8 weeks, 12 weeks

3. Patient Health Questionnaire-9 (PHQ-9)

   Higher scores on this ten-item measure reflects more severe depression. The total score (possible range 0-27) is created by summing the first nine items. We categorized PHQ severity levels coded as 0, 1, and 2 based on authors' research as minimal (0 through 4), mild/moderate (5 through 14), and moderately severe/severe (15 through 27). The recategorized scores are reported here.

   Measured: baseline, 4 weeks, 8 weeks, 12 weeks

4. Behavioral Activation for Depression Scale Short Form (BADS-SF)

   The Behavioral Activation for depression Scale Short Form has 9 questions each having a scale from 0 (Not at All) to 6 (Completely) with a total range of 0-54. Higher scores on this nine-item scale reflect lower engagement in avoidance and higher engagement in activation behaviors over the course of BA for depression.

   Measured: baseline, 4 weeks, 8 weeks, 12 weeks

5. Mental Health Services Satisfaction Survey (MHSSS)

   We created a ten-item measure in which higher scores reflected greater satisfaction with services they received. The measure had 10 questions each having a scale of 1(Strongly Disagree) to 5(Strongly Agree) with a total range of 10-50. Higher scores indicated a better outcome.

   Measured: After first study therapy session, 4 weeks, 8 weeks, 12 weeks

6. Working Alliance Inventory (WAI)

   We modified this measure to include items from the BHS from Group Health. The resulting 12-item scale measures the therapeutic relationship with higher scores indicating stronger alliance. With 12 questions and each having a scale of 1(Never) to 7(Always) the total range was 12-84.

   Measured: 4 weeks, 8 weeks, 12 weeks

7. Therapy Task Checklist (TTC) - Patient Version

   We developed the TTC. The Therapy Task Checklist-Patient Version with 25 questions and each having a scale of 0 (Never/Very Rarely) to 7 (All of the Time) has a total range of 0-100. Higher scores reflected more frequent use of evidence-based therapy tasks, positive outcomes.

   Measured: 4 weeks, 8 weeks, 12 weeks

8. Modified Practice Attitudes Scale (MPAS)

   The Modified Practice Attitudes Scale with eight questions, each having a scale of 0 (Not at all) to 4(To a very great extent), has a total range of 0-32. Higher scores on this eight-item scale reflect more positive attitudes towards evidence-based practices.

   Measured: Baseline, 12 weeks

9. Perceptions of Computer-Assisted Therapy Questionnaire (PCAT)

   The Perceptions of Computer-Assisted Therapy Questionnaire has 34 questions each having a scale of 1(Strongly Disagree) to 7 Strongly Agree). Thus, the total range was 34-238. Higher scores on this 34-item scale indicate stronger agreement with the benefits of computer-assisted therapy, or a better outcome.

   Measured: Baseline, 12 weeks

10. ASA-Monitoring and Feedback Version (ASA-MF)

    The ASA-Monitoring and Feedback Version (ASA-MF) measure has 18 questions each having a scale of 1(Strongly Disagree) to 5(Strongly Agree) with a total range of 18-90. Higher scores on this 18-item scale reflect positive attitudes about standardized and routine progress monitoring, or positive outcomes.

    Measured: Baseline, 4 weeks, 8 weeks, 12 weeks

11. Monitoring and Feedback Attitudes Scale (MFA)

    The Monitoring and Feedback Attitudes Scale has 14 questions and each has a scale of 1(Strongly Disagree) to 5(Strongly Agree), thus the total range was 14-70. Higher scores on this 14-item measure indicate more positive attitudes about routine progress monitoring and providing feedback to patients about treatment progress, or positive outcomes.

    Measured: Baseline, 4 weeks, 8 weeks, 12 weeks

12. Routine Monitoring (RM)

    We created a three-item measure where the total score is found by summing the items. The first two items are yes(scored 1)/no(scored 0) questions. The last item is a count measure that can be any number greater than or equal to 0. Thus, the total score can have any integer value greater than or equal to 0, with higher scores reflecting greater use of routine progress monitoring.

    Measured: Baseline, 4 weeks, 8 weeks, 12 weeks

13. Current Assessment Practice Evaluation-Revised (CAPER)

    We modified the original measure into nine items. The Current Assessment Practice Evaluation-Revised has 9 questions with each having a scale of 1(None, 0%) to 5 (Nearly All, 81-100%). Thus, the total range was 9-45 and higher scores reflect greater provider use of measurement-based care or positive outcomes.

    Measured: Baseline, 4 weeks, 8 weeks, 12 weeks

14. Therapy Task Checklist (TTC) - Provider Version

    The Therapy Task Checklist -Provider Version has 22 questions and each have a scale of 0(Never/Very Rarely) to 4 (All of the time) with a total range of 0-88. Higher scores reflected more frequent use of evidence-based therapy tasks, or positive outcomes.

    Measured: 4 weeks, 8 weeks, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted11 Dec 2014 (estimated)
2. Study startDec 2014
3. Primary completion31 Dec 2018
4. Study completion31 Dec 2018

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for DepressionStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.