NCT02140775

Return to Work Randomized Controlled Trial: Counseling After Fatigue Treatment in HIV/AIDS

Completed NA Results posted Last updated 16 March 2020

What this trial tests

NA trial testing Behavioral Activation Counseling in HIV Infection in 138 participants. Completed in 31 May 2019.

Timeline

1 April 2014

Primary endpoint
31 March 2019

31 May 2019

Quick facts

Lead sponsor	New York State Psychiatric Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	138
Start date	1 April 2014
Primary completion	31 March 2019
Estimated completion	31 May 2019
Sites	2 locations across United States

Drugs / interventions tested

• Behavioral Activation Counseling

Conditions studied

• HIV Infection — all drugs for HIV Infection →
• Fatigue — all drugs for Fatigue →

Sponsor

New York State Psychiatric Institute

Who can join

Adults 18 to 70, any sex, with HIV Infection or Fatigue. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Goal Attainment Scale - Modified (GAS): Responder (Score of 3 - Goal Achieved) vs. Non-Responder (Score of 1 or 2 - Goal NOT Achieved) Primary · GAS Goal Responder vs. Goal Non-Responder will be assessed at Follow Up (3-6 months after the end of counseling)

Goal Attainment Scale - Prior to the beginning of counseling, the patient met with a member of the clinical team to develop an outcome GAS scale specific to their personal return to work goal. A goal was carefully established to be obtainable within the framework of 3-6 months, and to have observable anchors that could be scored on 3 outcome levels. A score of 3 indicates that they achieved their predetermined work goal and they were considered a "Responder" to the counseling. A score 2 indicates that some of the specific steps were taken towards the goal, but that it was not fully achieved. A

Group	Value	95% CI
Behavioral Activation Counseling	29
Supportive Counseling	9

Environmental Reward Observation Scale (EROS) Secondary · EROS will be measured at Follow-up (3-6 months after the end of counseling)

This 10-item scale developed to assess changes in activity level and is based on the premise of response-contingent reinforcement. Score Range = 10 - 40 Higher scores suggest higher environmental reward.

Group	Value	95% CI
Behavioral Activation Counseling	27	± 7
Supportive Counseling	31	± 8

Behavioral Activation for Depression Scale (BADS) Secondary · BADS will be measured Follow-up (3-6 months after the end of counseling)

This 25 item scale total score is used to monitor change in Behavioral Activation (BA) protocols. Score Range = 0 - 150 Higher scores suggest greater activation and less avoidance, as well as less social and work impairment.

Group	Value	95% CI
Behavioral Activation (BA) Counseling	99	± 28
Supportive Counseling (SC)	102	± 27

Sponsor's own description

The current study is a randomized clinical trial comparing Behavioral Activation counseling with supportive counseling for HIV+ participants presenting with clinically significant fatigue whose energy has improved with armodafinil, who have the goal of returning to work or vocational training but have not done so on their own. A second cohort of HIV+ participants without significant fatigue at baseline, but who also have the goal of returning to work, will also be randomized to either Behavioral Activation counseling or supportive counseling. In both cohorts, the primary outcome is level of success regarding an employment related goal.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.