Cognitive Behavioral Therapy or Metta-Meditation in Reducing Distress in Caregivers of Phase I Trial Participants

PRIMARY OBJECTIVES:

I. To determine the feasibility of the Phase 1 Caregiver Life Line (P1CaLL) intervention as measured by the recruitment (at least 50% of those approached enroll) and retention (at least 50% of those that initiate sessions complete all sessions) and general acceptability (at least 50% of those that complete the intervention rate it as average or above average on a Likert Scale of acceptability).

SECONDARY OBJECTIVES:

I. To measure changes in distress symptoms as determined by the Depression and Anxiety Stress Scale (DASS) from baseline (week one) to post-assessment (week nine) in caregivers of phase 1 trial participants.

II. Evaluation of between-subject changes in the psychosocial variables from baseline (week one) to post-assessment (week nine) in caregivers of phase 1 trial participants.

EXPLORATORY OBJECTIVES:

I. Exploration of the acceptability of the intervention through a series of qualitative interviews in a subsample of participants.

OUTLINE:

Participants undergo cognitive behavioral therapy (CBT) consisting of a telephonic session covering stress management over 45-60 minutes once weekly for 4 weeks.

Participants are then randomized to 1 of 2 arms.

ARM A: Participants undergo CBT consisting of a telephonic session over 45-60 minutes once weekly for 4 weeks.

ARM B: Participants undergo metta-meditation consisting of a telephonic session and audio recordings over 45-60 minutes once weekly for 4 weeks.

After completion of study, participants are followed up at week 9.