Acupuncture (Jin's Three-Needle) versus sham acupuncture in treating mild-to-moderate depression: Study protocol for...

Area of Science:

• Integrative Medicine
• Clinical Trials
• Mental Health Research

Background:

• Mild-to-moderate depression is a growing global health concern with limited effective treatments.
• Existing pharmacological options often have adverse effects, necessitating alternative therapies.
• Jin's Three-Needle Acupuncture (JTN) presents a potential non-pharmacological intervention for depression.

Purpose of the Study:

• To evaluate the efficacy and safety of JTN for treating mild-to-moderate depression.
• To compare JTN's effects against sham acupuncture (SA) in a randomized controlled trial.
• To explore the underlying mechanisms of JTN in depression treatment.

Main Methods:

• A prospective, parallel-arm, single-blind, randomized controlled trial involving 106 participants.
• Participants were randomized to receive either JTN or SA for 8 weeks (3 sessions/week).
• Primary outcome assessed by Hamilton Depression Rating Scale (HAMD-17); secondary outcomes include SDS, PSQI, HAMA, SAS, and TCMSS at baseline and weeks 4, 6, 8.

Main Results:

• Primary outcome: HAMD-17 scores at week 8.
• Secondary outcomes: SDS, PSQI, HAMA, SAS, and TCMSS changes.
• Statistical analysis planned for intention-to-treat (ITT) and per-protocol (PP) datasets.

Conclusions:

• The study is expected to provide robust evidence on JTN's efficacy and safety for mild-to-moderate depression.
• Findings will contribute to understanding JTN's therapeutic mechanisms.
• This research may support JTN as a viable complementary treatment for depression.